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

作者信息

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

机构信息

D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA;

D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.

出版信息

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

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.