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Original

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 

Ryo Inose, Arisa Nakamura, Rina Omi, Shujiro Takeno, and Yuichi Muraki

Volume 61 (2023) p. 430 - 436

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 61 – No. 10/2023 (430-436)

Ryo Inose¹, Arisa Nakamura¹, Rina Omi¹, Shujiro Takeno², and Yuichi Muraki¹

¹Department of Clinical Pharmacoepidemiology, Kyoto Pharmaceutical University, Kyoto, and ²Real World Data Consulting, IQVIA Solutions Japan, Tokyo, Japan
Objective: The 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 methods: A 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. Results: In 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.
Conclusion: The 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^rd – 4^th year after initiating MTX therapy.Correspondence to:
Ryo Inose, PhD
Department of Clinical Pharmacoepidemiology
Kyoto Pharmaceutical University
5 Misasagi-nakauchi-cho,
Yamashina-ku, Kyoto-shi, Kyoto 607-8414, Japan
Email: [email protected]

Original

Sodium-glucose cotransporter-2 inhibitor treatment has differential effects on the incidence of various malignancies: Evidence from a spontaneous adverse reaction database

Ryo Inose and Yuichi Muraki

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Volume 63 (2025) p. 98 - 104

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 63 – No. 3/2025 (98-104)

Sodium-glucose cotransporter-2 inhibitor treatment has differential effects on the incidence of various malignancies: Evidence from a spontaneous adverse reaction database

Ryo Inose and Yuichi Muraki

Laboratory of Clinical Pharmacoepidemiology, Kyoto Pharmaceutical University, Yamashina-ku, Kyoto-shi, Kyoto, Japan
Objective: Sodium-glucose cotransporter (SGLT) 2 inhibitors are expected to demonstrate secondary effects against malignancy. However, long-term and large-scale data are required to evaluate the effects of SGLT2 inhibitors on malignancy, which has not been sufficiently studied in clinical practice. This study aimed to evaluate the association between SGLT2 inhibitors and malignancy using the spontaneous adverse reaction database.
Materials and methods: The United States Food and Drug Administration Adverse Event Reporting System database between 1997 (4Q) and 2020 (2Q) was used in this study. Reporting odds ratio (ROR) was selected as the safety-signaling measure. An inverse signal suggesting potential alternative therapeutic opportunities was defined when the upper limit of 95% confidence interval (CI) was < 1. The association between SGLT2 inhibitors and malignancies was evaluated.
Results: The total number of reports in the database during the study period was 13,106,455. SGLT2 inhibitors showed significant associations with pancreatic cancer (ROR: 3.08. 95% CI: 2.68 – 3.55), and kidney cancer (ROR: 1.39. 95% CI: 1.13 – 1.72). SGLT2 inhibitors showed significant inverse associations with breast cancer (ROR: 0.32. 95% CI: 0.27 – 0.39), lung cancer (ROR: 0.47. 95% CI: 0.37 – 0.59), liver cancer (ROR: 0.68. 95% CI: 0.50 – 0.93), and malignant melanoma (ROR: 0.49. 95% CI: 0.34 – 0.70).
Conclusion: SGLT2 inhibitors may increase the incidence of pancreatic cancer and kidney cancer, and decrease the incidence of breast cancer, lung cancer, liver cancer, and malignant melanoma. These associations need to be further examined in other clinical studies and research in the future.Correspondence to:
Ryo Inose, PhD
Laboratory of Clinical Pharmacoepidemiology
Kyoto Pharmaceutical University
5 Misasagi-nakauchi-cho, Yamashina-ku,
Kyoto-shi, Kyoto 607-8414, Japan
Email: [email protected]

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