The safety of baricitinib in patients with rheumatoid arthritis

ABSTRACT

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)-naïve 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.

KEYWORDS:

• Rheumatoid arthritis
• Janus kinase inhibitor
• baricitinib
• safety
• efficacy
• herpes zoster

Declaration of interest

M Harigai received salaries from Tokyo Women’s Medical University, particularly from the Division of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases, which were taken from unrestricted research grants from Ayumi Pharmaceutical Co.; Chugai Pharmaceutical Co., Ltd.; Eisai Co., Ltd.; Nippon Kayaku Co., Ltd.; Taisho Toyama Pharmaceutical Co., Ltd.; Takeda Pharmaceutical Co., Ltd.; Mitsubishi Tanabe Pharma Co.; and Teijin Pharma Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

A reviewer of this manuscript discloses acting as a consultant, speaker, receiving honoraria and attending advisory boards for Gilead, Pfizer, Abbvie and Lilly. Peer reviewers on this manuscript have no other relevant financial or other relationships to disclose.

Additional information

Funding

This work was supported by a research grant from The Japanese Ministry of Health, Labour, and Welfare (H30-menneki-shitei-002 and H29-nanchitou(nan)-ippann-023).