دورية أكاديمية
Interleukin-1 antagonism in type 1 diabetes of recent onset: two multicentre, randomised, double-blind, placebo-controlled trials
| العنوان: | Interleukin-1 antagonism in type 1 diabetes of recent onset: two multicentre, randomised, double-blind, placebo-controlled trials |
|---|---|
| المؤلفون: | Moran, A., Bundy, B., Becker, D. J., DiMeglio, L. A., Gitelman, S. E., Goland, R., Greenbaum, C. J., Herold, K. C., Marks, J. B., Raskin, P., Sanda, S., Schatz, D., Wherrett, D. K., Wilson, D. M., Krischer, J. P., Skyler, J. S., Pickersgill, L., de Koning, E., Ziegler, A. G., Boehm, B., Badenhoop, K., Schloot, N., Bak, J. F., Pozzilli, P., Mauricio, D., Donath, M. Y., Castano, L., Wagner, A., Lervang, H. H., Perrild, H., Mandrup-Poulsen, T., Aida Study Group, Pociot, F., Dinarello, C. A. |
| بيانات النشر: | The Lancet |
| سنة النشر: | 2013 |
| المجموعة: | University of Basel: edoc |
| الوصف: | BACKGROUND: Innate immunity contributes to the pathogenesis of autoimmune diseases, such as type 1 diabetes, but until now no randomised, controlled trials of blockade of the key innate immune mediator interleukin-1 have been done. We aimed to assess whether canakinumab, a human monoclonal anti-interleukin-1 antibody, or anakinra, a human interleukin-1 receptor antagonist, improved beta-cell function in recent-onset type 1 diabetes. METHODS: We did two randomised, placebo-controlled trials in two groups of patients with recent-onset type 1 diabetes and mixed-meal-tolerance-test-stimulated C peptide of at least 0.2 nM. Patients in the canakinumab trial were aged 6-45 years and those in the anakinra trial were aged 18-35 years. Patients in the canakinumab trial were enrolled at 12 sites in the USA and Canada and those in the anakinra trial were enrolled at 14 sites across Europe. Participants were randomly assigned by computer-generated blocked randomisation to subcutaneous injection of either 2 mg/kg (maximum 300 mg) canakinumab or placebo monthly for 12 months or 100 mg anakinra or placebo daily for 9 months. Participants and carers were masked to treatment assignment. The primary endpoint was baseline-adjusted 2-h area under curve C-peptide response to the mixed meal tolerance test at 12 months (canakinumab trial) and 9 months (anakinra trial). Analyses were by intention to treat. These studies are registered with ClinicalTrials.gov, numbers NCT00947427 and NCT00711503, and EudraCT number 2007-007146-34. FINDINGS: Patients were enrolled in the canakinumab trial between Nov 12, 2010, and April 11, 2011, and in the anakinra trial between Jan 26, 2009, and May 25, 2011. 69 patients were randomly assigned to canakinumab (n=47) or placebo (n=22) monthly for 12 months and 69 were randomly assigned to anakinra (n=35) or placebo (n=34) daily for 9 months. No interim analyses were done. 45 canakinumab-treated and 21 placebo-treated patients in the canakinumab trial a 25 anakinra-treated and 26 placebo-treated patients ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | unknown |
| تدمد: | 0140-6736 |
| العلاقة: | Moran, A. and Bundy, B. and Becker, D. J. and DiMeglio, L. A. and Gitelman, S. E. and Goland, R. and Greenbaum, C. J. and Herold, K. C. and Marks, J. B. and Raskin, P. and Sanda, S. and Schatz, D. and Wherrett, D. K. and Wilson, D. M. and Krischer, J. P. and Skyler, J. S. and Pickersgill, L. and de Koning, E. and Ziegler, A. G. and Boehm, B. and Badenhoop, K. and Schloot, N. and Bak, J. F. and Pozzilli, P. and Mauricio, D. and Donath, M. Y. and Castano, L. and Wagner, A. and Lervang, H. H. and Perrild, H. and Mandrup-Poulsen, T. and Aida Study Group, and Pociot, F. and Dinarello, C. A. (2013) Interleukin-1 antagonism in type 1 diabetes of recent onset: two multicentre, randomised, double-blind, placebo-controlled trials. Lancet, Vol. 381, no. 9881. pp. 1905-1915.; info:pmid/23562090; urn:ISSN:0140-6736 |
| DOI: | 10.1016/S0140-6736(13)60023-9 |
| الإتاحة: | https://doi.org/10.1016/S0140-6736Test(13)60023-9 http://edoc.unibas.ch/dok/A6338620Test https://edoc.unibas.ch/36533Test/ |
| حقوق: | info:eu-repo/semantics/closedAccess |
| رقم الانضمام: | edsbas.C27510B4 |
| قاعدة البيانات: | BASE |
| تدمد: | 01406736 |
|---|---|
| DOI: | 10.1016/S0140-6736(13)60023-9 |