Real-life drug persistence in patients with rheumatic diseases treated with CT-P13: a prospective observational cohort study (PERSIST)

Author:

Taylor Peter C1ORCID,Christensen Robin2,Moosavi Shahrzad3,Selema Pamela3,Guilatco Ruffy4,Fowler Heather5,Mueller Markus6,Liau Katherine F7,Haraoui Boulos8

Affiliation:

1. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK

2. Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen & Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark

3. Worldwide Safety and Risk Management, Pfizer Inc, New York, NY, USA

4. Global Biometrics & Data Management, Global Product Development, Pfizer Inc, Manila, Philippines

5. Clinical Development & Operations, Global Product Development, Pfizer Inc., London, UK

6. Medical Affairs, Pfizer Pharma GmbH, Berlin, Germany

7. Biosimilars, Pfizer, La Jolla, California, USA

8. Clinical Research Unit in Rheumatology, Institut de rhumatologie de Montréal, Montreal, Canada

Abstract

Abstract Objective Report results from PERSIST, a real-life, observational, prospective cohort study of CT-P13, an infliximab (IFX) biosimilar, for treatment of patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) or psoriatic arthritis (PsA) who were biologic-naïve or switched from IFX reference product (IFX-RP; Remicade®). Methods Adult patients were recruited during usual care at 38 sites in Europe and Canada, and enrolled by their physicians after meeting eligibility according to the country-approved label for CT-P13. Primary outcomes were to determine drug utilization, treatment persistence and assess safety. Patients were followed for up to 2 years. Data were analysed and reported descriptively. Results Of 351 patients enrolled, 334 were included in the analysis (RA, 40.4%; AS, 34.7%; PsA, 24.9%). The safety analysis set comprised all 328 patients treated with CT-P13. The majority (58.2%) of patients received CT-P13 monotherapy, most (72.6%) by dosing every 6 or 8 weeks. Mean treatment persistence was 449.2 days; 62.3% of patients completed 2-years treatment. In all, 214 treatment-emergent adverse events (TEAEs) were reported in 38.4% of patients. Most TEAEs were of mild or moderate intensity; 13 were severe. Most commonly reported TEAEs were drug ineffective (9.5%) and infusion-related reactions (5.2%). Most frequently reported infection-related TEAEs were upper respiratory tract infections (3.0%), nasopharyngitis (2.1%) and bronchitis (1.5%). No patients experienced tuberculosis. Conclusion : Drug utilization and treatment persistence with CT-P13 were consistent with historical reports of IFX-RP in this patient population. Safety findings did not identify new concerns for CT-P13 in the treatment of patients with RA, AS or PsA.

Publisher

Oxford University Press (OUP)

Subject

Rheumatology

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3