Psoriasis new drug approved in Japan! Injecting once every 3 months can improve the skin condition? .
The multinational biopharmaceutical company AbbVie announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the interleukin -23(IL-23) inhibitor SKYRIZI? (risankizumab) is used to treat adult patients with plaque psoriasis, systemic pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis, which cannot be fully relieved by conventional treatment. This approval is also the first approval of SKYRIZI in the world.
In an interview with the media, Dr. Mamitaro Ohtsuki, a professor of dermatology at Jiji Medical University, said: "Skyrizi only needs to take medicine once in the 0 th and 4 th weeks, and then once every 3 months (12 weeks), which may help psoriasis patients clear most skin symptoms and achieve the purpose of long-term treatment."
Clinical trial data
The approval is based on the efficacy and safety data of Phase 2 and Phase 3 clinical trials of sustaIMM, Ultima- 1, Ultima-2 and IMMvent. These studies evaluated the therapeutic effect of SKYRIZI on patients with plaque psoriasis, generalized pustular psoriasis and erythrodermic psoriasis in Japan, and these studies reached the main research end point.
With STELARA? (ustekinumab) Hu Milla? Compared with adalimumab, lisanzizumab has a higher skin clearance rate or almost clearance rate (sPGA 0/ 1), and the response rate at 16 weeks is 84%-88%.
Within one year (52 weeks), 56% and 60% of the patients who received Lisanzizumab treatment achieved complete skin clearance (PASI 100), while the corresponding data of STELARA treatment group were 2 1% and 30% respectively. In addition, there were no new safety incidents in the third-stage treatment of plaque psoriasis. The main data are as follows:
Main data
Michael Severino, president of AbbVie Pharmaceuticals, said: "With the approval of SKYRIZI in Japan, we have brought a brand-new treatment scheme to patients with psoriasis in Japan. SKYRIZI may improve the signs and symptoms of these patients with chronic immune-mediated diseases. We look forward to continuing to work with regulators to make this treatment option available to more patients around the world. "
Note: The above information is for reference only. Please consult your doctor for specific treatment plan.