Safety of Ixekizumab in Patients With Psoriatic Arthritis: Results From a Pooled Analysis of Three Clinical Trials.

ABSTRACT:

Objective

To evaluate ixekizumab safety in adults with psoriatic arthritis (PsA).

Methods

Safety data from 2 integrated data sets are presented: 1) 24-week, double-blind, placebo-controlled period of SPIRIT-P1 and SPIRIT-P2; and 2) all ixekizumab-treated patients of SPIRIT-P1 and SPIRIT-P2 plus SPIRIT-P3 open-label period. We report adverse event (AE) frequency and exposure-adjusted incidence rates per 100 patient-years at 12-week intervals to week 96.

Results

The placebo-controlled period had 678 patients (safety population): 224 placebo, 229 ixekizumab every 4 weeks, and 225 ixekizumab every 2 weeks. Overall, 1,118 patients received ixekizumab (total exposure 1,373.4 patient-years). In the placebo-controlled period, the frequencies of ixekizumab-treated patients exp

SUBMITTER: Mease P 

PROVIDER: S-EPMC6593968 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature