Claims for Patent: 12,539,329

Summary for Patent: 12,539,329

Title:	Treatment regimen for the treatment of autoimmune disorders
Abstract:	A novel treatment regimen is provided for the treatment of autoimmune disorders. Said novel treatment regimen provides for an efficacious treatment of autoimmune disorders with an advantageous safety profile and/or a high quality of life for the patient. Said novel treatment regimen provides for an advantageous benefit-risk ratio for patients endangered by the risk of infections.
Inventor(s):	Ursula Boschert, Urs Wiedemann
Assignee:	Merck Patent GmbH
Application Number:	US18/599,308
Patent Claims:	1. A method for treating Relapsing-Remitting Multiple Sclerosis (RRMS) or Secondary Progressive Multiple Sclerosis (SPMS) in a patient in need thereof, the method comprising: (a) identifying whether the patient is at risk of reactivation of latent varicella zoster virus (VZV), (b) vaccinating said patient at risk of reactivation varicella zoster virus (VZV) with a vaccine against said varicella zoster virus (VZV) reactivation within a timeframe of about 4 weeks prior to a first treatment period wherein cladribine is orally administered to said patient, and (c) administering cladribine during said first treatment period and one or more additional treatment periods orally to the patient at fixed dose per patient, per body weight and per treatment period, wherein said fixed dose is selected from the range of 1.75 mg/kg plus/minus 0.25 mg/kg, i) wherein said first treatment period and said one or more additional treatment periods in which cladribine is administered each have a duration from 1 to 3 months, ii) wherein each of said treatment periods in which cladribine is orally administered are separated by a period in which no cladribine is administered to said patient, and iii) wherein each of the periods in which no cladribine is administered to said patient has a duration of at least 9 months, with the proviso that said fixed dose per patient is about the same in all of the first treatment period and said one or more additional treatment periods wherein cladribine is administered, and wherein (a), (b) and (c) are performed in the order given above, thereby treating said patient against said autoimmune disorder and limiting the risk of said patient of reactivation of varicella zoster virus (VZV). 2. The method according to claim 1, wherein said vaccine is a recombinant, adjuvanted herpes zoster vaccine. 3. The method according to claim 1, wherein said patient at risk is to be vaccinated is having lymphopenia Grade ≥1, lymphopenia Grade ≥2, or lymphopenia Grade ≥3, at the time said vaccination is to take place. 4. The method according to claim 1, wherein said patient at risk is to be vaccinated is having absolute lymphocyte counts (ALC)<500 cells/μL at the time said vaccination is to take place. 5. The method according to claim 1, wherein at least one of the periods in which no cladribine is administered to said patient has a duration of 9 to 18 months. 6. The method according to claim 1, i) wherein the method comprises two or more treatment periods in which cladribine is administered, each with a duration from 1 to 3 months or 1 to 2 months, ii) wherein each of said two or more treatment periods are separated by a period in which no cladribine is administered to said patient, and iii) wherein each of the periods in which no cladribine is administered to said patient has a duration of at least 9 months or 10 to 16 months. 7. The method according to claim 1, i) wherein the method comprises two treatment periods in which cladribine is administered, each with a duration from 1 to 3 months, ii) wherein said two treatment periods are separated by a period in which no cladribine is administered to said patient, and iii) wherein the periods in which no cladribine is administered to said patient has a duration of 9 to 18 months. 8. The method according to claim 6, wherein at least one of the periods in which no cladribine is administered to said patient has a duration of 10 months to 14 months. 9. The method according to claim 1, wherein said vaccine is a non-live varicella zoster virus (VZV) vaccine, an inactivated VZV vaccine or a recombinant VZV vaccine. 10. The method according to claim 6, wherein said vaccine is a non-live varicella zoster virus (VZV) vaccine, an inactivated VZV vaccine or a recombinant VZV vaccine. 11. The method according to claim 1, wherein said vaccine is a non-live varicella zoster virus (VZV) vaccine, an inactivated VZV vaccine or a recombinant VZV vaccine. 12. The method according to claim 2, wherein said vaccine is a recombinant, adjuvanted herpes zoster vaccine that comprises recombinant varicella zoster virus glycoprotein E. 13. The method according to claim 6, wherein said vaccine is a recombinant, adjuvanted herpes zoster vaccine. 14. The method according to claim 1, wherein said vaccine is a recombinant, adjuvanted herpes zoster vaccine. 15. The method according to claim 13, wherein said vaccine is a recombinant, adjuvanted herpes zoster vaccine that comprises recombinant varicella zoster virus glycoprotein E. 16. The method according to claim 14, wherein said vaccine is a recombinant, adjuvanted herpes zoster vaccine that comprises recombinant varicella zoster virus glycoprotein E. 17. The method according to claim 1, wherein the vaccination according to step (b) is performed less than four weeks, less than three weeks or less than two weeks before the beginning of the first treatment course according to step (c). 18. The method according to claim 2, wherein said vaccination of said patient according to step (b) with said recombinant, adjuvanted herpes zoster vaccine is followed by one further vaccination of said patient with said recombinant, adjuvanted herpes zoster vaccine at least 3 weeks to about 8 months apart from said first vaccination according to step (b). 19. The method according to claim 2, wherein said vaccination of said patient according to step (b) with said recombinant, adjuvanted herpes zoster vaccine is followed by two or more further vaccinations of said patient with said recombinant, adjuvanted herpes zoster vaccine, wherein each further vaccination of said patient is at least 3 weeks to about 8 months apart from the previous vaccination with said recombinant, adjuvanted herpes zoster vaccine in said patient. 20. The method according to claim 3, wherein the vaccinations of said patient with said recombinant, adjuvanted herpes zoster vaccine are at least 2 months apart from each other. 21. The method according to claim 3, wherein the vaccinations of said patient with said recombinant, adjuvanted herpes zoster vaccine are 2 to 6 months apart from each other. 22. The method according to claim 6, wherein each treatment course in which cladribine is administered is separated from the next treatment course in which cladribine is administered by a cladribine free period of 9 to 18 months, by a cladribine free period of 10 to 16 months, or by a cladribine free period of 10 to 12 months. 23. The method according to claim 6, wherein each treatment course in which cladribine is administered is separated from the next treatment course in which cladribine is administered by a cladribine free period of 9 to 18 months, by a cladribine free period of 10 to 12 months. 24. The method according to claim 4, wherein the vaccinations of said patient with said recombinant, adjuvanted herpes zoster vaccine are at least 2 months apart from each other. 25. The method according to claim 4, wherein the vaccinations of said patient with said recombinant, adjuvanted herpes zoster vaccine are 2 to 6 months apart from each other. 26. The method according to claim 1, wherein vaccinating said patient according to step (b) is the first vaccination of said patient against said reactivation of varicella zoster virus (VZV) with said vaccine against said varicella zoster virus (VZV) reactivation. 27. The method according to claim 1, wherein said vaccine is a recombinant, adjuvanted herpes zoster vaccine, and wherein said vaccination according to step (b) is the first vaccination of said patient with said recombinant, adjuvanted herpes zoster vaccine. 28. The method according to claim 2, wherein said vaccine is administered at least two times to said patient, and wherein said vaccination according to step (b) is the first vaccination of said patient with said recombinant, adjuvanted herpes zoster vaccine. 29. The method according to claim 28, wherein the second administration of said two administrations of said vaccine is at least 3 weeks to about 8 months apart from said first vaccination according to step (b).