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Tocilizumab (Actemra), an interleukin-6 receptor inhibitor, may be effective in the treatment of patients with rheumatoid arthritis who have an inadequate response to anti-tumor necrosis factor-α therapy, according to research presented here at the 39th annual meeting of the American College of Clinical Pharmacology, Baltimore.
Tocilizumab (Actemra) (TCZ), an interleukin-6 receptor inhibitor, may be effective in the treatment of patients with rheumatoid arthritis (RA) who have an inadequate response to anti-tumor necrosis factor-α (anti-TNF-α) therapy, according to research presented here at the 39th annual meeting of the American College of Clinical Pharmacology, Baltimore.
In this analysis of the Research of Actemra Determining effIcacy after Anti-TNF failurEs (RADIATE) trial, a randomized, double-blind, phase 3 study, 489 patients with RA whose disease had failed treatment with 1 or more anti-TNF-α agent received either TCZ (4 or 8 mg/kg) or placebo every 4 weeks, plus methotrexate (10 to 25 mg/wk).
Primary efficacy outcome was American College of Rheumatology (ACR) 20 response at week 24. These responses were significantly better in patients receiving TCZ 8 mg and TCZ 4 mg compared with the control group (50%, 30.4%, and 10.1%, respectively; P≤.0001).
Remission based on mean disease activity scores based on 28 joints (DAS8) was also significantly greater in the TCZ 8-mg group compared with control (score <2.6; 30% vs 2%, respectively; P≤.0001).
The incidence of adverse events was similar in all 3 treatment groups (84% in TCZ 8 mg, 87% in TCZ 4 mg, and 81% in the control group). Serious adverse events were also similar in the 3 groups (6%, 7%, and 11%, respectively), as was the incidence of serious infection (5%, 2%, and 3%, respectively).
"Treatment with both doses of TCZ was significantly superior to control in achieving ACR20 response in patients with RA who had a previously inadequate response to anti-TNF-α therapy. Response to both doses of TCZ was rapid and was sustained throughout the study period. Improvement in ACR20 was seen as early as 2 weeks after therapy initiation," noted lead author Paul Emery, MD. Dr Emery is Arthritis Research Campaign professor of rheumatology, head of the Academic Unit of Musculoskeletal Medicine at the University of Leeds, and clinical director of rheumatology at the Leeds Teaching Hospitals Trust, UK.