FRI0575 The Unmet Need in The Norwegian Disease-Modifying Antirheumatic Drug Registry
Authors: I.C. Olsen, T.K. Kvien, E. Lie, R. Vasilescu, G. Wallenstein, S. Strengholt
Journal: Annals of the Rheumatic Diseases (2016)

<h3>Background</h3> Until 2012, the Norwegian disease-modifying antirheumatic drug (NOR-DMARD) registry included patients (pts) initiating treatment (trt) with conventional synthetic DMARDs (csDMARDs) and biologic DMARDs (bDMARDs). The revised NOR-DMARD protocol, implemented 2012–2013, includes bDMARDs only. <h3>Objectives</h3> Describe the outcomes of methotrexate (MTX) therapy and define the unmet need for further trt options for RA pts after MTX failure in the NOR-DMARD registry. <h3>Methods</h3> These analyses are based on data from two phases (P) of the NOR-DMARD registry: P1 – pts on csDMARDs and bDMARDs (2007–2011); P2 – pts on bDMARDs only (2012–2015). Using different selection criteria from P1 pts, MTX trt outcomes were assessed as follows: % of pts with inadequate response (IR) to MTX (defined as disease activity score 28–4 erythrocyte sedimentation rate [DAS28]&gt;3.2 at 6 months [mo]); reasons for MTX discontinuation (D/C); % of MTX-IR pts remaining on trt despite DAS28&gt;3.2 or DAS28&gt;5.1. ACR20/50/70 and EULAR good/moderate response rates were assessed using P1 and P2 data in pts receiving bDMARDs as monotherapy (mono), +MTX or +other csDMARDs. Results are presented using descriptive statistics from non-imputed observations. <h3>Results</h3> P1 and P2 included a total of 2698 and 709 RA trt courses, respectively. Of 780 MTX-naïve pts starting MTX mono in P1, 429 (42.9%) had DAS28&gt;3.2 at 6 mo; 381 of the 780 pts had available DAS28 data at Mo 12, and 30.9% pts had DAS28&gt;3.2 at 12 mo. Furthermore, 58.2% of pts who had DAS28&gt;3.2 at 6 mo remained at DAS28&gt;3.2 at 12 mo. 1364 pts were treated with any csDMARDs in P1, 28/1364 pts had DAS28&gt;5.1 for two consecutive visits and remained on trt. In P1 pts previously exposed to MTX starting any trt other than MTX mono (N=1388), 1005 pts had a reason for MTX D/C listed; 489/1005 (48.7%) pts D/C due to side effects. P1 included 1331 bDMARD trt courses: 279 (21.0%) as mono, 938 (70.5%) +MTX and 114 (8.6%) +other csDMARD. In P2 there were 709 trt courses with bDMARDs: 229 (32.3%) as mono, 413 (58.3%) +MTX and 67 (9.3%) +other csDMARD. In P1, bDMARD mono pts had slightly higher baseline disease activity and slightly worse patient-reported outcomes. In P2, baseline demographics and characteristics were generally similar across trt groups (gps). EULAR and ACR responses at Mo 6 were generally comparable across trt gps in P1, although the bDMARD+other csDMARD gp had numerically higher ACR70 and lower EULAR good responses vs other gps. In P2, ACR20 and ACR50 responses were generally similar between bDMARD trt gps at Mo 6. At Mo 6, numerically more pts on bDMARD mono (18.4%) achieved ACR70 vs bDMARD+MTX (10.7%) and bDMARD+other csDMARD (5.9%); similar results were also observed for EULAR good/moderate responses. % of pts with DAS28 remission at Mo 6 were 54.4% for bDMARD mono; 45.7% for bDMARD+MTX; and 50.0% for bDMARD+other csDMARD (Table). <h3>Conclusions</h3> Data from the NOR-DMARD registry showed that &gt;40% of MTX-treated pts had not achieved DAS28 low disease activity 6 mo. Despite pts advancement to bDMARDs, almost 50% failed to reach DAS28 remission at follow-up. This demonstrates substantial unmet medical need for pts with moderate to severe RA. Trt grp comparisons will be further explored. <h3>Acknowledgement</h3> Sponsored by Pfizer Inc. Editorial support provided by CMC (funded by Pfizer Inc). <h3>Disclosure of Interest</h3> I. Olsen: None declared, T. Kvien Consultant for: AbbVie, BMS, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Hospira, Merck-Serono, MSD, Novartis, Orion Pharma, Pfizer Inc, Roche, Sandoz, UCB, Speakers bureau: AbbVie, BMS, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Hospira, Merck-Serono, MSD, Novartis, Orion Pharma, Pfizer Inc, Roche, Sandoz, UCB, E. Lie Consultant for: AbbVie, Bristol-Myers Squibb, Hospira, Pfizer inc, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Hospira, Pfizer inc, UCB, R. Vasilescu Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, G. Wallenstein Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, S. Strengholt Shareholder of: Pfizer Inc, Employee of: Pfizer Inc