PT  - JOURNAL ARTICLE
AU  - Dinesh Khanna
AU  - Donald P. Tashkin
AU  - Athol U. Wells
AU  - James R. Seibold
AU  - Stephen Wax
AU  - Cristina Vazquez-Mateo
AU  - Patricia Fleuranceau-Morel
AU  - Doris Damian
AU  - Christopher P. Denton
TI  - STRATUS: A Phase II Study of Abituzumab in Patients With Systemic Sclerosis–associated Interstitial Lung Disease
AID  - 10.3899/jrheum.191365
DP  - 2021 Aug 01
TA  - The Journal of Rheumatology
PG  - 1295--1298
VI  - 48
IP  - 8
4099  - http://www.jrheum.org/content/48/8/1295.short
4100  - http://www.jrheum.org/content/48/8/1295.full
SO  - J Rheumatol2021 Aug 01; 48
AB  - 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.