Contrary to American College of Rheumatology recommendations, analysis of data from a clinical trial reveals methotrexate monotherapy as the best initial treatment for early rheumatoid arthritis that has a poor outlook.
O'Dell JR, Curtis JR, Mikuls TR et al., Validation of the Methotrexate-First Strategy in Patients With Early, Poor-Prognosis Rheumatoid Arthritis: Results From a Two-Year Randomized, Double-Blind Trial.Arthritis & Rheumatism. (2013) 65:1985–1994.
Post hoc analysis of data from a clinical trial not only confirms methotrexate (MTX) monotherapy as the best first-line therapy for early rheumatoid arthritis (RA) patients with a poor prognosis, but also shows patients starting on MTX alone fare just as well as -- if not better than -- those given immediate combination therapy.
Researchers conducted the Treatment of Early Rheumatoid Arthritis (TEAR) trial in two stages, testing 755 patients with early RA. They first randomized the participants into one of four treatment groups:
• MTX monotherapy
• MTX plus the TNFα inhibitor etanercept
• Triple therapy with MTX and the DMARDS sulfasalazine and hydroxychloroquine
• MTX alone with the option to step up to a combination therapy at 24 weeks
Retrospective information from two comparator groups informed the post-hoc analysis:
• Patients needing step-up therapy
• Patients given immediate combination therapy
Their DAS28-ER and radiographic progression scores (modified Sharp/van der Heijde) were compared at 48 and 102 weeks.
Overall, 28% of participants on MTX alone (n=89) had DAS28-ESR scores <3.2 at 24 weeks and did not need step-up therapy with potentially costly or toxic medication. These outcomes were similar to those among the patients who initially took combination therapy.
Among good responders to MTX, DAS28-ESR scores remained significantly lower at 36 weeks and nominally lower through 102 weeks.
There were no differences in adverse events across the treatment arms.
The researchers conclude that, although current American College of Rheumatology recommendations call for RA patients with poor prognoses to start with combination therapy, MTX monotherapy is clearly the most practical approach. This “will need to be considered when these recommendations are updated,” they add.