Session Title: 3S080: RA – Treatments I: Safety and Outcomes (845–850)
Session Type: ACR Abstract Session
Session Time: 2:30PM-4:00PM
Background/Purpose: Baricitinib (bari), an oral, selective inhibitor of Janus kinase (JAK) 1 and 2, is used to treat moderately to severely active RA in adults. The objective of the study was to update bari’s safety profile with data from an additional Phase 3 trial and ongoing long-term extension (LTE) study.
Methods: Long-term safety of once-daily bari was evaluated in the All-Bari-RA dataset: all patients exposed to any bari dose from 9 randomized trials (5 Phase 3, 3 Phase 2, 1 Phase 1b) and 1 LTE (data to 13-Feb-2018). Placebo comparisons were evaluated to Week 24 from 7 Phase 2/3 trials: patients randomized to placebo, bari 2-mg, or 4-mg, with censoring at rescue/treatment switch. Dose responses were evaluated in the 2/4-mg extended dataset from 4 Phase 2/3 trials: patients randomized to 2- or 4-mg, LTE data included; data censored at rescue/dose change (as-treated analysis) and, due to latent period for malignancy, analyzed without censoring (as-randomized analysis). Incidence rates (IRs) per 100 patient-years were calculated.
Results: A total of 3770 patients received bari (10,127 patient-years); maximum exposure was 7 years (Table). No significant differences were seen for bari 4-mg versus placebo in adverse events leading to permanent drug discontinuation, death, malignancy, serious infection, or major adverse cardiovascular events. Herpes zoster incidence rate (IR) was significantly higher for bari 4-mg versus placebo (3.8 vs 0.9) and numerically higher for bari 2-mg (3.1). IRs for deep vein thrombosis/pulmonary embolism were numerically higher in bari 4-mg versus placebo; IRs were similar in 2/4-mg-extended dataset. Malignancy (excluding non-melanoma skin cancer) IRs were 0.8 (2-mg) and 1.0 (4-mg; as-randomized analysis). Fewer than 1% of patients discontinued due to abnormal laboratory results.
Conclusion: In this updated integrated analysis of patients with active RA exposed to bari for up to 7 years, across safety topics, bari maintained a safety profile similar to that previously reported1 and acceptable in the context of demonstrated efficacy.
Reference: 1. Smolen JS et al. J Rheumatol. 2019;46:7-18.
To cite this abstract in AMA style:Genovese M, Smolen J, Takeuchi T, Burmester G, Brinker D, Rooney T, Zhong J, Mo D, Saifan C, Cardoso A, Issa M, Wu W, Winthrop K. Safety Profile of Baricitinib for the Treatment of Rheumatoid Arthritis up to 7 Years: An Updated Integrated Safety Analysis [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/safety-profile-of-baricitinib-for-the-treatment-of-rheumatoid-arthritis-up-to-7-years-an-updated-integrated-safety-analysis/. Accessed April 16, 2021.
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