Use of fcrn antagonists for treatment of generalized myasthenia gravis

A method of treating generalized myasthenia gravis (MG) in a subject, the method comprising administering to the subject an effective amount of an isolated FcRn antagonist, thereby treating MG in the subject, wherein:

• the subject, prior to first administration of the isolated FcRn antagonist, has confirmed diagnosis generalized MG, has Class II-IVa disease according to the Myasthenia Gravis Foundation of America (MGFA) classification system, and has an MG-ADL score of at least 5 with more than 50% of the score attributable to non-ocular items,
• the isolated FcRn antagonist consists of a variant Fc region, wherein said variant Fc region consists of two Fc domains which form a homodimer, wherein the amino acid sequence of each of the Fc domains of the variant Fc region consists of SEQ ID NO:
• 2, and
• the isolated FcRn antagonist is administered to the subject in a dose of about 10 mg/kg.

A method of treating generalized myasthenia gravis in a subject, the method comprising administering to the subject an isolated FcRn antagonist using a phased dosing schedule with an induction phase comprising about 1-5 doses of the isolated FcRn antagonist within 1 month, followed by a maintenance phase comprising a dose of FcRn antagonist every week (q1w), every two weeks (q2w), every three weeks (q3w), or every 4 weeks (q4w) thereafter, thereby treating the generalized myasthenia gravis in the subject, wherein:

• the subject, prior to first administration of the isolated FcRn antagonist, has confirmed diagnosis generalized MG, has Class II-IVa disease according to the Myasthenia Gravis Foundation of America (MGFA) classification system, and has an MG-ADL score of at least 5 with more than 50% of the score attributable to non-ocular items,
• the isolated FcRn antagonist consists of a variant Fc region, wherein said variant Fc region consists of two Fc domains which form a homodimer, wherein the amino acid sequence of each of the Fc domains of the variant Fc region consists of SEQ ID NO:
• 2, and
• the isolated FcRn antagonist is administered to the subject in a dose of about 10 mg/kg.

A method of treating generalized myasthenia gravis in a subject, the method comprising administering to the subject an isolated FcRn antagonist using a phased dosing schedule with an induction phase comprising about 1-5 doses of the isolated FcRn antagonist within 1 month, followed by a maintenance phase comprising one or more cycles as needed based on clinical need thereafter, each cycle comprising administering to the subject about 1-5 doses of the isolated FcRn antagonist within 1 month, thereby treating the generalized myasthenia gravis in the subject, wherein:

• the subject, prior to first administration of the isolated FcRn antagonist in the induction phase, has confirmed diagnosis generalized MG, has Class II-IVa disease according to the Myasthenia Gravis Foundation of America (MGFA) classification system, and has an MG-ADL score of at least 5 with more than 50% of the score attributable to non-ocular items,
• the subject, prior to first administration of the isolated FcRn antagonist in any cycle of the maintenance phase, has an MG-ADL score of at least 5 with more than 50% of the score attributable to non-ocular items,
• the isolated FcRn antagonist consists of a variant Fc region, wherein said variant Fc region consists of two Fc domains which form a homodimer, wherein the amino acid sequence of each of the Fc domains of the variant Fc region consists of SEQ ID NO:
• 2, and
• the isolated FcRn antagonist is administered to the subject in a dose of about 10 mg/kg.