Amgen and marketing partner Wyeth have been boosted by interim data from a study which shows that a combination of Enbrel and methotrexate is highly effective as a treatment for active early rheumatoid arthritis.

The findings from the 542-patient COMET study, which have been published in The Lancet, demonstrated that half of the patients treated with the combination of Enbrel (etanercept) and methotrexate achieved clinical remission and nearly all had no progression of joint damage. At one year, 50% of patients with active early moderate–to-severe RA who received the combo achieved clinical remission versus 28% of those treated with methotrexate alone.

Additionally, 80% of patients receiving Enbrel and methotrexate had no evidence of progression of joint damage as seen on x-ray, compared to 59% of those treated with methotrexate alone. Also, 61% of people treated with combination therapy demonstrated improvement in their functionality (versus 44% on only methotrexate) and the COMET trial also showed that patients on etanercept and methotrexate “had a nearly three-fold reduction in work stoppage”, the data revealed.

The study also showed that after one year, there were no differences in rates of serious infections or malignancies among patients taking both drugs, compared with just methotrexate. No cases of tuberculosis or demyelinating disease were reported and no new safety problems were identified.

Paul Emery of the University of Leeds and lead investigator on the COMET trial, said “we hope that these data encourage physicians to use clinical remission as a new standard for evaluating symptom control in the treatment of early RA”. He added that “clinical remission is highly relevant to patients’ daily lives as they cope with their symptoms”.

So more good news for Enbrel which had US sales of $951 million in the USA in the first quarter (+30%) and revenues in Europe, where Wyeth sells the drug, climbed 36% to $606 million. It is approved for RA and psoriasis.