DMT49
Real-World Utilization of Ofatumumab for Treatment of Multiple Sclerosis (MS): Trends Nine Months after FDA Approval
Ofatumumab (OMB) received FDA approval on Aug 2020 as the first B-cell therapy to be self-administered by a once-monthly subcutaneous autoinjector pen for relapsing forms of MS. This study provides the first comprehensive look at OMB initiation, over the first 9 months after FDA approval, using a nationally representative claims database.
Objectives:
To describe patient demographic and clinical characteristics, and prior disease modifying therapy (DMT) use among MS patients initiating OMB at 3, 6, and 9 months after FDA approval.
Methods:
This was a retrospective cohort study using IQVIA open-source US claims database. Adult patients with a diagnosis of MS, and a prescription of OMB from Aug 2020 to May 2021, were included. Index date was defined as the first OMB prescription claim. DMT-naïve patients were defined as no DMT prescribed 12 months prior to index date (baseline period). Separate analyses were conducted at 3 months (Oct 2020), 6 months (Feb 2021) and 9 months (May 2021) after FDA approval.
Results:
The number of patients initiating OMB increased from 243 at 3 months to 2,101 at 9 months. At 3 months after FDA approval, mean (standard deviation, SD) age was 47.6 (12.2) years, 21.4% were ≥ 55 years old, and 74.5% were female. The proportion of DMT-naïve patients was 46.9%. Ocrelizumab (OCR, 20.2%) was the most common DMT used before initiating OMB, followed by dimethyl fumarate (DMF, 18.6%), and teriflunomide (TRF, 17.8%), with median time from last DMT claim to OMB initiation being 168, 48, 34 days, respectively.
At 6 months after FDA approval, mean age was 48.2 (12.3) years, 32.7% were ≥ 55 years old, and 72.5% were female. The proportion of DMT-naïve patients was 54.8%. OCR (24.0%) was the most common DMT used before OMB, followed by DMF (20.5%) and TRF (13.5%), with median time from last DMT claim to OMB initiation being 174, 62, 51 days, respectively.
At 9 months after FDA approval, mean age was 48.3 (12.2) years, 33.4% were ≥ 55 years old, and 74.0% were female. The proportion of DMT-naïve patients was 58.4%. OCR (23.3%) was the most common DMT used before OMB, followed by DMF (17.5%) and TRF (15.2%), with median time from last DMT claim to OMB initiation being 179, 63, 64 days, respectively.
Conclusions:
Understanding the patient profile for those who initiated ofatumumab in real-world settings may help inform treatment decisions. Future studies on long-term effectiveness of OMB are needed.