golimumab vs PF-06410293

NCT00264537 · Phase 3 · completed

This trial was well designed -- randomized, fully blinded, and placebo-controlled with over 600 patients -- but its two main outcomes told different stories: the joint-damage (structural) outcome clearly favored golimumab plus methotrexate, while the joint-response (ACR50) outcome for the combined golimumab groups narrowly missed statistical significance against placebo, with only one of the individual dose comparisons reaching significance on its own. A well-designed trial with a split result on its co-primary outcomes does not qualify as strong evidence of benefit.

NCT02480153 · Phase 3 · completed

This was a randomized, quadruple-blind, active-controlled Phase 3 trial in 597 patients comparing PF-06410293 with adalimumab-EU on a hard clinical endpoint: ACR20 response at Week 12. The primary equivalence analysis succeeded, with the 95% confidence interval for the response rate difference falling entirely within the prespecified -14% to +14% margin (observed difference -2.98%, 95% CI -10.38% to 4.44%). The large sample size, blinding, active comparator, and met primary endpoint together provide strong evidence of equivalent efficacy.