Observational studyInternational journal of clinical pharmacology and therapeutics2023
Risks of malignant lymphoma in rheumatoid arthritis patients receiving methotrexate-alone and in combination therapy compared with the general population: A study based on a Japanese medical claims database.
Observational study in International journal of clinical pharmacology and therapeutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 6 citations in OpenAlex.
- A scoping review of real-world data sources for retrospective oncology analysis in Japan.ESMO real world data and digital oncology · 2026Review
- Evaluation of adverse drug reactions in cancer-related settings using diverse real-world data.Journal of pharmaceutical health care and sciences · 2026Review
- Mantle cell lymphoma exhibiting repeated progression with the initiation of a JAK-1 inhibitor for psoriatic arthritis.International journal of hematology · 2026Article
- Delayed recurrence of hepatitis E virus RNA in serum and feces after ribavirin therapy for chronic hepatitis E: importance of extended follow-up.Clinical journal of gastroenterology · 2025Article
- Article
- Estimating cancer risk in immune-mediated inflammatory diseases exposed to varying doses of tumour necrosis factor inhibitors.Journal of gastroenterology · 2025Article
- Risk of cancer and conventional syntethic DMARDS: A narrative review.Northern clinics of Istanbul · 2025Article
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Authors and funding
5 authors.
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Abstract
objectiveThe risk of malignancy in patients with rheumatoid arthritis (RA) treated with methotrexate (MTX) and biological disease-modifying antirheumatic drug (bDMARD) combination therapy is unknown. This study aimed to clarify the incidence of malignancy and the recommended monitoring period in patients receiving this combination therapy. MATERIALS AND
methodsA retrospective, observational study based on a large Japanese medical claims database was conducted between April 2013 and February 2020. Patients with RA were classified into MTX-alone and combination therapy groups, and the standardized incidence rates (SIR) of malignancy were calculated. The time of onset of malignancy in both groups was calculated.
resultsIn total, 2,052 patients received MTX-alone and 782 received combination therapy. The incidence of malignant lymphoma was significantly higher with MTX-alone therapy (SIR: 6.09, 95% confidence interval (CI): 1.58 - 10.61) and combination therapy (SIR: 20.86, 95% CI: 8.53 - 33.19) than in the general Japanese population. Furthermore, the combination therapy had a significantly higher risk of malignant lymphoma than the MTX-alone therapy (adjusted odds ratio: 4.27, 95% CI: 1.64 - 11.12). The median time from MTX prescription to the onset of malignant lymphoma was 3.58 years (interquartile range (IQR): 2.00 - 5.34 years) for MTX-alone and 3.42 years (IQR: 1.25 - 4.92 years) for combination therapy.
conclusionThe incidence of malignant lymphoma in the combination therapy group was extensively higher than that in the general Japanese population. Special attention is required for early symptoms of malignant lymphoma, particularly in the 3
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