Kits

A method for treating hereditary angioedema (HAE) attack or reducing the rate of HAE attack in a subject in need thereof and assessing efficacy of a treatment regimen in a subject, the method comprising:

• (i) obtaining a first plasma sample or serum sample from the subject;
• (ii) administering to the subject an antibody that binds human plasma kallikrein at about 300 mg every about two weeks in a first treatment period, which is about 4-9 months;
• (iii) monitoring the subject for HAE attack during the first treatment period;
• and
• (iv) reducing the dosage of the antibody to about 300 mg every about four weeks in the subject, who is free of HAE attack in the first treatment period;
• (v) obtaining a second plasma sample or serum sample from the subject after the administration of the antibody;
• (vi) measuring a concentration of one or more biomarkers associated with plasma kallikrein in the first plasma sample or serum sample;
• and
• (vii) measuring a concentration of the one or more biomarkers associated with plasma kallikrein in the second plasma sample or serum sample;
• wherein the treatment regimen is effective if the concentration of the one or more biomarkers is decreased in the second plasma sample or serum sample as compared to the first plasma sample or serum sample;
• and
• wherein the antibody comprises a heavy chain complementarity determining region (HC CDR) 1 having the amino acid sequence HYIMM (SEQ ID NO:
• 5), a HC CDR2 having the amino acid sequence GIYSSGGITVYADSVKG (SEQ ID NO:
• 6), a HC CDR3 having the amino acid sequence of RRIGVPRRDEFDI (SEQ ID NO:
• 7), a light chain complementarity determining region (LC CDR) 1 having the amino acid sequence RASQSISSWLA (SEQ ID NO:
• 8), a LC CDR2 having the amino acid sequence KASTLES (SEQ ID NO:
• 9) and a LC CDR3 having the amino acid sequence QQYNTYWT (SEQ ID NO:
• 10);
• wherein the one or more biomarkers comprises cleaved high molecular weight kininogen (HMWK);
• and
• wherein the subject is a human.