Objectives To determine in a retrospective cohort whether patients with psoriatic arthritis (PsA) who would not have fulfilled the inclusion criteria for randomised controlled trials (RCTs) for the TNF inhibitor (TNFi) chosen for their treatment (excl) have similar benefits and drug survival as those patients who would have (incl).
Methods All patients with rheumatic disorders who are treated with biological disease-modifying antirheumatic drugs in Iceland are registered in ICEBIO. On 1 February 2016, 329 individuals with PsA were registered in ICEBIO, of whom 231 had data available for their first start of TNFi and could be evaluated according to the inclusion criteria of the respective RCTs. Disease activity was collected at baseline using Visual Analogue Scale (pain, fatigue and global (patient and physician) assessments), swollen joint count (SJC) and tender joint count (TJC), Disease Activity Score 28-joint count C reactive protein (DAS28-CRP) and Health Assessment Questionnaire (HAQ). Treatment response was measured at 6 and 18 months according to American College of Rheumatology response criteria, DAS28-CRP and Disease Activity Score in Psoriatic Arthritis for 28 joints. Drug survival rate was also analysed.
Results The demographics of these two groups were similar at baseline, although the incl group had higher SJC (5.5 vs 3.8) and subsequently higher DAS28-CRP (4.6 vs 4.2). While a larger change in disease activity was observed in the incl group with respect to HAQ and SJC, both groups had similar disease activity at follow-up. Drug survival was similar in both groups.
Conclusions Patients with PsA who would not have fulfilled the inclusion criteria in RCTs reach similar disease activity scores at follow-up of 6 and 18 months and have similar drug survival as those patients who would have been included in RCTs.
- psoriatic arthritis
- DMARDs (biologic)
- outcomes research
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Contributors Conception or design of the work: OP, PSG, EER, AIG and BG. Data collection: NSK, OP and BG. Data analysis and interpretation: OP, TJL, AIG and BG. Drafting the article: OP and BG. Critical revision of the article: OP, TJL, AIG and BG. Final approval of the version to be published: OP, TJL, AIG, PSG, EER, NSK and BG.
Funding The study was partly funded by a research grant from NordForsk and the research funds of the University Hospital, Reykjavik, Iceland, and the Society for Rheumatology of Iceland.
Competing interests BG reports speaker's bureau from Amgen, Novartis and Pfizer, outside the submitted work. TJL reports personal fees from Celgene, outside the submitted work. The other authors have no competing interests to declare.
Patient consent for publication None required.
Ethics approval The study protocol was approved by the National Bioethics Committee and the Icelandic Data Protection Authority (VSNb2015120017/03.03).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Our data can be made available to other researchers if the research protocol is approved by the National Bioethics Committee and the Icelandic Data Protection Authority. However, due to our nation’s small population, the data would be identifiable if released in its entirety.
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