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Original Research

Risk of malignant lymphoma in patients with rheumatoid arthritis treated with biological disease-modifying antirheumatic drugs and methotrexate 

Ryo Inose, Kouichi Hosomi, Katsuyuki Takahashi, Satoshi Yokoyama, and Mitsutaka Takada

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Volume 57 (2019) p. 63 - 72

Abstract

Risk of malignant lymphoma in patients with rheumatoid arthritis treated with biological disease-modifying antirheumatic drugs and methotrexate 

Ryo Inose¹, Kouichi Hosomi², Katsuyuki Takahashi¹, Satoshi Yokoyama², and Mitsutaka Takada²

¹Department of Pharmacy, Osaka City University Hospital, and ²Division of Clinical Drug Informatics, School of Pharmacy, Kindai University, Osaka, Japan
Objective: This study investigated whether using biological disease-modifying antirheumatic drugs (bDMARDs) further increases the risk of malignant lymphoma in patients with rheumatoid arthritis undergoing methotrexate therapy using spontaneous adverse reaction databases in different countries. Materials and methods: Patient data were acquired from the US Food and Drug Administration’s Adverse Event Reporting System (FAERS), the Japanese Adverse Drug Event Report (JADER), and the Canada Vigilance Adverse Reaction Online Database (CVARD) from the first quarter of 2004 to the end of 2015. Data subset analysis was performed to investigate whether the use of bDMARDs further increased the risk of malignant lymphoma in patients receiving methotrexate therapy. Results: The FAERS subset data indicated a significant association between Hodgkin lymphoma and methotrexate with infliximab (reporting odds ratio (ROR): 8.28. 95% CI: 5.70 – 12.02; information component (IC): 2.04, 95% CI: 1.59 – 2.49). In addition, signal scores suggested that methotrexate with infliximab (ROR: 3.26. 95% CI: 2.68 – 3.98; IC: 1.31, 95% CI: 1.04 – 1.58) was significantly associated with non-Hodgkin lymphoma (NHL). The CVARD subset data also indicated a significant association between NHL and methotrexate with infliximab (ROR: 22.82. 95% CI: 5.02 – 103.78; IC: 1.77, 95% CI: 0.13 – 3.41). However, the JADER subset data revealed no significant associations. Conclusion: The present study shows that using infliximab further increases the risk of malignant lymphoma in patients receiving methotrexate therapy. Correspondence to:
Mitsutaka Takada, PhD
Division of Clinical Drug Informatics
Kindai University School of Pharmacy
3-4-1, Kowakae, Higashi-osaka, Osaka, 577-8502, Japan 
Email: takada@ phar.kindai.ac.jp

Original

Association between malignancy and methotrexate and biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis 

Ryo Inose, Natsue Hashimoto, Kouichi Hosomi, Satoshi Yokoyama, and Mitsutaka Takada

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Volume 58 (2020) p. 131 - 138

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 58 – No. 3/2020 (131-138)

Association between malignancy and methotrexate and biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis 

Ryo Inose¹, Natsue Hashimoto², Kouichi Hosomi², Satoshi Yokoyama², and Mitsutaka Takada²

¹Department of Pharmacy, Osaka City University Hospital, and ²Division of Clinical Drug Informatics, School of Pharmacy, Kindai University, Osaka, Japan
Objective: This study was aimed at investigating the risk of malignancies in rheumatoid arthritis patients treated with methotrexate (MTX), and whether the addition of biological disease-modifying antirheumatic drugs (bDMARDs) further increases the risk of malignancies in patients receiving MTX therapy, by using data from a spontaneous adverse reaction database.
Materials: Patient data from the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the end of 2015 were analyzed.
Methods: A data subset analysis was performed to investigate whether the use of bDMARDs further increased the risk of malignancies in patients receiving MTX therapy.
Results: MTX showed significant associations with all malignancies except liver cancer. bDMARDs showed significant associations with stomach cancer, colorectal cancer, prostate cancer, ovarian cancer, malignant melanoma, and lung cancer. In addition, bDMARD use increased the risk of breast, ovarian, and lung cancers in rheumatoid arthritis patients receiving MTX therapy.
Conclusion: MTX use was significantly associated with various malignancies. Moreover, concomitant use of bDMARDs further increased the risk of breast, ovarian, and lung cancers in MTX-treated patients with rheumatoid arthritis.Correspondence to:
 Mitsutaka Takada, PhD
Division of Clinical Drug Informatics
Kindai University School of Pharmacy
3-4-1, Kowakae, Higashi-osaka, Osaka, 577-8502, Japan
Email: takada@ phar.kindai.ac.jp

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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