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Clinical Trials

XELJANZ is approved to treat adults with moderate to severe ulcerative colitis when 1 or more TNF blockers did not work well or cannot be tolerated.

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.

Clinical study participants
Remission (few to no symptoms) was measured using the Mayo score
Efficacy and safety evaluated in multiple studies
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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:

Results Of The Studies

XELJANZ relieved some symptoms of UC as early as 2 weeks*

In these studies, decreases in rectal bleeding and stool frequency were experienced by patients in as little as 2 weeks. Individual results may vary.

XELJANZ helped patients achieve remission at 8 weeks*

Remission at 8 weeks. 18% of patients taking 10 mg of XELJANZ twice daily achieved remission at 8 weeks compared to 6% of patients taking placebo.

Improvement in appearance of intestinal lining. 30% of patients taking 10 mg of XELJANZ twice daily had improvement in the appearance of the intestinal lining at 8 weeks compared to 14% of patients taking placebo.

Clinical response at 8 weeks. 58% of patients taking 10 mg of XELJANZ twice daily experienced a clinical response at 8 weeks compared to 31% of patients taking placebo.

*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, 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:

Results Of The Study

XELJANZ has been proven to provide long-term remission at 1 year

Remission at 1 year. 41% of patients taking XELJANZ 10 mg twice daily (N = 197) and 34% of patients taking XELJANZ 5 mg twice daily (N = 198) were in remission when measured at 1 year as compared to those taking placebo (11%). (placebo N = 198)

Sustained steroid-free remission. Among patients in remission at the beginning of the study, 47% of patients taking XELJANZ 10 mg twice daily (N = 55) and 35% of patients taking XELJANZ 5 mg twice daily (N = 65) achieved sustained steroid-free remission, as compared with those taking placebo (5%). (placebo N = 59)

Sustained steroid-free remission in patients who failed on a TNF blocker,* like Remicade or Humira. Among patients in remission at the beginning of the study, 39% of patients taking XELJANZ 10 mg twice daily (N = 18) and 22% of patients taking XELJANZ 5 mg twice daily (N = 18) achieved steroid-free remission at both 6 months and 1 year as compared with those taking placebo (5%). (placebo N = 21)


*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, diarrhea, and shingles (herpes zoster). Learn more about the Most Important Information you should know about XELJANZ.

Talking To Your Doctor

No matter how long you’ve had UC, talking about it can feel difficult. But every appointment with your doctor is an opportunity to discuss your UC symptoms and treatment options. Use our list of questions to help start the conversation.

Get Helpful Questions

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