Safety and efficacy of ustekinumab or golimumab in patients with chronic sarcoidosis

Nabeel Y Hamzeh; Marc A Judson; Robert P Baughman; Ulrich Costabel; Marjolein Drent; Kevin F Gibson; Ganesh Raghu; Hidenobu Shigemitsu; Joseph B Barney; Daniel A Culver; Marlies S Wijsenbeek; Carlo Albera; Isham Huizar; Prasheen Agarwal; Carrie Brodmerkel; Rosemary Watt; Elliot S Barnathan

doi:10.1183/09031936.00000914

Back

Safety and efficacy of ustekinumab or golimumab in patients with chronic sarcoidosis

Journal article

Open access

Peer reviewed

Safety and efficacy of ustekinumab or golimumab in patients with chronic sarcoidosis

Nabeel Y Hamzeh, Marc A Judson, Robert P Baughman, Ulrich Costabel, Marjolein Drent, Kevin F Gibson, Ganesh Raghu, Hidenobu Shigemitsu, Joseph B Barney, Daniel A Culver, …

The European respiratory journal, Vol.44(5), pp.1296-1307

11/2014

DOI: 10.1183/09031936.00000914

PMID: 25034562

Files and links (1)

url

https://doi.org/10.1183/09031936.00000914View

Published (Version of record) Open Access

Abstract

Sarcoidosis is characterised by non-caseating granulomas that secrete pro-inflammatory cytokines, including interleukin (IL)-12, IL-23, and tumour necrosis factor (TNF)-α. Ustekinumab and golimumab are monoclonal antibodies that specifically inhibit IL-12/IL-23 and TNF-α, respectively. Patients with chronic pulmonary sarcoidosis (lung group) and/or skin sarcoidosis (skin group) received either 180 mg ustekinumab at week 0 followed by 90 mg every 8 weeks, 200 mg golimumab at week 0 followed by 100 mg every 4 weeks, or placebo. Patients underwent corticosteroid tapering between weeks 16 and 28. The primary end-point was week 16 change in percentage predicted forced vital capacity (ΔFVC % pred) in the lung group. Major secondary end-points were: week 28 for ΔFVC % pred, 6-min walking distance, St George's Respiratory Questionnaire (lung group), and Skin Physician Global Assessment response (skin group). At week 16, no significant differences were observed in ΔFVC % pred with ustekinumab (-0.15, p = 0.13) or golimumab (1.15, p = 0.54) compared with placebo (2.02). At week 28, there were no significant improvements in the major secondary end-points, although a nonsignificant numerically greater Skin Physician Global Assessment response was observed following golimumab treatment (53%) when compared with the placebo (30%). Serious adverse events were similar in all treatment groups. Although treatment was well tolerated, neither ustekinumab nor golimumab demonstrated efficacy in pulmonary sarcoidosis. However, trends towards improvement were observed with golimumab in some dermatological end-points.

Antibodies, Monoclonal, Humanized - therapeutic use

Double-Blind Method

Humans

Middle Aged

Sarcoidosis - drug therapy

Ustekinumab

Antibodies, Monoclonal - therapeutic use

Male

Interleukin-23 - antagonists & inhibitors

Interleukin-12 - antagonists & inhibitors

Sarcoidosis - physiopathology

Adult

Female

Chronic Disease

Tumor Necrosis Factor-alpha - antagonists & inhibitors

Antirheumatic Agents - therapeutic use

Details

Title: Subtitle: Safety and efficacy of ustekinumab or golimumab in patients with chronic sarcoidosis
Creators: Nabeel Y Hamzeh - Dept of Medicine, National Jewish Health, Denver, CO, USA
Marc A Judson - Dept of Medicine, Albany Medical College, Albany, NY, USA judsonm@mail.amc.edu
Robert P Baughman - Dept of Internal Medicine, University of Cincinnati Medical Center, Cincinnati, OH, USA
Ulrich Costabel - Ruhrlandklinik and University of Duisburg-Essen, Essen, Germany
Marjolein Drent - Dept of Interstitial Lung Diseases, Gelderse Vallei Hospital, Ede, The Netherlands
Kevin F Gibson - Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA, USA
Ganesh Raghu - Division of Pulmonary and Critical Care Medicine, University of Washington, Seattle, WA, USA
Hidenobu Shigemitsu - University of Southern California, Los Angeles, CA, USA Division of Pulmonary and Critical Care Medicine, University of Nevada School of Medicine, Las Vegas, NV, USA
Joseph B Barney - Pulmonary and Critical Care Medicine, University of Alabama, Birmingham, AL, USA
Daniel A Culver - Pulmonary, Allergy and Critical Care Medicine, Cleveland Clinic Foundation, Cleveland, OH, USA
Marlies S Wijsenbeek - Dept of Pulmonary Disease, Erasmus MC, University Hospital Rotterdam, Rotterdam, The Netherlands
Carlo Albera - Dept of Pulmonary Medicine, Erasmus Medical Centre, University Hospital Rotterdam, Rotterdam, The Netherlands
Isham Huizar - Dept of Medicine, Texas Tech University Health Science Center, Lubbock, TX, USA
Prasheen Agarwal - Biostatistics, Janssen Research and Development, LLC, Spring House, PA, USA
Carrie Brodmerkel - Immunology Biomarkers, Janssen Research and Development, LLC, Spring House, PA, USA
Rosemary Watt - Immunology, Janssen Research and Development, LLC, Spring House, PA, USA
Elliot S Barnathan - Immunology, Janssen Research and Development, LLC, Spring House, PA, USA
Resource Type: Journal article
Publication Details: The European respiratory journal, Vol.44(5), pp.1296-1307
DOI: 10.1183/09031936.00000914
PMID: 25034562
NLM abbreviation: Eur Respir J
ISSN: 0903-1936
eISSN: 1399-3003
Language: English
Date published: 11/2014
Academic Unit: Pulmonary, Critical Care, and Occupational Medicine; Internal Medicine
Record Identifier: 9984094324702771

Metrics

30 Record Views

150 Times Cited - Web of Science