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Patients' Time on Treatment Curve: Tofacitinib Monotherapy vs. Combination Therapy

Dr. Janet Pope  Featured
June 9 2016 10:52 PM ET via RheumReports RheumReports

Canadian authors including myself studied 12,000 patient-years of data from the open-label extension studies of the tofacitinib clinical trials (with follow-up to 7 years). This was part of a poster discussion group (Pope et al. #THUR0169). If you detect bias (good, bad or whatever, please let me know via RheumReports).

 What surprised me initially was a few things:

  • The durability of tofacitinib was the same with tofacitinib 5 mg bid (the approved dose) compared to 10 mg bid, which is only approved in 3 countries.

  • The durability was the same in the subsets of monotherapy and combination therapy (mostly with MTX) comparing tofacitinib at the two doses in those two subsets.

  • The chance of still taking tofacitinib looked similar in monotherapy and combination therapy.

  • The main reason for drop out was side effects.

  • However, no new safety signals or increased incidence of side effects (infection, malignancy, etc) were seen in the long-term users.

  • Herpes zoster rate in particular did not increase over time (it was consistent each year and more than expected versus patients with active RA, with approximately a 3-fold increase). Another presentation reported successful HZ immunization 2 weeks prior to starting either tofacitinib or placebo in patients with active RA.

  • The caveat is that patients receiving free ongoing treatment in an open-label extension study may be more (or less) apt to remain on treatment compared to real-world patients.

  • I wonder if the JAK inhibitors will have a class effect whereby monotherapy may be sufficient treatment (in some patients), and although there may be variable rates of HZ between JAK inhibitors, the incidence is higher than MTX users and higher compared to TNFi users.

  • We don't know if stopping MTX will affect tofacitinib responses and a study will need to be done to ask the question because in the extension studies, that question was not addressed.


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About the Author

Dr. Janet Pope
Dr. Janet Pope

Dr. Janet Pope is Professor of Medicine at Western University and Division Head of Rheumatology. Dr. Pope's research interests include epidemiologic studies in scleroderma, classification criteria in systemic sclerosis, systemic lupus erythematosus and rheumatoid arthritis.

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