ABSTRACT
Introduction: Siponimod is approved in Australia for adults with secondary progressive multiple sclerosis (SPMS). Prescreen requirements for siponimod include a CYP2C9 genotype test to determine maintenance dosing. An integrated digital platform, 'MSGo', was developed by Novartis and RxMx to support Healthcare Professionals and their multiple sclerosis patients. Objective(s): Data derived exclusively from MSGo was utilised to explore the onboarding experience of siponimod patients in Australia. Aim(s): To provide real world evidence on siponimod for SPMS patients in Australia. Method(s): The study enrolled >350 adults with SPMS registered in MSGo for siponimod in Australia. Primary endpoint is the average time for onboarding with key secondary endpoints addressing adherence and variables that influence onboarding and adherence. Result(s): Final data extraction on April 20th, 2022 included 368 patients (median age of 59y).CYP2C9 genotype testing took a median of 19 days (95%CI 17-21) from registration and maintenance doses of 2mg (n=166) or 1mg (n=27) were initiated as per label recommendations;1mg was initiated for two rare allele genotypes (*1*5 and*1*11) in the absence of label recommendations. Mixture-cure modelling estimated that 58% of patients will ever initiate siponimod, with a median time to initiation of 56d (95%CI 47-59) from registration. Among those who initiated siponimod the most common reported reason for delayed initiation was 'waiting for vaccination'. Self-reporting of daily treatment, captured under the treatment reminder function in MSGo, had a drop-off of ~25% after the first week of initiation;a continued decline in reporting over time limited assessment of adherence. Continued self-reporting of daily dosing trended lower with older patients with only 28% of those >70y continuing to self-report at day 90 compared to 47-69% with the younger age groups. The study uncovered the important role of care partners, with Cox regression analyses demonstrating that SPMS patients who nominated a care partner were more likely to initiate (HR:2.1, 95%CI 1.5-3.0) and to continue self-reporting their daily medication (HR:2.2, 95%CI 1.3-3.7). A total of 90 patients discontinued the study;48 prior to and 42 after siponimod exposure. Conclusion(s): This study provides insights into siponimod onboarding for adults living with SPMS in Australia and demonstrates the impact of MSGo and care partner support during a period challenged by the COVID-19 pandemic.
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.