| Abstract | BACKGROUND: Some patients with rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis are resistant to inhibitors of interleukin-1 and tumour necrosis factor. Raised levels of interleukin-6 are associated with both these conditions. Tocilizumab is a humanised monoclonal antibody that binds to both forms of interleukin-6 receptor that has recently been used in Phase III trials in rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis. METHODS: The study conducted an evaluation of Phase III trials with tocilizumab. RESULTS: In the Tocilizumab Pivotal Trial in Methotrexate Inadequate Responders the primary efficacy end-point was the proportion of subjects with a 20% improvement in their rheumatoid arthritis signs and symptoms according to the American College of Rheumatology criteria and, at 24 weeks, this value was 26% with placebo and was increased to 48 and 59% with tocilizumab at 4 and 8 mg respectively. In the trial of tocilizumab in systemic-onset juvenile idiopathic arthritis, the primary end-point in the open-label lead-in was the proportion of subjects achieving an American College of Rheumatology Pediatric 30 response and 91% of subjects had achieved this at 6 weeks. This response was maintained by the majority of subjects being treated with tocilizumab during a 12-week double-blind trial and 48 weeks of open trial follow-up. Small numbers of subjects developed infections in both studies. CONCLUSIONS: Provided long-term safety can be established, tocilizumab will probably become part of the treatment for rheumatoid arthritis and may become a major breakthrough for the treatment of systemic-onset juvenile idiopathic arthritis. |
| Authors | Sheila A Doggrell
(Affiliation: RMIT University, School of Medical Sciences, Discipline of Pharmaceutical Sciences, Bundoora, VIC3083, Australia. Sheila.doggrell at rmit.edu.au)
|
| Journal | Expert opinion on pharmacotherapy
(Expert Opin Pharmacother)
Vol. 9
Issue 11
Pg. 2009-13
(Aug 2008)
ISSN: 1744-7666 England |
| PMID | 18627338
(Publication Type: Journal Article)
|
| Chemical References |
- Antibodies, Monoclonal
- tocilizumab
|
| Topics |
- Adult
- Antibodies, Monoclonal
(administration & dosage, adverse effects, therapeutic use)
- Arthritis, Juvenile Rheumatoid
(drug therapy)
- Arthritis, Rheumatoid
(drug therapy)
- Child
- Clinical Trials, Phase III as Topic
- Dose-Response Relationship, Drug
- Humans
|
