What is Kyntheum - Brodalumab 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 given by mouth or by injection).
Kyntheum contains the active substance brodalumab.
How is Kyntheum used - Brodalumab?
Kyntheum can only be obtained with a prescription and should be used under the supervision of a doctor who has experience in diagnosing and treating 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 then every two weeks thereafter. Your doctor may decide to stop treatment if there is no improvement after 12-16 weeks.
If the doctor deems it appropriate, the patient can inject Kyntheum themselves, after receiving the relevant instructions. For further information, see the package leaflet.
How does Kyntheum - Brodalumab work?
The active ingredient 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 body's natural defenses). 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 was shown to be effective in treating plaque psoriasis in three main studies involving over 4 300 patients requiring systemic treatment. Plaque psoriasis improved more in patients treated with Kyntheum than in those given placebo (a dummy treatment) or ustekinumab (another psoriasis medicine that targets interleukin molecules).
Considering the results of the three studies combined, 85% of patients treated with Kyntheum achieved a 75% reduction in PASI scores (a criterion for assessing disease severity and affected skin area) after 12 weeks, compared to 6% of those who received placebo and 70% of patients who received ustekinumab. In addition, 79% of patients treated with Kyntheum had more or less patchy skin after 12 weeks, compared with 3% of patients treated with placebo and 70% of patients treated with ustekinumab.
Data from one study also showed that the benefits of Kyntheum treatment were maintained when treatment was continued for one 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, tiredness, diarrhea and oropharyngeal pain (pain in the mouth and throat).
Kyntheum must not be used in patients with potentially serious infections, such as tuberculosis, and in patients with active Crohn's disease (an inflammatory disease affecting the gut). Some cases of suicidal behavior have been reported in patients taking the medicine. Although there is no evidence of a link to the medicine, the decision to initiate treatment with Kyntheum in patients who have previously exhibited suicidal behavior or suffered from depression or anxiety should be made after a "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 if they get worse.
For the full list of restrictions and side effects reported with Kyntheum, see the package leaflet.
Why has Kyntheum - Brodalumab been approved?
While there have been recent advances in the treatment of plaque psoriasis, the need for new treatment options remains. Studies have shown that Kyntheum was extremely effective in clearing the skin and that the positive effects were maintained with prolonged use. The side effects are similar to those of other medicines that target interleukin molecules.
The European Medicines Agency 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?
The recommendations and precautions to be observed by healthcare professionals and patients for Kyntheum to be used safely and effectively have been set out in the summary of product characteristics and package leaflet.
More about Kyntheum - Brodalumab
For the full version of the EPAR and the summary of the Kyntheum Risk Management Plan, please consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Kyntheum therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The information on Kyntheum - Brodalumab published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
