Jonathan Kay, MD


July 12, 2013

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The AMPLE Trial

Hello. I'm Dr. Jonathan Kay, Professor of Medicine and Director of Clinical Research in the Division of Rheumatology at the University of Massachusetts Medical School and U Mass Memorial Medical Center, both in Worcester, Massachusetts. Today I am speaking to you from the 2013 European League Against Rheumatism (EULAR) Congress of Rheumatology here in Madrid, Spain. Thank you for joining me.

There were presentations on the AMPLE study,[1,2,3] which compared abatacept and adalimumab, each in combination with methotrexate for the treatment of rheumatoid arthritis. This comparative-effectiveness trial, which has been published in Arthritis & Rheumatism at an earlier stage, compared 2 biologic agents. However, the question remains as to what is the comparative effectiveness of traditional disease-modifying antirheumatic drug (DMARD) therapy with that of a biologic in patients who are inadequately responsive to methotrexate?

This specific question was addressed by a paper that was published online ahead of print in the New England Journal of Medicine[4] on June 11 of this year. This paper described a study in which Jim O'Dell and colleagues examined the effectiveness of triple therapy with hydroxychloroquine, sulfasalazine, and methotrexate compared with etanercept and methotrexate in patients with rheumatoid arthritis inadequately responsive to methotrexate, a clinical situation that we face commonly in practice.

This was a 48-week, double-blind, noninferiority trial conducted in 353 participants who were randomly assigned to either triple therapy or etanercept plus methotrexate. Patients had active rheumatoid arthritis despite methotrexate therapy. The patients who did not improve at 24 weeks according to a prespecified threshold of a decrease in the Disease Activity Score-28 (DAS28) of at least 1.2 were switched in a blinded fashion to the other therapy. The primary outcome was improvement in the DAS for 28 joints with a score ranging from 2 to 10. Higher scores indicate more disease activity.


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