What is Sylvant - Siltuximab and what is it used for?
Sylvant is a medicine that contains the active substance siltuximab . It is indicated for the treatment of adult patients with multicentric Castleman's disease who have tested negative for human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8). Castleman's disease is a disorder of the lymphatic system (a network of vessels that transport fluids from tissues through lymph nodes and into the bloodstream) characterized by abnormal growth of lymph node cells, which causes benign tumors. "Multicentric" means that the disease affects several lymph nodes as well as other organs of the body. Symptoms may include fatigue, night sweats, fever, peripheral neuropathy (pins and needles due to nervous system injuries) and enlarged liver and spleen. Because the number of patients with Castleman's disease is low, the disease is considered 'rare' and Sylvant was designated an 'orphan medicine' (a medicine used in rare diseases) on 30 November 2007.
How is Sylvant - Siltuximab used?
Sylvant can only be obtained with a prescription and must be administered by qualified healthcare professionals under appropriate medical supervision. Sylvant is available as a powder for solution for infusion (drip) into a vein. The recommended dose is 11 mg / kg body weight, to be administered by infusion over an hour. Sylvant is given every three weeks, until the patient no longer benefits from the treatment. During the first 12 months of treatment, blood tests should be performed before each Sylvant administration, and every nine months thereafter; in subjects showing abnormal blood test results or certain side effects it may be necessary to delay treatment. For more information, see the package leaflet.
How does Sylvant - Siltuximab work?
The active substance in Sylvant, siltuximab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) developed to recognize and bind to a specific structure (the antigen) present in the body. Siltuximab was designed to bind to a protein in the body called interleukin 6 (IL-6) and block its activity. Patients with Castleman's disease produce too many IL-6s, which are believed to contribute to the abnormal growth of certain cells in the lymph nodes. By binding to IL-6, siltuximab blocks its activity and stops abnormal cell growth, reducing the size of lymph nodes and symptoms of the disease. Sylvant is produced by a method known as "recombinant DNA technique"; that is, it is obtained from cells in which a gene (DNA) has been introduced which allows them to produce siltuximab.
What benefit has Sylvant - Siltuximab shown during the studies?
Sylvant has been studied in one main study involving 79 adults with multicentric Castleman's disease who tested negative for HIV and HHV-8. The effect of the medicine was compared with the effect produced by placebo (a dummy treatment) and the main measure of effectiveness was the percentage of patients who responded to therapy for at least 18 weeks, as shown by a 50% reduction ( "Partial response") or the total disappearance ("complete response") of tumors and disease symptoms. Sylvant was more effective than placebo in reducing tumor size and disease symptoms: 17 of 53 patients treated with Sylvant showed a partial response and one patient showed a complete response compared to none of the 26 patients treated with placebo. This effect has been maintained for almost a year.
What is the risk associated with Sylvant - Siltuximab?
The most common side effects of Sylvant (which may affect more than 2 in 10 people) are infections (including those affecting the upper respiratory tract (colds)), itching and eczema. The most serious side effect is an anaphylactic reaction (a severe allergic reaction). For the full list of side effects and limitations, see the package leaflet.
Why has Sylvant - Siltuximab been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Sylvant's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Sylvant has been shown to have a beneficial effect by reducing tumor size and symptoms in patients with multicentric Castleman's disease and that the positive effect appears to persist over time. The committee also acknowledged that there is an unmet medical demand for these subjects. As for safety, side effects with Sylvant were considered acceptable, but additional long-term data need to be collected.
What measures are being taken to ensure the safe and effective use of Sylvant - Siltuximab?
A risk management plan has been developed to ensure that Sylvant is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sylvant, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Sylvant is required to create a patient register in order to provide additional data on long-term safety. The company must ensure that healthcare professionals who could use the medicine receive information on how to enter patients in the registry. Further information is available in the summary of the risk management plan.
More information on Sylvant - Siltuximab
On 22 May 2014, the European Commission issued a marketing authorization for Sylvant, valid throughout the European Union. For more information on Sylvant therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The summary of the opinion of the Committee for Orphan Medicinal Products related to Sylvant is available on the Agency's website: ema.Europa.eu/Find medicine / Human medicines / Rare disease designation. Last update of this summary: 05-2014
