Background: The efficacy and safety of ofatumumab were demonstrated in Phase III ASCLEPIOS trials. This analysis provides the first account of real-world patients initiating ofatumumab in the first 3 months of availability in the United States (US).
Objectives: The study evaluated patient baseline demographic characteristics, prior disease-modifying therapy (DMT) use, and disease indicators in patients with multiple sclerosis (MS) initiating ofatumumab using a nationally representative claims database.
Methods: This retrospective cohort study, using IQVIA open-source claims data, included adult patients with a diagnosis of MS who initiated ofatumumab from August 2020-October 2020. The index date was defined based on the first prescription fill for ofatumumab, and the baseline period was 1-year prior to the index date. Patient demographics, treatment status (naïve prior-year vs experienced), geographical distribution, claims-based baseline disability levels, prior DMT use, and corresponding median time of washout period (treatment gap), were evaluated.
Results: Overall, 243 patients initiating ofatumumab were included in the study. Mean (±standard deviation [range]) age was 47.6 ± 12.2 (19-85) years, and 74% were females. Approximately 30% of patients were ?55 years of age. There were 69.1% of patients with commercial insurance and 13.6% with Medicare Part D. The majority of patients were from the Southern and Western regions of the US. Ofatumumab was mostly prescribed by neurologists (86.9%) vs PCP/NP/PAs. Most (63.4%) of the patients had a mild level of MS disability. Major comorbidities among patients were osteoarthritis (32.5%), hypertension (15.2%), and depression (10.7%). Overall, 56.8% were not on any DMT in the year prior to initiating ofatumumab. Patients commonly switched from ocrelizumab (24.8%), platform injectables (22.9%), dimethyl fumarate (22.9%) and natalizumab (13.3%). The median washout period for dimethyl fumarate, natalizumab, and ocrelizumab was 34, 35, and 168 days, respectively. Very few patients received the influenza vaccine pre or post ofatumumab use. Steroid and antihistamine use as premedication was minimal (<3.3% of patients). Conclusions: In the real-world, ofatumumab is being prescribed beyond the trial population. The majority of patients newly initiated ofatumumab with no treatment in the prior year. Understanding patient profile, prior DMT use, and corresponding washout periods in the real-world may help stakeholders guide treatment decisions.