Safety FindingsThe most common adverse events (AEs) in OPAL Broaden and OPAL Beyond over 12 and six months, respectively, were upper respiratory tract infection, nasopharyngitis and headache. 1e,2d In OPAL Broaden and OPAL Beyond, serious AEs were reported in 3.8% and 6.1% of patients taking tofacitinib 10 mg BID, and 7.5% and 3.8% of patients taking tofacitinib 5 mg BID. Among patients who received placebo for the first three months and then switched to tofacitinib, 5.8% and 3.0% of patients who went to tofacitinib 5 mg BID and 7.5% and 1.5% of patients who went to tofacitinib 10 mg BID, at 12 and six months respectively, experienced serious AEs. 1f,2e In OPAL Broaden, serious AEs were reported in 8.5% of patients taking adalimumab q2 wk. 1f Overall safety findings in these studies were consistent with those observed in the broader rheumatology clinical development program for tofacitinib. 1g,2f About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic inflammatory multisystem disease. 3 PsA causes joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis and irreversible joint damage. 4 An estimated three million people in the U.S. and Europe combined have active PsA. 5 Disease prevalence may even be higher because it is often misdiagnosed or goes undiagnosed altogether. 6,7 About XELJANZ (tofacitinib citrate) and XELJANZ XR (tofacitinib citrate) extended-release XELJANZ ®/XELJANZ XR ® (tofacitinib citrate) is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ is not currently approved for the treatment of psoriatic arthritis. Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of XELJANZ through a robust clinical development program. The efficacy and safety profile of XELJANZ has been studied in approximately 6,300 patients with moderate to severe rheumatoid arthritis (RA), amounting to more than 21,000 patient-years of drug exposure in the global clinical development program. 8 XELJANZ/XELJANZ XR U.S. Label Information XELJANZ (tofacitinib citrate)/XELJANZ XR (tofacitinib citrate) extended-release is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ/XELJANZ XR is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well. XELJANZ/XELJANZ XR may be used as a single agent or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs). Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.
- It is not known if XELJANZ/XELJANZ XR is safe and effective in people with hepatitis B or C.
- XELJANZ/XELJANZ XR is not for people with severe liver problems.
- It is not known if XELJANZ/XELJANZ XR is safe and effective in children.
- XELJANZ/XELJANZ XR can lower the ability of the immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Healthcare providers should test patients for TB before starting XELJANZ/XELJANZ XR, and monitor them closely for signs and symptoms of TB and other infections during treatment. People should not start taking XELJANZ/XELJANZ XR if they have any kind of infection unless their healthcare provider tells them it is okay.
- People may be at a higher risk of developing shingles.
- XELJANZ/XELJANZ XR may increase the risk of certain cancers by changing the way the immune system works. Lymphoma and other cancers, including skin cancers, can happen in patients taking XELJANZ/XELJANZ XR.
- The risks and benefits of treatment should be considered prior to initiating XELJANZ/XELJANZ XR in patients with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
- Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was observed in clinical studies with XELJANZ.
- Use of live vaccines should be avoided concurrently with XELJANZ/XELJANZ XR. Update immunizations in agreement with current immunization guidelines prior to initiating XELJANZ/XELJANZ XR therapy.
- Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr virus-associated post-transplant lymphoproliferative disorder).
- Some people taking XELJANZ/XELJANZ XR can get tears in their stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
- XELJANZ/XELJANZ XR should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis), or who have a narrowing within their digestive tract. Patients should tell their healthcare provider right away if they have fever and stomach-area pain that does not go away or a change in bowel habits.
- XELJANZ/XELJANZ XR can cause changes in certain lab test results including low blood cell counts, increases in certain liver tests, and increases in cholesterol levels. Healthcare providers should do blood tests before starting patients on XELJANZ/XELJANZ XR and while they are taking XELJANZ/XELJANZ XR, to check for these side effects. Normal cholesterol levels are important to good heart health. Healthcare providers may stop XELJANZ/XELJANZ XR treatment because of changes in blood cell counts or liver test results.
- Use of XELJANZ/XELJANZ XR in patients with severe hepatic impairment is not recommended.
- Patients should tell their healthcare providers if they plan to become pregnant or are pregnant.
- Patients should tell their healthcare providers if they plan to breastfeed or are breastfeeding. Patients and their healthcare provider should decide if they will take XELJANZ/XELJANZ XR or breastfeed. They should not do both.
- In carriers of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while using XELJANZ/XELJANZ XR. Healthcare providers may do blood tests before and during treatment with XELJANZ/XELJANZ XR.
- Common side effects include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, and nasal congestion, sore throat, and runny nose (nasopharyngitis).
|1 PJ Mease, S Hall, O FitzGerald, et al. Efficacy and Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, or Adalimumab in Patients with Active Psoriatic Arthritis and an Inadequate Response to Conventional Synthetic DMARDs: A Randomized, Placebo-Controlled, Phase 3 Trial.|
|a. Results. Pg 2. Para 2. Ln 3-6.|
|b. Background/Purpose. Pg 2. Para 1. Ln 2-3.|
|c. Methods. Pg 1. Para 2. Ln 4-5.|
|d. Pg 5. Table 2. Efficacy endpoints at Month 3 and Month 12.|
|e. Results. Pg 2. Para 2. Ln 8-10.|
|f. Pg 7. Table 3. Safety summary to Month 12.|
|g. Conclusion. Pg 2. Para 3. Ln 3-4.|
|2 DD Gladman, et al. Efficacy and Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Patients with Active Psoriatic Arthritis and an Inadequate Response to Tumor Necrosis Factor Inhibitors: OPAL Beyond, a Randomized, Double Blind, Placebo-Controlled, Phase 3 Trial.|
|a. Results. Pg 2. Para 2. Ln 3-4.|
|b. Background/Purpose. Pg 1. Para 1. Ln 2-4.|
|c. Pg 5. Table 2. Efficacy endpoints at Month 3 and Month 6.|
|d. Results. Pg 2. Para 2. Ln 8-10.|
|e. Pg 6. Table 3. Safety summary to Month 6.|
|f. Conclusion. Pg 2. Para 3. Ln 4-5.|
|3 Ritchlin CT, Kavanaugh A, Gladman DD, et al. Treatment recommendations for psoriatic arthritis. Ann Rheum Dis. 2009;68(9):1387-1394.|
|4 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health, US Department of Health and Human Services. Psoriatic arthritis overview. NIH publication 14-AR-8001. http://www.niams.nih.gov/health_info/Psoriatic_Arthritis/psoriatic-arthritis.pdf. Published October 2014.|
|5 Data on File. Decision Resources Group. Table 1-4: Number of Total Prevalent Cases of Psoriatic Arthritis in the Major Pharmaceutical Markets, 2013-2023. United States and Europe, 2016.|
|6 Helliwell P, Coates L, Chandran V, et al. Qualifying unmet needs and improving standards of care in psoriatic arthritis. Arthritis Care Res (Hoboken). 2014;66(12):1759-1766. Page 1/Paragraph 1/Introduction/Lines 1-3|
|7 Van de Kerkhof PCM, Reich K, Kavanaugh A, et al. Physician perspectives in the management of psoriasis and psoriatic arthritis: results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis survey. J Eur Acad Dermatol Venereol. 2015;29:2002-2010.|
|8 Pfizer Data on File.|