AbbVie Expands Immunology Portfolio in the European Union with the European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Adults with Active Psoriatic Arthritis
AbbVie (NYSE: ABBV) has announced that the European Commission (EC) has approved SKYRIZI.® (risankizumab, 150 mg, subcutaneous injection at week 0, week 4 and every 12 weeks thereafter) alone or in combination with methotrexate (MTX). This is for the treatment of active psoriatic arthritis in adults who have had an inadequate response. Or those who have been intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Marking the second indication for risankizumab, the Marketing Authorization will be valid in all member states of the European Union. This is as well as Iceland, Liechtenstein, Norway and Northern Ireland.
Professor Brian Kirby spoke about the European Commission Approval of risankizumab for the Treatment of Adults with Active Psoriatic Arthritis. He said “We know that almost 30% of Psoriasis patients will develop Psoriatic Arthritis. As a Dermatologist having treatments available that are effective on skin and the joints provide reassurance when treating Psoriasis patients. It is positive to see an additional treatment available for the treatment of PsA.”
“Discovering, developing, and delivering medicines that have a remarkable impact on patients’ lives is a complex endeavour. It takes time, expertise, and unwavering innovation,” said Andres Rodrigo, General Manager, AbbVie Ireland. “This approval is a significant milestone for AbbVie in our pursuit to continually raise standards of care, helping alleviate the burden experienced by patients with psoriatic disease.”
Risankizumab received EC approval based on data from two Phase 3 clinical studies, KEEPsAKE-1 and KEEPsAKE-2.1-6 In these studies, risankizumab met the primary endpoint of ACR20 response at week 24 versus placebo, and ranked secondary endpoints including, but not limited to, improvements in several clinical manifestations of psoriatic arthritis such as physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) and minimal disease activity (MDA) at week 24.1-3,6
Highlights from the pivotal Phase 3 program1-3,6
- In KEEPsAKE-1 and KEEPsAKE-2, 57.3 and 51.3 percent of patients receiving risankizumab achieved the primary endpoint of ACR20 response at week 24, respectively, versus 33.5 and 26.5 percent receiving placebo (p≤0.001).
- Risankizumab-treated patients showed significantly greater improvement from baseline in physical function as measured by HAQ-DI -0.31 and -0.22, compared to placebo -0.11 and -0.05 at week 24 (p≤0.001) in KEEPsAKE-1 and KEEPsAKE-2, respectively.
- At week 24, 25.0 percent and 25.6 percent of risankizumab-treated patients achieved MDA, in KEEPsAKE-1 and KEEPsAKE-2 respectively, compared to 10.2 percent and 11.4 percent of those on placebo (p≤0.001).
The safety profile of risankizumab in psoriatic arthritis was consistent with the safety profile of risankizumab in plaque psoriasis. This is with no new safety risks observed.6 Through week 24, serious adverse events occurred in 2.5 percent and 4.0 percent of patients treated with risankizumab in KEEPsAKE-1 and KEEPsAKE-2. This was respectively, compared with 3.7 percent and 5.5 percent on placebo.1-3,6
Rates of serious infections were 1.0 and 0.9 percent in risankizumab-treated patients in KEEPsAKE-1 and KEEPsAKE-2. This was respectively, and 1.2 and 2.3 percent in patients who received placebo.1-3,6
The rates of adverse events leading to discontinuation of the study drug were 0.8 percent and 0.9 percent. This is of patients treated with risankizumab in KEEPsAKE-1 and KEEPsAKE-2. This was respectively, compared with 0.8 percent and 2.3 percent on placebo.1-3,6 In KEEPsAKE-1, there was one death in the risankizumab group not related to the study drug per investigator.1,2,6 There were no deaths reported in KEEPsAKE-2.1,3,6
Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
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