Waiting to add a tumor necrosis factor inhibitor to therapy in patients with early, active rheumatoid arthritis (RA) who are initially treated with methotrexate (MTX) alone but have not met treatment targets at 26 weeks does not affect long-term outcomes and may prevent overtreatment, according to a study published in the Annals of the Rheumatic Diseases.
This 78-week, randomized, double-blind, phase 4 study (Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis [OPTIMA]; ClinicalTrials.gov identifier: NCT00420927) was conducted in methotrexate-naive patients with active RA for less than a year. OPTIMA compared 466 patients who were initially treated with a combination of adalimumab+MTX in 460 patients who received MTX alone and subsequently had adalimumab added to their therapy if they had not met treatment targets by week 26.
Compared with patients receiving MTX alone, greater proportions of patients receiving adalimumab+MTX achieved good clinical (53% vs 30%, respectively), functional (45% vs 33%, respectively), and radiographic (87% vs 72%, respectively) outcomes by week 26.
However, patients who received add-on therapy with adalimumab achieved similar clinical and functional outcomes compared with patients who initially received the combination of adalimumab+MTX from weeks 26 to 78.
Although significantly more patients who received the combination initially had no further radiographic disease progression compared with patients who were initially treated with MTX alone at weeks 52 and 78, these mean differences were not considered to be clinically relevant.
The authors concluded that, “Consistent with current treatment recommendations, starting with MTX monotherapy and optimising treatment by adding adalimumab after treatment failure at 26 weeks allowed patients with early RA to achieve comparable long-term clinical, functional and disease activity outcomes with patients who started with initial adalimumab+MTX combination therapy. This strategy also prevented potential overtreatment of approximately 25% of patients with early RA.”
The OPTIMA trial was funded by AbbVie, the manufacturer of adalimumab.
Kavanaugh A, van Vollenhoven R, Fleischmann RM, et al. Testing treat-to-target outcomes with initial methotrexate monotherapy compared with initial tumour necrosis factor inhibitor (adalimumab) plus methotrexate in early rheumatoid arthritis [published online November 16, 2017]. Ann Rheum Dis. doi:10.1136/annrheumdis-2017-211871