Methods of treating inflammatory disorders using high concentration natalizumab compositions

1. A method of treatment of a patient with an inflammatory disorder, the method comprising subcutaneously or intramuscularly administering a dose of 0.25 to 1.5 mL of a stable aqueous composition comprising 150 mg/mL natalizumab, 10 mM sodium phosphate buffer, 140 mM sodium chloride, and 0.04% (w/v) polysorbate 80, at pH 5.5-6.5.

2. The method of claim 1 , wherein the composition has a viscosity of 5-30 cP at ambient temperature.

3. The method of claim 1 , wherein the composition is stable for at least 12 months at a temperature of about 2° C. to about 8° C.

4. The method of claim 1 , wherein the composition is stable for at least 24 months at a temperature of about 2° C. to about 8° C.

5. The method of claim 1 , wherein the composition shows less than 10% aggregation following storage for at least 12 months at a temperature of about 2° C. to about 8° C.

6. The method of claim 1 , wherein the composition shows less than 10% aggregation following storage for 18 months at a temperature of about 2° C. to about 8° C.

7. The method of claim 1 , wherein the method comprises administering 1 mL of the composition.

8. The method of claim 1 , wherein the inflammatory disorder is multiple sclerosis.

9. The method of claim 1 , wherein the composition is administered subcutaneously.

10. The method of claim 1 , wherein the composition comprises sodium phosphate monobasic, monohydrate or sodium phosphate dibasic heptahydrate or both.

11. The method of claim 1 , wherein the composition retains its biological activity after storage of the composition for at least 12 months at a temperature of about 2° C. to about 8° C.

12. The method of claim 1 , wherein the composition has a potency of at least 97% at 25° C. after storage for 12 months at a temperature of 5° C.

13. The method of claim 1 , wherein the inflammatory disorder is asthma.

14. The method of claim 1 , wherein the inflammatory disorder is an arthritic disorder.

15. The method of claim 1 , wherein the inflammatory disorder is diabetes.

16. The method of claim 1 , wherein the inflammatory disorder is a fibrotic disorder.

17. The method of claim 1 , wherein the inflammatory disorder is an inflammatory bowel disease.

18. The method of claim 1 , wherein the method comprises subcutaneously or intramuscularly administering two doses of 1 mL of the composition.

19. A method of treatment of a patient with an inflammatory disorder, the method comprising subcutaneously or intramuscularly administering a dose of 0.25 to 1.5 mL of a stable aqueous composition consisting essentially of 150 mg/mL natalizumab, 10 mM sodium phosphate buffer, 140 mM sodium chloride, and 0.04% (w/v) polysorbate 80, at pH 5.5-6.5.

20. The method of claim 19 , wherein the composition has a viscosity of 5-30 cP at ambient temperature.

21. The method of claim 19 , wherein the composition is stable for at least 12 months at a temperature of about 2° C. to about 8° C.

22. The method of claim 19 , wherein the composition is stable for at least 24 months at a temperature of about 2° C. to about 8° C.

23. The method of claim 19 , wherein the composition shows less than 10% aggregation following storage for at least 12 months at a temperature of about 2° C. to about 8° C.

24. The method of claim 19 , wherein the composition shows less than 10% aggregation following storage for 18 months at a temperature of about 2° C. to about 8° C.

25. The method of claim 19 , wherein the method comprises administering 1 mL of the composition.

26. The method of claim 19 , wherein the inflammatory disorder is multiple sclerosis.

27. The method of claim 19 , wherein the composition retains its biological activity after storage of the composition for at least 12 months at a temperature of about 2° C. to about 8° C.

28. The method of claim 19 , wherein the composition has a potency of at least 97% at 25° C. after storage for 12 months at a temperature of 5° C.

29. The method of claim 19 , wherein the inflammatory disorder is an inflammatory bowel disease.

30. The method of claim 19 , wherein the method comprises subcutaneously or intramuscularly administering two doses of 1 mL of the composition.

31. A method of treatment of a patient with an inflammatory disorder, the method comprising subcutaneously or intramuscularly administering a dose of 0.25 to 1.5 mL of a stable aqueous composition consisting of 150 mg/mL natalizumab, 10 mM sodium phosphate buffer, 140 mM sodium chloride, and 0.04% (w/v) polysorbate 80, at pH 5.5-6.5.

32. The method of claim 31 , wherein the composition has a viscosity of 5-30 cP at ambient temperature.

33. The method of claim 31 , wherein the composition is stable for at least 12 months at a temperature of about 2° C. to about 8° C.

34. The method of claim 31 , wherein the composition is stable for at least 24 months at a temperature of about 2° C. to about 8° C.

35. The method of claim 31 , wherein the composition shows less than 10% aggregation following storage for at least 12 months at a temperature of about 2° C. to about 8° C.

36. The method of claim 31 , wherein the composition shows less than 10% aggregation following storage for 18 months at a temperature of about 2° C. to about 8° C.

37. The method of claim 31 , wherein the method comprises administering 1 mL of the composition.

38. The method of claim 31 , wherein the inflammatory disorder is multiple sclerosis.

39. The method of claim 31 , wherein the composition retains its biological activity after storage of the composition for at least 12 months at a temperature of about 2° C. to about 8° C.

40. The method of claim 31 , wherein the composition has a potency of at least 97% at 25° C. after storage for 12 months at a temperature of 5° C.

41. The method of claim 31 , wherein the inflammatory disorder is an inflammatory bowel disease.

42. The method of claim 31 , wherein the method comprises subcutaneously or intramuscularly administering two doses of 1 mL of the composition.

43. A method of treatment of a patient with multiple sclerosis, the method comprising subcutaneously or intramuscularly administering a dose of 0.25 to 1.5 mL of an aqueous composition comprising 150 mg/mL natalizumab, 10 mM sodium phosphate buffer, 140 mM sodium chloride, and 0.04% (w/v) polysorbate 80, at pH 5.5-6.5, wherein the composition has a viscosity of 5-30 cP at ambient temperature and shows less than 10% aggregation after storage for at least 12 months at a temperature of about 2° C. to about 8° C.

44. The method of claim 43 , wherein the method comprises subcutaneously or intramuscularly administering two doses of 1 mL of the composition.