Results from phase III trials of Skyrizi evaluating long-term effect on skin and joint symptoms in patients with psoriatic arthritis at week 100.- AbbVie

Results showed that at week 100 of the open-label extension period, patients receiving Skyrizi reported improvement in skin and joint symptoms, with more than half of patients in KEEPsAKE 1 and 2 achieving a 90 percent reduction in the Psoriasis Area and Severity Index (PASI 90) and an American College of Rheumatology 20 (ACR20) response. Additionally, the data demonstrated no new observed safety signals through 100 weeks. These results were featured during the "Late Breaking News" session at the 31st European Academy of Dermatology and Venereology (EADV) Hybrid Congress onsite in Milan and online.

The new data from the open-label extension period showed that at 100 weeks, 64 and 57 percent of patients initially treated with Skyrizi achieved ACR20 response in KEEPsAKE 1 and 2, respectively. Additionally, at week 100, 71 and 67 percent of patients from KEEPsAKE 1 and 2, respectively, initially treated with Skyrizi and who had a body surface area involvement greater than or equal to ?3 percent at baseline, achieved PASI 90. Furthermore, at week 100, pooled results from KEEPsAKE 1 and 2 showed that 76 and 57 percent of patients, respectively, initially treated with Skyrizi achieved resolution of dactylitis and enthesitis. For patients in KEEPsAKE 1 with nail psoriasis at baseline and who were initially treated with Skyrizi, mean scores for Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and modified Nail Psoriasis Severity Index (mNAPSI) were maintained at week 100 compared with week 52.

"Psoriatic arthritis often presents with musculoskeletal symptoms, including pain and swelling in the knees, wrists, ankles and fingers, as well as pain in the hips and heels, which can significantly reduce a person's quality of life," said Lars Erik Kristensen, M.D., Ph.D., consultant and head of science at the Parker Institute in Copenhagen, Denmark and associate professor, SUS University Hospital in Lund, Sweden. "These results highlight Skyrizi's potential to relieve symptoms in both biologic-naïve and -experienced patients with active psoriatic arthritis in the long-term."

Skyrizi was generally well-tolerated, and no new safety signals were noted in both KEEPsAKE 1 and 2 at 100 weeks of treatment. Serious treatment-emergent adverse events (TEAEs) occurred at 7.6 events/100 patient-years (E/100PY) and 9.9 E/100PY in KEEPsAKE 1 and 2, respectively. Rates of serious infections in KEEPsAKE 1 and 2 were 2.3 and 1.6 E/100PY, respectively. Major adverse cardiac events (MACE) occurred at 0.1 E/100PY in KEEPsAKE 1 and 0.5 E/100PY in KEEPsAKE 2. The rates of TEAEs leading to discontinuation of the study drug in KEEPsAKE 1 was 2. E/100PY and 1.2 E/100PY in KEEPsAKE 2.1 There were six deaths in KEEPsAKE 1, which were not related to the study drug, per investigator. In KEEPsAKE 2, there was one death not related to the study drug, per investigator.

Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.