AbbVie announced positive top-line results from two Phase 3 studies in adults with active psoriatic arthritis, KEEPsAKE-1 and KEEPsAKE-2, showing that significantly more patients treated with risankizumab (150 mg) achieved the primary endpoint of ACR20 response at week 24 versus placebo. In KEEPsAKE-1 and KEEPsAKE-2, 57 and 51 percent of patients receiving risankizumab achieved ACR20 response at week 24, respectively, versus 34 and 27% receiving placebo (p<0.001). Results of ranked secondary endpoints showed significant improvements in skin clearance (as measured by at least a 90 percent improvement in Psoriasis Area Severity Index [PASI 90]), physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) and minimal disease activity (MDA) at week 24. These two Phase 3 studies evaluated risankizumab in adult patients with active psoriatic arthritis, and included patients who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs). In KEEPsAKE-1, the ranked secondary endpoint of PsA Sharp/van der Heijde Score (PsA-mTSS) was 0.23 and 0.32 at week 24 in the risankizumab and placebo groups, respectively (p=0.496 [note: a lower score denotes lower radiographic progression]). In these studies, the safety profile of risankizumab through week 24 was generally consistent with safety findings in previous studies in psoriasis.1-4 Serious adverse events occurred in 2.5 percent and 4.0 percent of patients treated with risankizumab in KEEPsAKE-1 and KEEPsAKE-2, respectively, compared with 3.7 percent and 5.5 percent on placebo.1 Rates of serious infections were similar between treatment groups (1.0 and 0.9 percent in risankizumab-treated patients in KEEPsAKE-1 and KEEPsAKE-2, respectively, and 1.2 and 2.3 percent in patients who received placebo).1 The rates of adverse events leading to discontinuation of the study drug were 0.8 percent and 0.9 percent of patients treated with risankizumab in KEEPsAKE-1 and KEEPsAKE-2, respectively, compared with 0.8 percent and 2.3 percent on placebo.1 In KEEPsAKE-1, there was one death in the risankizumab group not related to the study drug per investigator.1 There were no deaths reported in KEEPsAKE-2. l results from the KEEPsAKE studies will be presented at upcoming medical conferences and published in a peer-reviewed medical journal. Use of risankizumab in psoriatic arthritis is not approved and its safety and efficacy have not been evaluated by regulatory authorities. Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.