Abstract | OBJECTIVES: METHODS: In an open-label, long-term extension trial following an initial 3-month randomised phase II trial, 143 of the 163 patients who participated in the initial blinded study received tocilizumab monotherapy (8 mg/kg) every 4 weeks. Concomitant therapy with non-steroidal anti-inflammatory drugs and/or oral prednisolone (10 mg daily maximum) was permitted. All patients were evaluated with American College of Rheumatology (ACR) improvement criteria, disease activity score ( DAS) in 28 joints, and the European League Against Rheumatism response, as well as for safety issues. RESULTS: 143 patients were enrolled in the open-label, long-term extension trial and 94 (66%) patients had completed 5 years as of March 2007. 32 patients (22%) withdrew from the study due to adverse events and one patient (0.7%) due to unsatisfactory response. 14 patients withdrew because of the patient's request or other reasons. The serious adverse event rate was 27.5 events per 100 patient-years, with 5.7 serious infections per 100 patient-years, based on a total tocilizumab exposure of 612 patient-years. Of the 88 patients receiving corticosteroids at baseline, 78 (88.6%) were able to decrease their corticosteroid dose and 28 (31.8%) discontinued corticosteroids. At 5 years, 79/94 (84.0%), 65/94 (69.1%) and 41/94 (43.6%) of the patients achieved ACR20, ACR50, and ACR70 improvement criteria, respectively. Remission defined as DAS28 less than 2.6 was achieved in 52/94 (55.3%) of the patients. CONCLUSION: In this 5-year extension study, tocilizumab demonstrated sustained long-term efficacy and a generally good safety profile.
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Authors | N Nishimoto, N Miyasaka, K Yamamoto, S Kawai, T Takeuchi, J Azuma |
Journal | Annals of the rheumatic diseases
(Ann Rheum Dis)
Vol. 68
Issue 10
Pg. 1580-4
(Oct 2009)
ISSN: 1468-2060 [Electronic] England |
PMID | 19019888
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Antirheumatic Agents
- Glucocorticoids
- Receptors, Interleukin-6
- tocilizumab
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Topics |
- Adult
- Aged
- Antibodies, Monoclonal
(adverse effects, therapeutic use)
- Antibodies, Monoclonal, Humanized
- Antirheumatic Agents
(adverse effects, therapeutic use)
- Arthritis, Rheumatoid
(drug therapy)
- Drug Therapy, Combination
- Epidemiologic Methods
- Female
- Glucocorticoids
(therapeutic use)
- Humans
- Male
- Middle Aged
- Receptors, Interleukin-6
(immunology)
- Treatment Outcome
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