Background/Purpose: Current guidelines consider MTX as initial gold standard treatment for patients (pts) with RA. They also propose various strategies for MTX inadequate responders, among which the most frequent are optimization of MTX therapy (alone or in combination with other csDMARDs or biological treatment). The objective of the trial was to explore the strategies applied in daily practice in RA pts with inadequate response to MTX.

Methods: STRATEGE is a prospective, observational, multicenter study. Main inclusion criteria were: confirmed RA diagnosis (ACR 1987 or ACR/EULAR 2010 criteria) and treatment by MTX monotherapy with clinical, structural, functional and/or therapeutic evolution leading to therapeutic management modification. Data were obtained at 2 time-points: baseline and 6-month follow-up.

Results: Between Sept 2014 and July 2015, 176 rheumatologists, at 90% with private practice, included 854 pts, 801 of which composed the analyzable baseline set. Pts baseline characteristics were [mean (SD)]: age: 57.4 (13.7) yrs; RA duration: 5.3 (6.7) yrs; DAS28: 4.0 (1.1), with the following distribution: <2.6 for 10%, >3.2 for 74% and >5.1 for 16%; HAQ: 1.1 (0.84); and extra-articular features and erosive disease for respectively 10.5% and 39.9% of pts. All pts were receiving MTX monotherapy, orally for 67.6% and at mean (SD) dose of 14.2 (4.1) mg/wk for oral and 16.6 (3.8) mg/wk for parenteral administration. Auto-injections were performed by 50.7% of pts treated parenterally. Concomitant treatment included corticosteroids for 45.8% of pts, at a mean (SD) dose of 8.2 (6.3) mg/d, and folic acid for 90.0%. After the inclusion visit, MTX prescription has been identically maintained (dose and route) for 28.1% of pts, interrupted for 1.9% and modified for 70.0%. Changes included dose increasing for 50.2%, dose tapering for 1.8% and a route modification for 21.4% (88.2% oral -> parenteral). After inclusion visit, MTX oral versus (vs) parenteral balance was respectively 49.8% at mean (SD) dose 16.2 (4.0) mg/wk vs 45.8%, 18.0 (3.9) mg/wk. Biologic treatment was initiated for 14.6%, in association with MTX for 95.7%. Other csDMARD treatment was initiated for 1.2% in monotherapy and for 3.6% in association with MTX. The reasons for treatment modification were mainly active RA (72.0%), worsening of clinical and biologic parameters (31.4%), radiographic progression (14.5%), remission not achieved (12.4%), steroid dependence (11.3%), and MTX intolerance 5.0%. Six-month follow-up results show that all the active treatment strategies were significantly and equally successful in improving disease activity (Table).

Conclusion: Consistently with all current guidelines, results of the large prospective observational French study STRATEGE reveal an important place held by initial MTX treatment optimization before initiation of a biotherapy and emphasize the importance of treat-to-target strategy.