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STRATUS: A phase II study of abituzumab in patients with systemic sclerosis- associated interstitial lung disease

The Journal of Rheumatology Aug 04, 2021

Khanna D, Tashkin DP, Wells AU, et al. - Good tolerability of abituzumab was evident with no new safety signals observed in patients with systemic sclerosis–associated interstitial lung disease (SSc-ILD) treated with it. Abituzumab merits further investigation as a treatment option for SSc-ILD.

  • Patients (≤ 75 yrs) with SSc-ILD on stable mycophenolate were randomly assigned (2:2:1) to receive intravenous abituzumab 1500 mg, abituzumab 500 mg, or placebo every 4 weeks for 104 weeks.

  • The annual rate of alteration in absolute forced vital capacity was set as the primary endpoint.

  • Premature termination of the study was attributed to slow enrollment (n = 75 screened, n = 24 randomized), precluding robust analysis of efficacy.

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