Pfizer Inc. (NYSE: PFE) 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).¹  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. 

Clinical Response

Nearly 70 percent of the 63 VERA patients who were treated with etanercept plus methotrexate achieved DAS28 clinical remission at one year, as compared with nearly 48 percent of the 157 ERA patients treated with the same combination therapy (P=0.0035).  Among those treated with methotrexate alone, only 35 percent of the 49 VERA patients and 32 percent of the 148 ERA patients achieved DAS28 clinical remission (P=0.7037).   

Radiographic Inhibition

In both groups (VERA and ERA), 80 percent of patients treated with etanercept plus methotrexate experienced no radiographic progression of joint damage at one year, as measured by a change in the modified Total Sharp Score (mTSS ≤0.5).  The mean change from baseline mTSS was 0.31 in VERA patients and 0.21 in ERA patients (P=0.8476).  Treatment with methotrexate alone resulted in 74 percent of the 46 VERA patients with radiographic non-progression compared to 50 percent of the 142 ERA patients reaching this criterion (P=0.0055).  

ABOUT THE COMET TRIAL

The COMET trial (COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis) was a 24 month, randomized, double blind, two period study to evaluate the efficacy and safety of the combination of etanercept and methotrexate and methotrexate alone in subjects with early moderate to severe rheumatoid arthritis.  During the first year of the COMET trial, patients with moderate to severe RA (DAS28≥3.2) received either 50 mg of etanercept weekly and up to 20 mg of methotrexate weekly or methotrexate alone. 

In the COMET trial, there were no differences in rates of serious infections or malignancies among patients in the etanercept plus methotrexate group compared with the methotrexate-only group.  No cases of tuberculosis or demyelinating disease were reported. 

In other RA clinical trials of etanercept, the most common adverse events were injection site reaction, infection and headache.  Rare cases of tuberculosis and demyelinating diseases have been reported in post-marketing surveillance.  

ABOUT RHEUMATOID ARTHRITIS

Rheumatoid arthritis is a chronic inflammatory disease that affects millions of people worldwide, and may get worse over time if not treated effectively, causing permanent damage to joints, deformity, loss of independence and work disability. 

ABOUT ENBREL

For full information about ENBREL, go to:  http://www.ema.europa.eu/humandocs/PDFs/EPAR/Enbrel/emea-combined-h262en.pdf  

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