Compliance and Persistence With Ofatumumab Treatment in Patients With Relapsing Multiple Sclerosis in Clinical Trials for Up to 4 Years
Enrique Alvarez1, Carrie Hersh2, Derrick Robertson3, Ayan Das Gupta4, Xixi Hu5, Ronald Zielman6, Ibolya Boer7, Andy Cheadle5, Jeffrey Cohen8
1Department of Neurology, Rocky Mountain Multiple Sclerosis Center at the University of Colorado, 2Lou Ruvo Center for Brain Health, Cleveland Clinic Mellen Program for MS, 3Multiple Sclerosis Division, Department of Neurology, University of South Florida, 4Novartis Healthcare, 5Novartis Pharmaceuticals Corporation, 6Novartis Pharma B.V., 7Novartis Pharma AG, 8Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic
Objective:
To evaluate compliance and persistence with ofatumumab in patients with relapsing multiple sclerosis (RMS) for up to 4 years across the core ofatumumab studies and the ALITHIOS extension study (NCT03650114).
Background:
In the pooled ASCLEPIOS I/II (NCT02792218/NCT02792231) trials, ofatumumab demonstrated superior efficacy and a similar safety profile to teriflunomide in patients with RMS. Sustained efficacy and consistent safety were observed in the ALITHIOS open-label extension for up to 4 years. In ASCLEPIOS I/II, 98.8% of patients had ≥80% compliance on ofatumumab; 82.9% of patients receiving ofatumumab completed the study on treatment up to 30 months.
Design/Methods:
Patients completing ASCLEPIOS I/II, APOLITOS (NCT03249714), and APLIOS (NCT03560739) could enter ALITHIOS. Compliance was analyzed for ≤4 years in overall, continuous (ofatumumab core), and newly switched (teriflunomide core and ofatumumab extension) groups. Compliance was defined as the duration of exposure divided by the duration of the on-treatment period multiplied by 100%; ≥80% compliance was considered compliant. The numbers of patients in ALITHIOS continuing ofatumumab and discontinuing treatment, along with reasons for discontinuation, were evaluated.
Results:
At data cutoff (September 25, 2021), compliance was 94.9%, 95.1%, and 94.4% in the overall (n=1969), continuous (n=1292), and newly switched (n=677) groups, respectively. Of 1715 patients who entered ALITHIOS, 12 (0.7%) were screening failures and 1703 received study treatment; 1508 (87.9%) were ongoing at data cutoff, and 195 (11.4%) discontinued study treatment. The primary reasons for discontinuation in ALITHIOS were patient/guardian decision (n=75 [4.4%]), adverse event (n=66 [3.8%]), pregnancy (n=12 [0.7%]), physician decision (n=12 [0.7%]), lack of efficacy (n=12 [0.7%]), lost to follow-up (n=8 [0.5%]), death (n=6 [0.3%]), noncompliance (n=2 [0.1%]), and protocol deviation (n=2 [0.1%]).
Conclusions:
High compliance was observed with monthly subcutaneous ofatumumab (~95% across core and open-label extension studies). A small proportion of patients discontinued ofatumumab, indicating high treatment persistence.