Long-term maintenance of certolizumab pegol safety and efficacy, in combination with methotrexate and as monotherapy, in rheumatoid arthritis patients

Fleischmann, Roy F., van Vollenhoven, Ronald F., Vencovský, Jiri, Alten, Rieke, Davies, Owen, Mountian, Irina, de Longueville, Marc, Carter, David and Choy, Ernest ORCID: https://orcid.org/0000-0003-4459-8609 2017. Long-term maintenance of certolizumab pegol safety and efficacy, in combination with methotrexate and as monotherapy, in rheumatoid arthritis patients. Rheumatology and Therapy 4 (1) , pp. 57-69. 10.1007/s40744-017-0060-8

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Abstract

Introduction The safety and efficacy of certolizumab pegol (CZP) 400 mg every 4 weeks (Q4W) monotherapy (FAST4WARD/NCT00548834) and in combination with methotrexate (MTX) (014/NCT00544154) in active rheumatoid arthritis (RA) has been published previously. This report outlines final long-term outcomes from the open-label extension (OLE) study (015/NCT00160693), which enrolled patients from these randomized controlled trials (RCTs). Methods Patients who withdrew from or completed the 24-week 014/FAST4WARD RCTs were enrolled and received CZP 400 mg Q4W with/without MTX. Exposure-adjusted event rates (ER) per 100 patient-years (PYs) of adverse events (AEs) and serious AEs (SAEs) were reported for all patients receiving ≥1 dose of CZP in RCTs or OLE (N = 427) between first CZP dose and up to 24 weeks after last CZP dose or study withdrawal. Efficacy assessments included clinical (ACR20/50/70 response rates, TJC, SJC) and patient-reported outcomes (HAQ-DI, PtGADA, pain, fatigue) to week 304 (5.8 years) in the CZP intent-to-treat population. SDAI and CDAI outcomes were analyzed post hoc. Outcomes for CZP monotherapy and CZP+MTX combination-therapy were compared. Results Globally, ERs of AEs and SAEs were 408.1 and 25.2 per 100 PY, respectively. Eleven patients had AEs leading to death (ER 0.6). Improvements in clinical and patient-reported outcomes during the 24-week RCTs were maintained to week 304, and were similar between all subpopulations. Conclusions The longest exposure duration to date with CZP 400 mg Q4W treatment confirmed the safety profile observed in previous studies. Initial improvements in signs and symptoms of RA, including PROs, were maintained in both CZP monotherapy and CZP + MTX combination-therapy patients.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Uncontrolled Keywords:	Certolizumab pegol Monotherapy Open-label extension Rheumatoid arthritis
Publisher:	Springer
ISSN:	2198-6576
Funders:	UCB
Date of First Compliant Deposit:	31 May 2017
Date of Acceptance:	28 March 2017
Last Modified:	06 May 2023 00:28
URI:	https://orca.cardiff.ac.uk/id/eprint/101008

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