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Herpes zoster in psoriasis patients treated with tofacitinib

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Winthrop KL1, Lebwohl M2, Cohen AD3, Weinberg JM2, Tyring SK4, Rottinghaus ST5, Gupta P5, Ito K5, Tan H5, Kaur M6, Egeberg A7, Mallbris L6, Valdez H8. J Am Acad Dermatol. 2017 Aug;77(2):302-309. doi: 10.1016/j.jaad.2017.03.023.

Abstract

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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.