| Safety and efficacy of the selective costimulation modulator abatacept in patients with rheumatoid arthritis receiving background methotrexate: a 5-year extended phase IIB study. | |
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MedLine Citation:
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PMID: 19273451 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To evaluate the safety and efficacy of abatacept plus methotrexate (MTX) over 5 years in patients with rheumatoid arthritis. METHODS: Patients were randomized to abatacept 10 or 2 mg/kg or placebo, plus MTX. Patients completing the 1-year, double-blind period entered the longterm extension, where all patients received a fixed dose of abatacept ~10 mg/kg. We describe safety analyses for all patients who received at least 1 dose of abatacept and efficacy analyses for the original ~10 mg/kg abatacept-treated group, over 5 years. RESULTS: Of the 235 abatacept- or placebo-treated patients completing the double-blind period, 219 entered the longterm extension; 130 (59.4%) were continuing at Year 5. No unexpected safety events were observed during the longterm extension compared with the double-blind period. Incidence rates of adverse events (AE) and serious AE were 489.7 and 20.0/100 patient-years in Year 1 versus 374.9 and 18.9/100 patient-years in the cumulative period, respectively. Using exploratory analyses, improvements observed at Year 1 in the 10 mg/kg group were maintained at Year 5, as assessed by ACR responses (ACR20=77.1% vs 82.7%; ACR50=53.0% vs 65.4%; ACR70=28.9% vs 40.4% at Years 1 and 5, respectively) and disease activity (Low Disease Activity State=48.2% vs 58.5%; Disease Activity Score-28-defined remission=25.3% vs 45.3% at Years 1 and 5, respectively). CONCLUSION: Abatacept maintained the efficacy observed at Year 1 over 5 years of treatment, and demonstrated consistent safety and tolerability. These data, along with relatively high retention rates, support the longterm clinical benefit provided by selective T cell costimulation modulation. Clinical trial registry: ClinicalTrials.gov; clinical trial registration number: NCT00254293. |
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Authors:
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Rene Westhovens; Joel M Kremer; Larry W Moreland; Paul Emery; Anthony S Russell; Tracy Li; Richard Aranda; Jean-Claude Becker; Keqin Qi; Maxime Dougados |
Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2009-02-27 |
Journal Detail:
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Title: The Journal of rheumatology Volume: 36 ISSN: 0315-162X ISO Abbreviation: J. Rheumatol. Publication Date: 2009 Apr |
Date Detail:
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Created Date: 2009-04-03 Completed Date: 2009-06-01 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7501984 Medline TA: J Rheumatol Country: Canada |
Other Details:
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Languages: eng Pagination: 736-42 Citation Subset: IM |
Affiliation:
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Department of Rheumatology, KU Leuven, Herestraat 49, B 3000 Leuven, Belgium. rene.westhovens@uz.kuleuven.ac.be |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00254293 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Antirheumatic Agents
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adverse effects,
therapeutic use* Arthritis, Rheumatoid / drug therapy* Double-Blind Method Drug Therapy, Combination Humans Immunoconjugates / adverse effects, therapeutic use* Methotrexate / therapeutic use* Placebos / therapeutic use Quality of Life Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Antirheumatic Agents; 0/Immunoconjugates; 0/Placebos; 0/abatacept; 59-05-2/Methotrexate |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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