Evidence map›Paper›PMID 33570260›Full record

ArticleACR open rheumatology2021

Postapproval Comparative Safety Study of Tofacitinib and Biological Disease-Modifying Antirheumatic Drugs: 5-Year Results from a United States-Based Rheumatoid Arthritis Registry.

Joel M Kremer, Clifton O Bingham, Laura C Cappelli, Jeffrey D Greenberg, Ann M Madsen, Jamie Geier, Jose L Rivas, Alina M Onofrei, Christine J Barr, Dimitrios A Pappas and 5 more

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

Article in ACR open rheumatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 83 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 4 pooled it
18.4field-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

83 citing papers in PubMed, 4 syntheses or guidelines pooled it, 136 citations in OpenAlex.

  1. Pooled it
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  14. Observational
  15. The risk of venous thromboembolism in RA.Rheumatology (Oxford, England) · 2026
    Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Immunosuppressants/Immunomodulators and Malignancy.Journal of clinical medicine · 2025
    Review

23 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

15 authors at 8 institutions in 2 countries.

Joel M KremerAlbany Medical College, Center for Rheumatology, Albany, New York.ORCID https://orcid.org/0000-0001-6674-9901
Clifton O BinghamJohns Hopkins University, Baltimore, Maryland.ORCID https://orcid.org/0000-0002-4752-5029
Laura C CappelliJohns Hopkins University, Baltimore, Maryland.ORCID https://orcid.org/0000-0003-2795-7059
Jeffrey D GreenbergCorrona, Waltham, Massachusetts, and New York University School of Medicine.
Ann M MadsenPfizer, New York, New York, USA.
Jamie GeierPfizer, New York, New York, USA.
Jose L RivasPfizer SLU, Madrid, Spain.
Alina M OnofreiCorrona, Waltham, Massachusetts.
Christine J BarrCorrona, Waltham, Massachusetts.
Dimitrios A PappasCorrona, Waltham, Massachusetts, and Columbia University, New York, New York.ORCID https://orcid.org/0000-0001-8338-027X
Heather J LitmanCorrona, Waltham, Massachusetts.
Kimberly J DandreoCorrona, Waltham, Massachusetts.
Andrea B ShapiroPfizer, Peapack, New Jersey.
Carol A ConnellPfizer, Groton, Connecticut.
Arthur KavanaughUniversity of California, San Diego School of Medicine, La Jolla.
Optron Systems (United States) · USPfizer (United States) · USJohns Hopkins University · USCenter for Rheumatology · USColumbia University · USNew York University · USSaint Louis University · ESUniversity of California San Diego · US

Funding

Corrona LLCPfizer Inc
6 · The paper itself

Abstract

objectiveTofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We compared 5-year adverse event (AE) incidence rates (IRs) between patients initiating tofacitinib and those initiating new biological disease-modifying antirheumatic drugs (bDMARDs) within the United States (US) Corrona RA registry.

methodsIRs (number of first events/100 patient-years) of major adverse cardiovascular events (MACE), serious infection events (SIEs), herpes zoster (HZ), malignancies, and death were estimated among tofacitinib and bDMARD initiators, regardless of dose/schedule, between November 6, 2012 (US Food and Drug Administration tofacitinib approval), and July 31, 2018 (follow-up through January 31, 2019). Propensity score (PS) methods were used to control for nonrandom prescribing practices. Hazard ratios (HRs) were calculated to compare rates using multivariable-adjusted Cox regression. Different risk windows were used for acute (MACE, SIEs, HZ, and venous thromboembolic events [VTEs]) and long-term (malignancy and death) events. VTEs were assessed descriptively.

resultsFor MACE, SIEs, and HZ, 1999 (3152.1 patient-years) and 8358 (12 869.4 years) tofacitinib and bDMARD initiators were included, respectively; for malignancy/death, 1999 (4505.6 patient-years) and 6354 (16 670.8 patient-years) initiators were included, respectively. AE rates were similar across cohorts, except for HZ, which was significantly higher with tofacitinib versus bDMARDs (PS-trimmed adjusted HR 2.32; 95% confidence interval [CI] 1.43-3.75). There were 45 (zero serious) and 88 (five serious) HZ events with tofacitinib and bDMARDs, respectively. Sensitivity analyses demonstrated similar results. VTE IRs (95% CI) were 0.29 (0.13-0.54) and 0.33 (0.24-0.45) for tofacitinib and bDMARDs, respectively.

conclusionIn this registry analysis, both cohorts had similar MACE, SIE, malignancy, death, and VTE rates; HZ rates were higher for tofacitinib initaitors than for bDMARD initiators.

Identifiers

PMID33570260
PMCPMC7966883
OpenAlexW3126579487

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.