Timing and Magnitude of Initial Change in Disease Activity Score 28 Predicts the Likelihood of Achieving Low Disease Activity at 1 Year in Rheumatoid Arthritis Patients Treated with Certolizumab Pegol: A Post-hoc Analysis of the RAPID 1 Trial
- 15 May 2012
- journal article
- research article
- Published by The Journal of Rheumatology in The Journal of Rheumatology
- Vol. 39 (7), 1326-1333
- https://doi.org/10.3899/jrheum.111171
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).Keywords
This publication has 10 references indexed in Scilit:
- Rapid Improvement in the Signs and Symptoms of Rheumatoid Arthritis Following Certolizumab Pegol Treatment Predicts Better Longterm Outcomes: Post-hoc Analysis of a Randomized Controlled TrialThe Journal of Rheumatology, 2011
- American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical TrialsAnnals Of The Rheumatic Diseases, 2011
- Current evidence for a strategic approach to the management of rheumatoid arthritis with disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritisAnnals Of The Rheumatic Diseases, 2010
- EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugsAnnals Of The Rheumatic Diseases, 2010
- Treating rheumatoid arthritis to target: recommendations of an international task forceAnnals Of The Rheumatic Diseases, 2010
- Clinical Activity After 12 Weeks of Treatment with Nonbiologics in Early Rheumatoid Arthritis May Predict Articular Destruction 2 Years LaterThe Journal of Rheumatology, 2010
- Six and 12 Weeks Treatment Response Predicts Continuation of Tumor Necrosis Factor Blockade in Rheumatoid Arthritis: An Observational Cohort Study from Southern SwedenThe Journal of Rheumatology, 2009
- Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: Findings of a fifty‐two–week, phase III, multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group studyArthritis & Rheumatism, 2008
- The need for prognosticators in rheumatoid arthritis. Biological and clinical markers: where are we now?Arthritis Research & Therapy, 2008
- Disease activity early in the course of treatment predicts response to therapy after one year in rheumatoid arthritis patientsArthritis & Rheumatism, 2007