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- DOI: 10.1002/acr.20331
- PMID: 20799264
- UKPMCID: 20799264
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American College of Rheumatology hybrid analysis of certolizumab pegol plus methotrexate in patients with active rheumatoid arthritis: Data from a 52-week phase III trial
Van Vollenhoven, R F; Felson, D; Strand, V; Weinblatt, M E; Luijtens, K; Keystone, E C
Arthritis care & research. 2011;63(1):128-134.
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Full-text held externally
- DOI: 10.1002/acr.20331
- PMID: 20799264
- UKPMCID: 20799264
Abstract
OBJECTIVE.: The ACR hybrid (a modified mean percent response to treatment) was officially recommended by the ACR as a revision to ACR20/50/70 scores but has not been tested in clinical trials. We performed a post hoc analysis of a phase III study of certolizumab pegol (RAPID 1) using the ACR hybrid. METHODS.: Patients with active RA were randomized to certolizumab pegol (200 mg or 400 mg every other week) plus methotrexate or placebo plus methotrexate. ACR hybrid scores were compared with ACR20/50/70 outcomes. RESULTS.: Differences between active treatment and placebo were significant throughout the study using the ACR20 and ACR hybrid outcomes. In the certolizumab pegol 200 mg group, the median ACR hybrid score at Week 52 (LOCF) was 49.99. 258/392 (65.8%) and 172/392 (43.9%) patients had ACR20 and ACR50 responses, respectively. An additional 55 (14.0%) and 59 (15.1%) patients had mean improvements in ACR core measures of >/=20% and >/=50%, respectively, and therefore had positive ACR hybrid scores, despite lacking ACR20 and ACR50 responses, respectively. In the placebo group, median ACR hybrid scores were <10 at most time points; unlike other measures, the ACR hybrid measure indicated worsening scores for many patients. CONCLUSION.: ACR hybrid analysis had greater sensitivity than traditional ACR20/50/70 criteria, demonstrating improvements in ACR20 nonresponders treated with certolizumab pegol. Negligible benefit was observed with placebo using ACR hybrid analysis.