PMID- 32174196 OWN - NLM STAT- MEDLINE DCOM- 20210121 LR - 20210121 IS - 1744-764X (Electronic) IS - 1474-0338 (Linking) VI - 19 IP - 5 DP - 2020 May TI - The safety of baricitinib in patients with rheumatoid arthritis. PG - 545-551 LID - 10.1080/14740338.2020.1743263 [doi] AB - Introduction: Despite improvement in disease outcomes and prognosis, a substantial number of patients with rheumatoid arthritis (RA) still require a novel agent for effective treatment. Baricitinib is a targeted synthetic disease-modifying antirheumatic drug (tsDMARDs) that selectively inhibits Janus kinase (JAK1/JAK2), an important enzyme in the pathogenesis of RA.Areas covered: This paper aimed to evaluate the pharmacodynamics and pharmacokinetics of baricitinib while reviewing its safety and efficacy in the treatment of RA.Expert opinion: Randomized controlled trials of baricitinib showed its efficacy and safety in patients with active RA who were methotrexate (MTX)-naive or were not adequately responsive to MTX, conventional synthetic DMARDs, or tumor necrosis factor inhibitors. Baricitinib may be suitable in patients who prefer oral therapy and do not have a history of severe renal impairment, recent history of malignancy, or risk factors for adverse events (AEs) such as venous thromboembolism, opportunistic infection, and diverticulitis. Dose adjustment of baricitinib, based on the assessment of patient conditions including their renal function and disease activity, is an important strategy for successful and safe treatment. However, long-term post-marketing surveillance studies with a larger sample size are required to evaluate the overall safety and AEs with low incidence rates in clinical settings. FAU - Honda, Suguru AU - Honda S AUID- ORCID: 0000-0003-4846-3234 AD - Department of Rheumatology, School of Medicine, Tokyo Women's Medical University, Tokyo, Japan. FAU - Harigai, Masayoshi AU - Harigai M AUID- ORCID: 0000-0002-6418-2603 AD - Department of Rheumatology, School of Medicine, Tokyo Women's Medical University, Tokyo, Japan. LA - eng PT - Journal Article PT - Review DEP - 20200321 PL - England TA - Expert Opin Drug Saf JT - Expert opinion on drug safety JID - 101163027 RN - 0 (Antirheumatic Agents) RN - 0 (Azetidines) RN - 0 (Purines) RN - 0 (Pyrazoles) RN - 0 (Sulfonamides) RN - EC 2.7.10.2 (JAK1 protein, human) RN - EC 2.7.10.2 (JAK2 protein, human) RN - EC 2.7.10.2 (Janus Kinase 1) RN - EC 2.7.10.2 (Janus Kinase 2) RN - ISP4442I3Y (baricitinib) SB - IM MH - Antirheumatic Agents/*administration & dosage/adverse effects/pharmacology MH - Arthritis, Rheumatoid/*drug therapy/physiopathology MH - Azetidines/*administration & dosage/adverse effects/pharmacology MH - Humans MH - Janus Kinase 1/antagonists & inhibitors MH - Janus Kinase 2/antagonists & inhibitors MH - Purines/*administration & dosage/adverse effects/pharmacology MH - Pyrazoles/*administration & dosage/adverse effects/pharmacology MH - Randomized Controlled Trials as Topic MH - Sulfonamides/*administration & dosage/adverse effects/pharmacology OTO - NOTNLM OT - Janus kinase inhibitor OT - Rheumatoid arthritis OT - baricitinib OT - efficacy OT - herpes zoster OT - safety EDAT- 2020/03/17 06:00 MHDA- 2021/01/22 06:00 CRDT- 2020/03/17 06:00 PHST- 2020/03/17 06:00 [pubmed] PHST- 2021/01/22 06:00 [medline] PHST- 2020/03/17 06:00 [entrez] AID - 10.1080/14740338.2020.1743263 [doi] PST - ppublish SO - Expert Opin Drug Saf. 2020 May;19(5):545-551. doi: 10.1080/14740338.2020.1743263. Epub 2020 Mar 21.