{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,22]],"date-time":"2026-04-22T07:21:22Z","timestamp":1776842482773,"version":"3.51.2"},"reference-count":31,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2017,9,6]],"date-time":"2017-09-06T00:00:00Z","timestamp":1504656000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2017,10]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Patients with rheumatoid arthritis (RA) are at increased risk of herpes zoster, and vaccination is recommended for patients ages 50 years and older, prior to starting treatment with biologic agents or tofacitinib. Tofacitinib is an oral JAK inhibitor for the treatment of RA. We evaluated its effect on the immune response and safety of live zoster vaccine (LZV).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this phase II, 14\u2010week, placebo\u2010controlled trial, patients ages 50 years and older who had active RA and were receiving background methotrexate were given LZV and randomized to receive tofacitinib 5 mg twice daily or placebo 2\u20133 weeks postvaccination. We measured humoral responses (varicella zoster virus [VZV]\u2013specific IgG level as determined by glycoprotein enzyme\u2010linked immunosorbent assay) and cell\u2010mediated responses (VZV\u2010specific T cell enumeration, as determined by enzyme\u2010linked immunospot assay) at baseline and 2 weeks, 6 weeks, and 14 weeks postvaccination. End points included the geometric mean fold rise (GMFR) in VZV\u2010specific IgG levels (primary end point) and T cells (number of spot\u2010forming cells\/10<jats:sup>6<\/jats:sup> peripheral blood mononuclear cells) at 6 weeks postvaccination.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>One hundred twelve patients were randomized to receive tofacitinib (n\u2009=\u200955) or placebo (n\u2009=\u200957). Six weeks postvaccination, the GMFR in VZV\u2010specific IgG levels was 2.11 in the tofacitinib group and 1.74 in the placebo group, and the VZV\u2010specific T cell GMFR was similar in the tofacitinib group and the placebo group (1.50 and 1.29, respectively). Serious adverse events occurred in 3 patients in the tofacitinib group (5.5%) and 0 patients (0.0%) in the placebo group. One patient, who lacked preexisting VZV immunity, developed cutaneous vaccine dissemination 2 days after starting tofacitinib (16 days postvaccination). This resolved after tofacitinib was discontinued and the patient received antiviral treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Patients who began treatment with tofacitinib 2\u20133 weeks after receiving LZV had VZV\u2010specific humoral and cell\u2010mediated immune responses to LZV similar to those in placebo\u2010treated patients. Vaccination appeared to be safe in all of the patients except 1 patient who lacked preexisting VZV immunity.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.40187","type":"journal-article","created":{"date-parts":[[2017,8,28]],"date-time":"2017-08-28T01:02:51Z","timestamp":1503882171000},"page":"1969-1977","source":"Crossref","is-referenced-by-count":109,"title":["The Safety and Immunogenicity of Live Zoster Vaccination in Patients With Rheumatoid Arthritis Before Starting Tofacitinib: A Randomized Phase II Trial"],"prefix":"10.1002","volume":"69","author":[{"given":"Kevin L.","family":"Winthrop","sequence":"first","affiliation":[{"name":"Oregon Health and Science University  Portland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ann G.","family":"Wouters","sequence":"additional","affiliation":[{"name":"Pfizer Inc New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ernest H.","family":"Choy","sequence":"additional","affiliation":[{"name":"Cardiff University School of Medicine Cardiff UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koshika","family":"Soma","sequence":"additional","affiliation":[{"name":"Pfizer Inc New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer A.","family":"Hodge","sequence":"additional","affiliation":[{"name":"Pfizer Inc New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chudy I.","family":"Nduaka","sequence":"additional","affiliation":[{"name":"Chudy I. 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