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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.

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2018-09-17

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Blanco, Francisco J
Rubio-Romero, Esteban
Sanmartí, Raimon
Díaz-Torné, César
Talavera, Pablo
Dunkel, Jochen
Naredo, Esperanza
SONAR Study Team

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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.

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Adolescent
Adult
Aged
Aged, 80 and over
Antirheumatic Agents
Arthritis, Rheumatoid
Certolizumab Pegol
Drug Administration Schedule
Female
Humans
Male
Middle Aged
Patient Reported Outcome Measures
Prospective Studies
Severity of Illness Index
Spain
Tumor Necrosis Factor-alpha
Ultrasonography, Doppler
Young Adult

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Keywords

Anti-TNF, Artritis reumatoide, Certolizumab pegol, Ecografía, Observacional, Observational, Rheumatoid Arthritis, Ultrasound

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