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



OCTAVE Induction 1 And OCTAVE Induction 2 Studies
The first two clinical studies, known as OCTAVE Induction 1
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
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
Remission is a time when you experience few to no symptoms of UC and UC symptoms are under control. In these clinical studies, remission was defined and measured using the Mayo score.
Improvement in appearance of intestinal lining. 30% of patients taking
Clinical response at 8 weeks. 58% of patients taking
Clinical response is one way to determine if a patient’s condition improves with the treatment being studied. In these studies, clinical response was measured using the Mayo score.
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
OCTAVE Sustain Study
The third study, known as OCTAVE Sustain in either of the first two induction studies (UC-I and UC-II).
Clinical response is one way to determine if a patient’s condition improves with the treatment being studied. In these studies, clinical response was measured using the Mayo score.
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
XELJANZ has been proven to provide
long-term remission at 1 year
Remission at 1 year. 41% of patients taking XELJANZ
Sustained steroid-free remission. Among patients in remission at the beginning of the study, 47% of patients taking XELJANZ
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
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
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


XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:
- Moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated
- Active psoriatic arthritis in which methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well or cannot be tolerated
- Moderately to severely active ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated
XELJANZ/XELJANZ Oral Solution is used to treat patients 2 years of age and older with active polyarticular juvenile arthritis.
It is not known if XELJANZ/XELJANZ XR is safe and effective in people with Hepatitis B or C.
XELJANZ/XELJANZ XR/XELJANZ Oral Solution is not recommended for people with severe liver problems.
It is not known if XELJANZ/XELJANZ Oral Solution is safe and effective in children for treatment other than active polyarticular juvenile arthritis.
It is not known if XELJANZ XR is safe and effective in children.
XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:
- Moderately to severely active » Read More