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Treatment with Methotrexate Alone Yields Similar Outcomes to Combination Therapy in Early RA

VBCR - April 2018, Vol 7, No 1 - Rheumatoid Arthritis
Alice Goodman

 

Treatment with Methotrexate Alone Yields Similar Outcomes to Combination Therapy in Early RA By Alice Goodman

A post hoc analysis of the recent OPTIMA trial supports the current treat-to-target strategy for patients with early rheumatoid arthritis (RA) that is recommended by the American College of Rheumatology and the European League Against Rheumatism (Kavanaugh A, et al. Ann Rheum Dis. 2018;77:289-292). The goal of this strategy is clinical remission or low disease activity, and the recommendation is to initiate treatment with methotrexate, adding a biologic disease-modifying antirheumatic drug, such as a tumor necrosis factor inhibitor (TNFi), if disease activity is not improved at 3 months or clinical target is not attained within 6 months and the patient has unfavorable prognostic markers.

In their analysis of the trial, Arthur Kavanaugh, MD, Professor of Medicine and Director of the Center for Innovative Therapy at UCLA at San Diego, and colleagues found that treatment-naïve patients with early RA treated with methotrexate monotherapy according to the recommendations (adding rescue adalimumab when treatment was not successful), achieved good clinical outcomes compared with those who initiated therapy with metho­trexate plus adalimumab. Patients who initiated methotrexate monotherapy had accrual of slight radiographic damage at week 26 compared with those who started therapy with methotrexate plus adalimumab.

“Consistent with current recommendations, starting with MTX [methotrexate] monotherapy and optimising treatment by adding adalimumab after treatment failure at 26 weeks allowed patients with early RA to achieve long-term clinical, functional, and disease activity outcomes that were comparable to outcomes in patients who started with initial adalimumab + MTX combination therapy. This strategy also prevented potential overtreatment of approximately 25% of patients with RA,” the authors wrote.

OPTIMA was a randomized, double-blind, phase 4, 2-period clinical trial that enrolled patients with early active RA. In period 1, patients were treated with weekly doses of methotrexate alone or methotrexate weekly plus adalimumab 40 mg every other week for 26 weeks. In period 2, those with stable low disease activity continued methotrexate monotherapy or were randomly assigned to either continue with methotrexate plus adalimumab, or to withdraw from adalimumab treatment and continue on methotrexate monotherapy. Patients who did not achieve low disease activity in period 1 maintained treatments of methotrexate plus adalimumab, or received adalimumab newly added to their methotrexate monotherapy.

At week 26, 53% of the 466 patients treated with adalimumab plus methotrexate achieved good clinical results at week 26, compared with 30% of the 460 patients treated with methotrexate monotherapy. In addition, 45% of those treated with adalimumab plus methotrexate had good functional results, compared with 33% of those treated with methotrexate alone. Lastly, 87% of those treated with adalimumab plus methotrexate reported good radiographic outcomes, compared with 72% of those treated with methotrexate monotherapy.

From week 26 to week 78, patients who received adalimumab following methotrexate failure reported clinical and functional results similar to those who were initially treated with adalimumab plus methotrexate. Although fewer patients initially treated with adalimumab plus methotrexate experienced radiographic progression at weeks 52 and 78, the investigators noted that the 1-point difference on the radiographic scale translated to “a negligible extent of irreversible functional impairment at the group level.”

“In early RA, starting with MTX monotherapy and adding TNFi after 26 weeks yields similar longer term clinical results as starting with TNFi + MTX combination therapy but allows a small but significant accrual of radiographic damage,” Dr Kavanaugh and colleagues concluded.

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Last modified: May 4, 2018
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