Introduction: To assess the impact of certolizumab pegol (CZP) treatment on clinical, patient-reported, and musculoskeletal ultrasound outcomes and to determine the treatment response time point most predictive of long-term outcomes in Italian patients with rheumatoid arthritis (RA). Methods: CZP-SPEED (NCT01443364) was a 52-week, open-label, prospective, interventional, multicenter study. Biologic-naïve patients with moderate-to-severe active RA, who had failed at least one DMARD treatment, received CZP (400 mg at weeks 0, 2, and 4, then 200 mg every 2 weeks) concomitantly with methotrexate. The primary objective was to identify the time point of clinical response decrease in 28-joint Disease Activity Score [DAS28(ESR)] ≥ 1.2 most predictive of a clinical response at week 52. Additional clinical and patient-reported outcomes were measured. Power Doppler (PD) ultrasound was used to assess synovial effusion, synovial proliferation, PD signal, cartilage damage, and bone erosion according to international guidelines. Results: A total of 132 patients were enrolled and received CZP; 91/132 (69%) completed to week 52. Predicted 52-week responses for early responders (week 2 onwards) were between 65% and 70%. Rapid improvements in joint cavity widening and PD signal were observed to week 8 and maintained to week 52. Cartilage damage and bone erosion were stable over 52 weeks. No new safety signals were identified. Conclusion: In Italian CZP-treated patients with moderate-to-severe RA, week 12 clinical responses may be predictive of long-term response at week 52. Rapid improvements in clinical, patient-reported, and musculoskeletal ultrasound outcomes were maintained to week 52. These data may aid rheumatologists to make earlier treatment decisions. Trial Registration: ClinicalTrials.gov identifier, NCT01443364. Funding: UCB Pharma.
Clinical, Ultrasound, and Predictability Outcomes Following Certolizumab Pegol Treatment (with Methotrexate) in Patients with Moderate-to-Severe Rheumatoid Arthritis : 52-Week Results from the CZP-SPEED Study / P. Sarzi-Puttini, E. Filippucci, S. Adami, P.L. Meroni, A. Batticciotto, L. Idolazzi, O. De Lucia, P. Talavera, T. Kumke, W. Grassi. - In: ADVANCES IN THERAPY. - ISSN 0741-238X. - 35:8(2018 Aug), pp. 1153-1168.
|Titolo:||Clinical, Ultrasound, and Predictability Outcomes Following Certolizumab Pegol Treatment (with Methotrexate) in Patients with Moderate-to-Severe Rheumatoid Arthritis : 52-Week Results from the CZP-SPEED Study|
|Parole Chiave:||Anti-TNF; Certolizumab pegol; Patient-reported outcome; Predictability; Rheumatoid arthritis; Rheumatology; Ultrasound; Pharmacology (medical)|
|Settore Scientifico Disciplinare:||Settore MED/16 - Reumatologia|
|Data di pubblicazione:||ago-2018|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1007/s12325-018-0751-8|
|Appare nelle tipologie:||01 - Articolo su periodico|
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