Evidence map›Paper›PMID 42661528›Full record

ArticleInternational journal of rheumatic diseases2026

Comparative Safety Analysis of Targeted Synthetic and Biologic Disease-Modifying Antirheumatic Drugs Among Patients With Rheumatoid Arthritis: A Nationwide Cohort Study in Japan.

Shiori Nishimura, Toshitaka Hirano, Soko Setoguchi, Hiroki Matsui, Yoshinori Takeuchi, Yasushi Inoue, Yoshiya Tanaka, Kunihiro Yamaoka, Yoichi Ii, Shintaro Hiro and 4 more

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of rheumatic diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

14 authors.

Shiori NishimuraDepartment of Healthcare Quality Assessment, The University of Tokyo Graduate School of Medicine, Bunkyo, Tokyo, Japan.ORCID https://orcid.org/0000-0003-1319-3158
Toshitaka HiranoPfizer Japan Inc., Shibuya, Tokyo, Japan.ORCID https://orcid.org/0009-0005-2932-6375
Soko SetoguchiDepartment of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
Hiroki MatsuiDepartment of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Bunkyo, Tokyo, Japan.
Yoshinori TakeuchiDepartment of Data Science, School of Data Science, Yokohama City University, Yokohama, Kanagawa, Japan.
Yasushi InoueDepartment of Rheumatology, Japanese Red Cross Fukuoka Hospital, Fukuoka, Fukuoka, Japan.
Yoshiya TanakaDepartment of Molecular Targeted Therapeutics, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.ORCID https://orcid.org/0000-0002-0807-7139
Kunihiro YamaokaDepartment of Rheumatology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.ORCID https://orcid.org/0000-0001-8858-9435
Yoichi IiPfizer R&D Japan G.K., Shibuya, Tokyo, Japan.ORCID https://orcid.org/0000-0001-6418-0547
Shintaro HiroPfizer R&D Japan G.K., Shibuya, Tokyo, Japan.
Masato HoshiPfizer Japan Inc., Shibuya, Tokyo, Japan.ORCID https://orcid.org/0000-0003-2874-1807
Naonobu SugiyamaPfizer Japan Inc (at time of study), Shibuya, Tokyo, Japan.
Yutaka MatsuyamaDepartment of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Bunkyo, Tokyo, Japan.ORCID https://orcid.org/0000-0003-2009-6831
Hiraku KumamaruDepartment of Healthcare Quality Assessment, The University of Tokyo Graduate School of Medicine, Bunkyo, Tokyo, Japan.ORCID https://orcid.org/0000-0002-9759-6191

Funding

Pfizer
6 · The paper itself

Abstract

aimTo compare risks of malignancy, opportunistic infections, and venous thromboembolism between the targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs) and biologic DMARDs (bDMARDs) at the 2nd and 3rd lines of therapy (LOT).

methodsWe conducted a cohort study using the National Database of Health Insurance Claims (2013-2021). Patients with rheumatoid arthritis (RA) initiating tsDMARDs or bDMARDs after conventional synthetic DMARDs (csDMARDs) were identified at the 2nd LOT or 3rd LOT. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated using Cox models weighted by inverse probability of treatment weighting.

resultsAmong 498 813 csDMARD initiators, 66 638 and 4177 initiated bDMARDs and tsDMARDs at 2nd LOT; 14 085 and 1757 initiated bDMARDs and tsDMARDs at 3rd LOT. For malignancy, HRs (95% CIs) for tsDMARDs versus bDMARDs were 0.92 (0.60-1.43) at 2nd LOT and 0.94 (0.53-1.65) at 3rd LOT. HRs (95% CIs) for pneumocystis pneumonia (PCP) and deep vein thrombosis (DVT) were as follows: PCP, 0.98 (0.75-1.29) at 2nd LOT and 1.12 (0.81-1.54) at 3rd LOT; DVT, 1.13 (0.64-1.99) at 2nd LOT and 0.96 (0.52-1.78) at 3rd LOT. In contrast, herpes zoster (HZ) risk was consistently higher with tsDMARDs (2nd LOT: HR, 2.61 [95% CI, 2.24-3.05]; 3rd LOT: HR, 2.90 [95% CI, 2.38-3.53]).

conclusionsIn the nationwide Japanese cohort, tsDMARDs did not show increased malignancy risk compared to bDMARDs, and PCP risk had no clear difference at 2nd and 3rd LOTs, whereas the risk of HZ was higher with tsDMARDs.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidBiological ProductsAdultAgedCohort StudiesFemaleHumansJapanMaleMiddle AgedNeoplasmsOpportunistic InfectionsRisk AssessmentRisk FactorsVenous ThromboembolismAntirheumatic AgentsBiological Productsbiologic disease‐modifying antirheumatic druginfectionJanus kinase inhibitormalignancytargeted synthetic disease‐modifying antirheumatic drugvenous thromboembolism

Identifiers

PMID42661528
PMCPMC13522856

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.