Key ACTEMRA/RoACTEMRA publication summaries
Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study
Nishimoto N, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Azuma J.
Ann Rheum Dis 2009; 68:1580–1584.
The STREAM study was an open-label, long-term extension of a 3-month, randomised, double-blind, placebo-controlled, Phase II study, conducted in Japan and designed to evaluate the safety and efficacy of long-term (5 years) tocilizumab (TCZ) monotherapy for patients with RA.
Following the initial 3-month study, 143 of 163 patients entered the extension study and received TCZ 8 mg/kg every 4 weeks for the first 12 weeks; dose reductions and treatment interval changes were permitted thereafter. The use of prednisolone and one non-steroidal anti-inflammatory drug was also permitted.
Key study results are summarised below.
- High patient retention was observed. Overall, 76% of patients completed 3 years and 66% completed 5 years of the study.
- ACR response rates increased during the first year and then remained constant throughout the remainder of the study.
- ACR20/50/70 responses of patients completing 5 years were 84%, 69% and 44%, respectively.
- TCZ significantly improved all core measures, including swollen and tender joint counts, C-reactive protein levels, Health Assessment Questionnaire scores and DAS28 within the first year and the improvements were sustained throughout the 5-year study.
- Over half (55%) of patients completing the 5-year study achieved DAS28 remission and 89% of patients who were being treated with corticosteroids at baseline were able to reduce the mean dose from 6.9 mg/day to 2.4 mg/day at 5 years.
- Thirty-two percent had discontinued corticosteroids completely at 5 years.
- The serious adverse event rate was 27.5 events per 100 patient-years.
The authors conclude that this 5-year extension study clearly demonstrates the excellent long-term efficacy and generally good safety profile of TCZ monotherapy in patients with active RA.