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Home » HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): SKYRIZI, RISANKIZUMAB, PSORIASIS, DATE OF AUTHORISATION: 26/04/2019, REVISION: 3, STATUS: AUTHORISED

HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): SKYRIZI, RISANKIZUMAB, PSORIASIS, DATE OF AUTHORISATION: 26/04/2019, REVISION: 3, STATUS: AUTHORISED

(AGENPARL) – LONDON (UNITED KINGDOM), mar 20 ottobre 2020

In 4 main studies involving over 2,100 patients with moderate to severe disease who required systemic treatment, Skyrizi was more effective than placebo (a dummy treatment) and comparator medicines at improving symptoms.

In the first two studies in a total of 997 patients, after 16 weeks of treatment around 75% of patients receiving Skyrizi had a reduction of at least 90% in PASI scores (a measure of how severe and widespread the skin lesions are), compared with around 45% of those receiving ustekinumab and around 4% of those receiving placebo. In addition, around 86% of patients receiving Skyrizi had clear or almost clear skin, compared with around 62% of those receiving ustekinumab and around 6% of those receiving placebo. Improvements in symptoms were maintained after 52 weeks of treatment with Skyrizi.

In the third study involving 605 patients, after 16 weeks of treatment 72% of patients receiving Skyrizi had a reduction of at least 90% in PASI scores, compared with 47% of those receiving adalimumab. In addition, 84% of patients receiving Skyrizi had clear or almost clear skin, compared with 60% of those receiving adalimumab.

Finally, in the fourth study involving 507 patients, after 16 weeks of treatment 73% of patients receiving Skyrizi had a reduction of at least 90% in PASI scores, compared with 2% of those receiving placebo. Around 84% of patients receiving Skyrizi had clear or almost clear skin, compared with around 7% of those receiving placebo. In a second part of this study, some patients who first received Skyrizi were then switched to placebo after 28 weeks while others remained on Skyrizi. At week 52, more patients who remained on Skyrizi had had clear or almost clear skin than those who were switched to placebo.

Fonte/Source: https://www.ema.europa.eu/en/medicines/human/EPAR/skyrizi

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