FDA Approves Kesimpta (ofatumumab) for Relapsing Forms of Multiple Sclerosis in Adults
The FDA has approved the subcutaneous CD20-directed cytolytic antibody Kesimpta (ofatumumab) for the treatment of relapsing forms of multiple sclerosis in adults. The indication includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This approval provides a new B-cell depleting therapy option that is self-administered monthly after an initial loading dose. The approval was based on two randomized, double-blind, double-dummy, active comparator-controlled trials (Study 1 and Study 2) of identical design, which compared Kesimpta to teriflunomide 14 mg orally once daily. The primary efficacy endpoint in both trials was the annualized relapse rate over the treatment period. The maximal treatment duration for an individual patient in these studies was 120 weeks. Key administration considerations include required pre-treatment screening for Hepatitis B virus and serum immunoglobulins, and the recommendation that the first injection be performed under the guidance of a healthcare professional.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
KESIMPTA is a CD20-directed cytolytic antibody.
KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Before initiating KESIMPTA, screen for Hepatitis B virus (HBV) and obtain serum quantitative immunoglobulins, aminotransferases, alkaline phosphatase, and bilirubin. Administer KESIMPTA by subcutaneous injection only. Initial Dosing: 20 mg administered at Weeks 0, 1, and 2. Subsequent Dosing: 20 mg administered monthly starting at Week 4. The first injection should be performed under the guidance of a healthcare professional. It is intended for patient self-administration in the abdomen, thigh, or outer upper arm. Vaccinations should be administered according to guidelines at least 4 weeks prior to initiation for live/live-attenuated vaccines and at least 2 weeks prior for inactivated vaccines.
The efficacy of KESIMPTA was demonstrated in two randomized, double-blind, double-dummy, active comparator-controlled clinical trials of identical design (Study 1 and Study 2) in patients with relapsing forms of MS. Patients had at least one relapse in the previous year, 2 relapses in the previous 2 years, or a T1 gadolinium-enhancing lesion in the previous year, and an EDSS score from 0 to 5.5. Patients were randomized to receive either KESIMPTA (20 mg subcutaneously on Days 1, 7, and 14, then every 4 weeks starting at Week 4) with daily oral placebo, or teriflunomide 14 mg orally once daily with matching subcutaneous placebo. The maximal treatment duration was 120 weeks. The primary endpoint was the annualized relapse rate (ARR) over the treatment period. Additional outcome measures included: the time to 3-month confirmed disability progression for the pooled populations, the number of T1 GdE lesions per scan at Weeks 48 and 96, and the annualized rate of new or enlarging T2 MRI lesions.
KESIMPTA is contraindicated in patients with active HBV confirmed by positive results for Hepatitis B surface antigen [HBsAg] and anti-HBV tests. For patients who are negative for HBsAg and positive for Hepatitis B core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment. Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion.
Not reported in label.
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