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Comparison of pharmacokinetics, safety and tolerability of secukinumab administered subcutaneously using different delivery systems in healthy volunteers and in psoriasis patients

Comparison of pharmacokinetics, safety and tolerability of secukinumab administered subcutaneously using different delivery systems in healthy volunteers and in psoriasis patients


Title: Comparison of pharmacokinetics, safety and tolerability of secukinumab administered subcutaneously using different delivery systems in healthy volunteers and in psoriasis patients
Author: Bruin, Gerard
Hockey, Hans Ulrich P.
La Stella, Phillip
Sigurgeirsson, Bárdur
Fu, Rong
Patekar, Manmath
Charef, Pascal
Woessner, Ralph
Boutouyrie-Dumont, Bruno
Date: 2020-02-01
Language: English
Scope: 14
Department: Faculty of Medicine
Series: British Journal of Clinical Pharmacology; 86(2)
ISSN: 0306-5251
DOI: https://doi.org/10.1111/bcp.14155
Subject: injection device; prefilled syringe; psoriasis; secukinumab; subcutaneous administration; therapeutic monoclonal antibody; Pharmacology; Pharmacology (medical)
URI: https://hdl.handle.net/20.500.11815/3415

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Citation:

Bruin , G , Hockey , H U P , La Stella , P , Sigurgeirsson , B , Fu , R , Patekar , M , Charef , P , Woessner , R & Boutouyrie-Dumont , B 2020 , ' Comparison of pharmacokinetics, safety and tolerability of secukinumab administered subcutaneously using different delivery systems in healthy volunteers and in psoriasis patients ' , British Journal of Clinical Pharmacology , vol. 86 , no. 2 , pp. 338-351 . https://doi.org/10.1111/bcp.14155

Abstract:

Aims: The aim of the study was to compare the pharmacokinetics (PK), safety and tolerability of secukinumab with different devices for subcutaneous (s.c.) administration of 2 mL. Methods: A phase 1 study in healthy subjects with 6 devices to administer 2 mL injection volumes was conducted to evaluate the serum PK, safety and tolerability of secukinumab following single s.c. injection of 300 mg in the abdomen (either side) or in the thigh (either leg). Primary PK endpoints were maximum observed serum concentration and area under the serum concentration–time curve. The impact of device, site and side of injection on serum exposure was evaluated. In a phase 3 study in psoriasis patients, PK of secukinumab was evaluated following multiple s.c. injections of 300 mg by either 2 × 1-mL prefilled syringe or 1 × 2-mL prefilled syringe. Results: Mean serum concentration–time profiles for administration as 2 × 1 mL injections or as 1 × 2 mL injections were similar. With an injection volume of 2 mL, perceived injection pain was not different from 2 × 1 mL injections. A nonclinically significant difference in PK endpoints was observed between thigh and abdomen. Results with a 2 mL prefilled syringe in a 1-year phase 3 study in patients confirmed PK results observed in the phase 1 study. Conclusion: Collective evidence from both studies demonstrated that 2-mL injections of secukinumab into the abdomen or thigh using different devices resulted in comparable PK characteristics and were all well tolerated without noticeable local reactions.

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Publisher Copyright: © 2019 Novartis. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society

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