RT Journal Article
T1 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.
A1 Blanco, Francisco J
A1 Rubio-Romero, Esteban
A1 Sanmartí, Raimon
A1 Díaz-Torné, César
A1 Talavera, Pablo
A1 Dunkel, Jochen
A1 Naredo, Esperanza
A1 SONAR Study Team, 
K1 Anti-TNF
K1 Artritis reumatoide
K1 Certolizumab pegol
K1 Ecografía
K1 Observacional
K1 Observational
K1 Rheumatoid Arthritis
K1 Ultrasound
AB 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 (400mg at Weeks 0, 2 and 4, then 200mg 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.
YR 2018
FD 2018-09-17
LK http://hdl.handle.net/10668/12971
UL http://hdl.handle.net/10668/12971
LA en
LA es
DS RISalud
RD Apr 12, 2025