Certolizumab inhibits radiographic progression in patients with early rheumatoid arthritis and high rheumatoid factor levels: a pooled, post-hoc analysis of the phase 3 C-EARLY and C-OPERA trials

Abstract

Objective: To assess radiographic progression in patients with early rheumatoid arthritis (RA) and poor prognostic factors treated with certolizumab pegol (CZP)+methotrexate (MTX) versus placebo (PBO)+MTX, stratified by rheumatoid factor (RF) level.

Methods: In a pooled, post-hoc analysis of phase 3 randomized trials (C-EARLY [NCT01519791] and C-OPERA [NCT01451203], patients were stratified by baseline RF level (low: <200 IU/mL; high: >= 200IU/mL). Change from baseline (Delta) in modified Total Sharp Score (mTSS) and components, predicted risk of RP, and disease activity are reported up to Week (Wk)52.

Results: Eight hundred and thirteen CZP+MTX-randomized (low RF: n=571; high RF: n=242) and 367 PBO+MTX-randomized (low RF: n=242; high RF: n=125) patients were included. Baseline characteristics were similar between treatments; however, patients with high RF had more severe disease. The proportion of patients with clinically meaningful radiographic worsening (Delta mTSS >5) at Wk24 was more comparable between patients with high and low RF levels randomized to CZP+MTX (low RF: 1.0% vs high RF: 0.0%) and was numerically lower than with PBO+MTX (2.8% vs 6.5%) and this pattern was maintained through Wk52. Clinical outcomes were generally favorable with PBO+MTX, but better with CZP+MTX. Conclusion: In MTX-na & iuml;ve patients with early RA, radiographic progression was more similar between CZP+MTX-treated patients with high and low RF levels, and consistently numerically lower, than PBO+MTX-treated patients. Irrespective of RF level, CZP+MTX better attenuated than MTX alone and was associated with more favorable clinical outcomes. Our findings suggest that RF level does not adversely influence radiographic response to CZP+MTX.