TY  - JOUR
A1  - Khanna, D
A1  - Tashkin, DP
A1  - Wells, AU
A1  - Seibold, JR
A1  - Wax, S
A1  - Vazquez-Mateo, C
A1  - Fleuranceau-Morel, P
A1  - Damian, D
A1  - Denton, CP
UR  - https://doi.org/10.3899/jrheum.191365
VL  - 48
AV  - public
JF  - The Journal of Rheumatology
N2  - 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 (NCT02745145). Adults (?75 years) with SSc-ILD on stable mycophenolate were randomized (2:2:1) to receive intravenous abituzumab 1500 mg, placebo, or abituzumab 500 mg every 4 weeks for 104 weeks. Primary endpoint: annual rate of change in absolute FVC. RESULTS: STRATUS was terminated prematurely due to slow enrolment (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.
EP  - 1298
KW  - clinical trial
KW  -  integrins
KW  -  interstitial lung disease
KW  -  systemic sclerosis
ID  - discovery10111583
IS  - 8
SP  - 1295
N1  - This version is the author accepted manuscript. For information on re-use, please refer to the publisher?s terms and conditions.
TI  - STRATUS, a Phase II Study of Abituzumab in Patients with Systemic Sclerosis-associated Interstitial Lung Disease
Y1  - 2021/08//
ER  -