Safety, pharmacokinetics, and preliminary efficacy of a specific anti-IL-1alpha therapeutic antibody (MABp1) in patients with type 2 diabetes mellitus

Journal of Diabetes and its Complications

Volumn 29, Issue 7, 2015, Pages 955-960

  Timper, Katharina ^a   Seelig, Eleonora ^a   Tsakiris, Dimitrios A ^a   Donath, Marc Y ^a  

^a UNIVERSITY HOSPITAL BASEL   (Switzerland)

Author keywords

Clinical trial; IL 1alpha; MABp1; Monoclonal antibody against IL 1alpha; Type 2 diabetes

Indexed keywords

ALBUMIN; ANTIDIABETIC AGENT; C PEPTIDE; C REACTIVE PROTEIN; CHOLESTEROL; CREATININE; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INSULIN; INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; INTERLEUKIN 6; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY MABP1; NEUTRALIZING ANTIBODY; PROINSULIN; TRIACYLGLYCEROL; UNCLASSIFIED DRUG; GLUCOSE BLOOD LEVEL; INTERLEUKIN 1ALPHA; MABP1 MONOCLONAL ANTIBODY;

ADULT; AGED; ANTIBODY TITER; ARTICLE; BONE INFECTION; BONE PAIN; BRONCHITIS; CHRONOTHERAPY; CREATININE BLOOD LEVEL; DIABETIC PATIENT; DIASTOLIC BLOOD PRESSURE; DIET RESTRICTION; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; EDEMA; FEMALE; FOLLOW UP; GASTROINTESTINAL SYMPTOM; GLUCOSE HOMEOSTASIS; HEEL SPUR; HUMAN; HYPERTRANSAMINASEMIA; HYPOKALEMIA; INFUSION RELATED REACTION; JAW DISEASE; KNEE INJURY; LEUKOCYTE COUNT; LIVER DYSFUNCTION; LIVER FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MANDIBULA INFECTION; MICROALBUMINURIA; MULTIPLE CYCLE TREATMENT; NON INSULIN DEPENDENT DIABETES MELLITUS; OPEN STUDY; OTALGIA; OTITIS MEDIA; PAIN; PANCREAS ISLET BETA CELL; PANCREAS ISLET CELL FUNCTION; PILOT STUDY; PRIORITY JOURNAL; PRURITUS; RHINORRHEA; SHOULDER DISEASE; SIDE EFFECT; SORE THROAT; SYSTOLIC BLOOD PRESSURE; TOOTH INFECTION; TREATMENT DURATION; TREATMENT OUTCOME; ANALYSIS; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; COMPARATIVE STUDY; DIABETES MELLITUS, TYPE 2; DOSE RESPONSE; DRUG ADMINISTRATION; DRUG EFFECTS; GLUCOSE BLOOD LEVEL; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; PATIENT SAFETY; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX;

AGED; ANTIBODIES, MONOCLONAL; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFUSIONS, INTRAVENOUS; INTERLEUKIN-1ALPHA; MALE; MIDDLE AGED; PATIENT SAFETY; PILOT PROJECTS; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84939573788     PISSN: 10568727     EISSN: 1873460X     Source Type: Journal    
DOI: 10.1016/j.jdiacomp.2015.05.019     Document Type: Article

References (17)

1. M. Boni-Schnetzler, J. Thorne, G. Parnaud, L. Marselli, J.A. Ehses, J. Kerr-Conte, and et al. Increased interleukin (IL)-1beta messenger ribonucleic acid expression in beta -cells of individuals with type 2 diabetes and regulation of IL-1beta in human islets by glucose and autostimulation The Journal of Clinical Endocrinology and Metabolism 93 10 2008 4065 4074 (Epub 2008/07/31)
2. C. Cavelti-Weder, A. Babians-Brunner, C. Keller, M.A. Stahel, M. Kurz-Levin, H. Zayed, and et al. Effects of gevokizumab on glycemia and inflammatory markers in type 2 diabetes Diabetes Care 35 8 2012 1654 1662 (Epub 2012/06/16)
3. C.A. Dinarello The interleukin-1 family: 10 years of discovery The FASEB Journal 8 15 1994 1314 1325 (Epub 1994/12/01)
4. J.A. Ehses, G. Lacraz, M.H. Giroix, F. Schmidlin, J. Coulaud, N. Kassis, and et al. IL-1 antagonism reduces hyperglycemia and tissue inflammation in the type 2 diabetic GK rat Proceedings of the National Academy of Sciences of the United States of America 106 33 2009 13998 14003 (Epub 2009/08/12)
5. S. Freigang, F. Ampenberger, A. Weiss, T.D. Kanneganti, Y. Iwakura, M. Hersberger, and et al. Fatty acid-induced mitochondrial uncoupling elicits inflammasome-independent IL-1alpha and sterile vascular inflammation in atherosclerosis Nature Immunology 14 10 2013 1045 1053 (Epub 2013/09/03)
6. J. He, I. Usui, K. Ishizuka, Y. Kanatani, K. Hiratani, M. Iwata, and et al. Interleukin-1alpha inhibits insulin signaling with phosphorylating insulin receptor substrate-1 on serine residues in 3 T3-L1 adipocytes Molecular Endocrinology 20 1 2006 114 124 (Epub 2005/09/10)
7. J. Hensen, C.P. Howard, V. Walter, and T. Thuren Impact of interleukin-1beta antibody (canakinumab) on glycaemic indicators in patients with type 2 diabetes mellitus: results of secondary endpoints from a randomized, placebo-controlled trial Diabetes & Metabolism 39 6 2013 524 531 (Epub 2013/10/01)
8. D.S. Hong, D. Hui, E. Bruera, F. Janku, A. Naing, G.S. Falchook, and et al. MABp1, a first-in-class true human antibody targeting interleukin-1alpha in refractory cancers: an open-label, phase 1 dose-escalation and expansion study The Lancet Oncology 15 6 2014 656 666 (Epub 2014/04/22)
9. C.M. Larsen, M. Faulenbach, A. Vaag, J.A. Ehses, M.Y. Donath, and T. Mandrup-Poulsen Sustained effects of interleukin-1 receptor antagonist treatment in type 2 diabetes Diabetes Care 32 9 2009 1663 1668 (Epub 2009/06/23)
10. C.M. Larsen, M. Faulenbach, A. Vaag, A. Volund, J.A. Ehses, B. Seifert, and et al. Interleukin-1-receptor antagonist in type 2 diabetes mellitus The New England Journal of Medicine 356 15 2007 1517 1526 (Epub 2007/04/13)
11. K. Maedler, P. Sergeev, F. Ris, J. Oberholzer, H.I. Joller-Jemelka, G.A. Spinas, and et al. Glucose-induced beta cell production of IL-1beta contributes to glucotoxicity in human pancreatic islets The Journal of Clinical Investigation 110 6 2002 851 860 (Epub 2002/09/18)
12. T. Mandrup-Poulsen, K. Bendtzen, C.A. Dinarello, and J. Nerup Human tumor necrosis factor potentiates human interleukin 1-mediated rat pancreatic beta-cell cytotoxicity Journal of Immunology 139 12 1987 4077 4082 (Epub 1987/12/15)
13. P.M. Ridker, E. Danielson, F.A. Fonseca, J. Genest, A.M. Gotto Jr., J.J. Kastelein, and et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein The New England Journal of Medicine 359 21 2008 2195 2207 (Epub 2008/11/11)
14. A. Rissanen, C.P. Howard, J. Botha, T. Thuren, and for the Global I. Effect of anti-IL-1beta antibody (canakinumab) on insulin secretion rates in impaired glucose tolerance or type 2 diabetes: Results of a randomized, placebo-controlled trial Diabetes, Obesity & Metabolism 14 12 2012 1088 1096 (Epub 2012/06/26)
15. J. Sloan-Lancaster, E. Abu-Raddad, J. Polzer, J.W. Miller, J.C. Scherer, A. De Gaetano, and et al. Double-blind, randomized study evaluating the glycemic and anti-inflammatory effects of subcutaneous LY2189102, a neutralizing IL-1beta antibody, in patients with type 2 diabetes Diabetes Care 36 8 2013 2239 2246 (Epub 2013/03/22)
16. T. Uno, J. He, I. Usui, Y. Kanatani, A. Bukhari, S. Fujisaka, and et al. Long-term interleukin-1alpha treatment inhibits insulin signaling via IL-6 production and SOCS3 expression in 3 T3-L1 adipocytes Hormone and Metabolic Research 40 1 2008 8 12 (Epub 2007/12/19)
17. E.J. van Asseldonk, R. Stienstra, T.B. Koenen, L.A. Joosten, M.G. Netea, and C.J. Tack Treatment with Anakinra improves disposition index but not insulin sensitivity in nondiabetic subjects with the metabolic syndrome: A randomized, double-blind, placebo-controlled study The Journal of Clinical Endocrinology and Metabolism 96 7 2011 2119 2126 (Epub 2011/04/22)