Evidence map›Paper›PMID 26318385›Full record

ReviewAnnals of the rheumatic diseases2016

Tuberculosis and other opportunistic infections in tofacitinib-treated patients with rheumatoid arthritis.

K L Winthrop, S-H Park, A Gul, M H Cardiel, J J Gomez-Reino, Y Tanaka, K Kwok, T Lukic, E Mortensen, D Ponce de Leon and 2 more

Open access · hybridAbstract readReview
In one paragraph

Review in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 111 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
111citing papers in PubMed, 5 pooled it
9.7field-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

111 citing papers in PubMed, 5 syntheses or guidelines pooled it, 248 citations in OpenAlex.

  1. Infection risk with JAK inhibitors in dermatoses: a meta-analysis.International journal of dermatology · 2025
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  15. Tuberculosis Infection Screening Recommendations for Targeted Immunotherapies: Comparison of US Prescribing Information, Clinical Resources, and Quality Measures.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
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  17. Updated review of Janus kinase inhibitors for the management of inflammatory bowel disease.World journal of gastrointestinal pharmacology and therapeutics · 2026
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51 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 6 countries.

K L WinthropOregon Health and Science University, Portland, Oregon, USA.
S-H ParkDivision of Rheumatology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea.
A GulIstanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.
M H CardielCentro de Investigación Clínica de Morelia SC, Morelia, Mexico.ORCID http://orcid.org/0000-0002-2731-9180
J J Gomez-ReinoHospital Clínico Universitario de Santiago, Santiago de Compostela, Spain.
Y TanakaUniversity of Occupational and Environmental Health, Kitakyushu, Japan.
K KwokPfizer Inc, New York, New York, USA.
T LukicPfizer Inc, New York, New York, USA.
E MortensenPfizer Inc, Collegeville, Pennsylvania, USA.
D Ponce de LeonPfizer Inc, Lima, Peru.
R RiesePfizer Inc, Groton, Connecticut, USA.
H ValdezPfizer Inc, New York, New York, USA.
Pfizer (United States) · USComplejo Hospitalario Universitario de Santiago · ESIstanbul University · TROregon Health & Science University · USThe Catholic University of Korea Seoul St. Mary's Hospital · KRUniversidad de Morelia · MXUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the risk of opportunistic infections (OIs) in patients with rheumatoid arthritis (RA) treated with tofacitinib.

methodsPhase II, III and long-term extension clinical trial data (April 2013 data-cut) from the tofacitinib RA programme were reviewed. OIs defined a priori included mycobacterial and fungal infections, multidermatomal herpes zoster and other viral infections associated with immunosuppression. For OIs, we calculated crude incidence rates (IRs; per 100 patient-years (95% CI)); for tuberculosis (TB) specifically, we calculated rates stratified by patient enrolment region according to background TB IR (per 100 patient-years): low (≤0.01), medium (>0.01 to ≤0.05) and high (>0.05).

resultsWe identified 60 OIs among 5671 subjects; all occurred among tofacitinib-treated patients. TB (crude IR 0.21, 95% CI of (0.14 to 0.30)) was the most common OI (n=26); median time between drug start and diagnosis was 64 weeks (range 15-161 weeks). Twenty-one cases (81%) occurred in countries with high background TB IR, and the rate varied with regional background TB IR: low 0.02 (0.003 to 0.15), medium 0.08 (0.03 to 0.21) and high 0.75 (0.49 to 1.15). In Phase III studies, 263 patients diagnosed with latent TB infection were treated with isoniazid and tofacitinib concurrently; none developed TB. For OIs other than TB, 34 events were reported (crude IR 0.25 (95% CI 0.18 to 0.36)).

conclusionsWithin the global tofacitinib RA development programme, TB was the most common OI reported but was rare in regions of low and medium TB incidence. Patients who screen positive for latent TB can be treated with isoniazid during tofacitinib therapy.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidClinical Trials as TopicHumansImmunocompromised HostImmunosuppressive AgentsIncidenceJanus Kinase 3Opportunistic InfectionsPiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolesRisk AssessmentTuberculosisAntirheumatic AgentsImmunosuppressive AgentsJanus Kinase 3PiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolestofacitinibDMARDs (synthetic)InfectionsRheumatoid ArthritisTreatmentTuberculosis

Identifiers

PMID26318385
PMCPMC4893093
OpenAlexW1925361523

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.