Subcutaneous Tocilizumab in Monotherapy or in Combination With Nonbiologic Disease-Modifying Antirheumatic Drugs in Latin American Patients With Moderate to Severe Active Rheumatoid Arthritis: A Multicenter, Phase IIIb Study.

Abstract

To assess the efficacy and safety of subcutaneous tocilizumab (TCZ) in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in Latin American patients with rheumatoid arthritis (RA) and inadequate response to previous csDMARDs. ML28700 was a multicenter, open-label, single-arm trial. Previously treated RA patients who had not received treatment with TCZ or any biological agent (n = 284) and with a baseline Disease Activity Score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) of 3.2 or greater were assigned to receive subcutaneous TCZ (162 mg/wk) in association with csDMARD for 24 weeks. Patients who achieved remission (DAS28-ESR <2.6) at week 24 continued with TCZ as monotherapy until week 52; otherwise, they continued with their assigned treatment. The primary efficacy end point was remission rate (DAS28-ESR <2.6) at weeks 24 and 52. Secondary objectives included disease activity scores, safety, and quality of life. At week 24, a total of 169 patients (59.5%; 95% confidence interval, 53.5%-65.3%) achieved remission, 91 patients (32.0%) had low disease activity, and 46 patients (8.4%) were not responders. Sustained remission at week 52 was achieved by 80.8% (n = 126) of patients who continued with TCZ monotherapy versus 44.6% (n = 37) of those on combination therapy. A total of 241 patients (84.9%; 95% confidence interval, 80.2%-88.8%) had at least 1 adverse event during follow-up. Adverse events led to drug modification in 32 patients (11.3%) or discontinuation in 21 patients (7.4%). Subcutaneous TCZ is an efficacious therapy with long-lasting results and tolerable adverse events in Latin American patients with RA.Trial registration no.: NCT02011334 Tozura Study Program.