Immunogenicity associated with metreleptin treatment in patients with obesity or lipodystrophy.

ABSTRACT:

Objective

Recombinant human leptin (metreleptin) improves glycaemia and hypertriglyceridaemia in patients with generalized lipodystrophy; antibody development with in vitro neutralizing activity has been reported. We aimed to characterize antimetreleptin antibody development, including in vitro neutralizing activity.

Design

Two randomized controlled studies in patients with obesity (twice-daily metreleptin ± pramlintide for 20-52 weeks; 2006-2009); two long-term, open-label studies in patients with lipodystrophy (once-daily or twice-daily metreleptin for 2 months to 12·3 years; 2000-2014).

Patients

A total of 579 metreleptin-treated patients with obesity and 134 metreleptin-treated patients with lipodystrophy (antibody/neutralizing activity data: n = 105).

Measurem

SUBMITTER: Chan JL 

PROVIDER: S-EPMC4875885 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature