Espen Andre Haavardsholm

• Helsingen, Lise Mørkved; Langeland, Eline Aurvoll; Pisani, Synne Eline Rotihaug; Vandvik, Per Olav; Haavardsholm, Espen A. & Malt, Ulrik Fredrik [Show all 10 contributors for this article] (2024). Glansbilder av nasjonale faglige retningslinjer fra Helsedirektoratet. Tidsskrift for Den norske legeforening. ISSN 0029-2001. 144(5). doi: 10.4045/tidsskr.24.0141.
• Dubovyk, Violetta; Vasileiadis, Georgios K.; Fatima, Tahzeeb; Zhang, Yuan; Kapetanovic, Meliha Crnkic & Kastbom, Alf [Show all 25 contributors for this article] (2024). Obesity is a risk factor for poor response to treatment in early rheumatoid arthritis: a NORD-STAR study. RMD Open. ISSN 2056-5933. 10(2). doi: 10.1136/rmdopen-2024-004227.
• Ørbo, Hilde Sofie Sager; Hammersbøen, Kristin Reine; Sexton, Joseph; Jyssum, Ingrid; Tveter, Anne Therese & Christensen, Ingrid Egeland [Show all 18 contributors for this article] (2024). Incidence and outcome of COVID-19 following vaccine and hybrid immunity in patients on immunosuppressive therapy: identification of protective post-immunisation anti-RBD antibody levels in a prospective cohort study. RMD Open. ISSN 2056-5933. 10(2). doi: 10.1136/rmdopen-2023-003545.
• Kjørholt, Kaja Eriksrud; Paulshus Sundlisæter, Nina; Aga, Anna-Birgitte; Sexton, Joseph; Olsen, Inge Christoffer & Fremstad, Hallvard [Show all 22 contributors for this article] (2024). Effects of tapering conventional synthetic disease-modifying antirheumatic drugs to drug-free remission versus stable treatment in rheumatoid arthritis (ARCTIC REWIND): 3-year results from an open-label, randomised controlled, non-inferiority trial. The Lancet Rheumatology. doi: 10.1016/S2665-9913(24)00021-3.
• Brun, Marthe Kirkesæther; Gehin, Johanna; Hammersbøen, Kristin Reine; Warren, David; Klaasen, Rolf & Sexton, Joseph [Show all 15 contributors for this article] (2024). Clinical consequences of infliximab immunogenicity and the effect of proactive therapeutic drug monitoring: exploratory analyses of the randomised, controlled NOR-DRUM trials. The Lancet Rheumatology. 6(4), p. e226–e236. doi: 10.1016/S2665-9913(23)00341-7.
• Kared, Hassen; Jyssum, Ingrid; Alirezaylavasani, Amin; Egner, Ingrid Marie; The Tran, Trung & Tietze, Lisa [Show all 17 contributors for this article] (2024). Dynamics of SARS-CoV-2 immunity after vaccination and breakthrough infection in rituximab-treated rheumatoid arthritis patients: a prospective cohort study. Frontiers in Immunology. ISSN 1664-3224. 15. doi: 10.3389/fimmu.2024.1296273.
• Holten, Karen; Paulshus Sundlisæter, Nina; Sexton, Joseph; Nordberg, Lena Bugge; Uhlig, Till & Kvien, Tore Kristian Aaserud [Show all 10 contributors for this article] (2024). Performance of the Rheumatoid Arthritis Impact of Disease (RAID) score in relation to flares in disease activity. RMD Open. ISSN 2056-5933. 10(1). doi: 10.1136/rmdopen-2023-003486.
• Lend, Kristina; Koopman, Frieda A.; Lampa, Jon; Jansen, Gerrit; Hetland, Merete L. & Uhlig, Till [Show all 18 contributors for this article] (2023). Methotrexate Safety and Efficacy in Combination Therapies in Patients With Early Rheumatoid Arthritis: A Post Hoc Analysis of a Randomized Controlled Trial. Arthritis & Rheumatology. ISSN 2326-5191. p. 1–14. doi: 10.1002/art.42730. Full text in Research Archive
• Berg, Inger Jorid; Tveter, Anne Therese; Bakland, Gunnstein; Hakim, Sarah; Kristianslund, Eirik & Lillegraven, Siri [Show all 15 contributors for this article] (2023). Follow-Up of Patients With Axial Spondyloarthritis in Specialist Health Care With Remote Monitoring and Self-Monitoring Compared With Regular Face-to-Face Follow-Up Visits (the ReMonit Study): Protocol for a Randomized, Controlled Open-Label Noninferiority Trial. JMIR Research Protocols. ISSN 1929-0748. 12(1), p. e52872– e52872. doi: 10.2196/52872. Full text in Research Archive
• Uhlig, Till; Karoliussen, Lars Fridtjof; Sexton, Joseph; Kvien, Tore Kristian Aaserud; Haavardsholm, Espen A. & Hammer, Hilde Berner (2023). Lifestyle factors predict gout outcomes: Results from the NOR-Gout longitudinal 2-year treat-to-target study. RMD Open. ISSN 2056-5933. 9(4). doi: 10.1136/rmdopen-2023-003600. Full text in Research Archive
• Jyssum, Ingrid; Gehin, Johanna; Sexton, Joseph; Kristianslund, Eirik; Hu, Yi & Warren, David [Show all 11 contributors for this article] (2023). Adalimumab serum levels and anti-drug antibodies: associations to treatment response and drug survival in inflammatory joint diseases. Rheumatology. ISSN 1462-0324. 63(6), p. 1746–1755. doi: 10.1093/rheumatology/kead525. Full text in Research Archive
• Uhlig, Till; Karoliussen, Lars Fridtjof; Sexton, Joseph; Provan, Sella Aarrestad; Kvien, Tore Kristian Aaserud & Haavardsholm, Espen A. [Show all 7 contributors for this article] (2023). Course and predictors of work productivity in gout - results from the NOR-Gout longitudinal 2-year treat-to-target study. Rheumatology. ISSN 1462-0324. 62(12), p. 3886–3892. doi: 10.1093/rheumatology/kead124. Full text in Research Archive Show summary

  Objectives In patients with gout there is a lack of longitudinal studies on the course of work productivity. We explored longitudinal changes in and predictors of work productivity over 2 years. Methods Patients in the NOR-Gout observational study with a recent gout flare and serum urate (sUA) >360 µmol/l attended tight-control visits during escalating urate lowering therapy according to a treat-to-target strategy. From the Work Productivity and Activity Impairment (WPAI) questionnaire, scores for work productivity and activity impairment were assessed over 2 years together with the Beliefs about Medicines Questionnaire and a variety of demographic and clinical variables. Results At baseline patients had a mean age of 56.4 years and 95% were males. WPAI scores at baseline were 5.0% work missed (absenteeism), 19.1% work impairment (presenteeism), 21.4% overall work impairment and 32.1% activity impairment. Work productivity and activity impairment improved during the first months, and remained stable at 1 and 2 years. Comorbidities were not cross-sectionally associated with WPAI scores at baseline, but predicted worse work impairment and activity impairment at year 1. The Beliefs about Medicines Questionnaire subscale with concerns about medicines at baseline independently predicted worse overall work impairment and worse activity impairment at year 1. Conclusions In patients with gout who were intensively treated to the sUA target, work productivity and activity impairment were largely unchanged and at 1 year predicted by comorbidities and patient concerns about medication.

• Lillegraven, Siri; Paulshus Sundlisæter, Nina; Aga, Anna-Birgitte; Sexton, Joseph; Olsen, Inge Christoffer & Lexberg, Åse [Show all 19 contributors for this article] (2023). Effect of tapered versus stable treatment with tumour necrosis factor inhibitors on disease flares in patients with rheumatoid arthritis in remission: a randomised, open label, non-inferiority trial. Annals of the Rheumatic Diseases. ISSN 0003-4967. 82(11), p. 1394–1403. doi: 10.1136/ard-2023-224476. Full text in Research Archive
• Brkic, Alen; Diamantopoulos, Andreas P; Hoff, Mari; Haavardsholm, Espen A.; Fevang, Bjørg Tilde Svanes & Brekke, Lene Kristin [Show all 11 contributors for this article] (2023). Exploring the impact of the national tender system on the use of costly drugs treating rheumatoid arthritis patients in ten rheumatology centers in Norway (2010–2019). BMC Health Services Research. ISSN 1472-6963. 23(1). doi: 10.1186/s12913-023-09975-7. Full text in Research Archive
• Østergaard, Mikkel; Van Vollenhoven, Ronald F; Rudin, Anna; Hetland, Merete Lund; Schrumpf, Marte & Nordström, Dan C [Show all 45 contributors for this article] (2023). Certolizumab pegol, abatacept, tocilizumab or active conventional treatment in early rheumatoid arthritis: 48-week clinical and radiographic results of the investigator-initiated randomised controlled NORD-STAR trial. Annals of the Rheumatic Diseases. ISSN 0003-4967. 82(10), p. 1286–1295. doi: 10.1136/ard-2023-224116. Full text in Research Archive
• Hammer, Hilde Berner; Pedersen, Sigve Lars; Jonsson, Maria Karolina; Mathsson-Alm, Linda; Gehring, Isabel & Sexton, Joseph [Show all 8 contributors for this article] (2023). Calprotectin, a sensitive marker of inflammation, is robustly assessed in plasma from patients with early or established rheumatoid arthritis by use of different laboratory methods. Scandinavian Journal of Clinical and Laboratory Investigation. ISSN 0036-5513. 83(5), p. 330–335. doi: 10.1080/00365513.2023.2225223. Full text in Research Archive
• Uhlig, Till; Karoliussen, Lars Fridtjof; Sexton, Joseph; Kvien, Tore Kristian Aaserud; Haavardsholm, Espen A. & Taylor, W.J. [Show all 7 contributors for this article] (2023). Beliefs about medicines in gout patients: results from the NOR-Gout 2-year study. Scandinavian Journal of Rheumatology. ISSN 0300-9742. doi: 10.1080/03009742.2023.2213507. Full text in Research Archive
• Lillegraven, Siri; Paulshus Sundlisæter, Nina; Aga, Anna-Birgitte; Sexton, Joseph; Solomon, Daniel H. & Van Der Heijde, Désirée [Show all 7 contributors for this article] (2023). Discontinuation of Conventional Synthetic Disease-Modifying Antirheumatic Drugs in Patients with Rheumatoid Arthritis and Excellent Disease Control. Journal of the American Medical Association (JAMA). ISSN 0098-7484. 329(12), p. 1024–1026. doi: 10.1001/jama.2023.0492.
• Brun, Marthe Kirkesæther; Hammersbøen, Kristin Reine; Viken, Marte Kathrine; Stenvik, Grethe-Elisabeth; Klaasen, Rolf & Gehin, Johanna [Show all 18 contributors for this article] (2023). HLA-DQ2 is associated with anti-drug antibody formation to infliximab in patients with immune-mediated inflammatory diseases. Journal of Internal Medicine. ISSN 0954-6820. 293(5), p. 648–655. doi: 10.1111/joim.13616. Full text in Research Archive
• Bjørlykke, Kristin H.; Ørbo, Hilde Sofie Sager; Tveter, Anne Therese; Jyssum, Ingrid; Sexton, Joseph & Tran, Trung [Show all 21 contributors for this article] (2022). Four SARS-CoV-2 vaccine doses or hybrid immunity in patients on immunosuppressive therapies: a Norwegian cohort study. The Lancet Rheumatology. 5(1), p. e36–e46. doi: 10.1016/S2665-9913(22)00330-7. Show summary

  Background Data on response and safety of repeated vaccinations and hybrid immunity in patients with immune-mediated inflammatory diseases on immunosuppressive therapy is needed to further develop vaccination strategies in this vulnerable population. This study aimed to evaluate hybrid immunity and humoral immune response and safety of four SARS-CoV-2 vaccine doses in patients with immune-mediated inflammatory diseases on immunosuppressive therapy. Methods This prospective observational Norwegian study of vaccine response to COVID-19 (Nor-vaC) included adult patients aged 18 years and older with immune-mediated inflammatory diseases (rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, Crohn's disease, or ulcerative colitis) on immunosuppressive therapy, who had received four SARS-CoV-2 vaccine doses (vaccine group) or three vaccine doses followed by COVID-19 (hybrid group), and healthy controls receiving three vaccine doses (control group). Patients were recruited from the Division of Rheumatology at Diakonhjemmet Hospital, Oslo, and the Department of Gastroenterology at Akershus University Hospital, Lørenskog. Patients who had COVID-19 before the third vaccine dose, and patients with allergies or intolerances to elements of the vaccine were excluded. Antibodies to the receptor-binding domain of SARS-CoV-2 spike protein (anti-RBD antibodies) were assessed 2–4 weeks following vaccination or COVID-19. This study is registered at Clinialtrials.gov, NCT04798625. Findings Between Nov 12, 2021, and April 19, 2022, 1458 participants with immune-mediated inflammatory diseases provided post-vaccination samples at 2–4 weeks following a third vaccine dose. After 544 participants were excluded, 715 (78%) of the remaining 914 participants received the fourth dose of the vaccine, and of these, 536 (75%) provided post-vaccination samples 2–4 weeks after their fourth vaccination (vaccine group). 199 (22%) of the 914 had COVID-19 after their third dose of the vaccine and of these, 167 (84%) provided samples (hybrid group). 256 of the eligible 703 patients had rheumatoid arthritis, 107 had spondyloarthritis, 115 had psoriatic arthritis, 130 had Crohn's disease, and 95 had ulcerative colitis). Median age was 56 years [IQR 45–65], 398 (57%) were women, and 305 (43%) were men. Patients in the vaccine group had higher anti-RBD antibody concentrations following the fourth vaccine dose (median 6192 BAU/ml [IQR 2878–11 243]) than after the third dose (median 5087 BAU/ml [1250–9081]; p< 0·0001), but lower antibody concentrations than the control group following the third dose (median 7595 BAU/ml [5916–12 001]; p< 0·0001). Antibody concentrations were higher in the patients in the hybrid group (23 548 BAU/ml [IQR 11 440–35 935]) than in the vaccine group (p<0·0001). No difference was found in antibody concentrations between the fourth dose of BNT162b2 (full-dose) and mRNA-1273 (half-dose). Patients and controls had a comparable safety profile after both three and four vaccine doses. Interpretation Vaccine boosters improve humoral immune responses and are safe in patients with immune-mediated inflammatory diseases on immunosuppressive therapy, and administration should be considered regularly in this patient group. Hybrid immunity with omicron induces a strong humoral response suggesting longer intervals between booster doses in this patient group.

• Smolen, Josef S; Landewé, Robert B M; Bergstra, Sytske Anne; Kerschbaumer, Andreas; Sepriano, Alexandre & Aletaha, Daniel [Show all 48 contributors for this article] (2022). EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Annals of the Rheumatic Diseases. ISSN 0003-4967. doi: 10.1136/ard-2022-223356.
• Kerola, Anne Mirjam; Kazemi, Amirhossein; Rollefstad, Silvia Christin Hellerud; Lillegraven, Siri; Sexton, Joseph & Wibetoe, Grunde [Show all 9 contributors for this article] (2022). All-cause and cause-specific mortality in rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: a nationwide registry study. Rheumatology. ISSN 1462-0324. 61(12), p. 4656–4666. doi: 10.1093/rheumatology/keac210. Full text in Research Archive Show summary

  Objectives To explore mortality and causes of death among Norwegian patients with RA, PsA and axial spondyloarthritis (axSpA) compared with the general population by conducting a nationwide registry-based cohort study. Methods Patients with RA, PsA and axSpA were identified from the Norwegian Patient Registry based on ICD-10 codes between 2008 and 2017. Using age as the time variable, all-cause and cause-specific mortality were estimated between 2010 and 2017 with the Kaplan–Meier estimator and the cumulative incidence competing risk method, respectively. Sex-, education level-, health region- and age group-adjusted hazard ratios (HRs) for mortality were estimated using Cox regression models. Results We identified 36 095 RA, 18 700 PsA and 16 524 axSpA patients (70%, 53% and 45% women, respectively). RA and axSpA were associated with increased all-cause mortality (HR 1.45 [95% CI: 1.41, 1.48] and HR 1.38 [95% CI: 1.28, 1.38], respectively). Women but not men with PsA had a slightly increased mortality rate (HR 1.10 [95% CI: 1.00, 1.21] among women and 1.02 [95% CI: 0.93, 1.11] among men). For all patient groups as well as for the general population, the three leading causes of death were cardiovascular diseases, neoplasms and respiratory diseases. RA patients had increased mortality from all of these causes, while axSpA patients had increased mortality from cardiovascular and respiratory diseases. Conclusion Even in the era of modern treatments for IJDs, patients with RA and axSpA still have shortened life expectancy. Our findings warrant further attention to the prevention and management of comorbidities.

• Syversen, Silje Watterdal; Jyssum, Ingrid; Tveter, Anne Therese; Sexton, Joseph; Christensen, Ingrid Egeland & Tran, Trung [Show all 20 contributors for this article] (2022). Immunogenicity and safety of a three-dose SARS-CoV-2 vaccination strategy in patients with immune-mediated inflammatory diseases on immunosuppressive therapy. RMD Open. ISSN 2056-5933. 8(2). doi: 10.1136/rmdopen-2022-002417. Full text in Research Archive
• Uhlig, Till; Karoliussen, Lars Fridtjof; Sexton, Joseph; Kvien, Tore Kristian; Haavardsholm, Espen A. & Perez-Ruiz, F. [Show all 7 contributors for this article] (2022). Fluctuation and change of serum urate levels and flares in gout: results from the NOR-Gout study. Clinical Rheumatology. ISSN 0770-3198. 41, p. 3817–3823. doi: 10.1007/s10067-022-06416-4. Full text in Research Archive
• Christensen, Ingrid Egeland; Jyssum, Ingrid; Tveter, Anne Therese; Sexton, Joseph; Tran, Trung & Mjaaland, Siri [Show all 19 contributors for this article] (2022). The persistence of anti-Spike antibodies following two SARS-CoV-2 vaccine doses in patients on immunosuppressive therapy compared to healthy controls—a prospective cohort study. BMC Medicine. ISSN 1741-7015. 20(1), p. 1–13. doi: 10.1186/s12916-022-02587-8. Full text in Research Archive Show summary

  Background The durability of vaccine-induced humoral immunity against SARS-CoV-2 in patients with immune-mediated inflammatory diseases (IMIDs) on immunosuppressive therapy is not known. The aim of this study was to compare the persistence of anti-Spike antibodies following two-dose SARS-CoV-2 vaccination between IMID patients and healthy controls and to identify factors associated with antibody decline. Methods IMID patients on immunosuppressive medication enrolled in the prospective observational Nor-vaC study were included. Participants received two-dose SARS-CoV-2 vaccination. Serum collected at two time points following vaccination (first assessment within 6–48 days, second within 49–123 days) were analyzed for antibodies binding the receptor-binding domain (RBD) of the SARS-CoV-2 Spike protein. Multivariable regression models estimated percent reduction in anti-RBD over 30 days and factors associated with reduction. Results A total of 1108 patients (403 rheumatoid arthritis, 195 psoriatic arthritis, 195 spondyloarthritis, 124 ulcerative colitis, 191 Crohn’s disease) and 134 controls provided blood samples within the defined intervals (median 19 days [IQR 15–24] and 97 days [87–105] after second vaccine dose). Antibody levels were lower in patients compared to controls at both time points, with median anti-RBD 2806 BAU/ml [IQR 1018–6068] in patients and 6187 BAU/ml [4105–7496] in controls (p<0.001) at first assessment, and 608 BAU/ml [IQR 58–1053] in patients and 1520 BAU/ml [979–3766] in controls (p<0.001) at second assessment. At second assessment, low anti-RBD antibody levels (defined as <200 BAU/ml) were found in 449 (41%) patients, and 6 (5%) controls (p<0.001). The change was − 83% in patients and − 66% in controls (p<0.001). Patients had a greater estimated 30 days percent reduction in anti-RBD levels compared to controls − 4.9 (95% CI − 7.4 to − 2.4), (p<0.05). Among therapies, mono- or combination treatment with tumor necrosis factor inhibitors was associated with the greatest decline. Conclusions Within 4 months after vaccination, antibody levels declined considerably in both IMID patients and controls. Patients had lower initial antibody levels and a more pronounced decline compared to healthy controls and were therefore more likely to decline to low antibody levels. These results support that IMID patients need additional vaccine doses at an earlier stage than healthy individuals.

• Podewski, A.F.; Glimm, A.M.; Fischer, I.; Bruyn, G.A.W.; Hanova, P. & Hammer, Hilde Berner [Show all 12 contributors for this article] (2022). The MCP2 and the wrist plus two extensor compartments are the most affected and responsive joints/tendons out of the US7 score in patients with rheumatoid arthritis-an observational study. Arthritis Research & Therapy. ISSN 1478-6354. 24(1), p. 1–13. doi: 10.1186/s13075-022-02874-y. Full text in Research Archive
• Brun, Marthe Kirkesæther; Goll, Guro Løvik; Jørgensen, Kristin Kaasen; Sexton, Joseph; Gehin, Johanna Elin & Sandanger, Øystein [Show all 15 contributors for this article] (2022). Risk factors for anti-drug antibody formation to infliximab: Secondary analyses of a randomised controlled trial. Journal of Internal Medicine. ISSN 0954-6820. 292(3), p. 477–491. doi: 10.1111/joim.13495. Full text in Research Archive
• Syversen, Silje Watterdal; Jyssum, Ingrid; Tveter, Anne Therese; Tran, Trung; Sexton, Joseph & Provan, Sella Aarrestad [Show all 22 contributors for this article] (2022). Immunogenicity and Safety of Standard and Third-Dose SARS-CoV-2 Vaccination in Patients Receiving Immunosuppressive Therapy. Arthritis & Rheumatology. ISSN 2326-5191. 74(8), p. 1321–1332. doi: 10.1002/art.42153. Full text in Research Archive
• Lend, Kristina; van Vollenhoven, Ronald F; Lampa, Jon; Lund Hetland, Merete; Haavardsholm, Espen A. & Nordström, Dan [Show all 18 contributors for this article] (2022). Sex differences in remission rates over 24 weeks among three different biological treatments compared to conventional therapy in patients with early rheumatoid arthritis (NORD-STAR): a post-hoc analysis of a randomised controlled trial. The Lancet Rheumatology. 4(10), p. e688–e698. doi: 10.1016/S2665-9913(22)00186-2. Full text in Research Archive
• Norvang, Vibeke; Haavardsholm, Espen A.; Tedeschi, Sara K.; Lyu, Houchen; Sexton, Joseph & Mjaavatten, Maria Dahl [Show all 9 contributors for this article] (2022). Using observational study data as an external control group for a clinical trial: an empirical comparison of methods to account for longitudinal missing data. BMC Medical Research Methodology. ISSN 1471-2288. 22(152), p. 1–10. doi: 10.1186/s12874-022-01639-0. Full text in Research Archive
• Hammer, Hilde Berner; Rollefstad, Silvia Christin Hellerud; Semb, Anne Grete; Jensen, Gro Elisabeth; Karoliussen, Lars Fridtjof & Terslev, L [Show all 9 contributors for this article] (2022). Urate crystal deposition is associated with inflammatory markers and carotid artery pathology in patients with intercritical gout: results from the NOR-Gout study. RMD Open. ISSN 2056-5933. 8(2), p. 1–5. doi: 10.1136/rmdopen-2022-002348. Full text in Research Archive
• Tønnessen, Theis Christian; Melleby, Arne Olav; Hauge-Iversen, Ida Marie; Espe, Emil Knut Stenersen; Ahmed, Muhammad Shakil & Ueland, Thor [Show all 12 contributors for this article] (2022). Impact of delayed type hypersensitivity arthritis on development of heart failure by aortic constriction in mice. PLOS ONE. ISSN 1932-6203. 17(1). doi: 10.1371/journal.pone.0262821. Full text in Research Archive Show summary

  Aims Patients with rheumatoid arthritis (RA) have increased risk of heart failure (HF). The mechanisms and cardiac prerequisites explaining this association remain unresolved. In this study, we sought to determine the potential cardiac impact of an experimental model of RA in mice subjected to HF by constriction of the ascending aorta. Methods Aorta was constricted via thoracotomy and placement of o-rings with inner diameter 0.55 mm or 0.66 mm, or sham operated. RA-like phenotype was instigated by delayed-type hypersensitivity arthritis (DTHA) two weeks after surgery and re-iterated after additional 18 days. Cardiac magnetic resonance imaging (MRI) was performed before surgery and at successive time points throughout the study. Six weeks after surgery the mice were euthanized, blood and tissue were collected, organ weights were documented, and expression levels of cardiac foetal genes were analysed. In a supplemental study, DTHA-mice were euthanized throughout 14 days after induction of arthritis, and blood was analysed for important markers and mediators of RA (SAP, TNF-α and IL-6). In order to put the latter findings into clinical context, the same molecules were analysed in serum from untreated RA patients and compared to healthy controls. Results Significant elevations of inflammatory markers were found in both patient- and murine blood. Furthermore, the DTHA model appeared clinically relevant when compared to the inflammatory responses observed in three prespecified RA severity disease states. Two distinct trajectories of cardiac dysfunction and HF development were found using the two o-ring sizes. These differences were consistent by both MRI, organ weights and cardiac foetal gene expression levels. Still, no difference within the HF groups, nor within the sham groups, could be found when DTHA was induced. Conclusion DTHA mediated systemic inflammation did not cause, nor modify HF caused by aortic constriction. This indicates other prerequisites for RA-induced cardiac dysfunction.

• Kerola, A.M.; Rollefstad, Silvia Christin Hellerud; Kazemi, Amirhossein; Wibetoe, Grunde; Sexton, Joseph & Mars, N. [Show all 10 contributors for this article] (2022). Psoriatic arthritis, axial spondyloarthritis and rheumatoid arthritis in Norway: nationwide prevalence and use of biologic agents. Scandinavian Journal of Rheumatology. ISSN 0300-9742. p. 1–9. doi: 10.1080/03009742.2021.1997436. Full text in Research Archive
• Uhlig, Till; Karoliussen, Lars Fridtjof; Sexton, Joseph; Kvien, Tore Kristian; Haavardsholm, Espen A. & Perez-Ruiz, Fernando [Show all 7 contributors for this article] (2022). One- and 2-year flare rates after treat-to-target and tight-control therapy of gout: results from the NOR-Gout study. Arthritis Research & Therapy. ISSN 1478-6354. 24:88, p. 1–11. doi: 10.1186/s13075-022-02772-3. Full text in Research Archive
• Sundlisæter, Nina Beate Paulshus; Sundin, Ulf Gunnar; Aga, Anna-Birgitte; Sexton, Joseph; Hammer, Hilde Berner & Uhlig, Till [Show all 9 contributors for this article] (2022). Inflammation and biologic therapy in patients with rheumatoid arthritis achieving versus not achieving ACR/EULAR Boolean remission in a treat-to-target study. RMD Open. ISSN 2056-5933. 8(1), p. 1–6. doi: 10.1136/rmdopen-2021-002013. Full text in Research Archive Show summary

  Objective To investigate limiting factors of American College of Rheumatology (ACR)/EULAR Boolean remission in rheumatoid arthritis (RA), and compare patients who fulfil the criteria to patients who only partly fulfil the criteria, with respect to imaging inflammation and biologic disease modifying anti-rheumatic drug (DMARD) usage. Methods Patients with DMARD-naïve RA were treated according to current recommendations in the the ARCTIC trial (Aiming for Remission in rheumatoid arthritis: a randomised trial examining the benefit of ultrasound in a Clinical TIght Control regimen). Limiting factors of reaching ACR/EULAR Boolean remission at 2 years were assessed. Imaging inflammation (ultrasound and MRI) in patients in remission was compared with patients failing to fulfil different components of the criteria. The OR of biologic therapy was calculated using logistic regression. Results Of 203 patients, 112 (55%) reached ACR/EULAR Boolean remission; 49 (24%) fulfilled three of four criteria. The main limiting factors were patient global assessment (PGA) (59%) and tender joints (22%). Imaging inflammation was not significantly different for patients in remission and patients not fulfilling the criteria due to elevated PGA and/or tender joints, but higher odds of using biologics (OR 3.63, 95% CI 1.73 to 7.61) were observed. Conclusions PGA and tender joints were the factors most often limiting achievement of ACR/EULAR Boolean remission. The level of imaging inflammation was not elevated in these patients compared with patients in remission, but the odds of using biologic DMARDs were higher. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

• Brkic, Alen; Diamantopoulos, Andreas P; Haavardsholm, Espen A.; Fevang, Bjørg Tilde Svanes; Brekke, Lene Kristin & Loli, Liz Paucar [Show all 11 contributors for this article] (2022). Exploring drug cost and disease outcome in rheumatoid arthritis patients treated with biologic and targeted synthetic DMARDs in Norway in 2010–2019 – a country with a national tender system for prescription of costly drugs. BMC Health Services Research. ISSN 1472-6963. 22(1), p. 1–15. doi: 10.1186/s12913-021-07425-w. Full text in Research Archive Show summary

  Abstract Background In Norway, an annual tender system for the prescription of biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) has been used since 2007. This study aimed to explore annual b/tsDMARDs costs and disease outcomes in Norwegian rheumatoid arthritis (RA) patients between 2010 and 2019 under the influence of the tender system. Methods RA patients monitored in ordinary clinical practice were recruited from 10 Norwegian centers. Data files from each center for each year were collected to explore demographics, disease outcomes, and the prescribed treatment. The cost of b/tsDMARDs was calculated based on the drug price given in the annual tender process. Results The number of registered RA patients increased from 4909 in 2010 to 9335 in 2019. The percentage of patients receiving a b/tsDMARD was 39% in 2010 and 45% in 2019. The proportion of b/tsDMARDs treated patients achieving DAS28 remission increased from 42 to 67%. The estimated mean annual cost to treat a patient on b/tsDMARDs fell by 47%, from 13.1 thousand euros (EUR) in 2010 to 6.9 thousand EUR in 2019. The mean annual cost to treat b/tsDMARDs naïve patients was reduced by 75% (13.0 thousand EUR in 2010 and 3.2 thousand EUR in 2019). Conclusions In the period 2010–2019, b/tsDMARD treatment costs for Norwegian RA patients were significantly reduced, whereas DAS28 remission rates increased. Our data may indicate that the health authorities’ intention to reduce treatment costs by implementing a tender system has been successful.

• Jyssum, Ingrid; Kared, Hassen; Tran, Trung; Tveter, Anne Therese; Provan, Sella Aarrestad & Sexton, Joseph [Show all 22 contributors for this article] (2021). Humoral and cellular immune responses to two and three doses of SARS-CoV-2 vaccines in rituximab-treated patients with rheumatoid arthritis: a prospective, cohort study. The Lancet Rheumatology. doi: 10.1016/S2665-9913(21)00394-5. Full text in Research Archive
• Uhlig, Till; Eskild, Tron Hovind; Karoliussen, Lars Fridtjof; Sexton, Joseph; Kvien, Tore Kristian & Haavardsholm, Espen A. [Show all 8 contributors for this article] (2021). Two-year reduction of dual-energy CT urate depositions during a treat-to-target strategy in gout in the NOR-Gout longitudinal study. Rheumatology. ISSN 1462-0324. 61, p. S181–S185. doi: 10.1093/rheumatology/keab533. Full text in Research Archive Show summary

  Objectives: There is a lack of large longitudinal studies of urate deposition measured by dual-energy computed tomography (DECT) during urate lowering therapy (ULT) in people with gout. We explored longitudinal changes in DECT urate depositions during a treat-to-target strategy with ULT in gout. Methods: Patients with a recent gout flare and serum-urate (sUA) >360 µmol/l attended tight-control visits during escalating ULT. The treatment target was sUA <360 µmol/l, and <300 µmol/l if presence of tophi.A DECT scanner (General Electric Discovery CT750 HD) acquired data from bilateral forefeet and ankles at baseline and after one and two years. Images were scored in known order, using the semi-quantitative Bayat method, by one experienced radiologist who was blinded to serum urate and clinical data. Four regions were scored: the first metatarsophalangeal (MTP1) joint, the other joints of the toes, the ankles and midfeet, and all tendons in the feet and ankles. Results: DECT was measured at baseline in 187 of 211 patients. The mean (S.D.) serum urate level (μmol/l) decreased from 501 (80) at baseline to 311 (48) at 12 months, and 322 (67) at 24 months.DECT scores at all locations decreased during both the first and the second year (p< 0.001 for all comparisons vs baseline), both for patients achieving and not achieving the sUA treatment target. Conclusions: In patients with gout, urate depositions in ankles and feet as measured by DECT decreased both in the first and the second year, when patients were treated using a treat-to-target ULT strategy.

• Syversen, Silje Watterdal; Jørgensen, Kristin Kaasen; Goll, Guro Løvik; Brun, Marthe Kirkesæther; Sandanger, Øystein & Hammersbøen, Kristin Reine [Show all 33 contributors for this article] (2021). Effect of Therapeutic Drug Monitoring vs Standard Therapy During Maintenance Infliximab Therapy on Disease Control in Patients With Immune-Mediated Inflammatory Diseases: A Randomized Clinical Trial. Journal of the American Medical Association (JAMA). ISSN 0098-7484. 326(23), p. 2375–2384. doi: 10.1001/jama.2021.21316. Show summary

  IMPORTANCE Proactive therapeutic drug monitoring (TDM), consisting of individualized treatment based on scheduled assessments of serum drug levels, has been proposed as an alternative to standard therapy to optimize efficacy and safety of infliximab and other biologic drugs. However, it remains unclear whether proactive TDM improves clinical outcomes during maintenance therapy. OBJECTIVE To assess whether proactive TDM during maintenance therapy with infliximab improves treatment efficacy by preventing disease worsening compared with standard infliximab therapy without TDM. DESIGN, SETTING, AND PARTICIPANTS Randomized, parallel-group, open-label clinical trial including 458 adults with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn disease, or psoriasis undergoing maintenance therapy with infliximab in 20 Norwegian hospitals. Patients were recruited from June 7, 2017, to December 12, 2019. Final follow-up took place on December 14, 2020. INTERVENTIONS Patients were randomized 1:1 to proactive TDM with dose and interval adjustments based on scheduled monitoring of serum drug levels and antidrug antibodies (TDM group; n = 228) or to standard infliximab therapy without drug and antibody level monitoring (standard therapy group; n = 230). MAIN OUTCOME AND MEASURES The primary outcomewas sustained disease control without disease worsening, defined by disease-specific composite scores or consensus about disease worsening between patient and physician leading to a major change in treatment (switching to another biologic drug, adding an immunosuppressive drug including glucocorticoids, or increasing the infliximab dose), during the 52-week study period. RESULTS Among 458 randomized patients (mean age, 44.8 [SD, 14.3] years; 216 women [49.8%]), 454 received their randomly allocated intervention and were included in the full analysis set. The primary outcome of sustained disease control without disease worsening was observed in 167 patients (73.6%) in the TDM group and 127 patients (55.9%) in the standard therapy group. The estimated adjusted difference was 17.6%(95%CI, 9.0%-26.2%; P < .001) favoring TDM. Adverse events were reported in 137 patients (60%) and 142 patients (63%) in the TDM and standard therapy groups, respectively. CONCLUSIONS AND RELEVANCE Among patients with immune-mediated inflammatory diseases undergoing maintenance therapy with infliximab, proactive TDMwas more effective than treatment without TDM in sustaining disease control without diseaseworsening. Further research is needed to compare proactive TDM with reactive TDM, to assess the effects on long-term disease complications, and to evaluate the cost-effectiveness of this approach. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03074656

• Aldridge, Jonathan; Lundell, Anna-Carin; Andersson, Kerstin; Mark, Linda; Hetland, Merete Lund & Østergaard, Mikkel [Show all 17 contributors for this article] (2021). Blood chemokine levels are markers of disease activity but not predictors of remission in early rheumatoid arthritis. Clinical and Experimental Rheumatology. ISSN 0392-856X. 40(7), p. 1393–1402. doi: 10.55563/clinexprheumatol/idogmj. Show summary

  Objectives: In early rheumatoid arthritis (eRA) plasma levels of specific chemokines have been shown to correlate with disease activity. However, it is unclear whether pre-treatment chemokine levels can predict disease remission at week 24, and it is not known how biological treatments with different modes of action affect plasma chemokine levels in patients with untreated eRA. Methods: This study included 347 Swedish patients with untreated eRA from the larger NORD-STAR randomised treatment trial. Here, eRA patients were treated with methotrexate combined with either prednisolone, anti-TNF (certolizumab-pegol), CTLA-4Ig (abatacept) or anti-IL6 receptor (tocilizumab). The primary clinical outcome was remission by clinical disease activity index (CDAI) defined as CDAI ≤ 2.8. Disease activity was assessed by CDAI, DAS28-ESR, DAS28-CRP, swollen joint counts, tender joint counts, ESR and CRP. The plasma concentrations of 14 chemokines were measured at baseline and after 24 weeks of treatment by bead-based immunoassay or ELISA. Results: Baseline plasma concentrations of CXCL10, CXCL8, CXCL9, CXCL11, CXCL5 and CCL2 correlated with baseline disease activity measures. After 24 weeks of treatment, plasma levels of CXCL10, CXCL8, CXCL9, CXCL11 and CXCL13 decreased in all treatment groups except in patients treated with anti-IL6 receptor. In multivariate factor analysis, plasma chemokine levels at baseline could not differentiate patients who attained remission by week 24 from those who did not in any of the treatment groups. Conclusions: In patients with untreated eRA, plasma levels of several chemokines correlate with disease activity at baseline but cannot predict remission after 24 weeks of treatment with methotrexate combined with prednisolone, anti‑TNF, CTLA‑4Ig or anti‑IL6R.

• Kerola, Anne Mirjam; Sexton, Joseph; Wibetoe, Grunde; Rollefstad, Silvia Christin Hellerud; Crowson, Cynthia Sue & Mars, Nina [Show all 10 contributors for this article] (2021). Incidence, sociodemographic factors and treatment penetration of rheumatoid arthritis and psoriatic arthritis in Norway. Seminars in Arthritis & Rheumatism. ISSN 0049-0172. 51(5), p. 1081–1088. doi: 10.1016/j.semarthrit.2021.08.006. Full text in Research Archive Show summary

  Objectives: To evaluate nationwide incidence, sociodemographic associations and treatment penetration of rheumatoid arthritis (RA) and psoriatic arthritis (PsA) in Norway. Methods: The study combined data from nationwide registries on the total Norwegian adult population (age ≥ 18). From the Norwegian Patient Registry, incident RA and PsA cases during 2011-2015 were identified with records of first and second healthcare episodes listing RA/PsA diagnostic codes, and ≥ 1 episode in an internal medicine or rheumatology unit with RA/PsA code during the two-year period after the first episode. Dispensed DMARD prescriptions were obtained from the Norwegian Prescription Database. Persons with dispensed DMARD prescriptions or biologic DMARDs given in hospitals > 12 months before the index date were excluded. Results: Incidence of RA/PsA in Norway was 42/26 per 100,000 person-years (55/28 among women and 28/23 among men). RA peak incidence was observed at ages 70-79 in both sexes, whereas the peak incidence of PsA occurred at ages 50-59. Age- and sex-standardized incidences of RA and PsA were lower among persons with higher education levels. Within a year from the index date, 82.4/57.4% of RA/PsA patients used synthetic DMARDs while 9.4/9.5% used biologic DMARDs. Conclusions: Register-based incidence estimates for RA and PsA in Norway are similar to other Nordic countries, but slightly higher than in previous Norwegian studies. Furthermore, we found that higher socioeconomic status was associated with lower incidence of both RA and PsA. Although conventional synthetic DMARDs were less often used in early PsA than RA, frequency of biologic DMARD prescriptions was comparable.

• Stockfelt, Marit; Lundell, Anna-Carin; Hetland, Merete Lund; Østergaard, Mikkel; Uhlig, Till & Schrumpf, Marte [Show all 19 contributors for this article] (2021). Plasma interferon-alpha is associated with double-positivity for autoantibodies but is not a predictor of remission in early rheumatoid arthritis-a spin-off study of the NORD-STAR randomized clinical trial. Arthritis Research & Therapy. ISSN 1478-6354. 23(1). doi: 10.1186/s13075-021-02556-1. Full text in Research Archive Show summary

  Background: The type I interferon (IFN) gene signature is present in a subgroup of patients with early rheumatoid arthritis (RA). Protein levels of IFNα have not been measured in RA and it is unknown whether they associate with clinical characteristics or treatment effect. Methods: Patients with early untreated RA (n = 347) were randomized to methotrexate combined with prednisone, certolizumab-pegol, abatacept, or tocilizumab. Plasma IFNα protein levels were determined by single molecular array (Simoa) before and 24 weeks after treatment initiation and were related to demographic and clinical factors including clinical disease activity index, disease activity score in 28 joints, swollen and tender joint counts, and patient global assessment. Results: IFNα protein positivity was found in 26% of the patients, and of these, 92% were double-positive for rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA). IFNα protein levels were reduced 24 weeks after treatment initiation, and the absolute change was similar irrespective of treatment. IFNα protein positivity was associated neither with disease activity nor with achievement of CDAI remission 24 weeks after randomization. Conclusion: IFNα protein positivity is present in a subgroup of patients with early RA and associates with double-positivity for autoantibodies but not with disease activity. Pre-treatment IFNα positivity did not predict remission in any of the treatment arms, suggesting that the IFNα system is distinct from the pathways of TNF, IL-6, and T-cell activation in early RA. A spin-off study of the NORD-STAR randomized clinical trial, NCT01491815 (ClinicalTrials), registered 12/08/2011, https://clinicaltrials.gov/ct2/show/NCT01491815 .

• Holten, Karen; Sundlisæter, Nina Beate Paulshus; Lillegraven, Siri; Sexton, Joseph; Nordberg, Lena Kristine Bugge & Moholt, Ellen [Show all 11 contributors for this article] (2021). Fatigue in patients with early rheumatoid arthritis undergoing treat-to-target therapy: predictors and response to treatment. Annals of the Rheumatic Diseases. ISSN 0003-4967. doi: 10.1136/annrheumdis-2021-220750. Full text in Research Archive Show summary

  Objectives: Fatigue is a frequent symptom in rheumatoid arthritis (RA) and has high impact on quality of life. We explored associations between disease activity and fatigue in patients with early RA during the initial 24 months of modern treat-to-target therapy and predictors of fatigue after 24 months of follow-up. Methods: Data were obtained from the treat-to-target, tight control Aiming for Remission in Rheumatoid Arthritis: a Randomised Trial Examining the Benefit of Ultrasound in a Clinical Tight Control Regime (ARCTIC) trial. Fatigue was measured on a visual analogue scale (VAS) from 0 to 100 mm and defined as clinically relevant if VAS was ≥20 mm. Baseline predictors of fatigue at 24 months were analysed by multivariable logistic regression. Results: 205 patients with fatigue data at baseline and 24 months were included. Median (25th, 75th percentiles) symptom duration was 5.4 months (2.8, 10.4), fatigue VAS 37.0 mm (13.0, 62.0) and mean Disease Activity Score (DAS) 3.4 (SD 1.1) at baseline. Prevalence of fatigue declined from 69% at baseline to 38% at 24 months. Fewer swollen joints (OR 0.92, 95% CI 0.87 to 0.98, p=0.006), lower power Doppler ultrasound score (OR 0.95, 95% CI 0.90 to 0.99, p=0.027) and higher patient global assessment (PGA) (OR 1.03, 95% CI 1.01 to 1.04, p<0.001) increased the risk of clinically relevant fatigue at 24 months. Not achieving remission at 6 months was associated with a higher risk of reporting fatigue at 24 months. Conclusions: Fatigue in patients with early RA was prevalent at disease onset, with a rapid and sustained reduction during treatment. Low objective disease activity and high PGA at baseline were predictors of clinically relevant fatigue at 24 months.

• Uhlig, Till; Karoliussen, Lars Fridtjof; Sexton, Joseph; Borgen, Tove; Haavardsholm, Espen A. & Kvien, Tore Kristian [Show all 7 contributors for this article] (2021). 12-month results from the real-life observational treat-to-target and tight-control therapy NOR-Gout study: Achievements of the urate target levels and predictors of obtaining this target. RMD Open. ISSN 2056-5933. 7(1). doi: 10.1136/rmdopen-2021-001628. Full text in Research Archive
• Lillegraven, Siri; Sundlisæter, Nina Beate Paulshus; Aga, Anna-Birgitte; Sexton, Joseph; Olsen, Inge Christoffer & Fremstad, Hallvard [Show all 21 contributors for this article] (2021). Effect of Half-Dose vs Stable-Dose Conventional Synthetic Disease-Modifying Antirheumatic Drugs on Disease Flares in Patients with Rheumatoid Arthritis in Remission: The ARCTIC REWIND Randomized Clinical Trial. Journal of the American Medical Association (JAMA). ISSN 0098-7484. 325(17), p. 1755–1764. doi: 10.1001/jama.2021.4542. Show summary

  IMPORTANCE Sustained remission has become an achievable goal for patients with rheumatoid arthritis (RA) receiving conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), but how to best treat patients in clinical remission remains unclear. OBJECTIVE To assess the effect of tapering of csDMARDs, compared with continuing csDMARDs without tapering, on the risk of flares in patients with RA in sustained remission. DESIGN, SETTING, AND PARTICIPANTS ARCTIC REWIND was a multicenter, randomized, parallel, open-label noninferiority study conducted in 10 Norwegian hospital-based rheumatology practices. A total of 160 patients with RA in remission for 12 months who were receiving stable csDMARD therapy were enrolled between June 2013 and June 2018, and the final visit occurred in June 2019. INTERVENTIONS Patients were randomly assigned to half-dose csDMARDs (n = 80) or stable-dose csDMARDs (n = 80). MAIN OUTCOMES AND MEASURES The primary end point was the proportion of patients with a disease flare between baseline and the 12-month follow-up, defined as a combination of Disease Activity Score (DAS) greater than 1.6 (threshold for RA remission), an increase in DAS score of 0.6 units or more, and at least 2 swollen joints. A disease flare could also be recorded if both the patient and investigator agreed that a clinically significant flare had occurred. A risk difference of 20% was defined as the noninferiority margin. RESULTS Of 160 enrolled patients (mean [SD] age, 55.1 [11.9] years; 66% female), 156 received the allocated therapy, of which 155 without any major protocol violations were included in the primary analysis population (77 receiving half-dose and 78 receiving stable-dose csDMARDs). Flare occurred in 19 patients (25%) in the half-dose csDMARD group compared with 5 (6%) in the stable-dose csDMARD group (risk difference, 18% [95% CI, 7%-29%]). Adverse events occurred in 34 patients (44%) in the half-dose group and 42 (54%) in the stable-dose group, none leading to study discontinuation. No deaths occurred. CONCLUSIONS AND RELEVANCE Among patients with RA in remission taking csDMARD therapy, treatment with half-dose vs stable-dose csDMARDs did not demonstrate noninferiority for the percentage of patients with disease flares over 12 months, and there were significantly fewer flares in the stable-dose group. These findings do not support treatment with half-dose therapy.

• Heinicke, Fatima; Zhong, Xiangfu; Flåm, Siri Tennebø; Breidenbach, Johannes; Leithaug, Magnus & Mæhlen, Marthe Thoresen [Show all 14 contributors for this article] (2021). MicroRNA Expression Differences in Blood-Derived CD19+ B Cells of Methotrexate Treated Rheumatoid Arthritis Patients. Frontiers in Immunology. ISSN 1664-3224. 12. doi: 10.3389/fimmu.2021.663736. Full text in Research Archive Show summary

  Rheumatoid arthritis (RA) is a complex disease with a wide range of underlying susceptibility factors. Recently, dysregulation of microRNAs (miRNAs) in RA have been reported in several immune cell types from blood. However, B cells have not been studied in detail yet. Given the autoimmune nature of RA with the presence of autoantibodies, CD19+ B cells are a key cell type in RA pathogenesis and alterations in CD19+ B cell subpopulations have been observed in patient blood. Therefore, we aimed to reveal the global miRNA repertoire and to analyze miRNA expression profile differences in homogenous RA patient phenotypes in blood-derived CD19+ B cells. Small RNA sequencing was performed on CD19+ B cells of newly diagnosed untreated RA patients (n=10), successfully methotrexate (MTX) treated RA patients in remission (MTX treated RA patients, n=18) and healthy controls (n=9). The majority of miRNAs was detected across all phenotypes. However, significant expression differences between MTX treated RA patients and controls were observed for 27 miRNAs, while no significant differences were seen between the newly diagnosed patients and controls. Several of the differentially expressed miRNAs were previously found to be dysregulated in RA including miR-223-3p, miR-486-3p and miR-23a-3p. MiRNA target enrichment analysis, using the differentially expressed miRNAs and miRNA-target interactions from miRTarBase as input, revealed enriched target genes known to play important roles in B cell activation, differentiation and B cell receptor signaling, such as STAT3, PRDM1 and PTEN. Interestingly, many of those genes showed a high degree of correlated expression in CD19+ B cells in contrast to other immune cell types. Our results suggest important regulatory functions of miRNAs in blood-derived CD19+ B cells of MTX treated RA patients and motivate for future studies investigating the interactive mechanisms between miRNA and gene targets, as well as the possible predictive power of miRNAs for RA treatment response.

• Sundin, Ulf Gunnar; Sundlisæter, Nina Beate Paulshus; Aga, Anna-Birgitte; Sexton, Joseph; Nordberg, Lena Kristine Bugge & Hammer, Hilde Berner [Show all 10 contributors for this article] (2021). Value of MRI and ultrasound for prediction of therapeutic response and erosive progression in patients with early rheumatoid arthritis managed by an aggressive treat-To-Target strategy. RMD Open. ISSN 2056-5933. 7:e001525(1), p. 1–11. doi: 10.1136/rmdopen-2020-001525. Full text in Research Archive
• Syversen, Silje Watterdal; Goll, Guro Løvik; Jørgensen, Kristin Kaasen; Sandanger, Øystein; Sexton, Joseph & Olsen, Inge Christoffer [Show all 33 contributors for this article] (2021). Effect of Therapeutic Drug Monitoring vs Standard Therapy During Infliximab Induction on Disease Remission in Patients With Chronic Immune-Mediated Inflammatory Diseases: A Randomized Clinical Trial. Journal of the American Medical Association (JAMA). ISSN 0098-7484. 325(17), p. 1744–1754. doi: 10.1001/jama.2021.4172. Full text in Research Archive Show summary

  Importance: Proactive therapeutic drug monitoring (TDM), defined as individualized drug dosing based on scheduled monitoring of serum drug levels, has been proposed as an alternative to standard therapy to maximize efficacy and safety of infliximab and other biological drugs. However, whether proactive TDM improves clinical outcomes when implemented at the time of drug initiation, compared with standard therapy, remains unclear. Objective: To assess whether TDM during initiation of infliximab therapy improves treatment efficacy compared with standard infliximab therapy without TDM. Design, setting, and participants: Randomized, parallel-group, open-label clinical trial of 411 adults with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn disease, or psoriasis initiating infliximab therapy in 21 hospitals in Norway. Patients were recruited from March 1, 2017, to January 10, 2019. Final follow-up occurred on November 5, 2019. Interventions: Patients were randomized 1:1 to receive proactive TDM with dose and interval adjustments based on scheduled monitoring of serum drug levels and antidrug antibodies (TDM group; n = 207) or standard infliximab therapy without drug and antibody level monitoring (standard therapy group; n = 204). Main outcomes and measures: The primary end point was clinical remission at week 30. Results: Among 411 randomized patients (mean age, 44.7 [SD, 14.9] years; 209 women [51%]), 398 (198 in the TDM group and 200 in the standard therapy group) received their randomized intervention and were included in the full analysis set. Clinical remission at week 30 was achieved in 100 (50.5%) of 198 and 106 (53.0%) of 200 patients in the TDM and standard therapy groups, respectively (adjusted difference, 1.5%; 95% CI, -8.2% to 11.1%; P = .78). Adverse events were reported in 135 patients (68%) and 139 patients (70%) in the TDM and standard therapy groups, respectively. Conclusions and relevance: Among patients with immune-mediated inflammatory diseases initiating treatment with infliximab, proactive therapeutic drug monitoring, compared with standard therapy, did not significantly improve clinical remission rates over 30 weeks. These findings do not support routine use of therapeutic drug monitoring during infliximab induction for improving disease remission rates.

• Syversen, Silje Watterdal; Goll, Guro Løvik; Jørgensen, Kristin Kaasen; Olsen, Inge Christoffer; Sandanger, Øystein & Gehin, Johanna Elin [Show all 13 contributors for this article] (2020). Therapeutic drug monitoring of infliximab compared to standard clinical treatment with infliximab: study protocol for a randomised, controlled, open, parallel-group, phase IV study (The NOR-DRUM study). Trials. ISSN 1745-6215. 21(13). doi: 10.1186/s13063-019-3734-4. Full text in Research Archive
• Hetland, Merete Lund; Haavardsholm, Espen A.; Rudin, Anna; Nordström, Dan C.; Nurmohamed, Michael & Gudbjornsson, Bjorn [Show all 43 contributors for this article] (2020). Active conventional treatment and three different biological treatments in early rheumatoid arthritis: Phase IV investigator initiated, randomised, observer blinded clinical trial. The BMJ. ISSN 1756-1833. 371, p. 1–10. doi: 10.1136/bmj.m4328. Full text in Research Archive
• Sundin, Ulf Gunnar; Aga, Anna-Birgitte; Skare, Øivind; Nordberg, Lena Kristine Bugge; Uhlig, Till & Hammer, Hilde Berner [Show all 10 contributors for this article] (2020). Conventional versus ultrasound treat to target: No difference in magnetic resonance imaging inflammation or joint damage over 2 years in early rheumatoid arthritis. Rheumatology. ISSN 1462-0324. 59(9), p. 2550–2555. doi: 10.1093/rheumatology/kez674. Full text in Research Archive
• Hammer, Hilde Berner; Karoliussen, Lars Fridtjof; Terslev, Lene; Haavardsholm, Espen A; Kvien, Tore Kristian & Uhlig, Till (2020). Ultrasound shows rapid reduction of crystal depositions during a treat-to-target approach in gout patients: 12-month results from the NOR-Gout study. Annals of the Rheumatic Diseases. ISSN 0003-4967. 79(11), p. 1500–1505. doi: 10.1136/annrheumdis-2020-217392.
• Gjefsen, Elisabeth; Bråten, Lars Christian Haugli; Goll, Guro Løvik; Wigemyr, Monica; Bolstad, Nils & Valberg, Morten [Show all 27 contributors for this article] (2020). The effect of infliximab in patients with chronic low back pain and Modic changes (the BackToBasic study): study protocol of a randomized, double blind, placebo-controlled, multicenter trial. BMC Musculoskeletal Disorders. ISSN 1471-2474. 21:698, p. 1–14. doi: 10.1186/s12891-020-03720-5. Full text in Research Archive
• Jørgensen, Kristin Kaasen; Goll, Guro Løvik; Sexton, Joseph; Bolstad, Nils; Olsen, Inge Christoffer & Asak, Øivind Wessel [Show all 29 contributors for this article] (2020). Efficacy and safety of CT-P13 in inflammatory bowel disease after switching from originator infliximab: Exploratory analyses from the NOR-SWITCH main and extension trials. BioDrugs. ISSN 1173-8804. 34(5), p. 681–694. doi: 10.1007/s40259-020-00438-7. Full text in Research Archive Show summary

  Background: The NOR-SWITCH main and extension trials demonstrated that switching from originator to biosimilar infliximab (CT-P13) is efficacious and safe across six diseases. However, a subgroup analysis of Crohn's disease (CD) in the main trial displayed a close to significant difference favouring originator infliximab, and more scientific data have therefore been requested. Objective: The aim was to assess treatment efficacy, safety, and immunogenicity in an explorative subgroup analysis in CD and ulcerative colitis (UC) in the NOR-SWITCH trials. Patients and methods: The 52-week, randomised, non-inferiority, double-blind, multicentre, phase 4 NOR-SWITCH study was followed by a 26-week open extension trial where all patients received treatment with CT-P13. Treatment efficacy, safety, and immunogenicity in CD and UC were assessed throughout the 78-week study period. Results: The main and extension trials included 155 and 93 patients with CD and 93 and 80 patients with UC, respectively. Demographic and baseline characteristics were comparable in both treatment arms within patient groups. There were no differences in the main and extension trials regarding changes in activity indices, C-reactive protein, faecal calprotectin, patient's and physician's global assessment of disease activity and patient-reported outcome measures in CD and UC. Moreover, comparable results were also demonstrated for trough serum levels, presence of anti-drug antibodies, and reported adverse events. Conclusion: Efficacy, safety, and immunogenicity of both the originator and biosimilar infliximab were comparable in CD and UC in the NOR-SWITCH main and extension trials. These explorative subgroup analyses confirm that there are no significant concerns related to switching from originator infliximab to CT-P13 in CD and UC.

• Norvang, Vibeke; Brinkmann, Gina Charlotte Hetland; Yoshida, Kazuki; Lillegraven, Siri; Aga, Anna-Birgitte & Sexton, Joseph Andrew [Show all 14 contributors for this article] (2020). Achievement of Remission in Two Early Rheumatoid Arthritis Cohorts Implementing Different Treat-to-Target Strategies. Arthritis & Rheumatology. ISSN 2326-5191. 72(7), p. 1072–1081. doi: 10.1002/art.41232. Full text in Research Archive
• Guderud, Kari; Sunde, Line Hagen; Flåm, Siri Tennebø; Mæhlen, Marthe Thoresen; Mjaavatten, Maria Dahl & Lillegraven, Siri [Show all 16 contributors for this article] (2020). Rheumatoid Arthritis Patients, Both Newly Diagnosed and Methotrexate Treated, Show More DNA Methylation Differences in CD4+ Memory Than in CD4+ Naïve T Cells. Frontiers in Immunology. ISSN 1664-3224. 11:194, p. 1–14. doi: 10.3389/fimmu.2020.00194. Full text in Research Archive
• Provan, Sella Aarrestad; Lillegraven, Siri; Sexton, Joseph; Angel, Kristin; Austad, Cathrine & Haavardsholm, Espen A. [Show all 8 contributors for this article] (2019). Trends in All-Cause and Cardiovascular Mortality in Patients With Incident Rheumatoid Arthritis: A 20-year Follow-Up Matched Case-Cohort Study. Rheumatology. ISSN 1462-0324. doi: 10.1093/rheumatology/kez371. Full text in Research Archive
• Sundin, Ulf Gunnar; Østergaard, Mikkel; Glinatsi, Daniel; Aga, Anna-Birgitte; Hørslev-Petersen, Kim & Hetland, Merete L. [Show all 13 contributors for this article] (2019). Validity and responsiveness of combined inflammation and combined joint damage scores based on the OMERACT rheumatoid arthritis MRI scoring system (RAMRIS). Journal of Rheumatology. ISSN 0315-162X. 46(9), p. 1222–1227. doi: 10.3899/jrheum.181064.
• Jonsson, Maria Karolina; Kantyka, Tomasz Tadeusz; Falkowski, Katherine; Aliko, Ardita; Aga, Anna-Birgitte & Lillegraven, Siri [Show all 10 contributors for this article] (2019). Peptidylarginine deiminase 4 (PAD4) activity in early rheumatoid arthritis. Scandinavian Journal of Rheumatology. ISSN 0300-9742. 49, p. 87–95. doi: 10.1080/03009742.2019.1641216.
• Lillegraven, Siri & Haavardsholm, Espen A. (2019). Subclinical treatment targets in rheumatology: Lessons from randomized clinical trials in rheumatoid arthritis. Rheumatic Disease Clinics of North America. ISSN 0889-857X. 45(4), p. 593–604. doi: 10.1016/j.rdc.2019.07.007.
• Terslev, Lene; Christensen, Robin; Aga, Anna-Birgitte; Sexton, Joseph; Haavardsholm, Espen A. & Hammer, Hilde Berner (2019). Assessing synovitis in the hands in patients with rheumatoid arthritis by ultrasound: an agreement study exploring the most inflammatory active side from two Norwegian trials. Arthritis Research & Therapy. ISSN 1478-6354. 21. doi: 10.1186/s13075-019-1930-y.
• Hammer, Hilde Berner; Michelsen, Brigitte; Sexton, Joseph; Haugen, Ida Kristin; Provan, Sella Aarrestad & Haavardsholm, Espen A. [Show all 8 contributors for this article] (2019). Swollen, but not tender joints, are independently associated with ultrasound synovitis: Results from a longitudinal observational study of patients with established rheumatoid arthritis. Annals of the Rheumatic Diseases. ISSN 0003-4967. 78, p. 1179–1185. doi: 10.1136/annrheumdis-2019-215321.
• Goll, Guro Løvik; Jørgensen, Kristin Kaasen; Sexton, Joseph; Olsen, Inge Christoffer; Bolstad, Nils & Haavardsholm, Espen A. [Show all 48 contributors for this article] (2019). Long‐term efficacy and safety of biosimilar infliximab (CT‐P13) after switching from originator infliximab: Open‐label extension of the NOR‐SWITCH trial. Journal of Internal Medicine. ISSN 0954-6820. 285(6), p. 653–669. doi: 10.1111/joim.12880. Full text in Research Archive
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• Holten, Karen; Sexton, Joseph; Kvien, Tore Kristian; Aga, Anna-Birgitte & Haavardsholm, Espen A. (2018). Comparative analyses of responsiveness between the Rheumatoid Arthritis Impact of Disease score, other patient-reported outcomes and disease activity measures: secondary analyses from the ARCTICstudy. RMD Open. ISSN 2056-5933. 4(2), p. 1–6. doi: 10.1136/rmdopen-2018-000754. Full text in Research Archive
• Norvang, Vibeke; Sexton, Joseph; Kristianslund, Eirik; Olsen, Inge Christoffer; Uhlig, Till & Bakland, Gunnstein [Show all 13 contributors for this article] (2018). Predicting achievement of the treatment targets at 6 months from 3-month response levels in rheumatoid arthritis: data from real-life follow-up in the NOR-DMARD study. RMD Open. ISSN 2056-5933. 4(2). doi: 10.1136/rmdopen-2018-000773. Full text in Research Archive
• Goll, Guro Løvik; Haavardsholm, Espen A. & Kvien, Tore Kristian (2018). Confiance des rhumatologues quant au passage a un biosimilaire. Revue du Rhumatisme (Edition Francaise). ISSN 1169-8330. p. 1–4. doi: 10.1016/j.rhum.2018.09.007.
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• Nordberg, Lena Kristine Bugge; Lillegraven, Siri; Aga, Anna-Birgitte; Sexton, Joseph; Lie, Elisabeth & Hammer, Hilde Berner [Show all 11 contributors for this article] (2018). The impact of ultrasound on the use and efficacy of intraarticular glucocorticoid injections in early rheumatoid arthritis: Secondary analyses from a randomized trial examining the benefit of ultrasound in a clinical tight control regimen. Arthritis & Rheumatology. ISSN 2326-5191. 70(8), p. 1192–1199. doi: 10.1002/art.40494.
• Jonsson, Maria Karolina; Hensvold, Aase Haj; Hansson, Monika; Aga, Anna-Birgitte; Sexton, Joseph & Mathsson-Alm, Linda [Show all 12 contributors for this article] (2018). The role of anti-citrullinated protein antibody reactivities in an inception cohort of patients with rheumatoid arthritis receiving treat-to-target therapy. Arthritis Research & Therapy. ISSN 1478-6354. 20. doi: 10.1186/s13075-018-1635-7. Full text in Research Archive
• Sundlisæter, Nina Beate Paulshus; Aga, Anna-Birgitte; Olsen, Inge Christoffer; Hammer, Hilde Berner; Uhlig, Till & Heijde, Desirée van der [Show all 9 contributors for this article] (2018). Clinical and ultrasound remission after 6 months of treat-to-target therapy in early rheumatoid arthritis: Associations to future good radiographic and physical outcomes. Annals of the Rheumatic Diseases. ISSN 0003-4967. 77(10), p. 1421–1425. doi: 10.1136/annrheumdis-2017-212830. Full text in Research Archive
• Glinatsi, Daniel; Schrumpf, Marte; Rudin, Anna; Nordström, Dan C.; Haavardsholm, Espen A. & Gudbjörnsson, Björn [Show all 12 contributors for this article] (2017). Head-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: Study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 study. Trials. ISSN 1745-6215. 18(161). doi: 10.1186/s13063-017-1891-x.
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• Jonsson, Maria Karolina; Sundlisæter, Nina Beate Paulshus; Nordal, Hilde Haugedal; Hammer, Hilde Berner; Aga, Anna-Birgitte & Olsen, Inge Christoffer [Show all 12 contributors for this article] (2017). Calprotectin as a marker of inflammation in patients with early rheumatoid arthritis. Annals of the Rheumatic Diseases. ISSN 0003-4967. 76(12), p. 2031–2037. doi: 10.1136/annrheumdis-2017-211695.
• Jørgensen, Kristin Kaasen; Olsen, Inge Christoffer; Goll, Guro Løvik; Lorentzen, Merete; Bolstad, Nils & Haavardsholm, Espen A. [Show all 10 contributors for this article] (2017). Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet. ISSN 0140-6736. 389(10086), p. 2304–2316. doi: 10.1016/S0140-6736(17)30068-5. Full text in Research Archive
• Nordberg, Lena Kristine Bugge; Lillegraven, Siri; Lie, Elisabeth; Aga, Anna-Birgitte; Olsen, Inge Christoffer & Hammer, Hilde Berner [Show all 11 contributors for this article] (2017). Patients with seronegative RA have more inflammatory activity compared with patients with seropositive RA in an inception cohort of DMARD-naïve patients classified according to the 2010 ACR/EULAR criteria. Annals of the Rheumatic Diseases. ISSN 0003-4967. 76(2), p. 341–345. doi: 10.1136/annrheumdis-2015-208873.
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• Moe, Rikke Helene; Haavardsholm, Espen A.; Lillegraven, Siri & semb, anne grete (2023). To av tre kan bli symptomfrie. [Newspaper]. VG online og papirutgave.
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• Brinchmann, Bendik Christian; Dietrichs, Erik Sveberg; Haavardsholm, Espen A. & Kalager, Mette (2020). Leger som forsker er navet i kunnskapsbasert medisin. Overlegen. ISSN 1503-2663.
• Jonsson, Maria Karolina; Sundlisæter, Nina Beate Paulshus; Nordal, Hilde Haugedal; Hammer, Hilde Berner; Aga, Anna-Birgitte & Heijde, Desirée van der [Show all 10 contributors for this article] (2018). Response to: 'Calprotectin is not independent from baseline erosion in predicting radiological progression in early rheumatoid arthritis' by Chevreau et al. Annals of the Rheumatic Diseases. ISSN 0003-4967. doi: 10.1136/annrheumdis-2017-212869.
• Goll, Guro Løvik; Haavardsholm, Espen A. & Kvien, Tore Kristian (2018). The confidence of rheumatologists about switching to biosimilars for their patients. Joint Bone Spine. ISSN 1297-319X. doi: 10.1016/j.jbspin.2018.03.009.
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