Abstract
Background: T-cells are pathogenic in rheumatoid arthritis (RA) and have an important role in persistent synovitis, even in established disease. Modulation of T-cell activity by blocking of costimulatory signals has been known to suppress inflammation and improves prognosis in RA. This study aims to assess the effect of costimulation blockade with Abatacept in patients with RA who were refractory to conventional synthetic/biological disease modifying anti-rheumatoid drugs (csDMARDs, bDMARDs). Methods: In this prospective study, 63 patients with active disease, measured by the European League Against Rheumatism (EULAR) disease activity score (DAS28-erythrocyte sedimentation rate [ESR]) ≥3.2, who had failed conventional therapy with at least 2 csDMARDs and/or antitumour necrosis factor (anti-TNF) agents (Infliximab/Etanercept) either standalone, or in combination, were initiated on Abatacept in fixed doses, which was given on days 1,15, and 29 and repeated every 28 days for 11 months, after taking informed consent. Biomarkers comprising ESR and DAS28-ESR score were measured at baseline and repeated at the end of 3, 6, and 12 months. The primary end-point was the achievement of remission as defined by DAS28-ESR score ≤ 2.6. Results: Sixty-three patients completed 6 monthly follow-up whereas 57 patients completed 12 months follow-up (90% follow-up rate). DAS28-ESR declined significantly at 3 months (P = 0) and improvements were sustained at 6th and 12th month. Treatment was discontinued in three patients due to inadequate response, and three patients were lost to follow-up. Nearly 52.6% patients achieved primary end-point. Most common adverse effects reported during the study period were headache (14.2%) and upper respiratory tract infection (9.5%). Conclusions: Abatacept is an effective and well-tolerated treatment option for Indian RA patients with an inadequate response to csDMARDs and TNF antagonists.
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