Multiple sclerosis:
Indications for: KESIMPTA
Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Clinical Trials:
The phase 3 ASCLEPIOS I (ClinicalTrials.gov Identifier: NCT02792218) and II (ClinicalTrials.gov Identifier: NCT02792231) trials compared the efficacy and safety of Kesimpta with teriflunomide, a pyrimidine synthesis inhibitor, in 1882 adult patients with relapsing forms of MS.
Patients were randomly assigned to receive Kesimpta 20mg subcutaneously on days 1, 7, and 14, followed by once monthly starting at week 4, or a daily oral placebo, or oral teriflunomide 14mg once daily. The primary end point of both studies was annualized relapse rate (ARR) in patients treated for up to 30 months.
Results showed that Kesimpta significantly reduced ARR by 51% and 58% in ASCLEPIOS I and II when compared with teriflunomide (ARR=0.11 and 0.10 vs 0.22 and 0.25, P <.001), respectively.
Kesimpta significantly reduced the risk of 3-month confirmed disability progression by 34.3% (P =.003) compared with teriflunomide.
Kesimpta also significantly reduced the number of T1 GdE lesions (P <.001) and the rate of new or enlarging T2 lesions (P <.001) in both studies.
Similar effects were observed in an exploratory subgroup analysis based on sex, age, body weight, prior non-steroid MD therapy, and baseline disability and disease activity.
Adult Dosage:
Perform first inj under the guidance of a healthcare provider. Give by SC inj into abdomen, thigh, or outer upper arm. Initially 20mg at Weeks 0, 1, and 2, followed by 20mg once monthly starting at Week 4.
Children Dosage:
Not established.
KESIMPTA Contraindications:
Active HBV infection.
KESIMPTA Warnings/Precautions:
Increased risk of infections. Delay Kesimpta in those with active infection until resolved. Risk of HBV reactivation. Perform HBV screening in all patients prior to initiation. Withhold at first sign/symptom of progressive multifocal leukoencephalopathy (PML) and evaluate; discontinue if confirmed. Monitor and treat if inj-related reactions occur. Monitor levels of quantitative serum immunoglobulins before initiating, during and after discontinuation until B-cell repletion; consider discontinuing if low immunoglobulins with a serious opportunistic infection or recurrent infections occur, or if prolonged hypogammaglobulinemia requires IV immunoglobulins. Complete all immunizations according to guidelines ≥4 weeks for live or live-attenuated vaccines, and if possible, ≥2 weeks for non-live vaccines prior to initiation. Infants born to mothers treated during pregnancy: do not administer live or live-attenuated vaccines before confirming B-cell recovery; non-live vaccines may be given prior to recovery, but should consider assessment of vaccine immune response. Advise females or reproductive potential to use effective contraception during and ≥6 months after the last dose. Pregnancy. Nursing mothers.
KESIMPTA Classification:
CD20-directed cytolytic monoclonal antibody.
KESIMPTA Interactions:
Concomitant live or live-attenuated vaccines: not recommended during treatment and after discontinuation until B-cell repletion. May interfere with the effectiveness of non-live vaccines. Potential additive immunosuppressive effects with other immunosuppressants including systemic corticosteroids.
Adverse Reactions:
Upper respiratory tract infection, headache, inj-related reactions, local inj-site reactions; infections, reduction in immunoglobulins.
Drug Elimination:
Ofatumumab is eliminated by both linear catabolic pathways and a non-linear B-cell mediated pathway. The half-life at steady state was estimated to be approximately 16 days following subcutaneous administration of repeated Kesimpta 20mg dosage.
Generic Drug Availability:
NO
How Supplied:
Single-dose prefilled Sensoready pen—1; Single-dose prefilled syringe—1
