XELJANZ is the first FDA approved Janus kinase (JAK) inhibitor for adults with moderate to severe RA. If methotrexate hasn’t done enough to help relieve your moderate to severe RA symptoms, and before you and your rheumatologist decide on another treatment option, ask if XELJANZ could be an option for you.
X-rays have shown that XELJANZ helps reduce further joint damage.
In some patients, XELJANZ can begin to work in as early as 2 weeks to help relieve joint pain and swelling. For some it can take as long as 3 to 6 months.*
* Individual results
XELJANZ is a pill proven to reduceRA joint pain, swelling, and joint damage in adults with moderate to severe RA, even without methotrexate.
†The Arthritis Foundation’s Ease-of-Use Commendation recognizes products, such as the XELJANZ bottle cap, proven to make life easier for people who have arthritis and other physical limitations.
Common side effects of XELJANZ/XELJANZ XR in rheumatoid arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, and runny nose (nasopharyngitis), and high blood pressure (hypertension).
Patients should always ask their doctors for medical advice about adverse events.
You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.
How XELJANZ Works
XELJANZ is a Janus kinase (JAK) inhibitor that helps disrupt JAK pathways from inside the cells, which are believed to play a role in inflammation. Watch to learn more about the science of XELJANZ and how JAK inhibitors are thought to work.
Clinical Trial Results
The effectiveness of XELJANZ, taken with and without a disease-modifying antirheumatic drug (DMARD), such as methotrexate, was tested in six studies that involved more than 4,200 adult patients with moderate to severe RA.
In A Study More Than Half (59%) Of XELJANZ Patients Felt An Improvement In Their RA Symptoms Within 3 Months.†
In the ORAL Solo Study, at 2 weeks, 30% of XELJANZ patients (71 out of 240) and 12% of placebo patients (14 out of 119) experienced a 20% reduction in tender and swollen joint counts and 3 of these 5 indicators: blood test that measures inflammation, patient assessment, physician assessment, pain scale, and disability/functional questionnaire. These measures are in accordance with the ACR20, a measuring standard that shows 20% or greater improvement of symptoms.
At 3 months, 59% of XELJANZ patients (143 out of 243) and 25% of placebo patients (31 out of 122) experienced an improvement in ACR20 scores. During this study, patients did not take methotrexate.
†Individual results may vary.
At 3 Months, More Than Half Of XELJANZ Patients Could More Easily Complete Common Daily Activities, Such As Getting Dressed, Walking Down Stairs, And Gripping Household Items.
In the ORAL Solo Study, a scale was used that defines RA disability as: 0-1 = mild; 1-2 = moderate to severe; 2+ = greater disability. At the study start, XELJANZ patients had a mean baseline score of 1.53.
At 3 months, XELJANZ patients saw an improved score of 1.05 (a statistically important difference) and, overall, 60% (143 out of 240) of XELJANZ patients experienced an improvement of ≥0.22 on the Health Assessment Questionnaire Disability Index (HAQ-DI) that assesses the following categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. During this study, patients did not take methotrexate.
XELJANZ Reduced Further Joint Pain And Swelling Caused By RA, Even Without The Use Of Methotrexate.
In the ORAL Solo Study, at 2 weeks, 30% of XELJANZ patients (71 out of 240) and 12% of placebo patients (14 out of 119) experienced a 20% reduction in tender and swollen joint counts and 3 of these 5 indicators: blood test that measures inflammation, patient assessment, physician assessment, pain scale, and disability/functional questionnaire.
At 3 months, 59% of XELJANZ patients (143 out of 243) and 25% of placebo patients (31 out of 122) experienced the same results. During this study, patients did not take methotrexate.
At 6 Months, XELJANZ Patients Experienced Less RA Joint Damage Progression Than Methotrexate Patients.
Based on two studies, XELJANZ was shown on X-rays to help reduce further structural joint damage.
In the ORAL Start Study, patients hadn't taken methotrexate prior to the study. However, XELJANZ is only approved for use in patients for whom methotrexate did not work well. At 6 months, XELJANZ patients got worse by 0.2 units of change on the modified Total Sharp Score (mTSS) scale, while patients taking methotrexate worsened by 0.8. mTSS measures joint damage progression in selected joints of the hands and feet. The higher the amount of change in the mTSS, the more joint damage has progressed.
In the ORAL Scan Study, patients who took XELJANZ and methotrexate had less progression of RA joint damage after 6 months (0.1) than those who took a placebo and methotrexate (0.5). However, the possibility was high enough that the difference between treatments may have been due to chance alone and not due to XELJANZ, so the results were not considered significant.