Format

Send to

Choose Destination
Rheumatol Ther. 2019 Dec;6(4):503-520. doi: 10.1007/s40744-019-00167-6. Epub 2019 Aug 13.

Two-Year Safety and Effectiveness of Peficitinib in Moderate-To-Severe Rheumatoid Arthritis: A Phase IIb, Open-Label Extension Study.

Author information

1
Stanford University, Palo Alto, CA, USA. genovese@stanford.edu.
2
Desert Medical Advances, Palm Desert, CA, USA.
3
Hospital Civil de Guadalajara FAA, CUCS UdG, Guadalajara, Mexico.
4
Centro de Investigación Clínica de Morelia SC, Morelia, Mexico.
5
Arthritis Associates, Orlando, FL, USA.
6
ARS Rheumatica sp.z.o.o, Reumatika, Warsaw, Poland.
7
Health Research of Oklahoma, Oklahoma City, OK, USA.
8
Astellas Pharma Global Development, Inc., Northbrook, IL, USA.
9
Altoona Center for Clinical Research, Duncansville, PA, USA.

Abstract

INTRODUCTION:

Peficitinib is a novel orally bioavailable, once-daily Janus kinase (JAK) inhibitor approved in Japan for the treatment of rheumatoid arthritis (RA). This 2-year extension study of two global phase IIb trials investigated the long-term safety and effectiveness of peficitinib.

METHODS:

All eligible patients with moderate-to-severe RA including patients in the placebo group who participated in one of two global phase IIb trials ('with methotrexate' or 'without methotrexate') were included in this 2-year open-label extension study and were converted to peficitinib 100 mg once daily. The primary objective was to evaluate an additional 2 years of safety by assessing treatment-emergent adverse events (AEs) and clinical laboratory evaluations for 105 weeks. Evaluation of an additional 2 years of effectiveness using American College of Rheumatology (ACR) 20/50/70 responses was the exploratory objective.

RESULTS:

Overall, 611 patients were enrolled in the extension study: 319 (52.2%) patients completed the study and 292 (48%) discontinued treatment, including for withdrawal of patient consent (n = 96), failure to achieve low disease activity (n = 62), and AE not including death (n = 41). AEs were reported in 463 (76%) patients. The most common AEs (per 100 patient-years) were upper respiratory tract infections (9.9) and urinary tract infections (7.2). Serious AEs were reported in 80 (13%) patients, with incidences per 100 patient-years of serious infections 2.7, herpes zoster 1.5 (including one herpes zoster ophthalmic), and malignancies 0.6 (most frequently basal cell carcinoma). At week 105, 269 (44%) patients demonstrated an ACR20 response relative to their respective phase IIb trial baselines.

CONCLUSION:

Among 319 patients who completed this 2-year extension of two global phase IIb studies, peficitinib 100 mg once daily demonstrated a stable safety profile and sustained effectiveness in patients with moderate-to-severe RA.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier, NCT01711814. Registered 19 October 2012.

FUNDING:

Astellas Pharma Global Development, Inc.

KEYWORDS:

Janus kinase (JAK) inhibitor; Long-term extension; Peficitinib; Rheumatoid arthritis

Supplemental Content

Full text links

Icon for Springer Icon for PubMed Central
Loading ...
Support Center