PMID- 36624354 OWN - NLM STAT- MEDLINE DCOM- 20230308 LR - 20230326 IS - 1865-8652 (Electronic) IS - 0741-238X (Print) IS - 0741-238X (Linking) VI - 40 IP - 3 DP - 2023 Mar TI - Safety and Effectiveness of SB2 (Infliximab Biosimilar) in Adult Patients with Immune-Mediated Inflammatory Diseases: A Post-Marketing Surveillance in Korea. PG - 1047-1061 LID - 10.1007/s12325-022-02404-x [doi] AB - INTRODUCTION: SB2 is a biosimilar of infliximab (IFX), which is approved for rheumatoid arthritis (RA), ankylosing spondylitis (AS), adult and pediatric Crohn's disease (CD), adult and pediatric ulcerative colitis (UC), psoriatic arthritis (PsA), and plaque psoriasis (PsO). The drug approval process in Korea includes post-marketing surveillance (PMS) studies to re-examine the safety and effectiveness of approved new medications. METHODS: This was a prospective, multi-center, open-label, observational, phase 4 PMS study of IFX-naive patients or patients switched from reference IFX or another IFX-biosimilar to SB2 in all approved indications. The primary endpoint was to evaluate the safety of SB2 reported as adverse events (AEs) and adverse drug reactions (ADRs). The secondary endpoint was to evaluate the effectiveness measured as investigators' overall effectiveness assessment, categorized as improved, stable, or worsened. Furthermore, disease-specific activity scores were collected for each indication [28-joint Modified Disease Activity Score (DAS28) for RA, Korean Bath Ankylosing Spondylitis Disease Activity Index (KBASDAI), Crohn's Disease Activity Index (CDAI), and Full Mayo Score for UC]. RESULTS: In the safety and effectiveness analysis, 180 and 128 patients were included, respectively. Most patients (83.9%) were IFX-naive patients and 16.1% were switched patients. RA (48.9%) and AS (31.1%) were the most frequent indications. Overall, 23 (12.8%) patients reported AEs and 14 (7.8%) patients reported ADRs. Serious adverse events (SAEs) were reported by 3 (1.7%) patients. As per investigators' overall effectiveness assessments, SB2 was effective in 94.6% (105/111) of IFX-naive patients and 82.4% (14/17) of switched patients. In IFX-naive patients, disease activity scores decreased significantly from baseline to week 30 (week 24 for AS); mean (SD) changes of disease scores for each indication were DAS28 - 1.9 (0.79) for RA, KBASDAI - 3.8 (1.68) for AS, CDAI - 200.4 (112.47) for CD, and Full Mayo Score - 6.6 (2.92) for UC. The persistence rate of SB2 treatments was 88.3% with median treatment duration of 30.1 weeks. CONCLUSION: This PMS study of the IFX-biosimilar SB2 in Korea confirmed the safety and effectiveness of SB2 in major indications. CI - (c) 2023. The Author(s). FAU - Kim, Dong W AU - Kim DW AD - Division of Rheumatology, Department of Internal Medicine, Inje University, Busan Paik Hospital, Busan, Korea. FAU - Lee, Yousun AU - Lee Y AD - Division of Rheumatology, Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea. FAU - Kim, Geuntae AU - Kim G AD - Division of Rheumatology, Department of Internal Medicine, Kosin University Gospel Hospital, Kosin University College of Medicine, Busan, Korea. FAU - Kim, Sang H AU - Kim SH AD - Division of Rheumatology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, Korea. FAU - Cho, Dae H AU - Cho DH AD - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea. FAU - Choi, Jeongmin AU - Choi J AD - Department of Internal Medicine, Inje University Sanggye Paik Hospital, Nowon-gu, Korea. FAU - Kwon, Yong H AU - Kwon YH AD - Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea. FAU - Park, Younjin AU - Park Y AD - Samsung Bioepis Co., Ltd., Incheon, Republic of Korea. FAU - Choi, Wooree AU - Choi W AD - Samsung Bioepis Co., Ltd., Incheon, Republic of Korea. FAU - Park, Dong I AU - Park DI AUID- ORCID: 0000-0003-2307-8575 AD - Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea. diksmc.park@samsung.com. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20230110 PL - United States TA - Adv Ther JT - Advances in therapy JID - 8611864 RN - B72HH48FLU (Infliximab) RN - 0 (Biosimilar Pharmaceuticals) MH - Child MH - Humans MH - Adult MH - Infliximab/adverse effects MH - *Spondylitis, Ankylosing/drug therapy MH - *Biosimilar Pharmaceuticals/adverse effects MH - Prospective Studies MH - *Arthritis, Psoriatic/drug therapy MH - *Arthritis, Rheumatoid/drug therapy MH - Treatment Outcome MH - Republic of Korea MH - Product Surveillance, Postmarketing PMC - PMC9989004 OTO - NOTNLM OT - Ankylosing spondylitis OT - Biosimilar OT - Crohn's disease OT - Psoriatic arthritis OT - Real world evidence OT - Remaloce OT - Rheumatoid arthritis OT - SB2 OT - TNF inhibitor OT - Ulcerative colitis EDAT- 2023/01/10 06:00 MHDA- 2023/03/09 06:00 PMCR- 2023/01/10 CRDT- 2023/01/09 23:27 PHST- 2022/10/13 00:00 [received] PHST- 2022/12/07 00:00 [accepted] PHST- 2023/01/10 06:00 [pubmed] PHST- 2023/03/09 06:00 [medline] PHST- 2023/01/09 23:27 [entrez] PHST- 2023/01/10 00:00 [pmc-release] AID - 10.1007/s12325-022-02404-x [pii] AID - 2404 [pii] AID - 10.1007/s12325-022-02404-x [doi] PST - ppublish SO - Adv Ther. 2023 Mar;40(3):1047-1061. doi: 10.1007/s12325-022-02404-x. Epub 2023 Jan 10.