Clinical, Patient-Reported, and Ultrasound Outcomes from an Open-Label, 12-week Observational : Study of Certolizumab Pegol in Spanish Patients with Rheumatoid Arthritis with or without Prior Anti-TNF Exposure
Blanco-García, F.J (INIBIC-Complejo Hospitalario Universitario A Coruña)
Rubio-Romero, E. (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Sanmartí, Raimon (Hospital Clínic i Provincial de Barcelona)
Díaz Torne, César (Institut d'Investigació Biomèdica Sant Pau)
Talavera, P. (UCB Pharma)
Dunkel, J. (UCB Pharma)
Naredo, E. (Hospital Fundación Jiménez Díaz)
Universitat Autònoma de Barcelona

Date:	2020
Abstract:	To assess the effectiveness and safety of certolizumab pegol (CZP) in Spanish patients with RA. SONAR (NCT01526434), a 12-week, open-label, prospective, observational, multicenter study. Patients with active RA for ≥3 months, according to ACR criteria, were treated with CZP (400 mg at Weeks 0, 2 and 4, then 200 mg every 2 weeks). The primary effectiveness endpoint was change from baseline (CFB) in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12. Other assessments included DAS28(ESR), patient's assessment of arthritis pain (PtAAP-VAS) and Short Form 36-item Health Survey (SF-36) physical component summary (PCS) and mental component summary (MCS). Joint inflammation was investigated using Power Doppler (PD) ultrasound (US), to detect effusion, synovial hypertrophy and synovial PD signal. PDUS outcomes assessed CFB to Week 12 in synovial hypertrophy, effusion and PD signal indices. A total of 77/80 enrolled patients received ≥1 dose of CZP. The 12-week mean reduction from baseline (SD) was −0. 6 (0. 6) for HAQ-DI and −2. 2 (1. 5) for DAS28(ESR). PtAAP-VAS was reduced from baseline (mean [SD]: −36. 8 [26. 8]) and improvements in SF-36 PCS and SF-36 MCS were reported. Synovial hypertrophy, effusion and PD signal indices were reduced from baseline to Week 12. One death was reported during the study. Spanish patients with RA demonstrated improvements in clinical, PDUS and patient-reported outcomes over 12 weeks of CZP treatment. No new safety signals were identified, and the safety profile was in line with previous CZP studies. These results support previous clinical trial findings investigating CZP treatment for active RA.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Castellà
Document:	Article ; recerca ; Versió publicada
Subject:	Anti-TNF ; Certolizumab pegol ; Observational ; Rheumatoid Arthritis ; Ultrasound
Published in:	Reumatologia Clinica, Vol. 16 Núm. 5 (septiembre 2020) , p. 345-352, ISSN 1885-1398

DOI: 10.1016/j.reuma.2018.07.009

8 p, 447.7 KB

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