Incidence of Malignancies and the Association with Biological Disease-Modifying Antirheumatic Drugs in Japanese Patients with Rheumatoid Arthritis: A Time-Dependent Analysis from the IORRA Patient Registry
Abstract Introduction Patients with rheumatoid arthritis (RA) may have an increased malignancy risk versus the general population, potentially elevated by biological disease-modifying antirheumatic drug (bDMARD) use. Using patient registry data, we determined malignancy risk, stratified by bDMARD us...
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Adis, Springer Healthcare
2024-07-01
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| Series: | Rheumatology and Therapy |
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| Online Access: | https://doi.org/10.1007/s40744-024-00689-8 |
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| author | Masayoshi Harigai Eiichi Tanaka Eisuke Inoue Ryoko Sakai Naohiro Sugitani Shigeyuki Toyoizumi Naonobu Sugiyama Hisashi Yamanaka |
| author_facet | Masayoshi Harigai Eiichi Tanaka Eisuke Inoue Ryoko Sakai Naohiro Sugitani Shigeyuki Toyoizumi Naonobu Sugiyama Hisashi Yamanaka |
| author_sort | Masayoshi Harigai |
| collection | DOAJ |
| description | Abstract Introduction Patients with rheumatoid arthritis (RA) may have an increased malignancy risk versus the general population, potentially elevated by biological disease-modifying antirheumatic drug (bDMARD) use. Using patient registry data, we determined malignancy risk, stratified by bDMARD use, among Japanese patients with RA versus the Japanese general population and investigated whether bDMARD use is a time-dependent risk factor for the development of malignancy. Methods Patients aged ≥ 18 years with ≥ 2 data entries of RA in the IORRA (Institute of Rheumatology, Rheumatoid Arthritis) patient registry, enrolled from January 2013–December 2018, were identified (‘All RA’ cohort). Patients were stratified into bDMARD (≥ 1 bDMARD received) or non-bDMARD (no history of bDMARDs) sub-cohorts. Malignancy incidence rates and standardized incidence ratios (SIRs) with 95% confidence intervals (CIs) versus the Japanese general population were calculated. Risk of RA medication use was analyzed using a time-dependent Cox proportional hazards model, after adjusting for covariates. Results A total of 8020 patients were identified for the All RA cohort; 2187 and 5833 for the bDMARD and non-bDMARD sub-cohorts, respectively. For all three cohorts, incidence of overall malignancies was similar versus the Japanese general population. Incidence of specific malignancies was also similar, but incidence of lymphoma was higher for all three cohorts (SIRs [95% CIs] 3.72 [2.71–4.93], 5.97 [3.34–9.59], and 2.79 [1.82–4.02], respectively). In the bDMARD sub-cohort, no increase in SIRs was observed for other site-specific malignancies. In the All RA cohort, use of methotrexate, tacrolimus, glucocorticoids, non-steroidal anti-inflammatory drugs, and bDMARDs were not associated with the risk of overall malignancy; the hazard ratio (95% CI) was 1.36 (0.96–1.93) for bDMARD use. Increased disease activity was a time-dependent risk factor of overall malignancy with a hazard ratio (95% CI) of 1.35 (1.15–1.59). Conclusions The use of bDMARDs was not a time-dependent risk factor for malignancy. |
| format | Article |
| id | doaj-art-796c6615710d4520b9bb31a6ac79d58e |
| institution | Kabale University |
| issn | 2198-6576 2198-6584 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Rheumatology and Therapy |
| spelling | doaj-art-796c6615710d4520b9bb31a6ac79d58e2025-01-19T12:38:22ZengAdis, Springer HealthcareRheumatology and Therapy2198-65762198-65842024-07-011151181119510.1007/s40744-024-00689-8Incidence of Malignancies and the Association with Biological Disease-Modifying Antirheumatic Drugs in Japanese Patients with Rheumatoid Arthritis: A Time-Dependent Analysis from the IORRA Patient RegistryMasayoshi Harigai0Eiichi Tanaka1Eisuke Inoue2Ryoko Sakai3Naohiro Sugitani4Shigeyuki Toyoizumi5Naonobu Sugiyama6Hisashi Yamanaka7Department of Rheumatology, Sanno HospitalDivision of Rheumatology, Department of Internal Medicine, Tokyo Women’s Medical University School of MedicineDivision of Rheumatology, Department of Internal Medicine, Tokyo Women’s Medical University School of MedicineDivision of Rheumatology, Department of Internal Medicine, Tokyo Women’s Medical University School of MedicineDivision of Rheumatology, Department of Internal Medicine, Tokyo Women’s Medical University School of MedicineBiometrics and Data Management, Pfizer R&D JapanInflammation & Immunology, Pfizer Japan IncDivision of Rheumatology, Department of Internal Medicine, Tokyo Women’s Medical University School of MedicineAbstract Introduction Patients with rheumatoid arthritis (RA) may have an increased malignancy risk versus the general population, potentially elevated by biological disease-modifying antirheumatic drug (bDMARD) use. Using patient registry data, we determined malignancy risk, stratified by bDMARD use, among Japanese patients with RA versus the Japanese general population and investigated whether bDMARD use is a time-dependent risk factor for the development of malignancy. Methods Patients aged ≥ 18 years with ≥ 2 data entries of RA in the IORRA (Institute of Rheumatology, Rheumatoid Arthritis) patient registry, enrolled from January 2013–December 2018, were identified (‘All RA’ cohort). Patients were stratified into bDMARD (≥ 1 bDMARD received) or non-bDMARD (no history of bDMARDs) sub-cohorts. Malignancy incidence rates and standardized incidence ratios (SIRs) with 95% confidence intervals (CIs) versus the Japanese general population were calculated. Risk of RA medication use was analyzed using a time-dependent Cox proportional hazards model, after adjusting for covariates. Results A total of 8020 patients were identified for the All RA cohort; 2187 and 5833 for the bDMARD and non-bDMARD sub-cohorts, respectively. For all three cohorts, incidence of overall malignancies was similar versus the Japanese general population. Incidence of specific malignancies was also similar, but incidence of lymphoma was higher for all three cohorts (SIRs [95% CIs] 3.72 [2.71–4.93], 5.97 [3.34–9.59], and 2.79 [1.82–4.02], respectively). In the bDMARD sub-cohort, no increase in SIRs was observed for other site-specific malignancies. In the All RA cohort, use of methotrexate, tacrolimus, glucocorticoids, non-steroidal anti-inflammatory drugs, and bDMARDs were not associated with the risk of overall malignancy; the hazard ratio (95% CI) was 1.36 (0.96–1.93) for bDMARD use. Increased disease activity was a time-dependent risk factor of overall malignancy with a hazard ratio (95% CI) of 1.35 (1.15–1.59). Conclusions The use of bDMARDs was not a time-dependent risk factor for malignancy.https://doi.org/10.1007/s40744-024-00689-8Rheumatoid arthritisOutcomesTherapeutics |
| spellingShingle | Masayoshi Harigai Eiichi Tanaka Eisuke Inoue Ryoko Sakai Naohiro Sugitani Shigeyuki Toyoizumi Naonobu Sugiyama Hisashi Yamanaka Incidence of Malignancies and the Association with Biological Disease-Modifying Antirheumatic Drugs in Japanese Patients with Rheumatoid Arthritis: A Time-Dependent Analysis from the IORRA Patient Registry Rheumatology and Therapy Rheumatoid arthritis Outcomes Therapeutics |
| title | Incidence of Malignancies and the Association with Biological Disease-Modifying Antirheumatic Drugs in Japanese Patients with Rheumatoid Arthritis: A Time-Dependent Analysis from the IORRA Patient Registry |
| title_full | Incidence of Malignancies and the Association with Biological Disease-Modifying Antirheumatic Drugs in Japanese Patients with Rheumatoid Arthritis: A Time-Dependent Analysis from the IORRA Patient Registry |
| title_fullStr | Incidence of Malignancies and the Association with Biological Disease-Modifying Antirheumatic Drugs in Japanese Patients with Rheumatoid Arthritis: A Time-Dependent Analysis from the IORRA Patient Registry |
| title_full_unstemmed | Incidence of Malignancies and the Association with Biological Disease-Modifying Antirheumatic Drugs in Japanese Patients with Rheumatoid Arthritis: A Time-Dependent Analysis from the IORRA Patient Registry |
| title_short | Incidence of Malignancies and the Association with Biological Disease-Modifying Antirheumatic Drugs in Japanese Patients with Rheumatoid Arthritis: A Time-Dependent Analysis from the IORRA Patient Registry |
| title_sort | incidence of malignancies and the association with biological disease modifying antirheumatic drugs in japanese patients with rheumatoid arthritis a time dependent analysis from the iorra patient registry |
| topic | Rheumatoid arthritis Outcomes Therapeutics |
| url | https://doi.org/10.1007/s40744-024-00689-8 |
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