GAD65 Antigen Therapy in Recently Diagnosed Type 1 Diabetes Mellitus
Identifieur interne : 000574 ( France/Analysis ); précédent : 000573; suivant : 000575GAD65 Antigen Therapy in Recently Diagnosed Type 1 Diabetes Mellitus
Auteurs : Johnny Ludvigsson [Suède] ; David Krisky [États-Unis] ; Rosaura Casas [Suède] ; Tadej Battelino [Slovénie] ; Luis Castano [Espagne] ; James Greening [Royaume-Uni] ; Olga Kordonouri [Allemagne] ; Timo Otonkoski [Finlande] ; Paolo Pozzilli [Italie] ; Jean-Jacques Robert [France] ; Henk J. Veeze [Pays-Bas] ; Jerry Palmer [États-Unis]Source :
- The New England journal of medicine [ 0028-4793 ] ; 2012.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Médecine.
English descriptors
- KwdEn :
Abstract
BACKGROUND The 65-kD isoform of glutamic acid decarboxylase (GAD65) is a major autoantigen in type 1 diabetes. We hypothesized that alum-formulated GAD65 (GAD-alum) can preserve beta-cell function in patients with recent-onset type 1 diabetes. METHODS We studied 334 patients, 10 to 20 years of age, with type 1 diabetes, fasting C-peptide levels of more than 0.3 ng per milliliter (0.1 nmol per liter), and detectable serum GAD65 autoantibodies. Within 3 months after diagnosis, patients were randomly assigned to receive one of three study treatments: four doses of GAD-alum, two doses of GAD-alum followed by two doses of placebo, or four doses of placebo. The primary outcome was the change in the stimulated serum C-peptide level (after a mixed-meal tolerance test) between the baseline visit and the 15-month visit. Secondary outcomes included the glycated hemoglobin level, mean daily insulin dose, rate of hypoglycemia, and fasting and maximum stimulated C-peptide levels. RESULTS The stimulated C-peptide level declined to a similar degree in all study groups, and the primary outcome at 15 months did not differ significantly between the combined active-drug groups and the placebo group (P=0.10). The use of GAD-alum as compared with placebo did not affect the insulin dose, glycated hemoglobin level, or hypoglycemia rate. Adverse events were infrequent and mild in the three groups, with no significant differences. CONCLUSIONS Treatment with GAD-alum did not significantly reduce the loss of stimulated C peptide or improve clinical outcomes over a 15-month period. (Funded by Diamyd Medical and the Swedish Child Diabetes Foundation; ClinicalTrials.gov number, NCT00723411.).
Affiliations:
- Allemagne, Espagne, Finlande, France, Italie, Pays-Bas, Royaume-Uni, Slovénie, Suède, États-Unis
- Basse-Saxe, Hollande-Méridionale, Latium, Pennsylvanie, Uusimaa, Washington (État), Île-de-France
- Hanovre, Helsinki, Paris, Pittsburgh, Rome, Rotterdam, Seattle
- Université d'Helsinki, Université de Washington
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Veeze</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Stichting Diabeter</s1><s2>Rotterdam</s2><s3>NLD</s3><sZ>11 aut.</sZ></inist:fA14><country>Pays-Bas</country><placeName><settlement type="city">Rotterdam</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author><author><name sortKey="Palmer, Jerry" sort="Palmer, Jerry" uniqKey="Palmer J" first="Jerry" last="Palmer">Jerry Palmer</name><affiliation wicri:level="4"><inist:fA14 i1="11"><s1>Department of Medicine, Veterans Affairs Puget Sound Health Care System and University of Washington</s1><s2>Seattle</s2><s3>USA</s3><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Seattle</settlement><region type="state">Washington (État)</region></placeName><orgName type="university">Université de Washington</orgName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno 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last="Ludvigsson">Johnny Ludvigsson</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Linköping University</s1><s2>Linköping</s2><s3>SWE</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ></inist:fA14><country>Suède</country><wicri:noRegion>Linköping University</wicri:noRegion></affiliation></author><author><name sortKey="Krisky, David" sort="Krisky, David" uniqKey="Krisky D" first="David" last="Krisky">David Krisky</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Diamyd Medical</s1><s2>Pittsburgh</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Pittsburgh</settlement><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Casas, Rosaura" sort="Casas, Rosaura" uniqKey="Casas R" first="Rosaura" last="Casas">Rosaura Casas</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Linköping University</s1><s2>Linköping</s2><s3>SWE</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ></inist:fA14><country>Suède</country><wicri:noRegion>Linköping University</wicri:noRegion></affiliation></author><author><name sortKey="Battelino, Tadej" sort="Battelino, Tadej" uniqKey="Battelino T" first="Tadej" last="Battelino">Tadej Battelino</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>University Medical Center-University Children's Hospital, Faculty of Medicine</s1><s2>Ljubljana</s2><s3>SVN</s3><sZ>4 aut.</sZ></inist:fA14><country>Slovénie</country><wicri:noRegion>Ljubljana</wicri:noRegion></affiliation></author><author><name sortKey="Castano, Luis" sort="Castano, Luis" uniqKey="Castano L" first="Luis" last="Castano">Luis Castano</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Hospital de Cruces-University of Basque Country, Barakaldo</s1><s2>Bizkaia</s2><s3>ESP</s3><sZ>5 aut.</sZ></inist:fA14><country>Espagne</country><wicri:noRegion>Bizkaia</wicri:noRegion></affiliation></author><author><name sortKey="Greening, James" sort="Greening, James" uniqKey="Greening J" first="James" last="Greening">James Greening</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Paediatrics, Leicester Royal Infirmary</s1><s2>Leicester</s2><s3>GBR</s3><sZ>6 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Leicester</wicri:noRegion></affiliation></author><author><name sortKey="Kordonouri, Olga" sort="Kordonouri, Olga" uniqKey="Kordonouri O" first="Olga" last="Kordonouri">Olga Kordonouri</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Diabetes Center for Children and Adolescents, Kinderkrankenhaus auf der Bult</s1><s2>Hannover</s2><s3>DEU</s3><sZ>7 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="2">Basse-Saxe</region><settlement type="city">Hanovre</settlement></placeName></affiliation></author><author><name sortKey="Otonkoski, Timo" sort="Otonkoski, Timo" uniqKey="Otonkoski T" first="Timo" last="Otonkoski">Timo Otonkoski</name><affiliation wicri:level="4"><inist:fA14 i1="07"><s1>Children's Hospital, University of Helsinki, and Helsinki University Central Hospital</s1><s2>Helsinki</s2><s3>FIN</s3><sZ>8 aut.</sZ></inist:fA14><country>Finlande</country><wicri:noRegion>Helsinki</wicri:noRegion><orgName type="university">Université d'Helsinki</orgName><placeName><settlement type="city">Helsinki</settlement><region type="région" nuts="2">Uusimaa</region></placeName></affiliation></author><author><name sortKey="Pozzilli, Paolo" sort="Pozzilli, Paolo" uniqKey="Pozzilli P" first="Paolo" last="Pozzilli">Paolo Pozzilli</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>University Campus Bio-Medico</s1><s2>Rome</s2><s3>ITA</s3><sZ>9 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Robert, Jean Jacques" sort="Robert, Jean Jacques" uniqKey="Robert J" first="Jean-Jacques" last="Robert">Jean-Jacques Robert</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Hôpital Necker-Enfants Malades, Université René Descartes Paris 5</s1><s2>Paris</s2><s3>FRA</s3><sZ>10 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Veeze, Henk J" sort="Veeze, Henk J" uniqKey="Veeze H" first="Henk J." last="Veeze">Henk J. Veeze</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Stichting Diabeter</s1><s2>Rotterdam</s2><s3>NLD</s3><sZ>11 aut.</sZ></inist:fA14><country>Pays-Bas</country><placeName><settlement type="city">Rotterdam</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author><author><name sortKey="Palmer, Jerry" sort="Palmer, Jerry" uniqKey="Palmer J" first="Jerry" last="Palmer">Jerry Palmer</name><affiliation wicri:level="4"><inist:fA14 i1="11"><s1>Department of Medicine, Veterans Affairs Puget Sound Health Care System and University of Washington</s1><s2>Seattle</s2><s3>USA</s3><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Seattle</settlement><region type="state">Washington (État)</region></placeName><orgName type="university">Université de Washington</orgName></affiliation></author></analytic><series><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antigen</term><term>Autoimmune disease</term><term>Diagnosis</term><term>Glutamate decarboxylase</term><term>Medicine</term><term>Treatment</term><term>Type 1 diabetes</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Diabète de type 1</term><term>Glutamate decarboxylase</term><term>Antigène</term><term>Traitement</term><term>Diagnostic</term><term>Maladie autoimmune</term><term>Médecine</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Médecine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND The 65-kD isoform of glutamic acid decarboxylase (GAD65) is a major autoantigen in type 1 diabetes. We hypothesized that alum-formulated GAD65 (GAD-alum) can preserve beta-cell function in patients with recent-onset type 1 diabetes. METHODS We studied 334 patients, 10 to 20 years of age, with type 1 diabetes, fasting C-peptide levels of more than 0.3 ng per milliliter (0.1 nmol per liter), and detectable serum GAD65 autoantibodies. Within 3 months after diagnosis, patients were randomly assigned to receive one of three study treatments: four doses of GAD-alum, two doses of GAD-alum followed by two doses of placebo, or four doses of placebo. The primary outcome was the change in the stimulated serum C-peptide level (after a mixed-meal tolerance test) between the baseline visit and the 15-month visit. Secondary outcomes included the glycated hemoglobin level, mean daily insulin dose, rate of hypoglycemia, and fasting and maximum stimulated C-peptide levels. RESULTS The stimulated C-peptide level declined to a similar degree in all study groups, and the primary outcome at 15 months did not differ significantly between the combined active-drug groups and the placebo group (P=0.10). The use of GAD-alum as compared with placebo did not affect the insulin dose, glycated hemoglobin level, or hypoglycemia rate. Adverse events were infrequent and mild in the three groups, with no significant differences. CONCLUSIONS Treatment with GAD-alum did not significantly reduce the loss of stimulated C peptide or improve clinical outcomes over a 15-month period. (Funded by Diamyd Medical and the Swedish Child Diabetes Foundation; ClinicalTrials.gov number, NCT00723411.).</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Espagne</li><li>Finlande</li><li>France</li><li>Italie</li><li>Pays-Bas</li><li>Royaume-Uni</li><li>Slovénie</li><li>Suède</li><li>États-Unis</li></country><region><li>Basse-Saxe</li><li>Hollande-Méridionale</li><li>Latium</li><li>Pennsylvanie</li><li>Uusimaa</li><li>Washington (État)</li><li>Île-de-France</li></region><settlement><li>Hanovre</li><li>Helsinki</li><li>Paris</li><li>Pittsburgh</li><li>Rome</li><li>Rotterdam</li><li>Seattle</li></settlement><orgName><li>Université d'Helsinki</li><li>Université de Washington</li></orgName></list><tree><country name="Suède"><noRegion><name sortKey="Ludvigsson, Johnny" sort="Ludvigsson, Johnny" uniqKey="Ludvigsson J" first="Johnny" last="Ludvigsson">Johnny Ludvigsson</name></noRegion><name sortKey="Casas, Rosaura" sort="Casas, Rosaura" uniqKey="Casas R" first="Rosaura" last="Casas">Rosaura Casas</name></country><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Krisky, David" sort="Krisky, David" uniqKey="Krisky D" first="David" last="Krisky">David Krisky</name></region><name sortKey="Palmer, Jerry" sort="Palmer, Jerry" uniqKey="Palmer J" first="Jerry" last="Palmer">Jerry Palmer</name></country><country name="Slovénie"><noRegion><name sortKey="Battelino, Tadej" sort="Battelino, Tadej" uniqKey="Battelino T" first="Tadej" last="Battelino">Tadej Battelino</name></noRegion></country><country name="Espagne"><noRegion><name sortKey="Castano, Luis" sort="Castano, Luis" uniqKey="Castano L" first="Luis" last="Castano">Luis Castano</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Greening, James" sort="Greening, James" uniqKey="Greening J" first="James" last="Greening">James Greening</name></noRegion></country><country name="Allemagne"><region name="Basse-Saxe"><name sortKey="Kordonouri, Olga" sort="Kordonouri, Olga" uniqKey="Kordonouri O" first="Olga" last="Kordonouri">Olga Kordonouri</name></region></country><country name="Finlande"><region name="Uusimaa"><name sortKey="Otonkoski, Timo" sort="Otonkoski, Timo" uniqKey="Otonkoski T" first="Timo" last="Otonkoski">Timo Otonkoski</name></region></country><country name="Italie"><region name="Latium"><name sortKey="Pozzilli, Paolo" sort="Pozzilli, Paolo" uniqKey="Pozzilli P" first="Paolo" last="Pozzilli">Paolo Pozzilli</name></region></country><country name="France"><region name="Île-de-France"><name sortKey="Robert, Jean Jacques" sort="Robert, Jean Jacques" uniqKey="Robert J" first="Jean-Jacques" last="Robert">Jean-Jacques Robert</name></region></country><country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="Veeze, Henk J" sort="Veeze, Henk J" uniqKey="Veeze H" first="Henk J." last="Veeze">Henk J. 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