Abstract | OBJECTIVE: METHODS: In this international, 6-month, open-label trial, patients had active RA, an inadequate response to anti-TNF therapy for 3 months or longer and a disease activity score in 28 joints (DAS28 ( C-reactive protein; CRP) of 5.1 or greater. "Washout" patients discontinued anti-TNF therapy 2 months or longer pre-screening; "direct-switch" patients began abatacept ( approximately 10 mg/kg) at their next scheduled anti-TNF therapy dose. RESULTS: 1046 patients were treated (449 washout, 597 direct-switch; baseline characteristics were similar between groups). At 6 months, adverse events (AE; 78.0% vs 79.2%), serious AE (11.1% vs 9.9%) and discontinuations due to AE (3.8% vs 4.0%) and serious AE (2.0% vs 1.3%) were comparable in washout versus direct-switch patients. There were no opportunistic infections. At 6 months, in washout versus direct-switch patients, similar clinically meaningful improvements were seen in DAS28 (CRP) (> or =1.2 unit improvement, 59.5% vs 53.6%, respectively; low disease activity state, 22.5% vs 22.3%; DAS28-defined remission, 12.0% vs 13.7%), physical function (health assessment questionnaire disability index > or =0.22 improvement; 46.3% vs 47.1%) and health-related quality of life (mean change in short-form 36 scores: physical component summary, 5.5 vs 6.1; mental component summary, 4.8 vs 5.4). CONCLUSION:
Abatacept demonstrated acceptable safety and tolerability and clinically meaningful efficacy over 6 months in patients with inadequate response to anti-TNF therapy. Results were comparable with or without a washout, supporting direct switching from anti-TNF therapy to abatacept as an option in clinical practice. TRIAL REGISTRATION NUMBER: NCT00124982.
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Authors | M Schiff, C Pritchard, J E Huffstutter, V Rodriguez-Valverde, P Durez, X Zhou, T Li, K Bahrt, S Kelly, M Le Bars, M C Genovese |
Journal | Annals of the rheumatic diseases
(Ann Rheum Dis)
Vol. 68
Issue 11
Pg. 1708-14
(Nov 2009)
ISSN: 1468-2060 [Electronic] England |
PMID | 19074911
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antirheumatic Agents
- Biomarkers
- Immunoconjugates
- Tumor Necrosis Factor-alpha
- Abatacept
- C-Reactive Protein
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Topics |
- Abatacept
- Adult
- Aged
- Antirheumatic Agents
(adverse effects, therapeutic use)
- Arthritis, Rheumatoid
(blood, drug therapy)
- Autoimmune Diseases
(chemically induced)
- Biomarkers
(blood)
- C-Reactive Protein
(metabolism)
- Female
- Humans
- Immunoconjugates
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Neoplasms
(chemically induced)
- Opportunistic Infections
(chemically induced)
- Quality of Life
- Severity of Illness Index
- Treatment Failure
- Treatment Outcome
- Tumor Necrosis Factor-alpha
(antagonists & inhibitors)
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