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

Diabetic Medicine

Volumn 31, Issue 4, 2014, Pages 399-402

  Ambery, P ^a   Donner, T W ^b   Biswas, N ^a   Donaldson, J ^a   Parkin, J ^a   Dayan, C M ^c  

^a GLAXOSMITHKLINE   (United Kingdom)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c CARDIFF UNIVERSITY SCHOOL OF MEDICINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

C PEPTIDE; MONOCLONAL ANTIBODY CD3; OTELIXIZUMAB; PLACEBO;

ADOLESCENT; ADOLESCENT DISEASE; ADULT; AREA UNDER THE CURVE; ARTICLE; CHILD; CONFIDENCE INTERVAL; CYTOKINE RELEASE; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FOLLOW UP; HEADACHE; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; LOW DRUG DOSE; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MIDDLE AGED; MULTICENTER STUDY; NAUSEA; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; TREATMENT OUTCOME;

ADOLESCENT; ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; C-PEPTIDE; CHILD; DIABETES MELLITUS, TYPE 1; DOUBLE-BLIND METHOD; EARLY TERMINATION OF CLINICAL TRIALS; FEMALE; HUMANS; MALE; TREATMENT OUTCOME;

EID: 84896116224     PISSN: 07423071     EISSN: 14645491     Source Type: Journal    
DOI: 10.1111/dme.12361     Document Type: Article

References (7)

1. Chatenoud L. CD3-specific antibody-induced active tolerance: from bench to bedside. Nat Rev Immunol 2003; 3: 123-132.
2. Keymeulen B, Walter M, Mathieu C, Kaufman L, Gorus F, Hilbrands R et al. Four-year metabolic outcome of a randomised controlled CD3-antibody trial in recent-onset type 1 diabetic patients depends on their age and baseline residual beta cell mass. Diabetologia 2010; 53: 614-623.
3. Mehta DS, Christmas RA, Waldmann H, Rosenzweig M. Partial and transient modulation of the CD3-T-cell receptor complex, elicited by low-dose regimens of monoclonal anti-CD3, is sufficient to induce disease remission in non-obese diabetic mice. Immunology 2010; 130: 103-113.
4. GlaxoSmithKline and Tolerx announce phase III DEFEND-1 study of otelixizumab in type 1 diabetes did not meet its primary endpoint. Available at http://us.gsk.com/html/media news/pressreleases/2011/2011_pressrelease_10039.htm Last accessed 26 November 2013.
5. http://clinicaltrials.gov/show/NCT00678886
6. Keymeulen B, Vandemeulebroucke E, Ziegler AG, Mathieu C, Kaufman L, Hale G et al. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes. N Engl J Med 2005; 352: 2598-2608.
7. O'Brien PC. Procedures for comparing samples with multiple endpoints. Biometrics 1984; 40: 1079-1087.