Background In the last decade, biologic therapy changed dramatically treatment options for rheumatoid arthritis (RA). However, a significant number of patients failed to maintain the initial response to a TNF blocker. More information is needed regarding efficacy and safety of multiple courses of biologics administered over extended periods of time.
Objectives To assess the clinical benefit of subsequent courses with Rituximab (RTX) in patients with moderate to severe active RA after the failure to different TNF inhibitors used in routine clinical practice in Romania.
Methods In this open-label, multicenter, prospective observational study started in 2010, patients were treated with RTX at each 6 months. Clinical efficacy was assessed at baseline and after each retreatment course at 6, 12, 18, 24, 30 and 36 months. Clinical assessments included disease activity (DAS-28), visual analogue scale (VAS) scores, Δ DAS-28 and Δ VAS. The previous anti-TNF treatments were; adalimumab (ADA), etanercept (ETA) and infliximab (INF). Statistical analyses: STATA SE 11.0 software, Comparison between all treatments and evaluations ANOVA and Kruskal-Wallis and Nptrend for trend across evaluations.
Results A total of 1087 adult patients with active RA and inadequate response to at least one TNF inhibitor received initial RTX treatment. In our cohort, 929 (85.5%) patients had only one anti-TNF treatment (no switch); 210 (19.3%) patients received ADA, 318 (29.3%) received ETA and 401 (36.9%) received INF and the rest of 158 (14.5%) had more than one. As a second TNF inhibitor, 59 (5.42%) patients received ADA, 63 (5.79%) received ETA and 36 (3.31%) received INF. Median DAS-28 values for all patients (1087)and each groups ADA, ETA, INF as first TNF inhibitors were: 5.76; 6.05; 5.75; 5.66 at baseline, 3.98; 4.07; 4.11; 3.84 at 6 months, 3,43; 3.43;3.48; 3.33 at 12 months, 2.98; 3.00; 3.11; 2.89 at 18 months, 2.79; 2.72; 2.85; 2.75 at 24 months, 2.67; 2.55; 2.65; 2.69 at 30 months and 2.57; 2.56; 2.41; 2.6 at 36 months. The median DAS28 values for the group (158) who received a second TNF inhibitor, 5.66; 3.955; 3;56; 2.91; 2.85; 2.71 and 2.57 followed the same linear decrease across evaluations at baseline, 6;12;18;24;30 and 36 months. ANOVA test between treatment and evaluations P <0.0001, between previous treatment P =0.0014. DAS-28 score has been improved for all groups of patients, independent from the TNF – inhibitor used as previous treatment. The VAS score was improved in the same manner, independent to previous treatment. ANOVA test between treatment and evaluations P<0.0001, between evaluations P <0.0001, test between previous treatment P =0.0003.
Conclusions In our study, Rituximab have demonstrated to be a reliable therapeutic option for all patients regardless the TNF inhibitor used in first line (adalimumab, etanercept or infliximab).
Disclosure of Interest None declared