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Safety Profile of Baricitinib For the Treatment of Rheumatoid Arthritis Over a Median of 3 Years of Treatment: An Updated Integrated Safety Analysis

Genovese MC, Smolen JS, Takeuchi T, Burmester G, Brinker D, Rooney TP, Zhong J, Daojun M, Saifan C, Cardoso A, Issa M, Wu W-S, Winthrop KL. - Lancet Rheumatol 2020;2:e347–57

RA is a chronic, life-long disease requiring long-term treatment. As such, it is important to understand the long-term safety profile of DMARDs. In this analysis, baricitinib maintained a stable safety profile during long-term exposure.

This baricitinib safety analysis included integrated data from nine Phase 3, 2, and 1b clinical trials, and one long-term extension, with data up to 360 weeks. 3700 patients were included, with maximum follow-up of almost 7 years – representing an additional 3,547 patient-years of study. Data include baricitinib doses ranging from 1–15 mg daily, with 2 mg and 4 mg daily doses used in the Phase 3 trials and the extension. Safety analysis included TEAEs, AEs leading to interruption or discontinuation, SAEs, deaths, and AEs of special interest – such as serious and opportunistic infections, malignancy, MACE, thromboembolic events, and gastrointestinal perforations.

In the placebo-controlled dataset, exposure-adjusted incidence of SAEs was similar between placebo and baricitinib 4 mg, but lower for 2 mg. No significant differences were seen for baricitinib versus placebo, or for 4 mg versus 2 mg in the incidence of death, malignancy, serious infection, or MACE. Herpes zoster incidence per 100 patient-years was higher for baricitinib versus placebo group, as were treatment-emergent infections. In this updated integrated analysis of patients exposed to baricitinib for almost 7 years, baricitinib maintained a similar safety profile to earlier analyses, and no new safety signals were identified.

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Upload date: June 2020

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