Evidence map›Paper›PMID 25902789›Full record

SynthesisAnnals of the rheumatic diseases2016

Tofacitinib, an oral Janus kinase inhibitor: analysis of malignancies across the rheumatoid arthritis clinical development programme.

Jeffrey R Curtis, Eun Bong Lee, Irina V Kaplan, Kenneth Kwok, Jamie Geier, Birgitta Benda, Koshika Soma, Lisy Wang, Richard Riese

Abstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis 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 75 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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

75 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  11. 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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15 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

9 authors.

Jeffrey R CurtisThe University of Alabama at Birmingham, Birmingham, Alabama, USA.
Eun Bong LeeSeoul National University College of Medicine, Seoul, Republic of Korea.
Irina V KaplanPfizer Inc, Groton, Connecticut, USA.
Kenneth KwokPfizer Inc, New York, New York, USA.
Jamie GeierPfizer Inc, New York, New York, USA.
Birgitta BendaPfizer Inc, Collegeville, Pennsylvania, USA.
Koshika SomaPfizer Inc, Groton, Connecticut, USA.
Lisy WangPfizer Inc, Groton, Connecticut, USA.
Richard RiesePfizer Inc, Groton, Connecticut, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). To further assess the potential role of Janus kinase inhibition in the development of malignancies, we performed an integrated analysis of data from the tofacitinib RA clinical development programme.

methodsMalignancy data (up to 10 April 2013) were pooled from six phase II, six Phase III and two long-term extension (LTE) studies involving tofacitinib. In the phase II and III studies, patients with moderate-to-severe RA were randomised to various tofacitinib doses as monotherapy or with background non-biological disease-modifying antirheumatic drugs (DMARDs), mainly methotrexate. The LTE studies (tofacitinib 5 or 10 mg twice daily) enrolled patients from qualifying prior phase I, II and III index studies.

resultsOf 5671 tofacitinib-treated patients, 107 developed malignancies (excluding non-melanoma skin cancer (NMSC)). The most common malignancy was lung cancer (n=24) followed by breast cancer (n=19), lymphoma (n=10) and gastric cancer (n=6). The rate of malignancies by 6-month intervals of tofacitinib exposure indicates rates remained stable over time. Standardised incidence ratios (comparison with Surveillance, Epidemiology and End Results) for all malignancies (excluding NMSC) and selected malignancies (lung, breast, lymphoma, NMSC) were within the expected range of patients with moderate-to-severe RA.

conclusionsThe overall rates and types of malignancies observed in the tofacitinib clinical programme remained stable over time with increasing tofacitinib exposure.

Indexed as

Administration, OralAdolescentAdultAgedAntirheumatic AgentsArthritis, RheumatoidClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDose-Response Relationship, DrugFemaleHumansIncidenceJanus Kinase 3MaleMiddle AgedMulticenter Studies as TopicAntirheumatic AgentsJanus Kinase 3PiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolestofacitinibDMARDs (synthetic)InflammationRheumatoid ArthritisTreatment

Identifiers

PMID25902789
PMCPMC4853586

What OpenQuestion holds

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Registered trials

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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.