Assessments of the unmet need in the management of patients with rheumatoid arthritis: analyses from the NOR-DMARD registry

Abstract

ObjectiveTo 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.MethodsData 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.ResultsThe 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).ConclusionAn 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 registrationClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT01581294.

Emerging Concepts and Challenges in Rheumatoid Arthritis Gene Therapy

“…Therapy with biologicals retards the progression of RA and preserves the functional status of involved joints. However, a significant fraction of patients with RA (10-20%) do not respond to any of the existing therapies [19]. Thus, attempts to find new targets for treating RA are ongoing.…”

Prevention and cure: The major unmet needs in the management of rheumatoid arthritis

“…However, despite the improved outcome for patients with RA, the majority of patients (up to 75%) do not achieve clinical remission (64). The percentage of patients achieving clinical remission is even lower when "sustained" remission (lasting at least six months) is taken into account (65)(66)(67).…”

Rheumatoid Arthritis Treatment. A Back to the Drawing Board Project or High Expectations for Low Unmet Needs?

“…Despite the many advantages of the csDMARDs, especially of MTX, they may still be used sub-optimally. Indeed, studies indicate that half of the RA patients discontinued MTX within the first 2 years of treatment and that MTX is frequently stopped rather than combined with other cs, b, or tsDMARDs [24]. Triple therapy combining MTX, HCQ, and SSZ may be a valuable alternative to the addition of b or tsDMARDs to MTX, in cases of inadequate response to MTX and in the absence of poor prognostic factors [35,36,37].…”

“…However, despite all this multilevel approach and progress in the field for RA diagnosis, monitoring and treatment, there are several reports in the literature showing that a significant number of RA patients does not achieve remission or LDA. This information comes from European and American registries as well as expert opinions, suggesting that there are still significant unmet needs for RA treatment [19,20,21,22,23,24,25].…”