Clinical Trials
The efficacy and safety of XELJANZ® (tofacitinib) were tested in 2 studies that included adult patients with active psoriatic arthritis. The studies included patients who were new to biologic disease-modifying antirheumatic drugs (DMARDs) as well as patients who hadn’t found enough symptom relief with a biologic DMARD. In each study, participants were divided randomly into groups, and 238 participants were treated with XELJANZ
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:
- 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
Patients in the clinical trials had active psoriatic arthritis for at least 6 months and had:
- At least 3 tender/painful joints
- At least 3 swollen joints
- Skin lesions associated with active plaque psoriasis
In these studies, 238 adult patients took
- 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)
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, which assesses the ability to complete different activities, such as dressing and grooming, arising, eating, walking, hygiene, reaching and gripping. - Reduced inflammation of the fingers or toes (dactylitis)
- Lowered the number of affected areas with enthesitis, inflammation that happens where tendons and ligaments insert into bone
The Health Assessment Questionnaire Disability Index
Common side effects of
The OPAL Broaden Study
OPAL Broaden was a study that included adult patients with active psoriatic arthritis who didn’t get enough symptom relief with a DMARD, like methotrexate. In this study, patients took either XELJANZ* or a placebo.* At 3 months, patients who received placebo were switched over to XELJANZ.
- At 2 weeks, 22% of patients taking XELJANZ (24 out of 107) versus 6% taking placebo (6 out of 105) had improvement in their psoriatic arthritis signs and symptoms, as measured by the ACR20
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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, 50% of patients taking XELJANZ (54 out of 107) versus 33% taking placebo (35 out of 105) had less joint swelling and tenderness, as measured by ACR20.
- At 1 year, 68% of patients taking XELJANZ (73 out of 107) had less joint swelling and tenderness, as measured by ACR20.
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
Rapid Joint Relief
XELJANZ reduced joint pain and swelling in as early as 2 weeks. For some, it took 3 to 6 months. Individual results may vary.†
Half of the patients taking XELJANZ experienced less joint pain and swelling at 3 months. Individual results may vary.†
Lasting Joint Relief
*All patients on XELJANZ or placebo also took a nonbiologic DMARD, such as methotrexate.
†Results were seen for patients taking XELJANZ in combination with a nonbiologic DMARD.
Common side effects of
The OPAL Beyond Study
OPAL Beyond was a study that included adult patients with active psoriatic arthritis who didn’t get enough symptom relief with at least 1 tumor necrosis factor inhibitor (TNFi), such as Enbrel® (etanercept) or Humira® (adalimumab). In this study, patients took either XELJANZ* or a placebo.* At 3 months, patients who received placebo were switched over to XELJANZ.
- At 2 weeks, 27% of patients taking XELJANZ (35 out of 131) versus 13% taking placebo (17 out of 131) had improvement in their psoriatic arthritis signs and symptoms, as measured by the ACR20
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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, 50% of patients taking XELJANZ (65 out of 131) versus 24% taking placebo (31 out of 131) had less joint swelling and tenderness, as measured by ACR20.
- At 6 months, 60% of patients taking XELJANZ (78 out of 131) had less joint swelling and tenderness, as measured by ACR20.
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
At 3 months, XELJANZ helped reduce inflammation where ligaments and tendons insert into bone (enthesitis).‡
At 3 months, XELJANZ helped reduce inflammation of fingers or toes (dactylitis).‡
*All patients on XELJANZ or placebo also took a nonbiologic DMARD, such as methotrexate.
‡Results were seen for patients taking XELJANZ in combination with a nonbiologic DMARD. These results were for patients who began the study with the symptom.
Common side effects of
Talking To Your Doctor
If your current treatment is not working well enough to manage your psoriatic arthritis 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
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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