In the United States alone, over 400,000 individuals are dealing with the challenges associated with multiple sclerosis (MS). Most recently, Sanofi, an international leader in healthcare, announced FDA approval of the prescription drug Lemtrada, for the treatment of patients with relapsing forms of multiple sclerosis. Due to its safety profile, Lemtrada is restricted in use only to patients who are unresponsive to two or more drugs designated for the treatment of MS. “Lemtrada is a natural treatment of sorts, being a one clone antibody. This monoclonal antibody is directed against a marker on certain T and B cells to destroy those cells. The other cells forming the front line of the immune system remain intact as Lemtrada targets the T and B cells reducing their entrance into the central nervous system where they can cause MS lesions. The bone marrow then will reboot and reproduce T and B cells that were lost. Lemtrada is administered twice, or once a year over two years. After the second rebooting, the hope is the second generation of post Lemtrada T and B cells are devoid of the potential to cause MS lesions” said Aaron Boster, neuroimmunologist at Ohio Health.
“Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada. Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy (REMS) will be instituted in order to help detect and manage the serious risks identified with treatment” said David Meeker, CEO and President at Genzyme.
The FDA approval of Lemtrada derives from two randomized CARE-MS Phase III pivotal studies, comparing treatment of Lemtrada and Rebif in patients with relapsing remitting MS who had active disease and were either new to the treatment (CARE-MS I) or who had not responded to previous treatment (CARE-MS II). The effects were observed in clinical trials over the course of two years and found that:
- In CARE-MS I, Lemtrada was much more effective than interferon beta-1a at reducing relapse rates on an annual basis.
- In CARE-MS II, Lemtrada was much more effective than interferon beta-1a at reducing relapse rates on an annual basis and slowing down progression of disability.
After the initial courses of treatment in the CARE-MS trials (administered at month 0 and month 12 via intravenous infusion), 64% of Lemtrada patients for CARE-MS I and 55% of Lemtrada patients for CARE-MS II did not receive any additional treatment throughout the next five years (through month 72). Moreover, the results found that:
- The relapse rates for CARE MS-I (0.12) and CARE MS II (0.15) remained consistent throughout the extension on an annual basis.
- About 77% of Lemtrada patients for CARE-MS I and 72% of Lemtrada patients for CARE-MS II did not experience worsening of disability through year 6.
- About 34% of Lemtrada patients for CARE-MS I and 43% of Lemtrada patients for CARE-MS II who had disability before receiving treatment with Lemtrada showed improvement in disability (confirmed EDSS score over at least 6 months) through year 6.
- Patients who received treatment with Lemtrada in CARE-MS I and II experienced a slowdown of brain shrinkage (brain atrophy) through year 6.
- Most patients had no evidence of MRI disease activity (no enhancing or enlarging T1 / T2 lesions) during years 3, 4, 5 and 6.
- The quantity of side effects associated with thyroid-related events was highest in year 3 and decreased afterward.
“The Lemtrada data being presented at ECTRIMS from the ongoing extension study illustrate that more than half of patients experienced sustained effects of treatment on disease activity, despite receiving their last treatment course five years previously. It is very promising to see these consistent effects over time across relapse, disability and MRI measures” said Dr. Alasdair Coles, Professor of the Department of Clinical Neurosciences at the University of Cambridge.
Lemtrada (alemtuzumab) is approved in well over 50 countries and is supported in clinical study programs involving the participation of around 1,500 patients worldwide and 5,400 patient-years of follow-up. “The FDA approval of Lemtrada is a significant milestone for people living with relapsing MS in the United States. We are pleased that the voices of the MS community have been recognized and that people with relapsing MS will now have access to a new, needed treatment option” said Dr. Timothy Coetzee, Chief Advocacy, Services and Research Officer at the National MS Society.
Notable side effects
Lemtrada includes a warning label, noting severe side effects that could result from its intake. The most common side effects of Lemtrada include headache, nausea, fever, fatigue, rash, urinary tract infection, fungal infection, herpes viral infection, weakness, dizziness, sore throat, swelling of the nose and throat, hives, itching, joint pain, chest pain, back pain, abdominal pain, oropharyngeal pain, diarrhea, vomiting, trouble breathing, paresthesia, flushing, pyrexia, nasopharyngitis, and pneumonitis. Lemtrada may also cause an increase in cancerous growths associated with melanoma, thyroid cancer, and lymphoproliferative disorders.
Due to the fact that Lemtrada can cause severe infusion reactions 24 hours or longer after receiving treatment, it is important to consult with your doctor before starting a treatment course. Speak with him or her if you:
- Have HIV.
- Have thyroid, kidney, or bleeding problems.
- Are pregnant or planning on becoming pregnant.
- Are breastfeeding or planning on breastfeeding.
- Have a recent and personal history of infection.
- Have received a live vaccination 6 weeks prior to receiving treatment with Lemtrada.
- Are planning on receiving any live vaccinations.
- Are taking a medication called Campath (alemtuzumab).
- Are taking any over the counter medications, herbal supplements or vitamins that could increase your risk of side effects or infections.
Your doctor may also recommend other medications to take before or after the infusion in order to reduce your chances of a severe infusion reaction or treat it after it has occurred. If a severe infusion reaction occurs while you are receiving treatment with Lemtrada, your infusion will be discontinued.
How is Lemtrada available?
Lemtrada is only available through the Lemtrada REMS - Risk Evaluation and Mitigation Strategy. The Lemtrada REMS is a distribution program that limits access to the prescription drug in the United Sates only through certified prescribers, specialty pharmacies, and healthcare facilities. The program aims to help educate both patients and healthcare professionals about the benefits and risk associated with Lemtrada for the purpose of managing relapsing forms of multiple sclerosis. “What we learned last year, at six-year data, is same as what we know now at seven-year data. The side effects profile has not increased. …It’s reassuring to know that as we move forward in time, we don’t pick up new scary stuff” said neuroimmunologist, Aaron Boster. Moreover, he went on to stress that “If there’s a key take-home [message], it’s that you can go back to another therapy … this does not close the door. I would submit to you that the MS is changed. And if, in fact, you were to go to a different therapy, you might find an easier time of controlling the disease process, because the mechanism of alemtuzumab has changed the milieu in the immune system.”
“The unmet need in MS remains high. It is a great day for people living with relapsing forms of MS in the United States, who will now have access to this new meaningful treatment” said Edward Fox, Director of the Multiple Sclerosis Clinic of Central Texas.