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Clinical Summary

Meta-analysis: secukinumab safe, effective in rheumatoid arthritis

Takeaway

  • A meta-analysis finds that secukinumab, a monoclonal antibody against IL-17, is safe and most effective at doses of 150 mg in patients with rheumatoid arthritis (RA) who had an inadequate response to TNF inhibitors.

Why this matters

  • Findings may be used to expand secukinumab's approval by the FDA to include RA.

Study design

  • Meta-analysis of 3 phase 3 randomized, placebo-controlled trials (n=1292), after a search of PubMed, EMBASE, and Web of Science.
  • All 3 trials involved patients with inadequate response to TNF inhibitors and used 3 doses (150 mg, 75 mg, or placebo).
  • Outcomes were 20%/50%/70% improvement over placebo in American College of Rheumatology criteria (ACR20/ACR50/ACR70, respectively).
  • Funding: National Natural Science Foundation of China; others.

Key results

  • Secukinumab 150 mg vs placebo at 24 weeks:
    • ACR20 (risk ratio [RR], 1.66; P<.0001; I2=0%).
    • ACR50 (RR, 1.88; P=.0009; I2=0%).
    • ACR70 (RR, 2.15; P=.02; I2=0%).
  • Secukinumab 75 mg vs placebo at 24 weeks:
    • ACR20 (RR, 1.62; P<.0001; I2=0%).
    • ACR50 and ACR70 were nonsignificant.
  • Secukinumab (pooled 150 and 75 mg) vs placebo at 24 weeks:
    • ACR20 (RR, 1.64; P<.00001; I2=0%).
    • ACR50 (RR, 1.77; P=.006; I2=30%).
    • ACR70 (RR, 2.03; P=.02; I2=0%).
  • No differences between placebo and pooled secukinumab group (150 and 75 mg) in adverse events (AEs) and serious AEs (overall RRs, 1.13 [P=.18] and 1.19 [P=.63], respectively).

Limitations

  • Moderate heterogeneity.

References


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