BREVACTA: SC Tocilizumab + DMARD Show Lasting Efficacy Up to Week 48
SAN DIEGO, CA—At the 2013 ACR/ARHP Annual Meeting, study authors presented data on subcutaneous (SC) tocilizumab that demonstrated long-term efficacy, including sustained ACR response rate and reduced joint damage progression over 48 weeks.
The BREVACTA study assessed the efficacy and safety of SC tocilizumab in patients with moderate-to-severe rheumatoid arthritis (RA) who had an inadequate response to >1 DMARD up to Week 24. Results showed that SC tocilizumab was superior compared with placebo, with a safety profile comparable to intravenous (IV) tocilizumab.
Alan Kivitz, MD, of the Altoona Center for Clinical Research, Duncansville, PA, and colleagues conducted an open-label extension study to report on the longer-term efficacy and safety data for SC tocilizumab up to Week 48. This was a Phase 3, randomized, multicenter, parallel-arm study that included a 24-week double-blind, placebo-controlled period followed by an open-label treatment for 72 weeks with an additional 8 weeks of safety follow-up.
Initially, patients were randomized 2:1 to receive SC tocilizumab 162mg or SC placebo every 2 weeks via a prefilled syringe, in combination with stable doses of pre-study DMARD(s).
At Week 24, patients remaining on the biweekly therapy in both arms were re-randomized 1:1 to receive open-label SC tocilizumab every 2 weeks via prefilled syringe or auto-injector pen. Efficacy was assessed to Week 48. Safety was assessed up to October 29, 2012 (when all patients had reached ≥Week 48) using adverse event reports and laboratory data.
A total of 437 patients were randomized at baseline to receive SC tocilizumab every 2 weeks, with 334 patients (76%) re-randomized at Week 24 to continue to receive SC tocilizumab every 2 weeks in the open-label phase.
Efficacy was maintained to Week 48, with the proportion of patients with ACR20 (62%), ACR 50 (45%), and ACR 70 (26%) responses. At Week 48, 45% of patients achieved clinical remission (DAS28 <2.6), and a clinically meaningful improvement in physical function (change from baseline in HAQ-DI ≥0.3) was seen in 62% of patients.
Mean reduction in radiographic progression of structural joint damage (measured as change in modified Total Sharp Score [mTSS]) was also maintained from Week 24 (0.62±2.692) to Week 48 (0.64±3.266). “The proportion of patients remained stable or improved from Week 24 to Week 48,” noted Dr. Kivitz.“Subcutaneous tocilizumab every 2 weeks is an effective treatment in rheumatoid arthritis and will offer an alternative route of administration and the possibility of self-administration,” concluded Dr. Kivitz. He added further that there was no change in the safety profile for SC tocilizumab compared with earlier evaluations and was consistent with that of IV tocilizumab.