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

• Published in: Advances in therapy 2018-08, Vol.35 (8), p.1153-1168
• Main Authors: Sarzi-Puttini, Piercarlo, Filippucci, Emilio, Adami, Silvano, Meroni, Pier Luigi, Batticciotto, Alberto, Idolazzi, Luca, De Lucia, Orazio, Talavera, Pablo, Kumke, Thomas, Grassi, Walter
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antirheumatic Agents - therapeutic use; Arthritis, Rheumatoid - drug therapy; Cardiology; Certolizumab Pegol - therapeutic use; Drug Therapy, Combination; Endocrinology; Female; Humans; Internal Medicine; Male; Medicine; Medicine & Public Health; Methotrexate - therapeutic use; Middle Aged; NCT; NCT01443364; Oncology; Original Research; Pharmacology/Toxicology; Prospective Studies; Rheumatology; Severity of Illness Index; Treatment Outcome
• ISSN: 0741-238X; 1865-8652; 1865-8652
• DOI: 10.1007/s12325-018-0751-8

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.