Novel generation of real world evidence through MSGo, a digital support program supporting the use of siponimod in secondary progressive multiple sclerosis patients in Australia

Abstract

Introduction: Siponimod is approved in Australia for adults with secondary progressive multiple sclerosis (SPMS). Initiating siponimod involves prescreening tests, including a CYP2C9 genotype test to determine siponimod maintenance dosing. Furthermore, patients undergo a 6-day titration prior to the maintenance phase. To support onboarding, an integrated digital platform, 'MSGo', has been developed by Novartis and RxMx® for Healthcare Professionals and their multiple sclerosis patients. Objective: Data derived exclusively from MSGo will be utilised to characterise the onboarding experience of siponimod patients in Australia. Aims: To provide real world evidence on siponimod for SPMS patients in Australia. Methods: The study will enrol 500 adults with SPMS registered in MSGo for siponimod treatment in Australia. The primary endpoint is the average time for onboarding with key secondary endpoints addressing adherence and the variables that influence onboarding and adherence. Results: As of April 19th, 2021, 211 patients have enrolled in the RWE study, with baseline patient characteristics revealing more females than males (70% vs 30%) and a median age range of 51-60 years. A total of 88 patients proceeded to at least the first titration dose;75 with at least one day of maintenance. Mixturecure modelling estimated a median time to initiation of 53 days in the predicted population of patients who will ever initiate on siponimod. Univariate Cox regression analyses demonstrated that patients who nominated a care partner at registration (n=27, 13%) appeared more likely to initiate siponimod earlier (p=0.017). A total of 163 CYP2C9 genotype assessments were performed through MSGo and the median time to receiving results from registration was 21 days (95% CI 18 to 28 days). Of these, 87 patients had their maintenance dose selected in MSGo, with all but one patient having the recommended maintenance dose selected 2 mg for CYP2C9∗1∗1 (n=58), ∗1∗2 (n=13), ∗2∗2 (n=1) and 1 mg for ∗1∗3 (n=10) and ∗2∗3 (n=4). 1 mg maintenance was selected for a patient with a rare ∗1∗5 genotype which currently has no dose recommendation. A total of 7 patients unenrolled from MSGo prior to siponimod initiation whilst 10 patients ceased after siponimod initiation. Conclusions: These interim results provide early insights into the siponimod onboarding experience for SPMS patients in Australia and demonstrate the utility of MSGo during a period challenged by the COVID-19 pandemic.