Assessments of the unmet need in the management of patients with rheumatoid arthritis: analyses from the NOR-DMARD registry. (30th November 2018)

• Record Type: Journal Article
• Authors: Olsen, Inge C; Lie, Elisabeth; Vasilescu, Radu; Wallenstein, Gene; Strengholt, Sander; Kvien, Tore K
• Is Part Of: Rheumatology. Volume 58:Number 3(2019)
• Page Start: 481
• Page End: 491
• Publication Date: 2018-11-30
• Subjects: rheumatoid arthritis -- real-world data -- registry -- NOR-DMARD -- biologic disease-modifying antirheumatic drugs -- MTX; Rheumatism -- Periodicals; Rheumatology -- Periodicals; 616.723005
• DOI: 10.1093/rheumatology/key338
• Languages: English
• ISSNs: 1462-0324

Abstract

Abstract: Objective: To describe the outcomes of MTX and biologic DMARD (bDMARD) treatment in patients with RA and assess unmet needs in patients who fail treatment, using real-world data from the Norwegian DMARD (NOR-DMARD) registry. Methods: Data included RA treatment courses from January 2007 until July 2016. Patients received MTX monotherapy (in MTX-naïve patients), bDMARD monotherapy, bDMARDs + MTX, or bDMARDs + other conventional synthetic DMARDs (csDMARDs). DAS28-4(ESR) was used to measure remission (<2.6) and inadequate response (>3.2) across all groups at Months 6 and 12. Estimated ACR20/50/70 and EULAR good and good/moderate response rates (based on DAS28-4[ESR] score) for bDMARDs were modelled at Months 6 and 12 using logistic mixed regression. DAS28-4(ESR) scores and changes from baseline, and rates and reasons for discontinuation, were evaluated for all groups over 24 months. Results: The 2778 treatment courses in this analysis included 714 MTX monotherapy, 396 bDMARD monotherapy, 1460 bDMARDs + MTX and 208 bDMARDs + other csDMARDs. Of patients with DAS28-4(ESR) data at Months 6 and 12 (25.0–34.1%), 33.9–47.2% did not switch treatment and were inadequate-responders at Month 12. There were no significant differences in efficacy between bDMARD groups (bDMARD monotherapy, or bDMARDs + MTX or other csDMARDs). Lack of efficacy was the most common reason for stopping treatment across all groups (13.7–22.1% over 24 months). Conclusion: An unmet treatment need exists for patients still experiencing inadequate response to MTX monotherapy and bDMARDs as monotherapy or in combination with MTX/other csDMARDs after 12 months. Trial registration: ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT01581294 .