Pfizer today announced that a greater proportion of very early moderate to severe rheumatoid arthritis (RA) patients (VERA; disease duration ≤4 months) achieved clinical remission (DAS28<2.6) when treated with etanercept in combination with methotrexate compared with early RA patients (ERA; disease duration >4 months to 2 years). These new data from a one-year post hoc analysis of the landmark COMET study were presented today at the European League Against Rheumatism (EULAR) Annual Meeting in Rome, Italy.
“This analysis supports the potential benefit of very early and continuous combination etanercept and methotrexate treatment, beginning at or before four months of diagnosis, for moderately to severely active RA to reduce the signs and symptoms of this chronic condition,” said Professor Paul Emery, lead COMET trial investigator and Professor of Rheumatology, University of Leeds, UK.
“This exploratory analysis is important to our further understanding of the timing of intervention for moderate to severe RA patients.”
Observed data from the COMET trial were used for this post-hoc analysis to compare the proportions of VERA patients and ERA patients treated with etanercept plus methotrexate who achieved selected clinical (DAS28) and radiographic responses at one year. DAS28 is a measure of joint swelling and tenderness (based on 28 joints), as well as overall disease activity measured by a global health assessment and an objective marker of inflammation (erythrocyte sedimentation rate). DAS28 is a validated tool used in clinical trials. Radiographic responses are measurements of the inhibition of joint damage observed through X-rays. DAS28 clinical remission at one year was the primary endpoint for this study. At baseline, DAS28 scores for the VERA (6.6) and ERA (6.4) patients were not significantly different. DAS28 clinical remission does not mean a complete absence of disease activity or drug free remission.