Skyrizi Improves PsA Signs and Symptoms
AbbVie’s risankizumab (SKYRIZI) showed greater improvements in psoriatic arthritis (PsA) signs and symptoms compared to treatment with placebo at week 24 in two Phase 3 clinical trials.
AbbVie’s risankizumab (SKYRIZI) showed greater improvements in psoriatic arthritis (PsA) signs and symptoms compared to treatment with placebo at week 24 in two Phase 3 clinical trials, according to research slated to be presented American College of Rheumatology (ACR) Convergence 2021.
Use of risankizumab in psoriatic arthritis is not approved in the U.S. or EU, and its safety and efficacy are currently under review by the respective regulatory authorities. Recently, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of risankizumab for the treatment of active psoriatic arthritis.
In 24-week integrated results from two Phase 3 clinical trials, KEEPsAKE 1 and KEEPsAKE 2, patients receiving risankizumab achieved higher rates of ACR20 (55.5%) than patients receiving placebo (31.3%) at week 24. Additionally, patients receiving risankizumab showed greater improvements in the key clinical and patient-reported outcome endpoints compared to patients receiving placebo.
Efficacy at Week 241*** | |||
Risankizumab 150 mg (N=707) | Placebo (N=700) | ||
ACR20, % | 55.5 | 31.3 | |
HAQ-DIa, change from baseline | -0.27 | -0.08 | |
PASI 90b, % | 53.2 | 10.0 | |
MDA, % | 25.2 | 10.6 | |
Resolution of enthesitisc, % | 48.4 | 34.8 | |
Resolution of dactylitisd, % | 68.1 | 51.0 | |
ACR20, ≥ 20 improvement in American College of Rheumatology score; HAQ-DI, Health Assessment Questionnaire-Disability Index; PASI 90, ≥90% reduction in Psoriasis Area Severity Index; MDA, minimal disease activity; PBO, placebo; RZB, risankizumab. |
*** P-value <0.001 |
a Non-missing data at baseline RZB N=706; PBO N=6 |
b For patients with involved body surface area ≥ 3% at baseline (RZB N=396; PBO N=391). |
c For patients with enthesitis at baseline (RZB N=444; PBO N=448). |
d For patients with dactylitis at baseline (RZB N=188; PBO N=204). |
"Many people living with psoriatic arthritis continue to experience burdensome symptoms, including joint pain, red and scaly skin and other manifestations of the disease," says Andrew Östör, MD study author, associate professor and consultant rheumatologist at Cabrini Hospital, Monash University and Emeritus Research, Melbourne, Australia, in a news release. "The data in this analysis show risankizumab could be a valuable treatment option to help patients find meaningful relief from the signs and symptoms of psoriatic arthritis."
Across these integrated week 24 data, the safety profile of risankizumab was generally similar to that observed in patients with psoriasis, and no new safety signals were identified.1 Serious treatment-emergent adverse events (TEAE) occurred in 3.0% of patients treated with risankizumab compared with 4.4% on placebo.1 Serious infections occurred in 1% of patients treated with risankizumab and 1.6% of patients treated with placebo.1 The rates of adverse events leading to discontinuation of the study drug were 0.8% of patients treated with risankizumab compared with 1.4% on placebo. In the risankizumab group, there was one death not related to the study drug per investigator and one major adverse cardiac event (MACE) was reported.