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

被引：23

作者：

Khanna, Dinesh ^{[1
]}

Tashkin, Donald P. ^{[2
]}

Wells, Athol U. ^{[3
,4
]}

Seibold, James R. ^{[5
]}

Wax, Stephen ^{[6
,7
]}

Vazquez-Mateo, Cristina ^{[6
]}

Fleuranceau-Morel, Patricia ^{[6
]}

Damian, Doris ^{[6
]}

Denton, Christopher P. ^{[8
]}

机构：

[1] Univ Michigan, Med, Scleroderma Program, Ann Arbor, MI 48109 USA

[2] Univ Calif Los Angeles, David Geffen Sch Med, OfMed, Los Angeles, CA 90095 USA

[3] Royal Brompton Hosp, Med, London, England

[4] Royal Brompton Hosp, London, England

[5] Scleroderma Res Consultants LLC, Aiken, SC USA

[6] EMD Serono Inc, Billerica, MA USA

[7] Neurogastrx Inc, Clin Res, Woburn, MA USA

[8] UCL, Expt Rheumatol, Royal Free Campus, London, England

来源：

JOURNAL OF RHEUMATOLOGY | 2021年 / 48卷 / 08期

关键词：

clinical trial; integrins; interstitial lung disease; systemic sclerosis;

D O I：

10.3899/jrheum.191365

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objective. To investigate the effects of abituzurnab 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-I ID 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 abituzurnab for treatment of SSc-ILD is required.

引用

页码：1295 / 1298

页数：4

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