AbbVie announced new patient-reported outcomes data from three pivotal Phase 3 trials evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, in adult patients with moderate to severe plaque psoriasis. Across all three trials, patients reported significant improvements in health-related quality of life, mental health and work productivity measures when treated with risankizumab. Data from these studies will be presented at the 27th European Academy of Dermatology and Venerology (EADV) Congress in Paris. Risankizumab is not approved by regulatory authorities and its safety and efficacy have not been established.
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At week 16, significantly more risankizumab-treated patients reported a psoriasis symptom scale (PSS) score of 0, indicating they were symptom-free based on a score assessing pain, redness and itchiness, compared with STELARA (ustekinumab) and placebo in ultIMMa-1 and ultIMMa-2. Significantly more patients treated with risankizumab continued to report a PSS score of 0 at one year (52 weeks) compared to ustekinumab.1 In IMMvent, significantly more patients treated with risankizumab achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1, indicating psoriasis no longer had impact on their life quality, compared to HUMIRA (adalimumab) at week 16. Risankizumab-treated patients maintained reported outcomes at week 44 in IMMvent.2 Improvements in hospital anxiety and depression scales (HADS) and work limitation questionnaire (WLQ), a measure of work productivity, were also reported.
"Patients treated with risankizumab reported significant improvements in severity of psoriasis symptoms and measures of quality of life compared to current standards of care, as consistently demonstrated by the results of all three Phase 3 pivotal trials," said Marek Honczarenko, M.D., Ph.D., vice president, global immunology development, AbbVie. "Patients with psoriasis are seeking new treatment options that help them not only to achieve and maintain clear skin, but may also improve their quality of life. These results add to the growing body of evidence demonstrating that risankizumab has the potential to be an important additional treatment option for patients with plaque psoriasis."
"Psoriasis can impact many aspects of a person's life, both physically and psychologically," said Prof. Matthias Augustin, Director, Institute and German Center for Health Services Research in Dermatology and Nursing IVDP, University Medical Center Hamburg. "Improvements in quality of life reported by patients as early as week 16 and up to one year show risankizumab's potential to significantly reduce the burden of psoriasis on daily life and adds to our knowledge about its clinical efficacy in psoriasis patients."