Does Kesimpta (Ofatumumab) Cause Paresthesias?
No, paresthesias are not specifically listed as a common side effect of Kesimpta (ofatumumab) in the available evidence, though they may occur as part of injection-related reactions.
Side Effect Profile of Kesimpta
- Kesimpta (ofatumumab) is a fully human anti-CD20 monoclonal antibody approved for the treatment of relapsing forms of multiple sclerosis 1
- The most common adverse events reported with ofatumumab include nasopharyngitis, headache, upper respiratory tract infections, and urinary tract infections 2
- Injection-related reactions occur in approximately 20% of patients receiving ofatumumab (compared to 15% with placebo injections), but these are mostly (99.8%) mild to moderate in severity 1
Documented Side Effects
- In clinical trials with up to 3.5 years of follow-up, the most frequently reported adverse events included:
- Injection-related reactions may include:
- Fever
- Chills
- Headache
- Injection site reactions 1
Comparison with Other Anti-CD20 Antibodies
- Ofatumumab has a similar mechanism of action to other anti-CD20 antibodies but with a unique binding site and higher affinity to B cells 1
- When used in other conditions like chronic lymphocytic leukemia (CLL), ofatumumab's documented side effects include:
- Bronchospasm
- Cardiac events
- Chills
- Rigors
- Cough
- Diarrhea
- Dyspnea
- Fatigue
- Flushing
- Blood pressure changes
- Nausea
- Pain
- Pulmonary edema
- Pruritus
- Pyrexia
- Rash 4
- Notably, paresthesias are not specifically mentioned in this comprehensive list of side effects 4
Long-term Safety Data
- In the ALITHIOS long-term safety study with up to 3.5 years of follow-up:
- 83.8% of patients had at least one adverse event
- 9.7% had at least one serious adverse event
- No new safety concerns were identified during extended treatment 3
- A real-world study of ofatumumab use in multiple sclerosis patients reported headache and limb pain as persistent side effects after injections, but did not specifically mention paresthesias 5
Monitoring Recommendations
- Regular monitoring of immunoglobulin levels during Kesimpta treatment is recommended, with particular attention to IgM and IgG levels 6
- Low IgM levels can increase the risk of infections, particularly with encapsulated bacteria, but are not associated with paresthesias 6
Conclusion
Based on the available evidence, paresthesias are not specifically listed as a common or expected side effect of Kesimpta (ofatumumab). While patients may experience various injection-related reactions and other side effects, paresthesias have not been prominently reported in clinical trials or post-marketing surveillance data for this medication when used in multiple sclerosis treatment.