Methods of treating progressive forms of multiple sclerosis comprising subcutaneously administering daclizumab
View Patent ↗The present disclosure relates to methods of treating individuals suffering from progressive forms of multiple sclerosis.
1. A method of treating a human subject suffering from a progressive form of multiple sclerosis, comprising subcutaneously administering to the subject about 150 mg to about 300 mg of a daclizumab once every four weeks for a period of at least one year,
wherein the daclizumab has one or both of the following:
(a) an N-terminal isoform with one glutamine residue and one valine residue that comprises 3%-12% of the total daclizumab;
(b) an N-linked oligosaccharide profile comprising two main peaks and a minor peak, wherein one of the two main peaks is G0-GlcNAc glycoform present in 7% to 15% of the AUC, the other main peak is G0 glycoform present in 81% to 88% of the AUC, and the minor peak is G1 glycoform present in 1% to 4% of the AUC when determined according to the method described in Section 7.6.14.
2. The method of claim 1 in which the progressive form of multiple sclerosis is secondary progressive multiple sclerosis.
3. The method of claim 1 wherein the daclizumab has an N-terminal isoform with one glutamine residue and one valine residue that comprises 3%-12% of the total daclizumab.
4. The method of claim 1 wherein the daclizumab has an N-linked oligosaccharide profile comprising two main peaks and a minor peak, wherein one of the two main peaks is G0-GlcNAc glycoform present in 7% to 15% of the AUC, the other main peak is G0 glycoform present in 81% to 88% of the AUC, and the minor peak is G1 glycoform present in 1% to 4% of the AUC when determined according to the method described in Section 7.6.14.
5. The method of claim 1 wherein the daclizumab has (a) an N-terminal isoform with one glutamine residue and one valine residue that comprises 3%-12% of the total daclizumab, and (b) an N-linked oligosaccharide profile comprising two main peaks and a minor peak, wherein one of the two main peaks is G0-GlcNAc glycoform present in 7% to 15% of the AUC, the other main peak is G0 glycoform present in 81% to 88% of the AUC, and the minor peak is G1 glycoform present in 1% to 4% of the AUC when determined according to the method described in Section 7.6.14.