PMID- 33958440 OWN - NLM STAT- MEDLINE DCOM- 20210831 LR - 20210831 IS - 2056-5933 (Electronic) IS - 2056-5933 (Linking) VI - 7 IP - 2 DP - 2021 May TI - Tofacitinib versus tocilizumab in the treatment of biological-naive or previous biological-failure patients with methotrexate-refractory active rheumatoid arthritis. LID - 10.1136/rmdopen-2021-001601 [doi] LID - e001601 AB - OBJECTIVES: To compare effectiveness between tofacitinib and tocilizumab treatments for biological disease-modifying antirheumatic drug (bDMARD)-naive patients or previous bDMARD-failure patients with active rheumatoid arthritis (RA) refractory to methotrexate (MTX). METHODS: We used two ongoing real-world registries of patients with RA who had first started tofacitinib or tocilizumab between August 2013 and February 2019 at our institutions. Clinical disease activity index (CDAI)-based improvements at 12 months were used for comparisons between tofacitinib and tocilizumab treatments, separately for bDMARD-naive and previous bDMARD-failure patients. RESULTS: A total of 464 patients with RA with high or moderate CDAI were enrolled (247 with tofacitinib and 217 with tocilizumab). After adjustments for treatment-selection bias by propensity score matching, we showed that tofacitinib was more likely to induce and maintain >/=85% improvement in CDAI (CDAI85), CDAI70 and remission at 12 months compared with tocilizumab in bDMARD-naive patients. After adjusting for concurrent use of MTX and prednisolone, the ORs of tofacitinib versus tocilizumab were 3.88 (95% CI 1.87 to 8.03) for CDAI85, 2.89 (95% CI 1.43 to 5.84) for CDAI70 and 3.31 (95% CI 1.69 to 6.48) for remission. These effects were not observed in bDMARD-failure patients. In tofacitinib treatment for bDMARD-failure patients, the number of previously failed bDMARD classes was not associated with CDAI-based improvements. The rate of overall adverse events was similar between both treatments. Similar ORs were obtained from patients adjusted by inverse probability of treatment weighting. CONCLUSIONS: Compared with tocilizumab, tofacitinib can induce greater improvements during the first 12-month treatment in bDMARD-naive patients, but this difference was not observed in previous bDMARD-failure patients. CI - (c) Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Mori, Shunsuke AU - Mori S AUID- ORCID: 0000-0001-7972-4252 AD - Rheumatology, National Hospital Organisation Kumamoto Saishun Medical Center, Koshi, Japan mori.shunsuke.ra@mail.hosp.go.jp. FAU - Urata, Yukitomo AU - Urata Y AUID- ORCID: 0000-0002-5424-2203 AD - Rheumatology, Tsugaru General Hospital United Municipalities of Tsugaru, Goshogawara, Japan. FAU - Yoshitama, Tamami AU - Yoshitama T AD - Rheumatology, Yoshitama Clinic for Rheumatic Diseases, Kirishima, Japan. FAU - Ueki, Yukitaka AU - Ueki Y AD - Rheumatic and Collagen Disease Center, Sasebo Chuo Hospital, Sasebo, Japan. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - England TA - RMD Open JT - RMD open JID - 101662038 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antirheumatic Agents) RN - 0 (Biological Products) RN - 0 (Piperidines) RN - 0 (Pyrimidines) RN - 87LA6FU830 (tofacitinib) RN - I031V2H011 (tocilizumab) RN - YL5FZ2Y5U1 (Methotrexate) SB - IM MH - Antibodies, Monoclonal, Humanized MH - *Antirheumatic Agents/adverse effects MH - *Arthritis, Rheumatoid/drug therapy MH - *Biological Products/therapeutic use MH - Humans MH - Methotrexate/adverse effects MH - Piperidines MH - Pyrimidines PMC - PMC8103932 OTO - NOTNLM OT - antirheumatic agents OT - arthritis OT - biological therapy OT - rheumatoid OT - therapeutics COIS- Competing interests: SM has received lecture fees from Pfizer Japan, Chugai Pharmaceutical Co, Astellas Pharma, Bristol-Myers Squibb K.K., Eisai Co, AbbVie GK, AYUMI Pharmaceutical Co, Asahi Kasei Pharma Co, Janssen Pharmaceutical K.K. and Mitsubishi Tanabe Pharma Co. YUrata has received lecture fees from Eli Lilly Japan K.K., Pfizer Japan and Chugai Pharmaceutical Co. YY has received lecture fees from Chugai Pharmaceutical Co, Bristol-Myers Squibb K.K., Mitsubishi Tanabe Pharma Co, Pfizer Japan, Janssen Pharmaceutical K.K., Takeda Pharmaceutical Co, Eli Lilly Japan K.K., AbbVie GK, AYUMI Pharmaceutical Co, Nippon Kayaku Co, Eisai Co, Teijin Pharma, UCB Japan Co, Boehringer Ingelheim, Nippon Zoki Pharmaceutical Co and Asahi Kasei Pharma Co. YUeki has received lecture fees from Chugai Pharmaceutical Co, Bristol-Myers Squibb K.K., Mitsubishi Tanabe Pharma Co, Pfizer Japan, Janssen Pharmaceutical K.K., Takeda Pharmaceutical Co, Eli Lilly Japan K.K., Astellas Pharma, Ono Pharmaceutical Co and Asahi Kasei Pharma Co. EDAT- 2021/05/08 06:00 MHDA- 2021/09/01 06:00 PMCR- 2021/05/05 CRDT- 2021/05/07 06:33 PHST- 2021/01/27 00:00 [received] PHST- 2021/04/13 00:00 [revised] PHST- 2021/04/22 00:00 [accepted] PHST- 2021/05/07 06:33 [entrez] PHST- 2021/05/08 06:00 [pubmed] PHST- 2021/09/01 06:00 [medline] PHST- 2021/05/05 00:00 [pmc-release] AID - rmdopen-2021-001601 [pii] AID - 10.1136/rmdopen-2021-001601 [doi] PST - ppublish SO - RMD Open. 2021 May;7(2):e001601. doi: 10.1136/rmdopen-2021-001601.