Less Radiographic Progression with Adalimumab Plus Methotrexate Versus Methotrexate Monotherapy Across the Spectrum of Clinical Response in Early Rheumatoid Arthritis

Objective. To determine the relationship between radiographic progression and clinical response for adalimumab plus methotrexate (MTX) versus either monotherapy in patients with early rheumatoid arthritis (RA) in the PREMIER study. Methods. Patients with early RA who received adalimumab Plus MTX (n = 240), adalimumab (n 222), or MTX (n = 216) were grouped by American College of Rheumatology (ACR) response, 29-joint Disease Activity Score (DAS28), or remission-like state [tender joint count (TJC) = 0; DAS28 < 2.6; swollen joint Count = 0: ACR 1001 at 26 and 104 weeks. Radiographic progression was assessed by cumulative probability plots. mean changes in total Sharp score (Delta TSS). and percentages of progressors (Delta TSS > 0.5). Results. Across the spectrum of clinical Outcomes, including ACR20 nonresponses and remission-like responses. therapy with adalimumab plus MTX permitted less radiographic progression at Weeks 26 and 104 than MTX monotherapy. Adalimumab monotherapy was generally intermediate. A strong. proportional relationship was observed between clinical response and radiographic efficacy only for MTX monotherapy. The monotherapies approximated the radiographic efficacy of adalimumab Plus MTX only among remission-like responders, although progression was significantly greater with MTX monotherapy versus adalimumab plus MTX for patients with TJC = 0. Concurrent clinical (DAS28 < 2.6) and radiographic (Delta TSS :5 0.5) remission was significantly more frequent at Week 104 with adalimurnab Plus MTX (45%) than with adalimumab (25%) or MTX (18%) monotherapy. Conclusion. In patients with early RA, adalimumab plus MTX resulted in less radiographic progression than MTX monotherapy across the Spectrum of clinical response, including ACR20 non-responses and remission-like responses. (First Release April 15 2009 J Rheumatol 2009:36: 1429-41; doi: 10.3899/jrheum.081018)