MedicalResearch.com Interview with:
Roy Fleischmann, MD MACR
Metroplex Clinical Research Center
Clinical Professor of Medicine
University of Texas Southwestern Medical Center
Dallas, TX 75231
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In the phase 3 studies of tofacitinib, it was noted that the clinical responses to tofacitinib monotherapy were higher than the responses to tofaciotinib plus MTX and that tofacitinib plus methotrexate had numerically higher clinical responses compared to adalimumab plus methotrexate. This study was a non-inferiority design which compared tofacitinib monotherapy to tofacitinib + MTX and to adalimumab +MTX and tofacitinib monotherapy to tofacitinib +MTX in MTX incomplete responders. It was found that tofacitinib + MTX is non-inferior to adalimumab + MTX (and vice versa) and neither was superior to the other. The results of tofacitinib to either combination was non-conclusive showing neither non-inferiority or inferiority, but suggesting that either combination will be effective in more patients in a group of patients.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: In a methotrexate incomplete responder, one can use either tofacitinib or adalimumab, both with MTX, and expect similar results in a group of patients.
It is better to add tofacitinib to MTX rather than switch to tofacitinib in these patients. If the patient cannot tolerate MTX, tofacitinib monotherapy is effective in a majority of patients. If the patient does well on the combination of tofacitinib + methotrexate, the physician can consider withdrawing MTX and many patients could continue to do well.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: What was not tested was whether tofacitinib is equally efficacious (non-inferior) to baricitinib, another JAK inhibitor. Although an interesting question, this study may never be done.
An ongoing study is testing the hypothesis that patients who do well on combination tofacitinib + MTX, maintain response when tofacitinib is withdrawn. This will be an interesting result.
Disclosures: Consultant and study grants from Pfizer, Lilly and AbbVie
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Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial
The Lancet , Volume 0 , Issue 0 16 June 2017
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