Date: Friday, November 6, 2020
Session Title: RA – Treatments Poster I: RA Treatments & Their Safety
Session Type: Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: To evaluate the safety of baricitinib in rheumatoid arthritis (RA) patients in clinical use.
Methods: An all-case post-marketing study of baricitinib, started in September 2017, collects safety and effectiveness for the first 24 weeks of treatment and continues to collect serious adverse events (SAEs) for 3 years. We report patients baseline demographics and adverse events (AEs) for patients completing the 24 weeks case report or discontinued before 24 weeks, as of December 2019.
Results: Data from 1992 patients were collected (females 80%). At dosing, the mean age was 64 years (median: 66 years), >65 years 54%; the mean RA duration was 11 years (median: 9 years), baricitinib dose regimen 4 mg 62%, 2 mg 27%, 4 mg → 2 mg 5%, 2 mg → 4 mg 4%, and others 3%. Pre-use of biologic DMARDs was 75% and targeted synthetic DMARDs was 21%; concomitant use of MTX was 55% and corticosteroid was 43%. 73% continued treatment for 24 weeks.
Totally, 536 patients (27%) had AEs. 4 patients died of adenocarcinoma, aspiration pneumonia, bacterial pneumonia, and pulmonary hypertension. The SAEs were 79 patients (4%): pneumonia (9), herpes zoster (5), bacterial pneumonia (4), osteonecrosis (3), anemia (3), aspiration pneumonia (3), fall (3), and femur fracture (3). The major adverse event of special interests were herpes zoster (58), serious infections (29), low hemoglobin or anemia (26), liver dysfunction (68), high lipid or hyperlipidemia (27), cardiovascular event (15), interstitial pneumonia (5), malignancy (7), and venous thromboembolism (2).
Conclusion: No new safety concern has been indicated. Encourage guideline-compliant use of baricitinib, as SAEs, including infections, have been reported.
To cite this abstract in AMA style:Atsumi T, Okamoto N, Takahashi N, Tamura N, Nakajima A, Nakajima A, Fujii T, Matsuno H, Takahashi Y, Inui F, Tsujimoto N, Nishikawa A, Ishii T, Takeuchi T, Kuwana M, Takagi M. Safety of Baricitinib in Patients with Rheumatoid Arthritis: Interim Report from All-Case Post‑Marketing Study in Clinical Use [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/safety-of-baricitinib-in-patients-with-rheumatoid-arthritis-interim-report-from-all-case-post%e2%80%91marketing-study-in-clinical-use/. Accessed May 11, 2021.
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