Session Type: Poster Session D
Session Time: 8:30AM-10:30AM
Background/Purpose: An all-case post marketing surveillance (PMS) of baricitinib, that started in Sep 2017, collects safety and effectiveness for the first 24 weeks of treatment and continues to collect serious adverse events (SAEs) for 3 years. The objective of this analysis was to evaluate safety of baricitinib in RA patients in clinical practice.
Methods: We report patient baseline demographics and adverse events (AEs) up to 24 weeks for patients whose case report files for 24-week data were completed as of Jun 2020.
Results: Data from 3445 patients were analyzed (females=80%, mean age=64 years, mean RA duration=12 years). Baricitinib dose regimen was as follows: 4mg, 60%, 2mg, 27%, 4mgà2mg, 5%, 2mgà4mg, 5%, and others, 2%. Concomitant use of MTX and glucocorticoid was 65% and 48%, respectively. Overall, 74% continued treatment for 24 weeks. AE and SAE were recognized in 887 (26%) and 122 patients (4%), respectively. Six patients died of pneumonia, aspiration pneumonia, bacterial pneumonia, cerebral infarction/interstitial lung disease (ILD)/aspiration pneumonia, adenocarcinoma, and colorectal cancer. Major AEs were as follows: herpes zoster=3%, liver dysfunction=3%, serious infection=1%, anemia=1%, hyperlipidemia=1%, malignancy=0.3%, interstitial pneumonia=0.2%, major adverse cardiovascular event (MACE)=0.1%, and venous thromboembolism (VTE)=0.1%.
Conclusion: Data do not show new safety concerns and encourage guideline-compliant use of Baricitinib.
To cite this abstract in AMA style:Fujii T, Atsumi T, Okamoto N, Takahashi N, Tamura N, Nakajima A, Nakajima A, Matsuno H, Tsujimoto N, Nishikawa A, Ishii T, Takeuchi T, Kuwana M, Takagi M. Safety of Baricitinib in Japanese Patients with Rheumatoid Arthritis (RA): The 2020 Interim Report from All-case Post Marketing Surveillance in Clinical Practice [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/safety-of-baricitinib-in-japanese-patients-with-rheumatoid-arthritis-ra-the-2020-interim-report-from-all-case-post-marketing-surveillance-in-clinical-practice/. Accessed December 3, 2022.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-of-baricitinib-in-japanese-patients-with-rheumatoid-arthritis-ra-the-2020-interim-report-from-all-case-post-marketing-surveillance-in-clinical-practice/