Claims for Patent: 12,533,408

Summary for Patent: 12,533,408

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:	US18/748,995
Patent Claims:	1. A method for treating multiple sclerosis (MS) in a patient in need thereof, the method comprising: (a) administering cladribine during a first treatment period orally to the patient at a fixed dose per patient, per body weight and per treatment period, wherein said fixed dose is 1.75 mg/kg plus/minus 0.25 mg/kg, (b) identifying whether the patient is at risk of reactivation of latent varicella zoster virus (VZV), (c) vaccinating said patient at risk of reactivation of varicella zoster virus (VZV) with a vaccine against said varicella zoster virus (VZV) reactivation, wherein said vaccine is a recombinant, adjuvanted herpes zoster vaccine that comprises recombinant varicella zoster virus glycoprotein E, and (d) administering cladribine during a 2nd and optionally 3rd treatment period orally to the patient at a fixed dose per patient, per body weight and per treatment period, wherein said fixed dose is 1.75 mg/kg plus/minus 0.25 mg/kg, with the proviso that said fixed dose per patient is about the same in all of the two or three treatment periods of (a) and (d) wherein cladribine is administered, and wherein (a), (b), (c) and (d) are performed in the order given above, thereby treating said patient against said MS and limiting the risk of said patient of reactivation of varicella zoster virus (VZV). 2. 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. 3. 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. 4. The method according to claim 1, i) wherein the method comprises said 1st, 2nd and optionally 3rd treatment periods in which cladribine is administered, each with a duration from 1 to 3 months, ii) wherein each of said 1st, 2nd and optionally 3rd 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. 5. The method according to claim 4, 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 the 1st and 2nd treatment periods in which cladribine is administered, each with a duration from 1 to 3 months, ii) wherein said 1st and 2nd 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. 7. 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 10 months to 14 months. 8. The method according to claim 1, wherein vaccinating said patient according to step (c) comprises the administration of two separate doses of said vaccine and wherein the administration of the first dose and the second dose of said vaccine are least 3 weeks to about 8 months apart from each other.