Methods for treating bullous pemphigoid using fcrn antagonists
Assigneeargenx BV
InventorsPeter Verheesen, Ivaylo Stoykov
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Abstract
Provided herein are methods of treating bullous pemphigoid using an effective amount of a human neonatal Fc receptor (FcRn) antagonist. FcRn antagonists for use in the treatment of bullous pemphigoid and for use in the manufacture of a medicament for the treatment of bullous pemphigoid are also provided herein.
Claims111
A method of treating bullous pemphigoid (BP) in a subject in need thereof, the method comprising administering to the subject an effective amount of a human neonatal Fc receptor (FcRn) antagonist.
An FcRn antagonist for use in the treatment of BP, wherein the treatment is performed according to the method of any one of the previous claims.
An FcRn antagonist for use in the manufacture of a medicament for the treatment of BP, wherein the treatment is performed according to the method of any one of the previous claims.
A method for monitoring efficacy of treatment of BP in a subject following treatment with a first FcRn antagonist, the method comprising:
- a) measuring in vitro a serum level of an anti-BP180 antibody and/or anti-BP230 antibody in a blood sample taken from the subject;
- and
- b) comparing the serum level of the anti-BP180 antibody and/or anti-BP230 antibody to a reference value associated with BP in the subject,
- wherein the treatment is not effective if the serum level of the anti-BP180 antibody and/or anti-BP230 antibody in the sample is greater than or equal to the reference value, and wherein the treatment is effective if the serum level of the anti-BP180 antibody and/or anti-BP230 antibody is less than the reference value.
A method of treating BP in a subject that has received a first FcRn antagonist and is receiving a corticosteroid dosing regimen, the method comprising:
- a) administering to the subject an effective amount of a second FcRn antagonist;
- b) measuring in vitro a serum level of an anti-BP180 antibody and/or anti-BP230 antibody in a blood sample taken from the subject;
- and
- c) comparing the serum level of the anti-BP180 antibody and/or anti-BP230 antibody to a reference value associated with BP in the subject,
- wherein the corticosteroid dosing regimen is maintained if the serum level of the anti-BP180 antibody and/or anti-BP230 antibody in the sample is greater than or equal to the reference value, or wherein the corticosteroid dosing regimen is tapered if the serum level of the anti-BP180 antibody and/or anti-BP230 antibody is less than the reference value.
A method for treating BP in a subject comprising:
- (a) administering to the subject one or more initial doses of an effective amount of a first FcRn antagonist;
- and
- (b) administering to the subject one or more further doses of an effective amount of a second FcRn antagonist if the serum level of an anti-BP180 antibody and/or anti-BP230 antibody in the subject after step (a) is greater than or equal to a reference value associated with BP in the subject, or discontinuing treatment with the first FcRn antagonist if the serum level of the anti-BP180 antibody and/or anti-BP230 antibody in the subject after step (a) is less than a reference value associated with active disease in the subject.
A method for treating BP in a subject, the method comprising:
- administering to the subject an effective amount of a second FcRn antagonist,
- wherein the BP has relapsed in the subject following prior therapy with a first FcRn antagonist, and wherein the subject has a serum level of an anti-BP180 antibody and/or anti-BP230 antibody that is greater than or equal to a reference value associated with BP in the subject.
A method for determining if a subject that has previously been treated for BP using a first FcRn antagonist requires further treatment with a second FcRn antagonist, the method comprising:
- a) measuring in vitro the serum level of an anti-BP180 antibody and/or anti-BP230 antibody in a blood sample taken from the subject;
- and
- b) comparing the serum level of the anti-BP180 antibody and/or anti-BP230 antibody to a reference value associated with BP in the subject,
- wherein if the serum level of the anti-BP180 antibody and/or anti-BP230 antibody in the sample is greater than or equal to the reference value, then the subject is in need of further treatment with the second FcRn antagonist.
A method of treating BP in a subject in need thereof, the method comprising administering to the subject an effective amount of a human FcRn antagonist and a corticosteroid, wherein a cumulative oral dose of the corticosteroid administered to the subject does not exceed 100 mg/kg, does not exceed 75 mg/kg, does not exceed 50 mg/kg, or does not exceed 25 mg/kg.
A method of treating BP in a subject in need thereof, the method comprising administering to the subject an effective amount of a human FcRn antagonist and a corticosteroid, wherein an oral prednisone equivalent dose of the corticosteroid administered to the subject does not exceed 1 mg/kg/day, does not exceed 0.75 mg/kg/day, does not exceed 0.5 mg/kg/day, does not exceed 0.3 mg/kg/day, does not exceed 0.25 mg/kg/day, does not exceed 0.2 mg/kg/day, does not exceed 0.15 mg/kg/day, or does not exceed 0.1 mg/kg/day.
A method of treating BP in a subject in need thereof, the method comprising administering to the subject an effective amount of a human FcRn antagonist and a corticosteroid, wherein an oral prednisone equivalent dose of the corticosteroid administered to the subject does not exceed 12.5 mg/day or does not exceed 10 mg/day.
Dependencies are inferred from the claim text.