Clinical Trials

Clinical Trials

The efficacy and safety of XELJANZ^® (tofacitinib) were tested in multiple studies, including two induction trials and one maintenance trial, that involved adult patients with moderate to severe ulcerative colitis who tried at least one type of medicine called steroids, immunosuppressants, or TNF blockers that did not work well or could not be tolerated. Of these patients, over 50% had previously tried and failed a TNF blocker, such as Remicade^® (infliximab) or Humira^® (adalimumab). Prior TNF-blocker failure was defined in these studies as inadequate response, loss of response, or intolerance. In each study, participants were given either XELJANZ or a sugar pill (placebo). They did not know which treatment they were receiving. Of the 1,139 participants included in the trial, 905 were treated with XELJANZ. Of the 593 participants who achieved clinical response in the induction trials and entered the maintenance trial, 395 were treated with XELJANZ.

OCTAVE Induction 1 And OCTAVE Induction 2 Studies

The first two clinical studies, known as OCTAVE Induction 1 (UC-I) and OCTAVE Induction 2 (UC-II), were identical. These Phase 3 placebo-controlled studies evaluated the efficacy and safety of XELJANZ in patients with moderate to severe ulcerative colitis (UC) who tried at least one type of medicine called steroids, immunosuppressants, or TNF blockers that did not work well or could not be tolerated. For 8 weeks in each study, 1,139 adults with moderate to severe UC were divided randomly into two groups and did not know if they received XELJANZ or a placebo.* (XELJANZ N = 598) (placebo N = 541)

In addition to evaluating the safety of XELJANZ, these studies measured:

• If patients achieved remission at 8 weeks
• If patients achieved improvement in the appearance of the lining of their colon at 8 weeks
• If patients achieved decreases in rectal bleeding and stool frequency in as little as 2 weeks

Results Of The Studies

_*Pooled data for OCTAVE 1 and OCTAVE 2. (placebo N = 234) (XELJANZ 10 mg N = 905).

Common side effects of XELJANZ in ulcerative colitis patients include nasal congestion, sore throat, runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, acne, diarrhea, and shingles (herpes zoster). Learn more about the Most Important Information you should know about XELJANZ.

OCTAVE Sustain Study

The third study, known as OCTAVE Sustain (UC-III), was used to assess XELJANZ as a maintenance treatment and involved patients who had achieved clinical response in either of the first two induction studies (UC-I and UC-II).

In addition to evaluating the safety of XELJANZ, this study measured:

• If patients were in remission at 1 year
• If patients achieved improvement in the appearance of the lining of their colon at 1 year
• If patients in remission at the beginning of the study were able to maintain steroid-free remission at both 6 months and 1 year

Results Of The Study

^*Prior TNF-blocker failure was defined in this study as inadequate response, loss of response, or intolerance.

Common side effects of XELJANZ in ulcerative colitis patients include nasal congestion, sore throat, runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, acne, diarrhea, and shingles (herpes zoster). Learn more about the Most Important Information you should know about XELJANZ.