Ab0455 baricitinib in the Treatment of Patients With Moderate to Severe Active Rheumatoid Arthritis in China: 24-Week Results of Post-Marketing Safety Study

Abstract

BackgroundBaricitinib, an orally selective inhibitor of JAK1 and JAK2, was approved for adult patients with moderate-to-severe rheumatoid arthritis (RA) in China. The recommended dose is 2mg once daily and 4mg once daily in patients who have inadequately responded to baricitinib 2mg once daily (for 3 months) or TNF inhibitors. A single-arm, prospective, non-interventional post-marketing safety study (PMSS) was conducted in Chinese RA patients to describe the safety and effectiveness of baricitinib at 24 weeks.ObjectivesTo describe the safety and effectiveness of baricitinib in real-world setting of treating patients with moderate to severe active RA.MethodsThis PMSS (starting July 2020) included 667 patients with RA treated with baricitinib (2 mg or/and 4mg/day) and followed up for 24 weeks. Safety and effectiveness (disease activity) were assessed for 24 weeks. All statistical analyses are descriptive.ResultsSafety analyses included 667 patients (females=82.3%, mean age=53.3 years, mean RA duration 86.9 months). 106 (15.9%) were ≥65 and <75years and 19 (2.8%) were ≥75 years. 29 (4.3%) had previously received biologic therapy. Baricitinib dose regimen was as follows: 2 mg/day, n = 580 (87.0%); 4 mg/day, n = 53 (7.9%); 2/4 mg, n = 34 (5.1%). Concomitant use of MTX and leflunomide occurred in 54.3% and 35.5%, respectively. The overall exposure of baricitinib was 262.1 patient-years; 197 (29.5%) patients withdrew from the study, mostly for patient’s decision (n = 101). Adverse events (AEs) occurred in 250 (37.5%) patients [serious: 28 (4.2%)]. Two patients (0.3%) died: one of pneumonia and one with no cause reported. The incidence of serious infection, herpes zoster and hepatotoxicity was 0.6%, 1.0%, and 3.4%, respectively. No case met laboratory criteria for potential Hy’s Law (ALT/AST ≥3 x ULN and TBL ≥2 x ULN). Malignancy occurred in one patient (thyroid cancer). No venous thromboembolism (VTE) or major adverse cardiovascular event (MACE) were reported during the study observation period (Table 1).In the effectiveness analysis at Week 24, the proportions of patients achieving remission/ low disease activity were 66.6% (235/353) for DAS28-CRP, 64.6% (228/353) for SDAI, and 63.5% (242/381) for CDAI (Figure 1).ConclusionIn conclusion, the safety and effectiveness profile of baricitinib in this Chinese PMSS was generally similar to that in the global RA population with no VTEs or MACE reported and no new safety signals.ReferencesNIL.Table 1.Safety summary among patients with RA treated with baricitinibn (%) PYE [EAIR]Safety Population (N=667)12 weeks24 weeksAE214 (32.08)124.04 [172.52]250 (37.48)198.58 [125.89]AEs related to study treatmentas judged by the investigator95 (14.24)139.99 [67.86]120 (17.99)236.65 [50.71]Death/2 (0.30)261.30 [0.77]SAE22 (3.30)147.03 [14.96]28 (4.20)256.72 [10.91]SAEs related to study treatmentas judged by the investigator8 (1.20)148.32 [5.39]10 (1.50)260.30 [3.84]Treatment discontinuation due to AEs20 (3.00)148.18 [13.50]24 (3.60)260.79 [9.20]AESISerious infection3 (0.45)148.52 [2.02]4 (0.60)260.99 [1.53]Hepatotoxicity16 (2.40)147.13 [10.87]23 (3.45)256.76 [8.96]VTE0148.63 [0.00]0261.30 [0.00]Herpes zoster, n (%)3 (0.45)7 (1.05)Malignancy, n (%)1 (0.15)1 (0.15)MACE, n (%)00Abbreviations: AE= adverse event; AESI= adverse event with special interest; EAIR= exposure-adjusted incidence rate; MACE= major adverse cardiovascular events; N= number of patients in the safety analysis set; n= number of patients in the specified category; PYE= patient-years of exposure; RA= rheumatoid arthritis; SAE= serious adverse event; VTE= venous thromboembolismUsed EAIR per 100 PYE (patient exposure censored at the event).AESI was based on the judgement of investigator recorded in eCRF (electronic case report form)MACE included myocardial infarction, cardiovascular death, and stroke.Acknowledgements:NIL.Disclosure of InterestsChan-yuan Wu: None declared, Qian Wang: None declared, Jian Shi: None declared, XIUYING ZHANG: None declared, Rong Du: None declared, Jieruo Gu: None declared, Qi-huan Liu: None declared, Jiao Yu Employee of: Eli Lilly and Company, Jia-wei Xu Employee of: Eli Lilly and Company, Yan-jie Zhang Employee of: Eli Lilly and Company, Hao Zhu Employee of: Eli Lilly and Company, Mengtao Li: None declared, Xiaofeng Zeng: None declared.