What is Kyntheum - Brodalumab used for and what is it used for?
Kyntheum is a medicine used to treat plaque psoriasis, a disease that causes red, scaly patches on the skin. It is used in adults whose disease is moderate to severe and who need systemic treatment (treatment with medicines administered orally or by injection).
Kyntheum contains the active substance brodalumab.
How is Kyntheum - Brodalumab used?
Kyntheum can only be obtained with a prescription and must be used under the supervision of a doctor experienced in the diagnosis and treatment of psoriasis.
Kyntheum is available as a solution for injection in pre-filled syringes. It is given as an injection under the skin. The recommended dose is 210 mg once a week for the first three weeks and every two weeks thereafter. Your doctor may decide to stop treatment if there is no improvement after 12-16 weeks.
If your doctor thinks it is appropriate, the Kyntheum injection can be given by the patients themselves after receiving the instructions. For more information, see the package leaflet.
How does Kyntheum - Brodalumab work?
The active substance in Kyntheum, brodalumab, is a monoclonal antibody, a protein designed to neutralize the activity of certain substances called interleukins 17 (A, F and A / F), messengers in the body's immune system (the natural defenses of the body).
Interleukins 17 contribute to the inflammation process that causes plaque psoriasis. By neutralizing the action of interleukins 17, brodalumab reduces inflammation and symptoms associated with the disease.
What benefit has Kyntheum - Brodalumab shown during the studies?
Kyntheum has been shown to be effective in the treatment of plaque psoriasis in three main studies involving over 4 300 patients who needed systemic treatment. Plaque psoriasis improved to a greater extent in patients treated with Kyntheum than in those given placebo (a dummy treatment) or with ustekinumab (another psoriasis medicine that targets interleukin molecules).
Considering the results of the three studies as a whole, 85% of patients treated with Kyntheum achieved a 75% reduction in PASI scores (a criterion for evaluating the severity of the disease and the area of the skin involved) after 12 weeks, against 6% of those who received placebo and 70% of patients who received ustekinumab. Furthermore, after 12 weeks, 79% of patients treated with Kyntheum had more or less a patchy skin, compared with 3% of patients treated with placebo and 70% of patients treated with ustekinumab.
Data from a study also showed that the benefits of Kyntheum treatment were maintained when treatment was continued for a year.
What are the risks associated with Kyntheum - Brodalumab?
The most common side effects with Kyntheum (which may affect more than 1 in 100 people) are joint pain, headache, fatigue, diarrhea and oropharyngeal pain (pain in the mouth and throat).
Kyntheum should not be given to patients with potentially serious infections, such as tuberculosis, and to patients with active Crohn's disease (an inflammatory disease affecting the bowel). Some cases of suicidal behavior have been reported in patients taking the medicine. Although there is no evidence of a link with the medicine, the decision to start treatment with Kyntheum in patients who have previously exhibited suicidal behavior or suffered from depression or anxiety must be taken after careful consideration of all risks and benefits for that patient. Kyntheum should be discontinued in patients who show new symptoms of depression or anxiety or in case of deterioration.
For the full list of restrictions and side effects reported with Kyntheum, see the package leaflet.
Why has Kyntheum - Brodalumab been approved?
Although there has been recent progress in the treatment of plaque psoriasis, the need for new therapeutic options remains. Studies have shown that Kyntheum was extremely effective in making the skin free from lesions and that the positive effects were maintained with prolonged use. The side effects are similar to those of other medicines that target the interleukin molecules.
The European Medicines Agency has therefore decided that Kyntheum's benefits are greater than its risks and recommended that it be approved for use in the EU
What measures are being taken to ensure the safe and effective use of Kyntheum - Brodalumab?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kyntheum have been included in the summary of product characteristics and the package leaflet.
More information on Kyntheum - Brodalumab
For the full version of the EPAR and the summary of the Kyntheum risk management plan, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Kyntheum therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
