title: Characteristics and outcomes of rheumatoid arthritis patients who started biosimilar infliximab.
abstract: To compare the characteristics of rheumatoid arthritis (RA) patients receiving either biosimilar or originator infliximab and to identify the effectiveness and safety of biosimilar infliximab in RA patients in real-world practice. RA patients who started either biosimilar or originator infliximab were selected using the prospective biologic disease-modifying anti-rheumatic drugs (DMARDs) registry: BIOlogics Pharmacoepidemiologic StudY (BIOPSY). Baseline characteristics of the two groups were compared, and short-term treatment outcomes, including DAS28-ESR and HAQ-DI scores, were compared after initiation of biosimilar or originator infliximab. The drug retention rates of the two groups were also compared. A total of 100 RA patients, 55 biosimilar, and 45 originator infliximab users were included in this analysis. Baseline characteristics of age, disease duration, and previous or current medications were similar in the two groups. Baseline DAS28-ESR was higher in the originator infliximab group (6.3 ± 1.1 vs. 5.8 ± 1.1, p = 0.02). The early DAS28-ESR remission rates observed 7.9 ± 1.8 months after starting biosimilar and originator infliximab were 15.0 and 25.0%, respectively (p = 0.47). The change in HAQ-DI did not differ between the two groups (0.4 ± 0.7 vs. 0.4 ± 0.8, p = 0.94). Patients treated with biosimilar infliximab in clinical practice had lower disease activity at the start of treatment than those receiving originator infliximab. Biosimilar infliximab was well-tolerated, safe, and of similar clinical effectiveness to originator infliximab. Larger number of patient and longer follow-up data will be needed to confirm the effectiveness and safety of biosimilar infliximab in clinical practice.
authors.affiliation: Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea.|Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.
authors.forename: Yoon-Kyoung
authors.initials: YK
authors.lastname: Sung
authors.affiliation: Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea.|Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.
authors.forename: Soo-Kyung
authors.initials: SK
authors.lastname: Cho
authors.affiliation: Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea.|Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.
authors.forename: Dam
authors.initials: D
authors.lastname: Kim
authors.affiliation: Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.
authors.forename: Soyoung
authors.initials: S
authors.lastname: Won
authors.affiliation: Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea.|Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea.
authors.forename: Chan-Bum
authors.initials: CB
authors.lastname: Choi
authors.affiliation: Department of Rheumatology, Hanyang University Guri Hospital, Guri, South Korea.
authors.forename: So-Young
authors.initials: SY
authors.lastname: Bang
authors.affiliation: Department of Rheumatology, Kyung Hee University Hospital, Seoul, South Korea.
authors.forename: Seung-Jae
authors.initials: SJ
authors.lastname: Hong
authors.affiliation: Department of Rheumatology, Ajou University Hospital, Suwon, South Korea.
authors.forename: Hyoun Ah
authors.initials: HA
authors.lastname: Kim
authors.affiliation: Department of Rheumatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
authors.forename: Eun-Mi
authors.initials: EM
authors.lastname: Koh
authors.affiliation: Department of Rheumatology, Hanyang University Guri Hospital, Guri, South Korea.
authors.forename: Hye-Soon
authors.initials: HS
authors.lastname: Lee
authors.affiliation: Department of Rheumatology, Ajou University Hospital, Suwon, South Korea.
authors.forename: Chang-Hee
authors.initials: CH
authors.lastname: Suh
authors.affiliation: Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea.
authors.forename: Dae-Hyun
authors.initials: DH
authors.lastname: Yoo
authors.affiliation: Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea. scbae@hanyang.ac.kr.|Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea. scbae@hanyang.ac.kr.
authors.forename: Sang-Cheol
authors.initials: SC
authors.lastname: Bae
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000069285:Infliximab / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D011446:Prospective Studies; D012042:Registries; D012074:Remission Induction; D056910:Republic of Korea; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors* / Q000276:immunology
chemical_list: D018501:Antirheumatic Agents; D001688:Biological Products; D059451:Biosimilar Pharmaceuticals; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab
keywords: Biologic DMARDs; Biosimilar; Effectiveness; Rheumatoid arthritis; Safety