OP-0043 – In Early RA, Patients with a Good Initial Response to MTX Monotherapy Continue to Have Excellent Clinical Outcomes during the First Year of Therapy
van Vollenhoven, Emestam, Geborek, Petersson, Coster, Wallbrand, Zickert, Theander, Thorner, Hellstrom, Teleman, Dackhammer, Akre, Forslind, Ljung, Oding, Wornert, Bratt; Stockholm, Sweden
Objectives
Treatment strategy trials in RA, such as the BeSt trial, suggest a benefit of initial combination therapy in RA patients. However, a significant proportion of RA patients will achieve remission with methotrexate monotherapy alone, and would be overtreated with an initial combination regimen. The authors present findings from the SWEFOT trial for the patients with an initial good response to methotrexate monotherapy.
Methods
RA patients with active early (< 1 yr) disease were randomized to unblinded combination therapy with methotrexate + infliximab vs. triple therapy (methotrexate + sulfasalazine + hydroxychloroquine) if they had not achieved a low disease activity state during a 3-4 month run-in with rapidly dose-escalated methotrexate. For these analyses, patients who were not randomized due to low disease activity on methotrexate monotherapy were followed for clinical outcomes with assessments every 3 months during “usual care”.
Results
Of the 487 patients with moderate to high disease activity enrolled in the trial, 145(30%) achieved low disease activity or remission by 4 months on methotrexate monotherapy. On subsequent follow-up, 124 (86%) continued on methotrexate monotherapy without additional changes to their regimen through the first 12 months of follow-up. At the 12 month time point, 25% of initial responders were no longer in a low-disease activity state; although changing or adding DMARDs was rare (12%). Interestingly, absolute response rates were better for this group than for any of the groups subsequently randomized at any of the follow-up time points.
Conclusion
Initial rapid response to methotrexate monotherapy defines a subset of RA patients with early active disease that will tend to maintain their early response.
Editorial
Comment Publicity from early combination regimen trials, such as BeSt, and marketing efforts from pharmaceutical manufacturers may tempt the practitioner to recommend combination treatment for all new RA patients. This trial elegantly demonstrates that there is likely a benefit to giving methotrexate monotherapy a reasonable chance to demonstrate efficacy. Further effort is needed to identify the predictors of early sustained response to methotrexate monotherapy and whether there is any radiographic detriment. It should be emphasized that the methotrexate is dosed very aggressively in this trial, with patients up to at least 20 mg per week well before 3 months, which may be the key to ensuring a 30% response rate for monotherapy.
