DOSAGE AND ADMINISTRATION SCHEDULE FOR THE TREATMENT OR PREVENTION OF GUILLAIN-BARRÉ SYNDROME USING THE C5 ANTIBODY CROVALIMAB

Claims

1. An anti-C5 antibody for use in a method of treating or preventing GBS in a subject, the method comprising the step a) a single intravenous administration of a loading dose of 1500 mg of antibody to C 5 b) followed by subcutaneous administration to the subject of at least one dose of 340 mg of the antibody to C5.

2. An antibody to C5 for use according to claim 1, wherein the subcutaneously administered dose of 340 mg is administered to the subject at least once at an interval of 1 day to 3 weeks after the start of intravenous administration of the antibody to C5.

3. An anti-C5 antibody for use according to claim 2, wherein IVIg is used in combination with the anti-C5 antibody for use in a method of treating or preventing GBS in a subject.

4. An antibody to C5 for use according to claim 3, wherein a dose of 400 mg / kg IVIg is administered intravenously at least once.

5. An anti-C5 antibody for use according to claim 4, wherein a dose of 400 mg / kg IVIg is administered intravenously daily on days 1, 2, 3, 4, and 5.

6. An anti-C5 antibody for use according to claims 2-5, wherein a subcutaneously administered loading dose of 340 mg of the anti-C5 antibody is administered to the subject once 1 day after the start of intravenous administration of the anti-C5 antibody.

7. An anti-C5 antibody for use according to claims 2-6, wherein the subject is administered at least one additional loading dose of 340 mg of the anti-C5 antibody subcutaneously 1 week or 2 weeks after the start of intravenous administration of the anti-C5 antibody.

8. An anti-C5 antibody for use according to any one of claims 2-7, wherein an additional loading dose of 340 mg of the anti-C5 antibody is administered to the subject subcutaneously 1 week and 2 weeks after the start of intravenous administration of the anti-C5 antibody once a week.

9. An antibody to C5 for use according to claim 6 or claim 7, wherein the subcutaneous administration to the subject of a dose of 340 mg of the antibody to C5 is repeated several times at intervals of at least 4 weeks.

10. An antibody to C5 for use according to any one of claims 1 to 9, wherein the method is carried out by the following administration steps: (i) a single intravenous administration to a subject of a loading dose of 1500 mg of an antibody to C5; (ii) subcutaneous administration to the subject of a dose of 340 mg of the anti-C5 antibody 1 day after the start of intravenous administration of the anti-C5 antibody; (iii) subcutaneous administration to the subject of a loading dose of 340 mg of the antibody to C5 at 1 week, 2 weeks, and 3 weeks after the start of intravenous administration of the antibody to C5 once a week.

11. An antibody to C5 for use according to any one of claims 1-10, wherein the antibody to C5 is used in combination with IVIg, wherein IVIg (a) administered intravenously at a dose of 400 mg / kg IVIg once on the same day as the loading dose of the antibody to C5 according to paragraph l(i), (b) administered intravenously at a dose of 400 mg / kg IVIg daily 1 day, 2 days, 3 days and 4 days after the start of intravenous administration of the antibody to C5.

12. An anti-C5 antibody for use according to any one of claims 1-11, wherein the subject has previously received treatment with at least one pharmacological product suitable for the treatment or prevention of a disease associated with C5, wherein the intravenously administered loading dose of 1500 mg of the anti-C5 antibody is administered to the subject after the last dose of the pharmacological product.

13. An antibody to C5 for use according to any one of claims 1-12, wherein the subject has a body weight greater than 100 kg.

14. An anti-C5 antibody for use according to any one of claims 1-13, wherein the concentration of the anti-C5 antibody determined in a biological sample of said subject is 100 μg / ml or more.

15. An anti-C5 antibody for use according to any one of claims 1 to 14, wherein the anti-C5 antibody is crovalimab.

16. A combination of an antibody to C5 and IVIg for use in a method of treating or preventing GBS in a subject, preferably in a subject weighing more than 100 kg, the method comprising the following sequential steps: (i) a single intravenous administration to the subject of a loading dose of 1500 mg of antibody to C5 and a single intravenous administration of 400 mg / kg IVIg on the same day, (ii) subcutaneous administration to the subject of a maintenance dose of 340 mg of the anti-C5 antibody 1 day after the start of intravenous administration of the anti-C5 antibody and intravenous administration of 400 mg / kg IVIg on the same day, (iii) intravenous administration of 400 mg / kg IVIg daily at 2 days, 3 days and 4 days after the start of intravenous administration of the antibody to C5, (IV) subcutaneous administration to the subject of a maintenance dose of 340 mg of the antibody to C5 at 1 week (7 days), 2 weeks (14 days), and 3 weeks (21 days) after the start of intravenous administration of the antibody to C5 once a week.