PMID- 31410787 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20200930 IS - 2198-6576 (Print) IS - 2198-6584 (Electronic) IS - 2198-6576 (Linking) VI - 6 IP - 4 DP - 2019 Dec TI - Two-Year Safety and Effectiveness of Peficitinib in Moderate-To-Severe Rheumatoid Arthritis: A Phase IIb, Open-Label Extension Study. PG - 503-520 LID - 10.1007/s40744-019-00167-6 [doi] AB - 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. FAU - Genovese, Mark C AU - Genovese MC AD - Stanford University, Palo Alto, CA, USA. genovese@stanford.edu. FAU - Greenwald, Maria W AU - Greenwald MW AD - Desert Medical Advances, Palm Desert, CA, USA. FAU - Gutierrez-Urena, Sergio R AU - Gutierrez-Urena SR AD - Hospital Civil de Guadalajara FAA, CUCS UdG, Guadalajara, Mexico. FAU - Cardiel, Mario H AU - Cardiel MH AD - Centro de Investigacion Clinica de Morelia SC, Morelia, Mexico. FAU - Poiley, Jeffrey E AU - Poiley JE AD - Arthritis Associates, Orlando, FL, USA. FAU - Zubrzycka-Sienkiewicz, Anna AU - Zubrzycka-Sienkiewicz A AD - ARS Rheumatica sp.z.o.o, Reumatika, Warsaw, Poland. FAU - Codding, Christine E AU - Codding CE AD - Health Research of Oklahoma, Oklahoma City, OK, USA. FAU - Wang, Annie AU - Wang A AD - Astellas Pharma Global Development, Inc., Northbrook, IL, USA. FAU - He, Weizhong AU - He W AD - Astellas Pharma Global Development, Inc., Northbrook, IL, USA. FAU - Amos, Rebecca AU - Amos R AD - Astellas Pharma Global Development, Inc., Northbrook, IL, USA. FAU - Vinueza, Raul AU - Vinueza R AD - Astellas Pharma Global Development, Inc., Northbrook, IL, USA. FAU - Wang, Xuegong AU - Wang X AD - Astellas Pharma Global Development, Inc., Northbrook, IL, USA. FAU - Garg, Jay P AU - Garg JP AD - Astellas Pharma Global Development, Inc., Northbrook, IL, USA. FAU - Kivitz, Alan J AU - Kivitz AJ AD - Altoona Center for Clinical Research, Duncansville, PA, USA. LA - eng SI - ClinicalTrials.gov/NCT01711814 PT - Journal Article DEP - 20190813 PL - England TA - Rheumatol Ther JT - Rheumatology and therapy JID - 101674543 PMC - PMC6858430 OTO - NOTNLM OT - Janus kinase (JAK) inhibitor OT - Long-term extension OT - Peficitinib OT - Rheumatoid arthritis EDAT- 2019/08/15 06:00 MHDA- 2019/08/15 06:01 PMCR- 2019/08/13 CRDT- 2019/08/15 06:00 PHST- 2019/04/03 00:00 [received] PHST- 2019/08/15 06:00 [pubmed] PHST- 2019/08/15 06:01 [medline] PHST- 2019/08/15 06:00 [entrez] PHST- 2019/08/13 00:00 [pmc-release] AID - 10.1007/s40744-019-00167-6 [pii] AID - 167 [pii] AID - 10.1007/s40744-019-00167-6 [doi] PST - ppublish SO - Rheumatol Ther. 2019 Dec;6(4):503-520. doi: 10.1007/s40744-019-00167-6. Epub 2019 Aug 13.