Abstract
Objective. To determine the relationship between timing and magnitude of Disease Activity Score [DAS28(ESR)] nonresponse (DAS28 improvement thresholds not reached) during the first 12 weeks of treatment with certolizumab pegol (CZP) plus methotrexate, and the likelihood of achieving low disease activity (LDA) at 1 year in patients with rheumatoid arthritis.
Methods. In a post-hoc analysis of the RAPID 1 study, patients achieving LDA [DAS28(ESR) ≤ 3.2] at Year 1 were assessed according to DAS28 nonresponse at various timepoints within the first 12 weeks.
Results. Seven-hundred eighty-three patients were included (CZP 200 mg, n = 393; CZP 400 mg, n = 390). A total of 86.9% of patients in the CZP 200 mg group had a DAS28 improvement of ≥ 1.2 by Week 12. Of the 13.1% of patients with DAS28 improvement < 1.2 by Week 12, only 2.0% had LDA at Year 1. Failure to achieve LDA at Year 1 depended on timing of nonresponse — 22.3%, 8.4%, and 2.0% of patients with DAS28 improvement < 1.2 by Weeks 1, 6, and 12, respectively, had LDA at Year 1 — and magnitude of initial lack of DAS28 improvement; for example, compared with the patients with DAS28 < 1.2 improvement, fewer patients with DAS28 < 0.6 had LDA at Year 1 (17.4%, 2.4%, and 0.0% at Weeks 1, 6, and 12, respectively).
Conclusion. Failure to achieve improvement in DAS28 within the first 12 weeks of therapy was predictive of a low probability of achieving LDA at Year 1. Moreover, the accuracy of the prediction was found to be strongly dependent on the magnitude and timing of the lack of the response. (Clinical Trial Registration Nos. NCT00152386 and NCT00175877).
Footnotes
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Supported by UCB Pharma, which sponsored the clinical trial from which the post-hoc analyses were performed. Prof. van der Heijde has received consultant fees from Abbott, Amgen, BMS, Centocor, Chugai, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, and Wyeth, and is a member of a Speaker’s Bureau for UCB Pharma. Prof. Keystone has received grants/research support from Abbott, Amgen, AstraZeneca, BMS, Centocor, F. Hoffmann-La Roche Inc., Genzyme, Merck, Novartis, Pfizer, and UCB Pharma; and has also received consultancy fees from Abbott, AstraZeneca, Biotest, BMS, Centocor, F. Hoffmann-La Roche Inc., Genentech, Merck, Nycomed, Pfizer, and UCB Pharma; and has received speaker honoraria from Abbott, BMS, F. Hoffmann-La Roche, Merck, Pfizer, and UCB Pharma. Dr. Curtis has received research grants and/or consulting/honoraria from Amgen, Abbott, UCB Pharma, Pfizer, BMS, Centocor, Genentech/Roche, and CORRONA. He also receives support from the NIH (AR053351) and AHRQ (R01HS018517). Prof. Landewé has served as a consultant for Abbott, Amgen, BMS, Centocor, Pfizer, Roche, Schering-Plough, UCB Pharma, and Wyeth. Prof. Schiff has received grant/research support and has served as a consultant for UCB Pharma. Dr. Khanna serves as a consultant for UCB Pharma and is a member of a Speaker’s Bureau for UCB Pharma; he also receives support from the American College of Rheumatology and NIH/NIAMS. Prof. Kvien has received grant/research support from UCB Pharma, Abbott, BMS, Roche, Schering-Plough, Wyeth, Pfizer, and MSD; and has served as a consultant/speaker for the same companies. Dr. Gervitz is an employee of UCB Pharma and owns shares of UCB Pharma. Prof. Furst has received grant/research support from Abbott, Actelion, Amgen, BMS, Centocor, Genentech, Gilead, GSK, Novartis, Roche, and UCB Pharma; he has served as a consultant for Abbott, Actelion, Amgen, BMS, Centocor, Genentech, Gilead, Novartis, and UCB Pharma; he is a member of a Speaker’s Bureau for Abbott, Actelion, and UCB Pharma (no promotional talks).
- Accepted for publication March 21, 2012.
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