TY - JOUR
T1 - Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis
T2 - Results from the REALISTIC phase IIIb study
AU - Weinblatt, Michael E.
AU - Fleischmann, Roy
AU - Huizinga, Tom W.J.
AU - Emery, Paul
AU - Pope, Janet
AU - Massarotti, Elena M.
AU - van vollenhoven, Ronald F.
AU - Wollenhaupt, Jürgen
AU - Bingham, Clifton O.
AU - Duncan, Ben
AU - Goel, Niti
AU - Davies, Owen R.
AU - Dougados, Maxime
N1 - Funding Information:
The authors thank all the investigators and patients who participated in this study. They also thank Marine Champsaur from UCB Pharma for critical review of the manuscript. They acknowledge the editorial services of Jaya Kolipaka and Andrew Richardson from PAREXEL, which were funded by UCB Pharma. UCB Pharma was involved in the study design, collection, analysis and interpretation of data.
PY - 2012/12
Y1 - 2012/12
N2 - Objective: To investigate the efficacy and safety of certolizumab pegol (CZP) in a broad population of patients with active RA. Methods: In this 12-week, double-blind period of the phase IIIb trial, RA patients with inadequate response to at least one DMARD were randomized 4:1 to CZP (400 mg at weeks 0, 2 and 4, followed by 200 mg every 2 weeks) or placebo (every 2 weeks) plus current therapy stratified by previous TNF inhibitor use, concomitant methotrexate use and disease duration (<2 vs ≥2 years). The primary outcome was ACR20 response rate at week 12. Results: Of 1063 patients (CZP = 851; placebo = 212), 37.6% had previous TNF inhibitor use. Baseline mean HAQ Disability Index (HAQ-DI) and DAS 28-joint assessment-ESR [DAS28(ESR)] values were 1.5 and 6.4 in the CZP group, and 1.6 and 6.4 in the placebo group, respectively. The primary endpoint was significant (week 12 ACR20, CZP vs placebo: 51.1 vs 25.9%; P < 0.001); differences were noted at week 2 (31.8 vs 8.5%; P < 0.001). HAQ-DI and DAS28(ESR) change from baseline and ACR50 were significant from week 2. Week 12 ACR20 responses were similar across CZP patient subgroups regardless of concomitant DMARD use at baseline. Adverse and serious adverse events were comparable between CZP and placebo, with no new safety signals. Conclusion: CZP was associated with rapid and consistent clinical responses and improved physical function in a diverse group of RA patients, irrespective of concomitant or previous therapy.
AB - Objective: To investigate the efficacy and safety of certolizumab pegol (CZP) in a broad population of patients with active RA. Methods: In this 12-week, double-blind period of the phase IIIb trial, RA patients with inadequate response to at least one DMARD were randomized 4:1 to CZP (400 mg at weeks 0, 2 and 4, followed by 200 mg every 2 weeks) or placebo (every 2 weeks) plus current therapy stratified by previous TNF inhibitor use, concomitant methotrexate use and disease duration (<2 vs ≥2 years). The primary outcome was ACR20 response rate at week 12. Results: Of 1063 patients (CZP = 851; placebo = 212), 37.6% had previous TNF inhibitor use. Baseline mean HAQ Disability Index (HAQ-DI) and DAS 28-joint assessment-ESR [DAS28(ESR)] values were 1.5 and 6.4 in the CZP group, and 1.6 and 6.4 in the placebo group, respectively. The primary endpoint was significant (week 12 ACR20, CZP vs placebo: 51.1 vs 25.9%; P < 0.001); differences were noted at week 2 (31.8 vs 8.5%; P < 0.001). HAQ-DI and DAS28(ESR) change from baseline and ACR50 were significant from week 2. Week 12 ACR20 responses were similar across CZP patient subgroups regardless of concomitant DMARD use at baseline. Adverse and serious adverse events were comparable between CZP and placebo, with no new safety signals. Conclusion: CZP was associated with rapid and consistent clinical responses and improved physical function in a diverse group of RA patients, irrespective of concomitant or previous therapy.
KW - Biologicals
KW - Rheumatoid arthritis
KW - Tumour necrosis factor
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U2 - 10.1093/rheumatology/kes150
DO - 10.1093/rheumatology/kes150
M3 - Article
C2 - 22923753
AN - SCOPUS:84870317631
SN - 1462-0324
VL - 51
SP - 2204
EP - 2214
JO - Rheumatology (United Kingdom)
JF - Rheumatology (United Kingdom)
IS - 12
M1 - kes150
ER -