Mayzent (Siponimod) Onboarding of Secondary Progressive Multiple Sclerosis (SPMS) Patients With MSGo

Novartis

Status: Completed

Conditions: Secondary Progressive Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT05826028

CBAF312AAU02

Details and patient eligibility

About

This study was a retrospective, non-interventional, longitudinal, descriptive study. This study did not have a key underlying hypothesis, rather it was designed to explore the onboarding and adherence of SPMS patients in Australia to Mayzent (siponimod) treatment.

Initiating siponimod involves pre-screen tests, including a CYP2C9 genotype test to determine siponimod maintenance dosing, and patients underwent a 6-day titration prior to maintenance. The MSGo platform was developed to support onboarding. It is an integrated digital platform that functions as a patient support service.

Enrollment: 368 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Adult patients with SPMS as per the treating physician's clinical assessment (Therapeutic Goods Administration [TGA]-approved indication of Mayzent).
• Expanded Disability Status Scale (EDSS) of 3.0 to 6.5 (inclusive).
• Patients accessing Mayzent via the Mayzent Experience Program (MEP) must have met the MEP criteria, and if available, the Pharmaceutical Benefits Scheme (PBS) restrictions recommended by the Pharmaceutical Benefits Advisory Committee (PBAC).
• Patients accessing Mayzent via the PBS must have met the PBS restrictions.

Exclusion criteria

• Patients who were contraindicated for Mayzent treatment according to the TGA-approved Product Information.
• Patients diagnosed with clinically isolated syndrome or primary progressive multiple sclerosis (MS).