Clinical Trials
The efficacy and safety of XELJANZ® (tofacitinib) were tested in 6 clinical trials that included adult patients with moderate to severe rheumatoid arthritis (RA). In each study, participants were divided randomly into treatment groups, and 1,589 participants were treated with XELJANZ
Patients in 5 of the 6 clinical trials had moderate to severe RA, which is defined as having:
- At least 6 tender/painful joints
- At least 6 swollen joints
- Lab test results that indicated inflammation in joints
Two of the clinical trials required patients to have 3 or more joint erosions or a lab test result indicating RA.
These studies measured if XELJANZ:
- Reduced joint pain and swelling
- Improved the ability to accomplish certain daily activities. Improvement in physical function was measured by the Health Assessment Questionnaire Disability Index
(HAQ-DI) ![]()
, which assesses the ability to complete different activities, such as dressing and grooming, arising, eating, walking, hygiene, reaching and gripping. - Affected the progression of structural joint damage (in 2 of the studies)
The Health Assessment Questionnaire Disability Index
Common side effects of
The ORAL Solo Study
ORAL Solo was a study that included adult patients with moderate to severe RA in whom biologic or nonbiologic DMARDs did not work well or could not be tolerated. Patients took either XELJANZ alone or a placebo alone. At 3 months, patients who received placebo were switched over to XELJANZ.
- At 2 weeks, 30% of XELJANZ patients (71 out of 240) and 12% of placebo patients (14 out of 119) had an improvement in their RA signs and symptoms as measured by ACR20
![]()
response criteria. - Physician assessed overall health and progress information
- Patient assessed overall health and progress information
- Pain scale
- Physical function (measured by the Health Assessment Questionnaire Disability Index, known as
HAQ-DI) - Lab test results that measure the amount of inflammation in joints
- At 3 months, 59% of XELJANZ patients (143 out of 243) and 25% of placebo patients (31 out of 122) experienced an improvement in their RA signs and symptoms as measured by ACR20.
- At 6 months, 69% of XELJANZ patients (168 out of 243) had an improvement in their RA signs and symptoms as measured by ACR20.
- At 3 months, 60% of XELJANZ patients (143 out of 240) and 39% of placebo patients (47 patients out of 120) experienced improvement in physical function as measured by the Health Assessment Questionnaire Disability Index
(HAQ-DI) .
A measuring standard created by the American College of Rheumatology (ACR). The "20" stands for 20% or greater reduction in the number of tender/painful and swollen joints as well as an improvement of 20% or more in at least three of the following measures:
Results Of The Study
More than half (59%) of XELJANZ patients felt an improvement in their RA symptoms within 3 months.*
*Individual results may vary.
XELJANZ reduced further joint pain and swelling caused by RA, even without the use of methotrexate.
Common side effects of
The ORAL Start & ORAL Scan Studies
Based on two studies, XELJANZ was shown on
The ORAL Start Study
ORAL Start was a study that included adult patients with moderate to severe RA who hadn't taken methotrexate prior to the study. However, XELJANZ is only approved for use in patients for whom methotrexate did not work well. Patients took either XELJANZ alone or methotrexate alone.
At 6 months, patients who took XELJANZ had less progression of RA joint damage than patients who took methotrexate, as measured by the modified Total Sharp Score (mTSS)
.
Scores joint damage progression by grading erosion in the hands and feet, and the presence of joint space narrowing in the hands, wrists, and feet.
- At 6 months, 73% of patients treated with XELJANZ
5 mg twice daily experienced no radiographic progression![]()
of joint damage compared to 55% of patients taking methotrexate.
X-ray is used to measure if there is a change from baseline in the mTSS score that grades erosion in the hands and feet, and the presence of joint space narrowing in the hands, wrists, and feet.
The ORAL Scan Study
ORAL Scan was a study of adult patients with moderate to severe RA in whom methotrexate did not work well. Patients took either XELJANZ and methotrexate or placebo and methotrexate.
At 6 months, patients who took XELJANZ and methotrexate had less progression of RA joint damage than patients who took placebo and methotrexate, as measured by the modified Total Sharp Score (mTSS).†
- At 6 months, 84% of patients treated with XELJANZ
5 mg twice daily plus methotrexate experienced no radiographic progression of joint damage compared to 74% of patients who took placebo plus methotrexate.†
†There is a possibility that the difference between treatments may have been due to chance alone and not due to XELJANZ, so the results were not considered significant.
Results Of The Studies
Less Joint Damage
At 6 months, XELJANZ patients experienced less joint damage progression than methotrexate patients.
Common side effects of
Talking To Your Doctor
If your current treatment is not working well enough to manage your RA symptoms, it’s important to speak up with your doctor. Every appointment is an opportunity to discuss symptom concerns, different treatment options, and how your disease is affecting some aspects of your daily life. 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
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
Indications
Important Safety Information