TY - JOUR
T1 - Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment
AU - Winthrop, Kevin L.
AU - Curtis, Jeffrey R.
AU - Yamaoka, Kunihiro
AU - Lee, Eun Bong
AU - Hirose, Tomohiro
AU - Rivas, Jose L.
AU - Kwok, Kenneth
AU - Burmester, Gerd R.
N1 - Funding Information:
Medical writing support, under the guidance of the authors, was provided by Sarah Piggott, MChem, and Gemma Turner, PhD, CMC Connect, McCann Health Medical Communications, and Kirsteen Munn, PhD, on behalf of CMC Connect, McCann Health Medical Communications, and was funded by Pfizer Inc, New York, NY, USA, in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461-464). The authors thank Rajneesh Singh (Covance) and Haiyun Fan (Pfizer Inc) for their statistical support.
Funding Information:
These studies were sponsored by Pfizer Inc. The journal?s Rapid Service Fee for this article was also funded by Pfizer Inc. Medical writing support, under the guidance of the authors, was provided by Sarah Piggott, MChem, and Gemma Turner, PhD, CMC Connect, McCann Health Medical Communications, and Kirsteen Munn, PhD, on behalf of CMC Connect, McCann Health Medical Communications, and was funded by Pfizer Inc, New York, NY, USA, in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461-464). The authors thank Rajneesh Singh (Covance) and Haiyun Fan (Pfizer Inc) for their statistical support. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. All authors were involved in drafting the article or revising it critically for important intellectual content, approved the final version to be submitted for publication, and agree to be accountable for all aspects of the work. KL Winthrop, JR Curtis, T Hirose, and K Kwok were involved in study conception and design. EB Lee, T Hirose, and GR Burmester were invoved in the acquisition of data. All authors were involved in the analysis/interpretation of data. Kevin L Winthrop has received grant/research support from Bristol-Myers Squibb and is a consultant for AbbVie, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Pfizer Inc, Roche, and UCB. Jeffrey R Curtis has received grant/research support from Amgen, CorEvitas, Crescendo Bio, and Pfizer Inc and is a consultant for AbbVie, Amgen, Bristol-Myers Squibb, CorEvitas, Eli Lilly, Janssen, Myriad, Pfizer Inc, Roche/Genentech, and UCB. Kunihiro Yamaoka is a consultant for, and has received speaker fees and/or honoraria from, AbbVie, Actelion, Astellas, Chugai, Eisai, Eli Lilly, Gilead, GlaxoSmithKline, Janssen, Mitsubishi Tanabe, Nippon Shinyaku, Pfizer Inc, and Takeda. Eun Bong Lee is a consultant for Pfizer Inc, and has received research grants from GC Pharma and Handok Inc. Gerd R Burmester has received grant/research support from Pfizer Inc and is a consultant and a member of speakers? bureau for AbbVie, Eli Lilly, Gilead, and Pfizer Inc. Tomohiro Hirose, Jose L Rivas, and Kenneth Kwok are employees and shareholders of Pfizer Inc. The studies were conducted in accordance with the Declaration of Helsinki, the International Council for Harmonisation Guidelines for Good Clinical Practice, and local regulations. All patients provided informed consent, and Institutional Review Board approval was provided by all participating institutions. Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information.
Publisher Copyright:
© 2021, The Author(s).
PY - 2022/2
Y1 - 2022/2
N2 - Introduction: Risk of herpes zoster (HZ) is increased with Janus kinase inhibitor use. We evaluated clinical study data relating to HZ management in patients with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) receiving tofacitinib. Methods: This post hoc analysis included data from 21 RA and 3 PsA clinical studies; data were pooled for tofacitinib doses. Outcomes of HZ events (serious and non-serious) and tofacitinib treatment changes were evaluated in response to first and second HZ events. Median time to resolution was stratified by dermatomal involvement, history of HZ prior to tofacitinib, changes to tofacitinib treatment, anti-viral and corticosteroid use, and tofacitinib dose. Results: Seven hundred eighty-three (11.1%, N = 7061) patients with RA experienced ≥ 1 HZ event, 63 (8.0%) of whom had ≥ 2 HZ events. In patients with PsA, 36 (4.6%, N = 783) experienced ≥ 1 HZ event, 1 (2.8%) of whom had ≥ 2 HZ events. For most HZ events, tofacitinib treatment was unchanged or temporarily discontinued. The majority of patients received anti-viral treatment, most within 3 days of onset. Post-herpetic neuralgia developed in 6.9% and 3.2% of patients with RA with first and second events, respectively, and in 2.8% of patients with PsA with a first event. Most first and second events resolved (RA: 97.6% and 96.8%, respectively; PsA: 94.4% and 100%, respectively). Median time to resolution was 22.0 days for first and 15.0 days for second events for RA and 20.5 days for first and 11.0 days for second events (n = 1) for PsA. Time to resolution of first events for RA and PsA was generally numerically shorter for patients with single dermatomal HZ, history of HZ, or anti-viral use versus those without. Conclusion: Among patients receiving tofacitinib, recurrent events were more common in patients with RA versus PsA; HZ duration was shorter for repeat events. Trial Registration: NCT01262118, NCT01484561, NCT00147498, NCT00413660, NCT00550446, NCT00603512, NCT00687193, NCT01164579, NCT00976599, NCT01059864, NCT01359150, NCT02147587, NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT01039688, NCT02187055, NCT00413699, NCT00661661, NCT01877668, NCT01882439, NCT01976364.
AB - Introduction: Risk of herpes zoster (HZ) is increased with Janus kinase inhibitor use. We evaluated clinical study data relating to HZ management in patients with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) receiving tofacitinib. Methods: This post hoc analysis included data from 21 RA and 3 PsA clinical studies; data were pooled for tofacitinib doses. Outcomes of HZ events (serious and non-serious) and tofacitinib treatment changes were evaluated in response to first and second HZ events. Median time to resolution was stratified by dermatomal involvement, history of HZ prior to tofacitinib, changes to tofacitinib treatment, anti-viral and corticosteroid use, and tofacitinib dose. Results: Seven hundred eighty-three (11.1%, N = 7061) patients with RA experienced ≥ 1 HZ event, 63 (8.0%) of whom had ≥ 2 HZ events. In patients with PsA, 36 (4.6%, N = 783) experienced ≥ 1 HZ event, 1 (2.8%) of whom had ≥ 2 HZ events. For most HZ events, tofacitinib treatment was unchanged or temporarily discontinued. The majority of patients received anti-viral treatment, most within 3 days of onset. Post-herpetic neuralgia developed in 6.9% and 3.2% of patients with RA with first and second events, respectively, and in 2.8% of patients with PsA with a first event. Most first and second events resolved (RA: 97.6% and 96.8%, respectively; PsA: 94.4% and 100%, respectively). Median time to resolution was 22.0 days for first and 15.0 days for second events for RA and 20.5 days for first and 11.0 days for second events (n = 1) for PsA. Time to resolution of first events for RA and PsA was generally numerically shorter for patients with single dermatomal HZ, history of HZ, or anti-viral use versus those without. Conclusion: Among patients receiving tofacitinib, recurrent events were more common in patients with RA versus PsA; HZ duration was shorter for repeat events. Trial Registration: NCT01262118, NCT01484561, NCT00147498, NCT00413660, NCT00550446, NCT00603512, NCT00687193, NCT01164579, NCT00976599, NCT01059864, NCT01359150, NCT02147587, NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT01039688, NCT02187055, NCT00413699, NCT00661661, NCT01877668, NCT01882439, NCT01976364.
KW - Anti-viral
KW - Clinical management
KW - Herpes zoster
KW - Infections
KW - Psoriatic arthritis
KW - Rheumatoid arthritis
KW - Tofacitinib
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U2 - 10.1007/s40744-021-00390-0
DO - 10.1007/s40744-021-00390-0
M3 - Article
AN - SCOPUS:85120649695
SN - 2198-6576
VL - 9
SP - 243
EP - 263
JO - Rheumatology and Therapy
JF - Rheumatology and Therapy
IS - 1
ER -