Treating headache comprising administering an antibody to calcitonin gene-related peptide
The invention features methods for preventing or treating CGRP associated disorders such as vasomotor symptoms and/or headaches (e.g., migraine, cluster headache, and tension headache) by administering an anti-CGRP antagonist antibody. Compositions for use in the disclosed methods are also provided. Antagonist antibody G1 and antibodies derived from G1 directed to CGRP are also described.
1. A method of treating or reducing incidence of headache in a subject comprising administering to the subject a dose once every three months of a monoclonal antibody that inhibits the calcitonin gene-related peptide (CGRP) pathway, wherein the dose administered every three months is between 100-2000 mg, and wherein the monoclonal antibody comprises a CDR H1 as set forth in SEQ ID NO: 3; a CDR H2 as set forth in SEQ ID NO: 4; a CDR H3 as set forth in SEQ ID NO: 5; a CDR L1 as set forth in SEQ ID NO: 6; a CDR L2 as set forth in SEQ ID NO: 7; and a CDR L3 as set forth in SEQ ID NO: 8.
2. The method of claim 1 , wherein the headache is migraine headache.
3. The method of claim 2 , wherein the migraine headache is chronic migraine headache.
4. The method of claim 2 , wherein the migraine headache is episodic migraine headache.
5. The method of claim 1 , wherein the incidence of headache is reduced for at least seven days after a single administration.
6. The method of claim 1 , wherein monthly headache hours experienced by the subject after said administering is reduced by 40 or more hours from a pre-administration level in the subject.
7. The method of claim 1 , wherein monthly headache days experienced by the subject after said administering is reduced by 3 or more days from a pre-administration level in the subject.
8. The method of claim 1 , wherein monthly headache hours experienced by the subject after said administering is reduced by 25% or more relative to a pre-administration level in the subject.
9. The method of claim 1 , wherein the administering is subcutaneous or intravenous administration.
10. The method of claim 1 , wherein the administering comprises utilizing a pre-filled syringe comprising the monoclonal antibody.
11. The method of claim 1 , wherein the monoclonal antibody is formulated at a concentration of at least 150 mg/mL.
12. The method of claim 1 , comprising administering to the subject a second agent simultaneously or sequentially with the monoclonal antibody.
13. The method of claim 12 , wherein the second agent is selected from the group consisting of: 5-HT1 agonists, triptans, ergot alkaloids, and non-steroidal anti-inflammatory drugs.
14. The method of claim 13 , wherein the second agent is a triptan.
15. The method of claim 12 , wherein use of the second agent by the subject is decreased by at least 15% after administering the monoclonal antibody.
16. The method of claim 1 , wherein the subject is human.
17. The method of claim 1 , wherein the monoclonal antibody is human or humanized.
18. The method of claim 1 , wherein the dose administered once every three months is 675 mg.
19. The method of claim 18 , wherein the dose of 675 mg is administered as three injections of 225 mg each.
20. The method of claim 19 , wherein each 225 mg injection is 1.5 mL.
21. The method of claim 19 , wherein the injections are subcutaneous injections.
22. The method of claim 19 , wherein the injections are injections into the abdomen, thigh, or upper arm of the subject's body.
23. A method of treating or reducing incidence of headache in a subject comprising administering to the subject a 675 mg dose of a monoclonal antibody that inhibits the calcitonin gene-related peptide (CGRP) pathway once every three months;
wherein the monoclonal antibody comprises a CDR H1 as set forth in SEQ ID NO: 3; a CDR H2 as set forth in SEQ ID NO: 4; a CDR H3 as set forth in SEQ ID NO: 5; a CDR L1 as set forth in SEQ ID NO: 6; a CDR L2 as set forth in SEQ ID NO: 7; and a CDR L3 as set forth in SEQ ID NO: 8; and
wherein the 675 mg dose is administered as three consecutive 225 mg subcutaneous injections of 1.5 mL to the abdomen, thigh, or upper arm of the subject's body.