What is Taltz - Ixekizumab used for?
Taltz is a medicine used to treat moderate to severe plaque psoriasis, a disease that causes red, scaly patches on the skin. It is used in adult patients who need systemic therapy (treatment with medicines that act at the level of the whole body). Taltz contains the active ingredient ixekizumab.
How is Taltz used - Ixekizumab?
Taltz can only be obtained with a prescription and must be used under the supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Taltz is available in pre-filled syringes for injection or in pen-type injectors. It is given by injection under the skin. The first dose is 160 mg (two injections), followed by an injection of 80 mg every two weeks for the first 12 weeks and then every four weeks thereafter. Your doctor may decide to stop treatment if there is no improvement after 16 - 20 weeks. If your doctor thinks it is appropriate, patients can inject themselves with Taltz after receiving instructions. For more information, see the summary of product characteristics (included with EPAR).
How does Taltz - Ixekizumab work?
The active ingredient of Taltz, ixekizumab, is a monoclonal antibody, a protein developed to bind to a messenger molecule called interleukin 17A and present in the body's immune system (the body's natural defenses). Interleukin 17A is involved in the effects of the immune system that cause psoriasis, including inflammation. Ixekizumab binds to interleukin 17A, blocking its action and reducing the activity of the immune system; thus, it reduces the symptoms of psoriasis.
What benefit has Taltz - Ixekizumab shown during the studies?
Studies have shown that Taltz is effective in treating plaque psoriasis in patients requiring systemic therapy. Plaque psoriasis has improved to a greater extent in patients treated with Taltz than in those treated with placebo (a dummy treatment) or with etanercept, another medicine used in psoriasis therapy.
In three main studies involving more than 3, 800 psoriasis patients, 89% of those treated with Taltz every two weeks achieved a 75% reduction in the PASI score (a measure of disease severity and skin area concerned) after 12 weeks. This figure compares with the 4% obtained from patients treated with placebo and 48% obtained from patients treated with etanercept, in two of the main studies. Furthermore, 82% of patients treated with Taltz had a skin free or almost free of psoriasis after 12 weeks compared to 4% of patients treated with placebo and 39% of patients treated with etanercept.
In two studies, treatment was prolonged in patients who achieved improvement of psoriasis with Taltz given every two weeks for 12 weeks. At the end of a further treatment with Taltz given every 4 weeks for 48 weeks, 78% of the patients obtained a skin free or almost free of psoriasis.
What is the risk associated with Taltz - Ixekizumab?
The most common side effects with Taltz (which may affect more than 1 in 10 people) are pain and redness at the injection site and infections in the nose, throat or chest. Taltz should not be used in patients who may have serious infections such as tuberculosis. For the full list of restrictions and side effects reported with Taltz, see the package leaflet.
Why has Taltz - Ixekizumab been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Taltz's benefits are greater than its risks and recommended that it be approved for use in the EU. The medicine has been shown to be effective in the treatment of moderate to severe plaque psoriasis and its side effects are in line with those of other similar medicines for psoriasis.
What measures are being taken to ensure the safe and effective use of Taltz - Ixekizumab?
A risk management plan has been developed to ensure that Taltz 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 Taltz, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Taltz - Ixekizumab
For the full version of the EPAR and the summary of the Taltz risk management plan, see the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Taltz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
