Evidence map›Paper›PMID 28845604›Full record

ArticleArthritis & rheumatology (Hoboken, N.J.)2017

Herpes Zoster and Tofacitinib: Clinical Outcomes and the Risk of Concomitant Therapy.

Kevin L Winthrop, Jeffrey R Curtis, Stephen Lindsey, Yoshiya Tanaka, Kunihiro Yamaoka, Hernan Valdez, Tomohiro Hirose, Chudy I Nduaka, Lisy Wang, Alan M Mendelsohn and 3 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Arthritis & rheumatology (Hoboken, N.J.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 114 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
114citing papers in PubMed, 5 pooled it
18.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

114 citing papers in PubMed, 5 syntheses or guidelines pooled it, 233 citations in OpenAlex.

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54 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 2 countries.

Kevin L WinthropOregon Health and Science University, Portland.
Jeffrey R CurtisUniversity of Alabama at Birmingham.
Stephen LindseyOchsner Medical Center, Baton Rouge, Louisiana.
Yoshiya TanakaUniversity of Occupational and Environmental Health Japan, Kitakyushu, Japan.
Kunihiro YamaokaKeio University School of Medicine, Tokyo, Japan.
Hernan ValdezPfizer, New York, New York.
Tomohiro HirosePfizer Japan, Tokyo, Japan.
Chudy I NduakaPfizer Inc., Collegeville, Pennsylvania.
Lisy WangPfizer, Groton, Connecticut.
Alan M MendelsohnPfizer Inc., Collegeville, Pennsylvania.
Haiyun FanPfizer Inc., Collegeville, Pennsylvania.
Connie ChenPfizer, New York, New York.
Eustratios BananisPfizer Inc., Collegeville, Pennsylvania.
Pfizer (United States) · USKeio University · JPOchsner Medical Center · USOregon Health & Science University · USPfizer (Japan) · JPUniversity of Alabama at Birmingham · USUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePatients with rheumatoid arthritis (RA) are at increased risk of herpes zoster (HZ), and the risk appears to be increased in patients treated with tofacitinib. The aim of this study was to evaluate whether concomitant treatment with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or glucocorticoids (GCs) contributes to the increased risk of HZ in RA patients treated with tofacitinib.

methodsHZ cases were identified from the databases of 2 phase I, 9 phase II, 6 phase III, and 2 long-term extension studies of tofacitinib in RA patients. Crude incidence rates (IRs) of all HZ events (serious and nonserious) per 100 patient-years (with 95% confidence intervals [95% CIs]) were calculated for unique patients. Within phase III studies, we described HZ rates according to concomitant csDMARD treatment and baseline GC use. A multivariable Cox proportional hazards regression model was used to evaluate HZ risk factors across studies.

resultsAcross all studies (6,192 patients; 16,839 patient-years), HZ was reported in 636 tofacitinib-treated patients (IR 4.0, 95% CI 3.7-4.4). In most cases (93%), HZ was classified as nonserious, and the majority of patients (94%) had involvement of only 1 dermatome. HZ IRs varied across regions, from 2.4 (95% CI 2.0-2.9) in Eastern Europe to 8.0 (95% CI 6.6-9.6) in Japan and 8.4 (95% CI 6.4-10.9) in Korea. Within phase III studies, HZ IRs varied according to tofacitinib dose, background csDMARD treatment, and baseline use of GCs. The IRs were numerically lowest for monotherapy with tofacitinib 5 mg twice daily without GCs (IR 0.56 [95% CI 0.07-2.01]) and highest for tofacitinib 10 mg twice daily with csDMARDs and GCs (IR 5.44 [95% CI 3.72-7.68]). Age, GC use, tofacitinib dose, and enrollment within Asia were independent risk factors for HZ.

conclusionPatients receiving treatment with tofacitinib and GCs appear to have a greater risk of developing HZ compared with patients receiving tofacitinib monotherapy without GCs.

Indexed as

AdultAgedAntirheumatic AgentsArthritis, RheumatoidChloroquineClinical Trials as TopicDatabases, FactualDose-Response Relationship, DrugDrug Therapy, CombinationFemaleGlucocorticoidsHerpes ZosterHumansIncidenceIsoxazolesLeflunomideAntirheumatic AgentsChloroquineGlucocorticoidsIsoxazolesLeflunomideMethotrexatePiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolestofacitinib

Identifiers

PMID28845604
PMCPMC5656820
OpenAlexW2748091531

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.