- Approval supported by data from two Phase 3 studies evaluating SKYRIZI in psoriatic arthritis patients, KEEPsAKE-1 and KEEPsAKE-2[1-3]

- These two Phase 3 studies evaluated SKYRIZI 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)[1-6]

- In KEEPsAKE-1 and KEEPsAKE-2, statistical significance was achieved for the primary endpoint of ACR20 response for efficacy and multiple secondary endpoints, including physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) and Minimal Disease Activity (MDA)[6]

- The safety profile of SKYRIZI in patients with psoriatic arthritis was consistent with the safety profile of SKYRIZI in plaque psoriasis patients[6]

- Psoriatic arthritis is a systemic inflammatory disease that impacts the skin and joints, affecting approximately 30 percent of patients with psoriasis[7-10]

NORTH CHICAGO, Ill., Nov. 17, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today 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), for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Marking the second indication for SKYRIZI, the Marketing Authorization will be valid in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland.

"People living with psoriatic arthritis struggle with psoriatic lesions and joint inflammation that causes swelling and pain. Reducing these symptoms may give people the ability to resume their daily activities and improve their quality of life," said Michael Severino, M.D., vice chairman and president, AbbVie. "We are excited by the EC approval of SKYRIZI for the treatment of adults with active psoriatic arthritis."

SKYRIZI received EC approval based on data from two Phase 3 clinical studies, KEEPsAKE-1 and KEEPsAKE-2.1-3,6 In these studies, SKYRIZI 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 SKYRIZI achieved the primary endpoint of ACR20 response at week 24, respectively, versus 33.5 and 26.5 percent receiving placebo (p