Would You Take Lemtrada for Multiple Sclerosis?
The Food and Drug Administration (FDA) has approved Lemtrada (alemtuzumab) for treatment of relapsing-remitting multiple sclerosis. Based on the information released about the drug thus far, would you take this medication?
Lemtrada had a rocky road on the way to approval for multiple sclerosis. However, it staggered across the finish line complete with a boxed warning listing all of its serious and even fatal possible effects.
To make the approval even more questionable, the drug will be available only through a limited distribution program, and certified pharmacies, prescribers, and patients will be the only ones allowed access. Alemtuzumab also is considered to be a third-line treatment option for the disease, according to Genzyme (a Sanofi company), the manufacturer.
Boxed warning and side effects
The boxed warning required to appear on the medication states the following:
- That its use may cause “serious, sometimes fatal autoimmune conditions such as immune thrombocytopenia (2% of patients in trials) and anti-glomerular basement membrane disease.”
- That it is associated with an increased risk of lymphoproliferative disorders, thyroid cancer, and melanoma
- That patients should be monitored for 48 months after their last infusion using complete blood counts with differential, serum creatinine levels, and urinalysis
- Use of Lemtrada was associated with new cases of autoimmune thyroid disorders in 34 percent of patients.
- Infection rates were 71 percent among Lemtrada users compared with 53 percent taking interferon beta-1a in controlled clinical trials
- Herpes infection rates were 17 percent among Lemtrada patients compared with 3 percent of those using interferon beta-1a
Use of Lemtrada also can cause abdominal pain, arthralgia, back pain, diarrhea, dizziness, extremity pain, fatigue, fever, flushing, fungal infections, headache, herpes viral infection, hives, insomnia, nasopharyngitis, nausea, rash, thyroid gland disorders, sinusitis, upper respiratory tract infections, urinary tract infections, and vomiting. Infections can be severe and common.
About Lemtrada and multiple sclerosis
Alemtuzumab is not a stranger to the healthcare market. For years, individuals with certain types of leukemia have been treated with this drug under the name Campath.
Now, recent clinical trials have shown that alemtuzumab may be helpful in MS. The drug targets a protein called CD52, which is abundant on B and T cells. These cells are believed to be involved in the inflammatory process in the disease.
Alemtuzumab temporarily depletes the number of circulating T and B cells after treatment. Over time, the cells repopulate but immune response changes so that the body’s attack of myelin is reduced or shut down in most individuals.
In clinical trials for drug approval, Lemtrada was significantly more effective than interferon beta-1a when it came to reducing relapse rate: a 55 percent relative reduction. After two years, the percentage of patients who remained relapse-free was 78 percent for individuals who took Lemtrada and 59 percent for those taking interferon beta-1a.
In a second trial, the percentage of patients who remained free of relapse was 65 percent for Lemtrada users and 47 for those taking interferon beta-1a. The amount of change in lesion volume between the two groups was not significantly different.
Lemtrada is administered via infusion. The first dose is given at 12 mg daily for five consecutive days. The second dose is administered 12 months later for three consecutive days. Before each treatment period and for the first three days, patients must take high doses of corticosteroids (1,000 mg methylprednisolone or equivalent). Another requirement is use of an anti-viral prophylaxis for herpes taken on the first day of treatment and continuing for two months.
Lemtrada is the latest in a series of medications developed for treatment of relapsing-remitting multiple sclerosis. Concerns over the safety of this drug resulted in strong label warnings, including the caveat that it should “generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.”