Bruin, Gerardus, Hockey, Hans-Ulrich, Patekar, Manmath, Charef, Pascal, Woessner, Ralph, Boutouyrie-Dumont, Bruno, Fu, Rong, Philip, La Stella and Bardur, Sigurgeirsson (2020) Comparison of pharmacokinetics, safety and tolerability of secukinumab administered subcutaneously using different 2 mL delivery systems in healthy volunteers and in psoriasis patients. British journal of clinical pharmacology. pp. 1-14.

Abstract

Aims
The aim of the study was to compare the pharmacokinetics, safety and tolerability of secukinumab with different devices for subcutaneous administration of 2 mL (i.e. 300 mg) secukinumab.
Methods
A phase 1 study in healthy subjects with six devices to administer 2 mL injection volumes was conducted to evaluate the serum pharmacokinetics (PK), safety and tolerability of secukinumab following s.c. injection of 300 mg in the abdomen or in the thigh at either the left or right side of the body. Primary PK endpoints were maximum observed concentration (Cmax), and areas under the curve (AUCinf and AUClast). The impact of 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 x 1 mL prefilled syringe or 1 x 2 mL prefilled syringe.
Results
Mean serum concentration-time profiles for administrations as 2 x 1mL injections or as 1 x 2 mL injections were similar. With an injection volume of 2 mL, perceived injection pain was not different from 2 x 1 mL injections. A non-clinically significant difference in PK endpoints was observed between thigh and abdomen. Results with a 2 mL prefilled syringe in a one year phase 3 study in patients confirmed PK results observed in the phase 1 study.
Conclusions
Collective evidence from a phase 1 study and phase 3 study demonstrated that 2 mL injections of secukinumab into the abdomen or thigh using different devices resulted in comparable PK characerisitics and were all well tolerated without noticable pain experiences.

Item Type:	Article
Date Deposited:	28 Jan 2020 00:45
Last Modified:	28 Jan 2020 00:45
URI:	https://oak.novartis.com/id/eprint/40116