Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs.

ABSTRACT:

Introduction

Theoretical risks of biologic agents remain under study.

Objective

The aim of this study was to integrate 1-year safety data from 12 ustekinumab registrational trials.

Methods

Patients had moderate-to-severe plaque psoriasis, active psoriatic arthritis (PsA) (± methotrexate), or moderate-to-severe Crohn's disease (CD; failed/intolerant of immunomodulators/corticosteroids). Psoriatic patients received subcutaneous ustekinumab 45/90 mg or placebo, generally at week 0, week 4, then every 12 weeks thereafter, while those with CD received a single intravenous ustekinumab dose (130 mg or weight range-based dosing of approximately 6 mg/kg) or placebo induction dose at week 0, followed by subcutaneous ustekinumab 90 mg at week 8 and every 8/12 weeks thereafter. T

SUBMITTER: Ghosh S 

PROVIDER: S-EPMC6520311 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature