New data from Phase III trials of ABBV 066 in plaque psoriasis.- Abbvie.

AbbVie announced new patient-reported outcomes data from three pivotal Phase III trials evaluating ABBV 066 (risankizumab), 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. Risankizumab is not approved by regulatory authorities and its safety and efficacy have not been established.

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. 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. Improvements in hospital anxiety and depression scales (HADS) and work limitation questionnaire (WLQ), a measure of work productivity, were also reported.

AbbVie has previously announced positive top-line results from ultIMMa-1, ultIMMa-2 and IMMvent. Efficacy and safety results from the ultIMMa-1 and ultIMMa-2 studies were recently published in The Lancet. Safety results from all three Phase III trials have been previously reported. Data from these studies will be presented at the 27th European Academy of Dermatology and Venerology (EADV) Congress in Paris.