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Efficacy and safety of low-dose otelixizumab anti-CD3 monoclonal antibody in preserving C-peptide secretion in adolescent type 1 diabetes: DEFEND-2, a randomized, placebo-controlled, double-blind, multi-centre study

Ambery, P. ; Donner, T. W. ; Biswas, N. ; Donaldson, J. ; Parkin, J. ; Dayan, C. M.

Diabetic medicine, 2014-04, Vol.31 (4), p.399-402 [Periódico revisado por pares]

Oxford: Blackwell Publishing Ltd

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Título:
Efficacy and safety of low-dose otelixizumab anti-CD3 monoclonal antibody in preserving C-peptide secretion in adolescent type 1 diabetes: DEFEND-2, a randomized, placebo-controlled, double-blind, multi-centre study
Autor: Ambery, P. ; Donner, T. W. ; Biswas, N. ; Donaldson, J. ; Parkin, J. ; Dayan, C. M.
Assuntos: Adolescent ; Adult ; Antibodies, Monoclonal, Humanized - therapeutic use ; Biological and medical sciences ; C-Peptide - secretion ; Child ; Diabetes Mellitus, Type 1 - drug therapy ; Diabetes. Impaired glucose tolerance ; Double-Blind Method ; Early Termination of Clinical Trials ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Etiopathogenesis. Screening. Investigations. Target tissue resistance ; Feeding. Feeding behavior ; Female ; Fundamental and applied biological sciences. Psychology ; Humans ; Male ; Medical sciences ; Treatment Outcome ; Vertebrates: anatomy and physiology, studies on body, several organs or systems ; Vertebrates: endocrinology
É parte de: Diabetic medicine, 2014-04, Vol.31 (4), p.399-402
Notas: ArticleID:DME12361
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Appendix S1. List of investigators in the DEFEND-2 trial.Figure S1. DEFEND-2 CONSORT diagram.Figure S2. Absolute lymphocytes by treatment group over time (safety population).Table S1. Patient background characteristics. Table S2. Stimulated C-peptide area under the curve change from baseline: adolescents vs. adults. Table S3. Number (%) of subjects reporting adverse events (affecting at least 5% of subjects in any group) (safety population).
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Descrição: Aims Phase III DEFEND‐2 investigated whether otelixizumab (3.1 mg over 8 days) preserved C‐peptide secretion in patients with new‐onset Type 1 diabetes, focusing on adolescents (12–17 years). Methods One hundred and seventy‐nine patients (54 adolescents) were randomized to otelixizumab or placebo. The primary endpoint was change in 2‐h mixed‐meal‐stimulated C‐peptide area under the curve at month 12. Enrolment was suspended in April 2011 following negative efficacy results from DEFEND‐1. DEFEND‐2 terminated early after 12 months' efficacy and safety follow‐up. Results Change from baseline C‐peptide was not significantly different [∆ = –0.09 nmol/l (95% CI –0.17 to 0; P = 0.051)]. No differential C‐peptide effect was seen for otelixizumab in adolescents and more adverse events were reported. Conclusions Efficacy and tolerability of otelixizumab was similar to DEFEND‐1. The 3.1‐mg dose was non‐efficacious in adults and adolescents. Further investigation of the mechanism of action seen at higher doses and therapeutic window is required. Clinical Trials Registry No: NCT 00763451 What's new? DEFEND‐2 was intended as a confirmatory study to DEFEND‐1, which tested the efficacy and safety of low‐dose otelixizumab (3.1 mg) in 281 adolescents and adults with new‐onset Type 1 diabetes; DEFEND‐2 studied this dose in a population enriched with adolescents. Following lack of efficacy in DEFEND–1, enrolment of new subjects to DEFEND‐2 was suspended; analysis of 6‐month data also showed no efficacy advantage of otelixizumab, but reaffirmed the safety of this dose. These results are important to further understanding of Type 1 diabetes; additional research is needed to establish the optimal dose of otelixizumab.
Editor: Oxford: Blackwell Publishing Ltd
Idioma: Inglês

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Efficacy and safety of low-dose otelixizumab anti-CD3 monoclonal antibody in preserving C-peptide secretion in adolescent type 1 diabetes: DEFEND-2, a randomized, placebo-controlled, double-blind, multi-centre study

Ambery, P. ; Donner, T. W. ; Biswas, N. ; Donaldson, J. ; Parkin, J. ; Dayan, C. M.

Oxford: Blackwell Publishing Ltd

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