Rheumatoid Arthritis: Oral JAK Inhibitor Tofacitinib May Be Superior to Methotrexate

Bethanie Wilkinson, Ph.D. Pfizer  445 Eastern Point Rd. Groton, CT 06340MedicalResearch.com Interview with
Bethanie Wilkinson, Ph.D.
Pfizer
445 Eastern Point Rd.
Groton, CT 06340

 

MedicalResearch: What are the main findings of the study?

Dr. Wilkinson: ORAL Start showed that XELJANZ (tofacitinib citrate) 5 and 10 mg twice daily (BID), taken by itself without methotrexate (MX), inhibited the progression of structural damage and reduced the signs and symptoms of rheumatoid arthritis (RA), and was statistically significantly superior to methotrexate on these measures at Month 6 (primary endpoint) and at all measured time points up to 24 months in patients with rheumatoid arthritis who had not previously received methotrexate or therapeutic doses of methotrexate.  XELJANZ is not indicated in patients who had not previously received methotrexate.

  •  Both doses of XELJANZ met the study’s co-primary efficacy endpoints of mean change from baseline in van der Heijde modified Total Sharp Score (mtss) [0.18 and 0.04 (both P<0.001) for tofacitinib 5 and 10 mg BID, respectively, versus 0.84 for MTX], and ACR70 response rates [25.5% and 37.7% for tofacitinib 5 and 10 mg BID (both P<0.001) versus 12.0% for MTX], at Month 6.
  • These results were sustained at all measured time points up to 24 months.

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Using Electronic Medical Records to Follow Methotrexate Side Effects

Gabriela Schmajuk M.D. M.S. Department of Medicine (Rheumatology) University of California, San Francisco San Francisco VA Medical Center San Francisco, CA 94121MedicalResearch.com Interview with:
Gabriela Schmajuk M.D. M.S.
Department of Medicine (Rheumatology)
University of California, San Francisco
San Francisco VA Medical Center
San Francisco, CA 94121

MedicalResearch.com: What are the main findings of the study?

Dr. Schmajuk: Our main findings were that moderate LFT abnormalities were uncommon
in the first 7 months of methotrexate use among new users, and more
likely to occur in patients with obesity, untreated high cholesterol,
pre-methotrexate LFT elevations, biologic agent use, and lack of folic
acid supplementation.
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Rheumatoid Arthritis: Are Two Drugs Better than One?

Dr Janet E Pope Division of Rheumatology, Department of Medicine The University of Western Ontario, St Joseph's Health Centre 268 Grosvenor Street, London, ON, Canada N6A 4V2MedicalResearch.com Interview with:
Dr. Janet E Pope
Division of Rheumatology, Department of Medicine
The University of Western Ontario, St Joseph’s Health Centre
268 Grosvenor Street, London, ON, Canada N6A 4V2

 

MedicalResearch.com: What are the main findings of the study?

 Dr. Pope: We performed a RCT of patients who were stable for 6 months of etanercept added to methotrexate (inadequate responders to Mtx) who were randomized to stopping Mtx or continuing Mtx to determine if in the next 6 months (and later as the trial continues) the response rate would be the same if Mtx was discontinued. Overall, Mtx + etanercept was not statistically equivalent to etanercept alone (ie non-inferiority did not occur); implying 6 months after stopping Mtx, the etanercept patients on monotherapy performed slightly less well than those on combination therapy.
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