Dataset Information

A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Giant Cell Arteritis.

ABSTRACT:

Introduction

To evaluate the efficacy and safety of sirukumab in giant cell arteritis (GCA).

Methods

In this multicentre, randomised, double-blind, placebo-controlled, two-part phase 3 trial (NCT02531633; Part A [52-week double-blind treatment]; Part B [104-week follow-up]), patients with GCA were randomised (3:3:2:2:2) to sirukumab 100 mg every 2 weeks plus 6-month or 3-month prednisone taper, sirukumab 50 mg every 4 weeks plus 6-month prednisone taper, or placebo every 2 weeks plus 6-month or 12-month prednisone taper. The primary endpoint was the proportion of patients in sustained remission at week 52. Secondary endpoints included disease flare and safety. The study was terminated early (October 2017; sponsor decision).

Results

Of 161 patients randomised (sirukumab: n?=?107; placebo: n?=?54), 28 (17.4%) completed week 52 (median treatment duration: 24-30 weeks). In a revised intent-to-treat (ITT) subgroup (completed week 52 or discontinued before study termination [n?=?55]); six patients (all receiving sirukumab) achieved the primary endpoint. In the ITT population (n?=?161), the proportion of patients with flares (week 2-52) was lower with sirukumab (18.4-30.8%) than placebo (37.0-40.0%). The proportion of patients with flares (week 2-12) was highest with sirukumab 100 mg every 2 weeks plus 3-month prednisone taper (23.1%). In Part A, 94.4% of patients reported???1 treatment-emergent adverse event (TEAE); 19.3% reported serious TEAEs. The proportions of patients with TEAEs were generally similar across treatment arms. No deaths occurred.

Conclusions

Although data were limited due to early termination and shortened treatment duration, sirukumab treatment resulted in numerically lower proportions of patients with flare by week 52 versus placebo, with no unexpected safety findings.

Trial registration

Clinicaltrials.gov: NCT02531633.

SUBMITTER: Schmidt WA

PROVIDER: S-EPMC7695797 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Giant Cell Arteritis.

Schmidt Wolfgang A WA Dasgupta Bhaskar B Luqmani Raashid R Unizony Sebastian H SH Blockmans Daniel D Lai Zhihong Z Kurrasch Regina H RH Lazic Ivana I Brown Kurt K Rao Ravi R

Rheumatology and therapy 20200825 4

<h4>Introduction</h4>To evaluate the efficacy and safety of sirukumab in giant cell arteritis (GCA).<h4>Methods</h4>In this multicentre, randomised, double-blind, placebo-controlled, two-part phase 3 trial (NCT02531633; Part A [52-week double-blind treatment]; Part B [104-week follow-up]), patients with GCA were randomised (3:3:2:2:2) to sirukumab 100 mg every 2 weeks plus 6-month or 3-month prednisone taper, sirukumab 50 mg every 4 weeks plus 6-month prednisone taper, or placebo every 2 weeks p ...[more]

PMID: 32844378

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Dataset Information

A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Giant Cell Arteritis.

Introduction

Methods

Results

Conclusions

Trial registration

Publications

A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Giant Cell Arteritis.

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