A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of
- PDF / 1,456,227 Bytes
- 18 Pages / 595.276 x 790.866 pts Page_size
- 19 Downloads / 204 Views
ORIGINAL RESEARCH
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 Wolfgang A. Schmidt . Bhaskar Dasgupta . Raashid Luqmani . Sebastian H. Unizony . Daniel Blockmans . Zhihong Lai
.
Regina H. Kurrasch . Ivana Lazic . Kurt Brown . Ravi Rao Received: June 10, 2020 Ó The Author(s) 2020
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 Digital Features To view digital features for this article go to: https://doi.org/10.6084/m9.figshare.12746993. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40744020-00227-2) contains supplementary material, which is available to authorized users.
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)
W. A. Schmidt Medical Center for Rheumatology, Immanuel Krankenhaus Berlin (Buch), Berlin, Germany
D. Blockmans Department of General Internal Medicine, University Hospital Gasthuisberg, Leuven, Belgium
B. Dasgupta Rheumatology, Southend University Hospital NHS Foundation Trust, Essex, UK
Z. Lai (&) R. H. Kurrasch K. Brown Immunoinflammation, GlaxoSmithKline, Collegeville, PA, USA e-mail: [email protected]
R. Luqmani Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK
I. Lazic Biostatistics, GlaxoSmithKline, Stevenage, Hertfordshire, UK
S. H. Unizony Rheumatology, Massachusetts General Hospital, Boston, MA, USA
R. Rao Immunology and Specialty Medicine, GlaxoSmithKline, Stevenage, Hertfordshire, UK
Rheumatol Ther
was highest with sirukumab 100 mg every 2 weeks plus 3-month prednisone taper (23.1%). In Part A, 94.4% of patients reported C 1 treatment-emergent adverse event (TEAE); 19.3% reported serious TEAEs. The proportions of patients with TEAEs were generally similar across treatment arms
Data Loading...
