Abstract | BACKGROUND: METHODS: We did this randomised, double-blind, parallel-group, phase 4 superiority study in 76 centres in 15 countries in North and South America, Australasia, and Europe. We enrolled patients who were aged at least 18 years, had severe rheumatoid arthritis for 6 months or more, and were intolerant to methotrexate or were inappropriate for continued methotrexate treatment. Patients were randomly assigned (1:1; block size of four) to receive tocilizumab 8 mg per kg bodyweight intravenously every 4 weeks plus placebo subcutaneously every 2 weeks or adalimumab 40 mg subcutaneously every 2 weeks plus placebo intravenously every 4 weeks for 24 weeks. Investigators, patients, and sponsor personnel were masked to assignment. The primary endpoint was change in disease activity score using 28 joints (DAS28) from baseline to week 24. This trial is registered with ClinicalTrials.gov, number NCT01119859. FINDINGS: We screened 452 patients and enrolled 326 patients. The intention-to-treat population contained 325 patients (163 assigned to tocilizumab, 162 assigned to adalimumab). Week 24 mean change from baseline in DAS28 was significantly greater in the tocilizumab group (-3·3) than in the adalimumab group (-1·8) patients (difference -1·5, 95% CI -1·8 to -1·1; p<0·0001). 16 of 162 (10%) patients in the adalimumab group versus 19 of 162 (12%) in the tocilizumab group had serious adverse events. More patients in the tocilizumab group than in the adalimumab group had increased LDL-cholesterol, increased alanine aminotransferase concentrations, and reduced platelet and neutrophil counts. INTERPRETATION: FUNDING: F Hoffmann-La Roche.
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Authors | Cem Gabay, Paul Emery, Ronald van Vollenhoven, Ara Dikranian, Rieke Alten, Karel Pavelka, Micki Klearman, David Musselman, Sunil Agarwal, Jennifer Green, Arthur Kavanaugh, ADACTA Study Investigators |
Journal | Lancet (London, England)
(Lancet)
Vol. 381
Issue 9877
Pg. 1541-50
(May 04 2013)
ISSN: 1474-547X [Electronic] England |
PMID | 23515142
(Publication Type: Clinical Trial, Phase IV, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2013 Elsevier Ltd. All rights reserved. |
Chemical References |
- Antibodies, Monoclonal, Humanized
- Antirheumatic Agents
- Adalimumab
- tocilizumab
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Topics |
- Adalimumab
- Adult
- Aged
- Antibodies, Monoclonal, Humanized
(therapeutic use)
- Antirheumatic Agents
(therapeutic use)
- Arthritis, Rheumatoid
(therapy)
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
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