Kevin L Winthrop1, Mark Lebwohl2, Arnon D Cohen3, Jeffrey M Weinberg2, Stephen K Tyring4, Scott T Rottinghaus5, Pankaj Gupta5, Kaori Ito5, Huaming Tan5, Mandeep Kaur6, Alexander Egeberg7, Lotus Mallbris6, Hernan Valdez8. 1. Oregon Health and Science University, Portland, Oregon. Electronic address: Winthrop@ohsu.edu. 2. Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York. 3. Department of Quality Measures and Research, Clalit Health Services, Tel Aviv, Israel; Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer-Sheva, Israel. 4. University of Texas Health Science Center, Houston, Texas. 5. Pfizer Inc, Groton, Connecticut. 6. Pfizer Inc, Collegeville, Pennsylvania. 7. Department of Dermatology and Allergy, Herlev and Gentofte Hospital, Hellerup, Denmark. 8. Pfizer Inc, New York, New York.
Abstract
BACKGROUND: Tofacitinib is an oral Janus kinase (JAK) inhibitor. Immunomodulatory therapies can increase the risk for herpes zoster (HZ) in patients with psoriasis. OBJECTIVE: To evaluate the relationship between tofacitinib use and HZ risk. METHODS: We used phases 2 and 3 and long-term extension (LTE) data from the tofacitinib development program in psoriasis to calculate HZ incidence rates (IR; events per 100 patient-years); potential HZ risk factors were evaluated using Cox-proportional hazard models. RESULTS: One hundred thirty (3.6%) patients on tofacitinib (IR 2.55), no patients on placebo, and 2 using etanercept (IR 2.68) developed HZ. Nine patients (7%) were hospitalized, and 8 (6%) had multidermatomal HZ; no encephalitis, visceral involvement, or deaths occurred. In total, 121 (93%) patients on tofacitinib continued or resumed use after HZ. HZ risk factors included Asian descent (hazard ratio [HR] 2.92), using tofacitinib 10 mg twice daily (vs 5 mg twice daily; HR 1.72), prior use of biologics (HR 1.72), and older age (HR 1.30). LIMITATIONS: Generalizability to other psoriasis populations might be limited. The effect of HZ vaccination was not studied. CONCLUSION: Tofacitinib is associated with increased HZ risk relative to placebo. Asian race, increasing age, higher dose, and prior biologic exposure are associated with heightened risk.
BACKGROUND:Tofacitinib is an oral Janus kinase (JAK) inhibitor. Immunomodulatory therapies can increase the risk for herpes zoster (HZ) in patients with psoriasis. OBJECTIVE: To evaluate the relationship between tofacitinib use and HZ risk. METHODS: We used phases 2 and 3 and long-term extension (LTE) data from the tofacitinib development program in psoriasis to calculate HZ incidence rates (IR; events per 100 patient-years); potential HZ risk factors were evaluated using Cox-proportional hazard models. RESULTS: One hundred thirty (3.6%) patients on tofacitinib (IR 2.55), no patients on placebo, and 2 using etanercept (IR 2.68) developed HZ. Nine patients (7%) were hospitalized, and 8 (6%) had multidermatomal HZ; no encephalitis, visceral involvement, or deaths occurred. In total, 121 (93%) patients on tofacitinib continued or resumed use after HZ. HZ risk factors included Asian descent (hazard ratio [HR] 2.92), using tofacitinib 10 mg twice daily (vs 5 mg twice daily; HR 1.72), prior use of biologics (HR 1.72), and older age (HR 1.30). LIMITATIONS: Generalizability to other psoriasis populations might be limited. The effect of HZ vaccination was not studied. CONCLUSION:Tofacitinib is associated with increased HZ risk relative to placebo. Asian race, increasing age, higher dose, and prior biologic exposure are associated with heightened risk.
Authors: Gerd R Burmester; Peter Nash; Bruce E Sands; Kim Papp; Lori Stockert; Thomas V Jones; Huaming Tan; Ann Madsen; Hernan Valdez; Stanley B Cohen Journal: RMD Open Date: 2021-05