A multicenter observational study aiming to evaluate the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin- angioedema
The bradykinin-angioedema (AE-BK) is characterized by recurrent and unpredictable episodes of swelling; it can be disabling and disfiguring and the attacks affecting the larynx can be life-threatening. The clinical symptoms depend on accumulation of bradykinin (BK), a vasoactive peptide responsible for vasodilation and increase of vascular leakage. BK formation depends on activation of the kallikrein-kinin cascade leading to uncontrolled generation of plasma kallikrein and subsequent proteolysis of high molecular-weight kininogen (HK). Lanadelumab is a fully human monoclonal antibody inhibitor of plasma kallikrein, thereby preventing BK production; it represents an attractive therapeutic strategy for BK-AE prophylaxis. The aim of this study is to evaluate the kallikrein inhibition by assessing the levels of cleaved HK and the immunogenicity of the lanadelumab.
Study Type
OBSERVATIONAL
Enrollment
80
Chu Grenoble Alpes
Grenoble, France
RECRUITINGCHU Rouen
Rouen, France
RECRUITINGEvaluation of the efficacy of the kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema
Levels of cleaved HK measured by Western Blot
Time frame: 3 months
Evaluation of the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema between T0 and the others visits
Levels of cleaved HK as measured by Western Blot Ratio Day 7/ Day 0, Ratio Month 6/ Day 0, Ratio Month 12/ Day (and if possible Month 24/ Day 0) of the levels of cleaved HK as measured by Western Blot \- SE2: antidrug antibodies in the sera of patients at Months 3, 6, 12 (and if possible Month 24).
Time frame: Day 7; 6, 12 and if possible 24 months
Immunogenicity of lanadelumab
Levels of antidrug antibodies in the sera of patients
Time frame: Months 3, 6, 12 (and 24 if possible)
Evaluation of therapeutic escape
Increase/absence of decrease of the number of attacks during lanadelumab administration
Time frame: Months 3, 6, 12 and if possible 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.