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Study Compares Methotrexate-Only Versus Combination Therapy in Early RA

Kelly Davio
A recent study evaluated the treat-to-target strategy by assessing whether patients with early rheumatoid arthritis (RA) who start methotrexate as monotherapy had similar or worse outcomes compared with patients who started with adalimumab plus methotrexate.
Guidelines from the European League Against Rheumatism and the American College of Rheumatology recommend clinical remission (or low disease activity [LDA] if clinical remission is unlikely) as the treatment goal for a patient with rheumatoid arthritis (RA). While conventional disease-modifying antirheumatic drugs (DMARDs), including methotrexate, are recommended as part of an initial treatment strategy, if disease activity has not improved at 3 months, or a clinical target is not reached at 6 months, the addition of a biologic therapy, such as an anti–tumor necrosis factor (anti-TNF) is recommended.

A recent study published in Annals of the Rheumatic Diseases evaluated the treat-to-target strategy by assessing whether patients with early RA who start methotrexate as monotherapy, (followed by the anti-TNF agent adalimumab if they failed to achieve treatment goals with methotrexate alone), had similar or worse outcomes compared to patients who started with adalimumab plus methotrexate.

The 78-week, randomized, double-blind, phase 4 study included methotrexate-naïve patients who had active RA for more than 1 year. In the first study period, patients received methotrexate as monotherapy weekly (n = 460) or adalimumab at 40 mg every other week plus methotrexate weekly for 26 weeks (n = 466). In the second period, patients with stable LDA continued methotrexate as monotherapy or were re-randomized to adalimumab plus methotrexate for continuation or adalimumab withdrawal.

The researchers found the following:
  • A significantly greater proportion of patients initially treated with adalimumab plus methotrexate (53%) compared with patients treated with methotrexate monotherapy (30%) achieved LDA (defined as a Disease Activity Score-28, with C-reactive protein, of less than 3.2).
  • 45% of patients in the adalimumab plus methotrexate group, versus 33% of those in the methotrexate monotherapy group, achieved normal function (defined as a Health Assessment Questionnaire Disability Index score of less than 0.5).
  • 87% of patients in the adalimumab plus methotrexate group, versus 72% of the methotrexate monotherapy group, demonstrated radiographic non-progression at week 26.
  • From weeks 26 to 78, patients transitioned to adalimumab from methotrexate monotherapy achieved similar clinical and functional outcomes compared with patients initially treated with adalimumab plus methotrexate.
  • Significantly more patients initially treated with adalimumab plus methotrexate had no radiographic progression at weeks 52 and 78 versus patients initially treated with methotrexate (86% versus 72% for both time points).
The researchers concluded that starting treatment with methotrexate as monotherapy and adding adalimumab if a patient fails to respond adequately at 26 weeks allowed patients with early RA to achieve comparable long-term clinical, functional, and disease-activity outcomes as those who began initial adalimumab plus methotrexate combination therapy, and that this strategy helped to prevent overtreatment of patients with early RA.

 
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