PMID- 34762577 OWN - NLM STAT- MEDLINE DCOM- 20220322 LR - 20220428 IS - 1744-764X (Electronic) IS - 1474-0338 (Linking) VI - 21 IP - 4 DP - 2022 Apr TI - Search of official nationwide database in Japan for adverse events associated with disease-modifying antirheumatic drug therapies: focus on therapies in combination with methotrexate. PG - 573-580 LID - 10.1080/14740338.2022.2006180 [doi] AB - BACKGROUND: Disease-modifying antirheumatic drugs (DMARDs) are essential for rheumatoid arthritis (RA) therapy. The adverse events (AEs) evaluation should focus on that methotrexate (MTX) is frequently prescribed in combination with others (combination MTX). METHODS: A search of the website of the official Japanese Agency for AEs, including lymphoproliferative disease (LPD), cytopenia, interstitial pneumonia, infectious pneumonia other than Pneumocystis jirovecii pneumonia (PCP) (i-Pn), and PCP, associated with MTX, tacrolimus, adalimumab, tocilizumab, and abatacept therapies reported from 2014 to 2016 was performed. Number of each AE cases and its ratio to total number of AEs cases were examined. Combination MTX was checked for RA cases. RESULTS: A total of 8874 cases were listed. In 3955 MTX cases, LPD was most frequent (36.4%). In any of the other four DMARDs cases, i-Pn was most frequent (4.2 ~ 15.3%); PCP cases showed most frequent combination MTX (94.4%). In total, including cases reported for MTX therapy, 98.2% of LPD and 97.6% of PCP cases had MTX, and less than 90% of the other AEs cases had MTX. CONCLUSION: LPD was by far the most frequent AE associated with MTX therapy. PCP was strongly associated with combination MTX. For any of the other four DMARDs, i-Pn was most frequent. FAU - Inokuma, Shigeko AU - Inokuma S AUID- ORCID: 0000-0001-9797-1169 AD - Chiba Central Medical Center; National Center for Global Health and Medicine, Kohnodai Hospital, Chiba, Japan. LA - eng PT - Journal Article DEP - 20220314 PL - England TA - Expert Opin Drug Saf JT - Expert opinion on drug safety JID - 101163027 RN - 0 (Antirheumatic Agents) RN - FYS6T7F842 (Adalimumab) RN - YL5FZ2Y5U1 (Methotrexate) SB - IM MH - Adalimumab MH - *Antirheumatic Agents/adverse effects MH - *Arthritis, Rheumatoid/complications/drug therapy MH - Drug Therapy, Combination MH - Humans MH - Japan/epidemiology MH - Methotrexate/adverse effects MH - Treatment Outcome OTO - NOTNLM OT - Adverse event OT - DMARD (disease-modifying antirheumatic drug) OT - Pneumocystis jirovecii pneumonia OT - lymphoproliferative disease OT - methotrexate EDAT- 2021/11/12 06:00 MHDA- 2022/03/23 06:00 CRDT- 2021/11/11 17:15 PHST- 2021/11/12 06:00 [pubmed] PHST- 2022/03/23 06:00 [medline] PHST- 2021/11/11 17:15 [entrez] AID - 10.1080/14740338.2022.2006180 [doi] PST - ppublish SO - Expert Opin Drug Saf. 2022 Apr;21(4):573-580. doi: 10.1080/14740338.2022.2006180. Epub 2022 Mar 14.