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  • Title: Less radiographic progression with adalimumab plus methotrexate versus methotrexate monotherapy across the spectrum of clinical response in early rheumatoid arthritis.
    Author: Emery P, Genovese MC, van Vollenhoven R, Sharp JT, Patra K, Sasso EH.
    Journal: J Rheumatol; 2009 Jul; 36(7):1429-41. PubMed ID: 19369462.
    Abstract:
    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, 28-joint Disease Activity Score (DAS28), or remission-like state [tender joint count (TJC) = 0; DAS28 < 2.6; swollen joint count = 0; ACR100] at 26 and 104 weeks. Radiographic progression was assessed by cumulative probability plots, mean changes in total Sharp score (DeltaTSS), and percentages of progressors (DeltaTSS > 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 (DeltaTSS <or= 0.5) remission was significantly more frequent at Week 104 with adalimumab 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.
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