STRATUS: A Phase II Study of Abituzumab in Patients With Systemic Sclerosis-associated Interstitial Lung Disease

Dinesh Khanna; Donald P Tashkin; Athol U Wells; James R Seibold; Stephen Wax; Cristina Vazquez-Mateo; Patricia Fleuranceau-Morel; Doris Damian; Christopher P Denton

doi:10.3899/jrheum.191365

STRATUS: A Phase II Study of Abituzumab in Patients With Systemic Sclerosis-associated Interstitial Lung Disease

J Rheumatol. 2021 Aug;48(8):1295-1298. doi: 10.3899/jrheum.191365. Epub 2020 Oct 1.

Authors

Dinesh Khanna¹, Donald P Tashkin², Athol U Wells³, James R Seibold⁴, Stephen Wax⁵, Cristina Vazquez-Mateo⁶, Patricia Fleuranceau-Morel⁶, Doris Damian⁶, Christopher P Denton⁷

Affiliations

¹ D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; khannad@med.umich.edu.
² D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
³ A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK.
⁴ J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA.
⁵ S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current).
⁶ C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA.
⁷ C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK.

PMID: 33004536
DOI: 10.3899/jrheum.191365

Abstract

Objective: To investigate the effects of abituzumab in systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Methods: STRATUS was a phase II, double-blind, parallel-group, multicenter trial (ClinicalTrials.gov: NCT02745145). Adults (≤ 75 yrs) with SSc-ILD on stable mycophenolate were randomized (2:2:1) to receive intravenous abituzumab 1500 mg, abituzumab 500 mg, or placebo every 4 weeks for 104 weeks. The primary endpoint was the annual rate of change in absolute forced vital capacity.

Results: STRATUS was terminated prematurely due to slow enrollment (n = 75 screened, n = 24 randomized), precluding robust analysis of efficacy. Abituzumab was well tolerated; no new safety signals were detected.

Conclusion: Further investigation of abituzumab for treatment of SSc-ILD is required.

Keywords: clinical trial; integrins; interstitial lung disease; systemic sclerosis.

Publication types

Clinical Trial, Phase II
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Antibodies, Monoclonal, Humanized / therapeutic use
Humans
Lung
Lung Diseases, Interstitial* / drug therapy
Lung Diseases, Interstitial* / etiology
Scleroderma, Systemic* / complications
Scleroderma, Systemic* / drug therapy
Vital Capacity

Substances

Antibodies, Monoclonal, Humanized
Abituzumab

Associated data

ClinicalTrials.gov/NCT02745145