Session Information
Session Type: Poster Session (Tuesday)
Session Time: 9:00AM-11:00AM
Background/Purpose: Peficitinib, a novel oral Janus kinase (JAK) inhibitor, has demonstrated efficacy in studies of Japanese, Korean and Taiwanese patients with RA. This analysis of pooled safety data examines new safety findings and incidence rates for AEs of special interest in studies.
Methods: Safety data from 4 clinical studies of adult patients with active RA defined by 1987 ACR criteria or 2010 ACR/EULAR criteria were pooled. The pooled Phase (Ph) 3 studies included safety data from the Asian Ph 3 study (RAJ3) and Japanese Ph 3 study (RAJ4). The pooled Ph 2/3 studies included Ph 2b study (RAJ1), RAJ3, RAJ4 and extension study (RAJ2 [data cut-off, May 31, 2018]). RAJ1 included RA patients irrespective of RA treatment history including untreated state. RAJ3 included RA patients with inadequate response to conventional DMARDs including MTX. RAJ4 included RA patients who were inadequate responders to MTX. RAJ2 is an open-label extension study of patients completing these 3 studies.
Safety was assessed by monitoring adverse events (AEs) and serious adverse events (SAEs), and summarized using MedDRA Preferred Terms. Two pooled datasets (Ph 3 studies pooled and Ph 2/3 studies pooled) were used for the analyses.
Results: A total of 1052 patients were included in the pooled Ph 2 and 3 studies; of those patients, 843 were enrolled into RAJ2 (Table 1). Patient characteristics were similar across all treatment groups. Overall exposure to peficitinib in Ph 2/3 studies was 2336.3 patient-years. Across the 4 studies, there were 3 deaths.
In the pooled Ph 3 studies, there were no deaths. The overall incidence of AEs was similar between the 2 peficitinib groups (Table 2): 88.5% in the peficitinib 100 mg/day group, 87.7% in the peficitinib 150 mg/day group, and 89.0% in the etanercept (ETN) group. The incidence of SAEs was 9.4%, 7.6%, and 9.0%, respectively. In the peficitinib 100 mg/day group, 9.4% of patients discontinued due to an AE. The most common AE in patients receiving peficitinib was nasopharyngitis, which occurred in 30.5% of patients (31.0% in the ETN group).
Among AEs of special interest in the pooled Ph 3 studies, the incidence (95% CI) of serious infections was 2.9 (1.9, 4.6) in patients receiving peficitinib and 2.0 (0.8, 5.5) in those receiving ETN (Table 3). The incidence of herpes zoster-related disease was greater in peficitinib groups (5.7 [4.2, 7.9]) than in placebo (2.3 [0.6, 9.4]) or ETN groups (2.6 [1.1, 6.2]), and the overall incidence of malignancies (0.6 [0.2, 1.6]) was similar to that in the placebo and ETN groups (1.2 [0.2, 8.3] and 0.5 [0.1, 3.6], respectively).
Conclusion: This analysis provides an overview of safety across peficitinib clinical studies in patients with RA, and shows it is well tolerated with no major specific concerns with longer term administration of peficitinib.
Table 1_v1.0
Table 2_v1.0
Table 3_v1.0
To cite this abstract in AMA style:
Takeuchi T, Tanaka Y, Rokuda M, Izutsu H, Kaneko Y, Fukuda M, Kato D. Adverse Events of Special Interest in Patients with Rheumatoid Arthritis Treated with Peficitinib in Asian Population: Pooled Safety Findings [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/adverse-events-of-special-interest-in-patients-with-rheumatoid-arthritis-treated-with-peficitinib-in-asian-population-pooled-safety-findings/. Accessed .« Back to 2019 ACR/ARP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/adverse-events-of-special-interest-in-patients-with-rheumatoid-arthritis-treated-with-peficitinib-in-asian-population-pooled-safety-findings/