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Dose-Exposure-Respo...
Dose-Exposure-Response Relationship of the Investigational Anti-Interleukin-13 Monoclonal Antibody Tralokinumab in Patients With Severe, Uncontrolled Asthma
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- Baverel, Paul G. (author)
- MedImmune, Clin Pharmacol Drug Metab & Pharmacokinet, Cambridge, England
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- White, Nicholas (author)
- MedImmune, Clin Pharmacol Drug Metab & Pharmacokinet, Cambridge, England
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- Vicini, Paolo (author)
- MedImmune, Clin Pharmacol Drug Metab & Pharmacokinet, Cambridge, England
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- Karlsson, Mats O (author)
- Uppsala universitet,Institutionen för farmaceutisk biovetenskap
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- Agoram, Balaji (author)
- MedImmune, Clin Pharmacol Drug Metab & Pharmacokinet, Cambridge, England;FortySeven Inc, Clin Pharmacol & DMPK, Menlo Pk, CA USA
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(creator_code:org_t)
- 2017-09-28
- 2018
- English.
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In: Clinical Pharmacology and Therapeutics. - : Wiley. - 0009-9236 .- 1532-6535. ; 103:5, s. 826-835
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
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- Interleukin (IL)-13 is involved in the pathogenesis of some types of asthma. Tralokinumab is a human immunoglobulin G(4) monoclonal antibody that specifically binds to IL-13. Two placebo-controlled phase II studies (phase IIa, NCT00873860 and phase IIb, NCT01402986) have been conducted in which tralokinumab was administered subcutaneously. This investigation aimed to characterize tralokinumab's dose-exposure-response (forced expiratory volume in 1 s (FEV1)) relationship in patients with asthma and to predict the most appropriate dose for phase III. An integrated population pharmacokinetic-pharmacodynamic (PK/PD) modeling analysis was required for phase III dose selection, due to differing phase II patient populations, designs, and regimens. Analysis of combined datasets enabled the identification of tralokinumab's dose-exposure-FEV1 response relationship in patients with asthma. Near-maximal FEV1 increase was predicted at a dose of 300 mg SC once every 2 weeks (Q2W). This dose was chosen for tralokinumab in the phase III clinical development program for treatment of severe, uncontrolled asthma.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Lungmedicin och allergi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Respiratory Medicine and Allergy (hsv//eng)
Publication and Content Type
- ref (subject category)
- art (subject category)
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