Date: 2012-07-27
Type of information:
phase: 3
Announcement: results
Company: Roche (Switzerland)
Product: RoActemra® (tocilizumab)
Action
mechanism: RoActemra® (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody.
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial
details: BREVACTA is a randomised, double-blind, parallel-group study of RoActemra® SC versus placebo SC in combination with traditional DMARDs in patients with moderate to severe, active RA who had an inadequate response to DMARD therapy. BREVACTA was designed to assess the efficacy of treatment with RoActemra® 162 mg SC given every 2 weeks versus placebo given every 2 weeks, both in combination with DMARDs, based on ACR20 response at Week 24. Safety profile was assessed with regard to adverse events and laboratory assessments.
656 patients were randomly assigned in a 2:1 ratio to two treatment groups at baseline. 437 patients received RoActemra® / SC (Group A) every two weeks administered with a prefilled syringe (PFS) and 219 received placebo SC (Group B) every two weeks with a PFS. All patients continued their background DMARD therapy. At Week 24 patients were re-randomised to continue receiving administration with the PFS or to change to administration with an autoinjector (AI). Furthermore all patients on placebo were switched to receive RoActemra® SC 162mg every two weeks. Secondary endpoints included assessment of prevention of progression of structural joint damage at week 24 between the two groups, ACR50 and 70, DAS28 response, DAS28 low disease activity and DAS28 remission.
Latest
news: Roche has announced that the BREVACTA study of RoActemra® (tocilizumab, known as Actemra® outside Europe) given as a subcutaneous (SC) injection to patients with rheumatoid arthritis met its primary endpoint. After 24 weeks of treatment, rheumatoid arthritis patients who received RoActemra® every two weeks were significantly more likely to have experienced at least a 20% improvement in tender and swollen joint counts than those given placebo injections (ACR20). Preliminary safety analysis showed that the adverse event profile of RoActemra® SC was consistent with previous findings.
BREVACTA is the second positive study of an SC formulation of RoActemra® and follows results reported in May from the SUMMACTA study. Roche intends to submit these data with health authorities globally to gain approval for the SC formulation of RoActemra®.
Analysis of X-ray results, a secondary endpoint in BREVACTA, also showed patients who received RoActemra® (SC every two weeks were significantly less likely to have experienced worsening joint damage at week 24 than those given a placebo SC injection in combination with DMARDs. Statistical significance was also achieved on other key secondary endpoints including ACR50 and 70, DAS28 low disease activity and DAS28 remission. Data from BREVACTA will be submitted for presentation at an upcoming medical meeting.
