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Long-Term Safety and Efficacy of Tocilizumab in Early Systemic Sclerosis-Interstitial Lung Disease: Open Label Extension of a Phase 3 Randomized Controlled Trial

Khanna, D; Lin, CJF; Furst, DE; Wagner, B; Zucchetto, M; Raghu, G; Martinez, FJ; ... focuSSced investigators; + view all (2022) Long-Term Safety and Efficacy of Tocilizumab in Early Systemic Sclerosis-Interstitial Lung Disease: Open Label Extension of a Phase 3 Randomized Controlled Trial. American Journal of Respiratory and Critical Care Medicine , 205 (6) pp. 674-684. 10.1164/rccm.202103-0714OC. Green open access

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Abstract

RATIONALE: Tocilizumab, an anti-interleukin-6 receptor antibody, had no statistically significant effect on skin sclerosis but preserved lung function over 48 weeks in patients with early systemic sclerosis-associated interstitial lung disease in a phase 3 randomized controlled trial. OBJECTIVES: Assess long-term safety and efficacy of tocilizumab. METHODS: Adults with diffuse cutaneous systemic sclerosis for ≤60 months and elevated acute-phase reactants, including those with interstitial lung disease, received weekly placebo or tocilizumab 162 mg subcutaneously in the 48-week, double-blind period then open-label tocilizumab from weeks 48 to 96 (placebo-tocilizumab; continuous-tocilizumab). MEASUREMENTS AND MAIN RESULTS: Eighty-two of 107 placebo-tocilizumab and 85 of 105 continuous-tocilizumab patients completed 96 weeks. Mean age and disease duration were 48 years and 23 months; high-resolution computed tomography revealed interstitial lung disease in 61%. Mean (95% CI) change in modified Rodnan skin score from baseline to week 96 was -8.4 (-10.0, -6.8) for placebo-tocilizumab and -9.6 (-10.9, -8.4) for continuous-tocilizumab. Mean (95% CI) change in forced vital capacity (percent-predicted) from baseline to week 96 was -3.3 (-5.1, -1.5) for placebo-tocilizumab and -0.5 (-2.4, 1.3) for continuous-tocilizumab among completers and, in post hoc analysis, -4.1 (-6.7, -1.6) and -0.6 (-3.1, 2.0), respectively, among completers with interstitial lung disease (mean [95% CI] change from weeks 48 to 96: 0.9 [-0.8, 2.7] and -0.4 [-2.3, 1.5], respectively). Rates per 100 patient-years of serious adverse events from weeks 48 to 96 were 14.8 for placebo-tocilizumab and 15.8 for continuous-tocilizumab. CONCLUSIONS: Tocilizumab preserved lung function, slowing decline in forced vital capacity, in patients with systemic sclerosis, including those with interstitial lung disease. Long-term safety was consistent with the known safety profile of tocilizumab. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT01791153.

Type: Article
Title: Long-Term Safety and Efficacy of Tocilizumab in Early Systemic Sclerosis-Interstitial Lung Disease: Open Label Extension of a Phase 3 Randomized Controlled Trial
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1164/rccm.202103-0714OC
Publisher version: https://doi.org/10.1164/rccm.202103-0714OC
Language: English
Additional information: This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/). For commercial usage and reprints, please e-mail Diane Gern (dgern@thoracic.org).
Keywords: biological therapy, lung diseases, interstitial, respiratory function tests, scleroderma, systemic
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inflammation
URI: https://discovery.ucl.ac.uk/id/eprint/10140388
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