TY - JOUR
T1 - Herpes zoster in psoriasis patients treated with tofacitinib
AU - Winthrop, Kevin L.
AU - Lebwohl, Mark
AU - Cohen, Arnon D.
AU - Weinberg, Jeffrey M.
AU - Tyring, Stephen K.
AU - Rottinghaus, Scott T.
AU - Gupta, Pankaj
AU - Ito, Kaori
AU - Tan, Huaming
AU - Kaur, Mandeep
AU - Egeberg, Alexander
AU - Mallbris, Lotus
AU - Valdez, Hernan
N1 - Funding Information:
Funding sources: Supported by Pfizer Inc .
Funding Information:
Conflicts of interest: Dr Winthrop has received research funds from Pfizer and BMS. He has received consultant honoraria from Pfizer, UCB, BMS, Lilly, AbbVie, and Galapagos. Dr Lebwohl is an employee of Mount Sinai, which receives research funds from Amgen, Anacor, Boehringer Ingleheim, Celgene, Lilly, Janssen Biotech, Kadmon, LEO Pharmaceuticals, Medimmune, Novartis, Pfizer, Sun Pharmaceuticals, and Valeant. Dr Cohen has been an advisor, consultant, investigator, or speaker for Abbvie, Boehringer, Ingelheim, Dexcel Pharma, Janssen, Neopharm, Novartis, Perrigo, Pfizer, and Rafa. Dr Weinberg has received honoraria from Pfizer. Dr Tyring has received research grants from Pfizer. Drs Rottinghaus, Egeberg, and Mallbris were employees of Pfizer Inc at the time of the analysis. Drs Gupta, Ito, Tan, Kaur, and Valdez are employees and shareholders of Pfizer Inc.
Publisher Copyright:
© 2017 American Academy of Dermatology, Inc.
PY - 2017/8
Y1 - 2017/8
N2 - 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.
AB - 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.
KW - JAK
KW - herpes zoster
KW - psoriasis
KW - shingles
KW - tofacitinib
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U2 - 10.1016/j.jaad.2017.03.023
DO - 10.1016/j.jaad.2017.03.023
M3 - Article
C2 - 28711084
AN - SCOPUS:85028293018
SN - 0190-9622
VL - 77
SP - 302
EP - 309
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
IS - 2
ER -