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 - 08/10/26
, Peter C. Taylor b, Gerd Burmester c, Yoshiya Tanaka d, Tsutomu Takeuchi e, f, Jeffrey R. Curtis g, Clementina Lopez-Medina h, William H. Robinson i, j, Thomas Huizinga k, Paul Mahoney l, Bernard Lauwerys m, Baran Ufuktepe m, Ted R. Mikuls nHighlights |
• | We conducted post-hoc analyses on 2 phase 3 trials in MTX-naïve patients with early RA. |
• | We compared CZP + MTX vs PBO + MTX, stratified by high vs low RF level. |
• | Radiographic worsening was low through 52 weeks with CZP + MTX. |
• | High RF level did not adversely influence radiographic progression with CZP + MTX. |
• | CZP + MTX may be more effective than MTX alone in MTX-naïve patients with early RA. |
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: ≥ 200 IU/mL). Change from baseline (Δ) 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 (ΔmTSS > 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-naïve 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.
Le texte complet de cet article est disponible en PDF.Keywords : Rheumatoid arthritis, Radiographic progression, Certolizumab pegol, Rheumatoid factor, C-EARLY, C-OPERA
Plan
Vol 93 - N° 5
Article 106087- octobre 2026 Retour au numéro
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