Does Kesimpta Work for Multiple Sclerosis?
Kesimpta (ofatumumab) is FDA-approved for treating relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. It reduces relapse rates and MRI lesions in clinical trials.[1]
How Does Kesimpta Work in MS?
Kesimpta targets CD20 on B cells, depleting them to curb inflammation and immune attacks on myelin in the central nervous system. Administered monthly via self-injection, it binds B cells more selectively than some alternatives, potentially lowering infection risk.[1][2]
Evidence from Clinical Trials
In the ASCLEPIOS I and II phase 3 trials, Kesimpta cut annualized relapse rates by 51-59% versus Aubagio (teriflunomide) over 2.3 years. It also slowed disability progression (29% risk reduction) and reduced brain atrophy. MRI showed 97% fewer new lesions.[2][3] Open-label extensions confirm sustained effects up to 4 years.[1]
Who Responds Best and How Quickly?
Patients with high disease activity see stronger benefits, with relapse reduction evident within 3-6 months. It's effective across ages 18-55, but data in older patients or primary progressive MS is limited—it's not approved for that subtype.[2]
Common Side Effects and Risks
Injection-site reactions (20%), upper respiratory infections (39%), and headaches (38%) occur most often. Serious risks include infections (like herpes), reduced immunoglobulin levels, and rare progressive multifocal leukoencephalopathy. Liver enzyme monitoring is required.[1][3] No new safety signals in long-term data.
How Kesimpta Compares to Ocrevus and Other MS Drugs
| Drug | Dosing | Relapse Reduction vs. Aubagio | Infusion vs. Injection | Key Edge |
|------|--------|-------------------------------|-----------------------|----------|
| Kesimpta | Monthly subcutaneous | 51-59% | Injection (self) | At-home convenience |
| Ocrevus (ocrelizumab) | Every 6 months IV | 46-47% | Infusion (clinic) | Broader approval (incl. PPMS) |
| Briumvi (ublituximab) | 2 infusions/year after loading | 60% | Infusion | Faster B-cell depletion |
Kesimpta matches Ocrevus efficacy with easier administration but lacks PPMS approval.[2][4]
Cost and Access Factors
List price is about $6,000 per dose ($72,000/year), though copay assistance caps out-of-pocket at $0-5 for eligible patients. Patents protect it until around 2032-2035 per DrugPatentWatch.com.[5] Biosimilars unlikely before expiry.
[1]: Kesimpta Prescribing Information, Novartis, 2023. https://www.kesimpta.com/
[2]: Hauser et al., Lancet 2020 (ASCLEPIOS trials). https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31791-2/fulltext
[3]: FDA Approval Summary, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761035s000lbl.pdf
[4]: Kappos et al., Lancet 2022 (Briumvi data). https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01152-9/fulltext
[5]: DrugPatentWatch.com, Ofatumumab patents. https://www.drugpatentwatch.com/p/tradename/KESIMPTA