A pooled safety analysis of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis treated over a median of 2 years

Abstract

Objective

To evaluate the safety of peficitinib for the treatment of rheumatoid arthritis (RA) in Asian patients.

Methods

Safety data from one Phase 2b, two Phase 3, and one open-label long-term extension study [data cut-off 31 May 2018] were pooled into Phase 3 studies (peficitinib 100 and 150 mg/day, and placebo) and Phase 2/3 studies (all peficitinib-treated patients). Incidence rates per 100 patient-years (PY) of adverse events (AEs) of special interest were calculated.

Results

Overall, 1052 patients received peficitinib for 2336.3 PY of exposure (median 2.1 years); four deaths occurred, including one death after the studies. AE incidence was similar across peficitinib 100 and 150 mg/day groups (Phase 3 studies). Respective peficitinib and placebo incidence rates (95% confidence interval) per 100 PY were 2.9 (1.9, 4.6) and 0.0 for serious infections, 5.7 (4.2, 7.9) and 2.3 (0.6, 9.4) for herpes zoster-related disease, and 0.6 (0.2, 1.6) and 1.2 (0.2, 8.3) for malignancies (excluding non-melanoma skin cancer) (Phase 3 studies), and 0.1 (0.0, 0.3) for venous thromboembolism in all peficitinib-treated patients (Phase 2/3 studies).

Conclusion

Peficitinib was well tolerated in Asian patients with RA over a median of 2 years, with no observed dose or temporal dependency for AEs with prolonged administration.

Keywords:

• Janus kinase
• peficitinib
• pooled safety analysis
• rheumatoid arthritis

Conflict of interest

TT has received grants from Astellas Pharma Inc., AbbVie GK, and Eisai Co. Ltd, and has received speaking fees and/or honoraria from Astellas Pharma Inc., AbbVie GK, Pfizer Japan Inc., Eisai Co. Ltd, Gilead Sciences Inc., and Eli Lilly Japan K.K.

YT reports speaking fees and/or honoraria from Daiichi-Sankyo, Eli Lilly, Novartis, YL Biologics, Bristol-Myers, Eisai, Chugai, AbbVie, Astellas, Pfizer, Sanofi, Asahi-Kasei, GlaxoSmithKline, Mitsubishi-Tanabe, Gilead, and Janssen, and has received research grants from Mitsubishi-Tanabe, Chugai, AbbVie, Takeda, UCB, Daiichi-Sankyo and Eisai.

MR, HI, YK, MF and DK are employees of Astellas Pharma Inc.

Acknowledgments

The authors would like to thank the patients involved in these studies, the study investigators, and team staff. Medical writing support was provided by Anne-Marie Edwards, MChem, and Rhian Harper Owen, PhD, for Cello Health MedErgy (Europe) and funded by Astellas Pharma, Inc.

These data were presented in part as a poster at the ACR/ARHP Annual Meeting, November 8–13, 2019, Atlanta, Georgia, USA; and as posters and an oral presentation at the JCR Annual Meeting, August 4–6, 2020 (online meeting).

Data availability statement

Researchers may request access to anonymized participant level data, trial level data and protocols from Astellas sponsored clinical trials at www.clinicalstudydatarequest.com. For the Astellas criteria on data sharing see: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Astellas.aspx.

Additional information

Funding

This study was sponsored by Astellas Pharma, Inc.