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Teplizumab Preserve...
Teplizumab Preserves C-Peptide in Recent-Onset Type 1 Diabetes
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- Hagopian, William (författare)
- Pacific Northwest Diabet Research Institute, WA USA
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- Ferry, Robert J Jr. (författare)
- Le Bonheur Childrens Hospital, TN USA
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- Sherry, Nicole (författare)
- Massachusetts Gen Hospital, MA USA
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- Carlin, David (författare)
- MacroGenics, MD USA
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- Bonvini, Ezio (författare)
- MacroGenics, MD USA
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- Johnson, Syd (författare)
- MacroGenics, MD USA
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- Stein, Kathryn E. (författare)
- MacroGenics, MD USA
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- Koenig, Scott (författare)
- MacroGenics, MD USA
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- Daifotis, Anastasia G. (författare)
- MacroGenics, MD USA
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- Herold, Kevan C. (författare)
- Yale University, CT USA
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- Ludvigsson, Johnny (författare)
- Östergötlands Läns Landsting,Linköpings universitet,Avdelningen för kliniska vetenskaper,Hälsouniversitetet,Barn- och ungdomskliniken i Linköping
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(creator_code:org_t)
- 2013-10-18
- 2013
- Engelska.
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Ingår i: Diabetes. - : American Diabetes Association. - 0012-1797 .- 1939-327X. ; 62:11, s. 3901-3908
- Relaterad länk:
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https://liu.diva-por... (primary) (Raw object)
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https://diabetes.dia...
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https://urn.kb.se/re...
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https://doi.org/10.2...
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Abstract
Ämnesord
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- 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.
Nyckelord
- MEDICINE
- MEDICIN
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Diabetes
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Hagopian, Willia ...
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Ferry, Robert J ...
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Sherry, Nicole
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Carlin, David
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Bonvini, Ezio
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Johnson, Syd
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visa fler...
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Stein, Kathryn E ...
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Koenig, Scott
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Daifotis, Anasta ...
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Herold, Kevan C.
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Ludvigsson, John ...
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- Artiklar i publikationen
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Diabetes
- Av lärosätet
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Linköpings universitet