Monday, September 21, 2015

Tofacitinib demonstrates efficacy in Phase 3 ulcerative colitis induction trials

Source:  UpdatesPlus-IBD
  • Pfizer has announced topline results from two identical OCTAVE induction studies
  • Both studies met their primary endpoints (remission at 8wks) The two studies evaluated oral tofacitinib (10mg BID) in 1139 patients with moderate/severe ulcerative colitis
  • Patients must have been previously been intolerant or unresponsive to corticosteroids, azathioprine/6 MP), or a TNFi
  • Pfizer's press release comments that that are no new AEs
  • A third study, OCTAVE Sustain investigating maintenance treatment with tofacitinib is anticipated by the end of 2016

Comments:  Obviously further data are required before tofacitinib can be more fully evaluated as an option in ulcerative colitis patients.  Safety is one issue, particularly as a 10mg dose was employed rather than the 5mg dose of tofacitinib approved as Xeljanz in the US for rheumatoid arthritis.  The absence of new AEs is promising, however it will be important to know the rate of known AEs.  This is not only important for ulcerative colitis; safety data may be important for use in psoriasis as well, since treatment with 10mg tofacitinib is required to produce non-inferior efficacy to that of Enbrel in the psoriasis study, OPT Compare.  The degree of efficacy in ulcerative colitis remains to be seen and particularly whether prior treatment history affects tofacitininb response.  It is unclear if OCTAVE will be presented at UEGW in October, from where we will be reporting.  The late breaker deadline was August 25. [Contact us if you are interested in our conference reporting service]

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