PittsburghV1, Canada, Analysis, bibRecord, 000331

B-Lymphocyte Depletion With Rituximab and β-Cell Function: Two-Year Results

Identifieur interne : 000331 ( Canada/Analysis ); précédent : 000330; suivant : 000332

B-Lymphocyte Depletion With Rituximab and β-Cell Function: Two-Year Results

Auteurs : Mark D. Pescovitz [États-Unis] ; Carla J. Greenbaum [États-Unis] ; Brian Bundy [États-Unis] ; Dorothy J. Becker [États-Unis] ; Stephen E. Gitelman [États-Unis] ; Robin Goland [États-Unis] ; Peter A. Gottlieb [États-Unis] ; Jennifer B. Marks [États-Unis] ; Antoinette Moran [États-Unis] ; Philip Raskin [États-Unis] ; Henry Rodriguez [États-Unis] ; Desmond A. Schatz [États-Unis] ; Diane K. Wherrett [Canada] ; Darrell M. Wilson [États-Unis] ; Jeffrey P. Krischer [États-Unis] ; Jay S. Skyler [États-Unis]

Source :

Diabetes care [ 0149-5992 ] ; 2014.

RBID : Pascal:14-0058609

Descripteurs français

Pascal (Inist)
- Rituximab, Lymphocyte B, Anticorps monoclonal, Immunothérapie, Cellule β, Fonction cellulaire, Résultat, Endocrinologie, Maladie métabolique, Nutrition, Homme, Anticancéreux, Immunomodulateur, Immunodépresseur, Traitement.
Wicri :
- topic : Nutrition, Homme.

English descriptors

KwdEn :
- Antineoplastic agent, B-Lymphocyte, Cell function, Endocrinology, Human, Immunomodulator, Immunosuppressive agent, Immunotherapy, Metabolic diseases, Monoclonal antibody, Nutrition, Result, Rituximab, Treatment, β Cell.

Abstract

OBJECTIVE We previously reported that selective depletion of B-lymphocytes with rituximab, an anti-CD20 monoclonal antibody, slowed decline of β-cell function in recent-onset type 1 diabetes mellitus (T1DM) at 1 year. Subjects were followed further to determine whether there was persistence of effect. RESEARCH DESIGN AND METHODS Eighty-seven subjects (aged 8-40 years) were randomly assigned to, and 81 received, infusions of rituximab or placebo on days 1, 8, 15, and 22. The primary outcome-baseline-adjusted mean 2-h area under the curve (AUC) serum C-peptide during a mixed-meal tolerance test (MMTT) at 1 year-showed higher C-peptide AUC with rituximab versus placebo. Subjects were further followed with additional MMTTs every 6 months. RESULTS The rate of decline of C-peptide was parallel between groups but shifted by 8.2 months in rituximab-treated subjects. Over 30 months, AUC, insulin dose, and HbA_1c were similar for rituximab and placebo. However, in evaluating change in C-peptide over the entire follow-up period, the rituximab group means were significantly larger as compared within assessment times with the placebo group means using a global test (P=0.03). Odds ratio for loss of C-peptide to <0.2 nmol/L following rituximab was 0.565 (P=0.064). B-lymphocytes recovered to baseline values by 18 months. Serum IgG levels were maintained in the normal range but IgM levels were depressed. CONCLUSIONS Like several other immunotherapeutic approaches tested, in recent-onset T1DM, rituximab delays the fall in C-peptide but does not appear to fundamentally alter the underlying pathophysiology of the disease.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3898764

Affiliations:

Links to Exploration step

Pascal:14-0058609

Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">B-Lymphocyte Depletion With Rituximab and β-Cell Function: Two-Year Results</title>
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</affiliation>
</author>
<author><name sortKey="Krischer, Jeffrey P" sort="Krischer, Jeffrey P" uniqKey="Krischer J" first="Jeffrey P." last="Krischer">Jeffrey P. Krischer</name>
<affiliation wicri:level="4"><inist:fA14 i1="03"><s1>University of South Florida</s1>
<s2>Tampa, FL</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><settlement type="city">Tampa</settlement>
<region type="state">Floride</region>
</placeName>
<orgName type="university">Université de Floride du Sud</orgName>
</affiliation>
</author>
<author><name sortKey="Skyler, Jay S" sort="Skyler, Jay S" uniqKey="Skyler J" first="Jay S." last="Skyler">Jay S. Skyler</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>University of Miami Diabetes Research Institute</s1>
<s2>Miami, FL</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>University of Miami Diabetes Research Institute</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Diabetes care</title>
<title level="j" type="abbreviated">Diabetes care</title>
<idno type="ISSN">0149-5992</idno>
<imprint><date when="2014">2014</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Diabetes care</title>
<title level="j" type="abbreviated">Diabetes care</title>
<idno type="ISSN">0149-5992</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic agent</term>
<term>B-Lymphocyte</term>
<term>Cell function</term>
<term>Endocrinology</term>
<term>Human</term>
<term>Immunomodulator</term>
<term>Immunosuppressive agent</term>
<term>Immunotherapy</term>
<term>Metabolic diseases</term>
<term>Monoclonal antibody</term>
<term>Nutrition</term>
<term>Result</term>
<term>Rituximab</term>
<term>Treatment</term>
<term>β Cell</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Rituximab</term>
<term>Lymphocyte B</term>
<term>Anticorps monoclonal</term>
<term>Immunothérapie</term>
<term>Cellule β</term>
<term>Fonction cellulaire</term>
<term>Résultat</term>
<term>Endocrinologie</term>
<term>Maladie métabolique</term>
<term>Nutrition</term>
<term>Homme</term>
<term>Anticancéreux</term>
<term>Immunomodulateur</term>
<term>Immunodépresseur</term>
<term>Traitement</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Nutrition</term>
<term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">OBJECTIVE We previously reported that selective depletion of B-lymphocytes with rituximab, an anti-CD20 monoclonal antibody, slowed decline of β-cell function in recent-onset type 1 diabetes mellitus (T1DM) at 1 year. Subjects were followed further to determine whether there was persistence of effect. RESEARCH DESIGN AND METHODS Eighty-seven subjects (aged 8-40 years) were randomly assigned to, and 81 received, infusions of rituximab or placebo on days 1, 8, 15, and 22. The primary outcome-baseline-adjusted mean 2-h area under the curve (AUC) serum C-peptide during a mixed-meal tolerance test (MMTT) at 1 year-showed higher C-peptide AUC with rituximab versus placebo. Subjects were further followed with additional MMTTs every 6 months. RESULTS The rate of decline of C-peptide was parallel between groups but shifted by 8.2 months in rituximab-treated subjects. Over 30 months, AUC, insulin dose, and HbA<sub>1c</sub>
 were similar for rituximab and placebo. However, in evaluating change in C-peptide over the entire follow-up period, the rituximab group means were significantly larger as compared within assessment times with the placebo group means using a global test (P=0.03). Odds ratio for loss of C-peptide to <0.2 nmol/L following rituximab was 0.565 (P=0.064). B-lymphocytes recovered to baseline values by 18 months. Serum IgG levels were maintained in the normal range but IgM levels were depressed. CONCLUSIONS Like several other immunotherapeutic approaches tested, in recent-onset T1DM, rituximab delays the fall in C-peptide but does not appear to fundamentally alter the underlying pathophysiology of the disease.</div>
</front>
</TEI>
<affiliations><list><country><li>Canada</li>
<li>États-Unis</li>
</country>
<region><li>Californie</li>
<li>Floride</li>
<li>Ontario</li>
<li>Pennsylvanie</li>
<li>État de New York</li>
</region>
<settlement><li>New York</li>
<li>Pittsburgh</li>
<li>San Francisco</li>
<li>Tampa</li>
<li>Toronto</li>
</settlement>
<orgName><li>Université Columbia</li>
<li>Université de Floride du Sud</li>
<li>Université de Pittsburgh</li>
<li>Université de Toronto</li>
</orgName>
</list>
<tree><country name="États-Unis"><noRegion><name sortKey="Pescovitz, Mark D" sort="Pescovitz, Mark D" uniqKey="Pescovitz M" first="Mark D." last="Pescovitz">Mark D. Pescovitz</name>
</noRegion>
<name sortKey="Becker, Dorothy J" sort="Becker, Dorothy J" uniqKey="Becker D" first="Dorothy J." last="Becker">Dorothy J. Becker</name>
<name sortKey="Bundy, Brian" sort="Bundy, Brian" uniqKey="Bundy B" first="Brian" last="Bundy">Brian Bundy</name>
<name sortKey="Gitelman, Stephen E" sort="Gitelman, Stephen E" uniqKey="Gitelman S" first="Stephen E." last="Gitelman">Stephen E. Gitelman</name>
<name sortKey="Goland, Robin" sort="Goland, Robin" uniqKey="Goland R" first="Robin" last="Goland">Robin Goland</name>
<name sortKey="Gottlieb, Peter A" sort="Gottlieb, Peter A" uniqKey="Gottlieb P" first="Peter A." last="Gottlieb">Peter A. Gottlieb</name>
<name sortKey="Greenbaum, Carla J" sort="Greenbaum, Carla J" uniqKey="Greenbaum C" first="Carla J." last="Greenbaum">Carla J. Greenbaum</name>
<name sortKey="Krischer, Jeffrey P" sort="Krischer, Jeffrey P" uniqKey="Krischer J" first="Jeffrey P." last="Krischer">Jeffrey P. Krischer</name>
<name sortKey="Marks, Jennifer B" sort="Marks, Jennifer B" uniqKey="Marks J" first="Jennifer B." last="Marks">Jennifer B. Marks</name>
<name sortKey="Moran, Antoinette" sort="Moran, Antoinette" uniqKey="Moran A" first="Antoinette" last="Moran">Antoinette Moran</name>
<name sortKey="Raskin, Philip" sort="Raskin, Philip" uniqKey="Raskin P" first="Philip" last="Raskin">Philip Raskin</name>
<name sortKey="Rodriguez, Henry" sort="Rodriguez, Henry" uniqKey="Rodriguez H" first="Henry" last="Rodriguez">Henry Rodriguez</name>
<name sortKey="Rodriguez, Henry" sort="Rodriguez, Henry" uniqKey="Rodriguez H" first="Henry" last="Rodriguez">Henry Rodriguez</name>
<name sortKey="Schatz, Desmond A" sort="Schatz, Desmond A" uniqKey="Schatz D" first="Desmond A." last="Schatz">Desmond A. Schatz</name>
<name sortKey="Skyler, Jay S" sort="Skyler, Jay S" uniqKey="Skyler J" first="Jay S." last="Skyler">Jay S. Skyler</name>
<name sortKey="Wilson, Darrell M" sort="Wilson, Darrell M" uniqKey="Wilson D" first="Darrell M." last="Wilson">Darrell M. Wilson</name>
</country>
<country name="Canada"><region name="Ontario"><name sortKey="Wherrett, Diane K" sort="Wherrett, Diane K" uniqKey="Wherrett D" first="Diane K." last="Wherrett">Diane K. Wherrett</name>
</region>
</country>
</tree>
</affiliations>
</record>

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B-Lymphocyte Depletion With Rituximab and β-Cell Function: Two-Year Results

B-Lymphocyte Depletion With Rituximab and β-Cell Function: Two-Year Results

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