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3. Teplizumab for treatment of type 1 diabetes (Protégé study): 1-year results from a randomised, placebo-controlled trial

Author

Sherry, Nicole, Hagopian, William, Ludvigsson, Johnny, Jain, Sunil M, Wahlen, Jack, Ferry, Robert J, Jr, Bode, Bruce, Aronoff, Stephen, Holland, Christopher, Carlin, David, King, Karen L, Wilder, Ronald L, Pillemer, Stanley, Bonvini, Ezio, Johnson, Syd, Stein, Kathryn E, Koenig, Scott, Herold, Kevan C, and Daifotis, Anastasia G

Published
2011
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12. Papio spp. Colon microbiome and its link to obesity in pregnancy

Author

Li, XuanJi, Rensing, Christopher, Taylor, William L., Costelle, Caitlin, Brejnrod, Asker Daniel, Ferry, Robert J., Jr., Higgins, Paul B., Folli, Franco, Kottapalli, Kameswara Rao, Hubbard, Gene B., Dick, Edward J., Jr., Yooseph, Shibu, Nelson, Karen E., Schlabritz-Loutsevitch, Natalia, Li, XuanJi, Rensing, Christopher, Taylor, William L., Costelle, Caitlin, Brejnrod, Asker Daniel, Ferry, Robert J., Jr., Higgins, Paul B., Folli, Franco, Kottapalli, Kameswara Rao, Hubbard, Gene B., Dick, Edward J., Jr., Yooseph, Shibu, Nelson, Karen E., and Schlabritz-Loutsevitch, Natalia

Published
2018

14. Teplizumab Preserves C-Peptide in Recent-Onset Type 1 Diabetes

Author

Hagopian, William, Ferry, Robert J Jr., Sherry, Nicole, Carlin, David, Bonvini, Ezio, Johnson, Syd, Stein, Kathryn E., Koenig, Scott, Daifotis, Anastasia G., Herold, Kevan C., Ludvigsson, Johnny, Hagopian, William, Ferry, Robert J Jr., Sherry, Nicole, Carlin, David, Bonvini, Ezio, Johnson, Syd, Stein, Kathryn E., Koenig, Scott, Daifotis, Anastasia G., Herold, Kevan C., and Ludvigsson, Johnny

Abstract

Protege was a phase 3, randomized, double-blind, parallel, placebo-controlled 2-year study of three intravenous teplizumab dosing regimens, administered daily for 14 days at baseline and again after 26 weeks, in new-onset type 1 diabetes. We sought to determine efficacy and safety of teplizumab immunotherapy at 2 years and to identify characteristics associated with therapeutic response. Of 516 randomized patients, 513 were treated, and 462 completed 2 years of follow-up. Teplizumab (14-day full-dose) reduced the loss of C-peptide mean area under the curve (AUC), a prespecified secondary end point, at 2 years versus placebo. In analyses of prespecified and post hoc subsets at entry, U.S. residents, patients with C-peptide mean AUC andgt;0.2 nmol/L, those randomized 6 weeks after diagnosis, HbA(1c) andlt;7.5% (58 mmol/mol), insulin use andlt;0.4 units/kg/day, and 8-17 years of age each had greater teplizumab-associated C-peptide preservation than their counterparts. Exogenous insulin needs tended to be reduced versus placebo. Antidrug antibodies developed in some patients, without apparent change in drug efficacy. No new safety or tolerability issues were observed during year 2. In summary, anti-CD3 therapy reduced C-peptide loss 2 years after diagnosis using a tolerable dose., Funding Agencies|MacroGenics, Inc (Rockville, MD)||Johnson Johnson||Tolerx||MacroGenics||JDRF|2008-502|Le Bonheur Foundation (Memphis, TN)

Published
2013
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18. Teplizumab preserves C-peptide in recent-onset type 1 diabetes: two-year results from the randomized, placebo-controlled Protégé trial.

Author

Hagopian, William, Ferry Jr, Robert J, Sherry, Nicole, Carlin, David, Bonvini, Ezio, Johnson, Syd, Stein, Kathryn E, Koenig, Scott, Daifotis, Anastasia G, Herold, Kevan C, Ludvigsson, Johnny, Protégé Trial Investigators, and Ferry, Robert J Jr

Abstract

Protégé was a phase 3, randomized, double-blind, parallel, placebo-controlled 2-year study of three intravenous teplizumab dosing regimens, administered daily for 14 days at baseline and again after 26 weeks, in new-onset type 1 diabetes. We sought to determine efficacy and safety of teplizumab immunotherapy at 2 years and to identify characteristics associated with therapeutic response. Of 516 randomized patients, 513 were treated, and 462 completed 2 years of follow-up. Teplizumab (14-day full-dose) reduced the loss of C-peptide mean area under the curve (AUC), a prespecified secondary end point, at 2 years versus placebo. In analyses of prespecified and post hoc subsets at entry, U.S. residents, patients with C-peptide mean AUC >0.2 nmol/L, those randomized ≤6 weeks after diagnosis, HbA1c <7.5% (58 mmol/mol), insulin use <0.4 units/kg/day, and 8-17 years of age each had greater teplizumab-associated C-peptide preservation than their counterparts. Exogenous insulin needs tended to be reduced versus placebo. Antidrug antibodies developed in some patients, without apparent change in drug efficacy. No new safety or tolerability issues were observed during year 2. In summary, anti-CD3 therapy reduced C-peptide loss 2 years after diagnosis using a tolerable dose. [ABSTRACT FROM AUTHOR]

Published
2013
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21. Contributors

Author

Alter, Craig A., Caplin, Neil, De León, Diva D., Ferry, Robert J., Jr., Grimberg, Adda, Hale, Daniel E., Henwood, Maria J., Kache, Saraswati, Katz, Lorraine E. Levitt, Kulin, Howard E., Lee, Mary M., Lee, Peter A., Magge, Sheela, Misra, Madhusmita, Moshang, Thomas, Jr., Rossi, Wilma C., Thornton, Paul S., Weinzimer, Stuart A., and Xu, Weizhen

Published
2005
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23. Gale Encyclopedia of Medicine

Author

Gale and Gale

Abstract

Timely, comprehensive resource for consumers interested in health information.

Published
2020

24. Gale Encyclopedia of Medicine

Author

Jacqueline L. Longe and Jacqueline L. Longe

Subjects
Medicine--Encyclopedias, Internal medicine--Encyclopedias
Abstract

The updated edition of this authoritative, comprehensive, in-depth medical guide features information on almost 2,000 medical topics in language accessible to adult laypersons. Disease/disorder articles typically cover definition; description; causes and symptoms; diagnosis; treatments; prevention; and more. Test/treatment articles typically cover definition; purposes; precautions; preparation; risks; normal and abnormal results; and much more. Biographical and historical sidebars appear throughout the text. This edition includes new entries, updated entries, 890 color images and illustrations, a comprehensive subject index, and a timeline of major medical breakthroughs/events. Previous edition also available.

Published
2015

25. The Gale Encyclopedia of Children’s Health: Infancy Through Adolescence

Author

Jacqueline L. Longe and Jacqueline L. Longe

Subjects
Pediatrics--Encyclopedias, Children--Diseases--Encyclopedias, Children--Health and hygiene--Encyclopedias, Pediatrics, Maternal and infant welfare
Abstract

The second edition of The GALE ENCYCLOPEDIA OF CHILDREN'S HEALTH is a completely updated edition that contains over 200 new entries with a total of 793 entries. The four-volume set provides in-depth coverage of pediatric diseases and disorders, along with issues related to physical and cognitive/behavioral development. It is an appropriate resource for parents, teachers and allied health students.

Published
2011

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