The efficacy and safety of divozilimab in patient with systemic sclerosis: 48-week results of the randomized double-blind placebo-controlled phase III clinical study LIBERIUS DOI Creative Commons
L. P. Ananyeva, M. Starovoytova, I. Z. Gaydukova

et al.

Rheumatology Science and Practice, Journal Year: 2025, Volume and Issue: 63(2), P. 158 - 167

Published: May 1, 2025

The aim of the study is to evaluate efficacy, safety and immunogenicity divozilimab (DIV), anti-CD20 monoclonal antibody, in patients with systemic sclerosis (SS). Materials methods . Patients SS according ACR/EULAR (American College Rheumatology/ European Alliance Associations for Rheumatology) 2013 criteria modified Rodnan skin score (mRSS) ≥10 ≲20 forced vital capacity (FVC) ≥40% from due took part study. Infusions DIV 250 mg were administered on weeks 0 2, 500 – week 24 subsequent use open mode, starting 48. This publication presents data obtained 48 trial (before infusion at 48). Primary endpoint was change mRSS baseline dynamic FVC estimated as secondary endpoint. evaluation included frequency profile adverse events reactions (ARs). Immunogenicity assessed by detection binding neutralizing anti-drug antibodies Results 151 randomized into two groups: ( n =76) Placebo =75). most female; median duration disease about 3–4 years. initial value 14 13 points PBO groups, respectively. –5.8±1.1 group –2.7±1.0 (adjusted mean difference (AMD) 95% confidence interval –3.1 (–4.5; –1.7); p <0.0001). lung function stable treated DIV. A comparable demonstrated. frequent ARs a decrease number lymphocytes. There no severe serious group. All mild moderate. 5.3% (4/76) had without activity. Conclusion Divosilimab has demonstrated significant severity fibrosis, positive effect respiratory favorable profile, which allows consider it promising therapeutic option SS.

Language: Английский

Emerging Mechanisms and Biomarkers Associated with T-Cells and B-Cells in Autoimmune Disorders DOI
Azhagu Madhavan Sivalingam

Clinical Reviews in Allergy & Immunology, Journal Year: 2025, Volume and Issue: 68(1)

Published: Feb. 11, 2025

Language: Английский

Citations

0
The efficacy and safety of divozilimab in patient with systemic sclerosis: 48-week results of the randomized double-blind placebo-controlled phase III clinical study LIBERIUS DOI Creative Commons
L. P. Ananyeva, M. Starovoytova, I. Z. Gaydukova

et al.

Rheumatology Science and Practice, Journal Year: 2025, Volume and Issue: 63(2), P. 158 - 167

Published: May 1, 2025

The aim of the study is to evaluate efficacy, safety and immunogenicity divozilimab (DIV), anti-CD20 monoclonal antibody, in patients with systemic sclerosis (SS). Materials methods . Patients SS according ACR/EULAR (American College Rheumatology/ European Alliance Associations for Rheumatology) 2013 criteria modified Rodnan skin score (mRSS) ≥10 ≲20 forced vital capacity (FVC) ≥40% from due took part study. Infusions DIV 250 mg were administered on weeks 0 2, 500 – week 24 subsequent use open mode, starting 48. This publication presents data obtained 48 trial (before infusion at 48). Primary endpoint was change mRSS baseline dynamic FVC estimated as secondary endpoint. evaluation included frequency profile adverse events reactions (ARs). Immunogenicity assessed by detection binding neutralizing anti-drug antibodies Results 151 randomized into two groups: ( n =76) Placebo =75). most female; median duration disease about 3–4 years. initial value 14 13 points PBO groups, respectively. –5.8±1.1 group –2.7±1.0 (adjusted mean difference (AMD) 95% confidence interval –3.1 (–4.5; –1.7); p <0.0001). lung function stable treated DIV. A comparable demonstrated. frequent ARs a decrease number lymphocytes. There no severe serious group. All mild moderate. 5.3% (4/76) had without activity. Conclusion Divosilimab has demonstrated significant severity fibrosis, positive effect respiratory favorable profile, which allows consider it promising therapeutic option SS.

Language: Английский

Citations

0