AbbVie Submits Regulatory Applications for SKYRIZI® (risankizumab) in Psoriatic Arthritis to FDA and EMA

- Submissions supported by two Phase 3 studies in patients with active psoriatic arthritis in which SKYRIZI demonstrated improved skin and joint symptoms and physical function, with a greater proportion of patients achieving minimal disease activity versus placebo[1]
- In the pivotal studies, patients treated with SKYRIZI received four maintenance doses a year, following two initiation doses[1]
- Psoriatic arthritis is a systemic inflammatory disease that impacts the skin and joints, affecting approximately 30 percent of patients with psoriasis[2-5]
- AbbVie remains committed to working with regulatory authorities to bring SKYRIZI to more patients living with immune-mediated diseases AbbVie (NYSE: ABBV) today announced that it has submitted applications seeking approval for SKYRIZI^® (risankizumab-rzaa, 150 mg) to the U.S. Food and Drug Administration (FDA) and for SKYRIZI^® (risankizumab, 150 mg) to the European Medicines Agency (EMA) for the treatment of adults with active psoriatic arthritis.¹ The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).¹

"Most patients living with psoriatic arthritis experience both skin and joint disease which can be especially burdensome. Despite advancements, many patients cannot find relief from the signs and symptoms of this disease," said Michael Severino, M.D., vice chairman and president, AbbVie. "We are dedicated to providing options that can help more patients living with psoriatic arthritis reach their treatment goals."

In the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 studies, SKYRIZI demonstrated significant improvements in disease activity (as measured by ACR20 response and minimal disease activity), skin clearance (as measured by at least a 90 percent improvement in Psoriasis Area Severity Index [PASI 90]) and physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) at week 24 versus placebo.^1* In both studies, significantly more patients treated with SKYRIZI achieved the primary endpoint of ACR20 response at week 24 versus placebo.¹ The safety profile of SKYRIZI in these studies was generally consistent with the safety profile of SKYRIZI in plaque psoriasis, with no new safety risks observed.^1,6-8

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

*Minimal disease activity is defined as the fulfillment of five of seven outcome measures: Tender joint count ≤1; swollen joint count ≤1; PASI ≤1 or body surface area-psoriasis ≤3 percent; Patient's Assessment of Pain Numerical Rating Scale (NRS) ≤1.5; Patient Global Assessment-Disease Activity NRS ≤2.0; HAQ-DI score ≤0.5; and Leeds Enthesitis Index ≤1. Skin symptoms were measured by a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90). Physical function was measured by the HAQ-DI.

About Psoriatic Arthritis

Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin.^3,4 In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue, stiffness in the joints and cause a red, scaly rash.^3,4

About KEEPsAKE-1 and KEEPsAKE-2^1,9,10

KEEPsAKE-1 and KEEPsAKE-2 are both Phase 3, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of SKYRIZI in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated SKYRIZI in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated SKYRIZI in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs. Patients were randomized to SKYRIZI 150 mg or placebo followed by SKYRIZI 150 mg at week 24. Patients randomized to SKYRIZI received four maintenance doses a year, following two initiation doses.

The primary endpoint for both studies was the achievement of ACR20 response at week 24. Ranked secondary endpoints included change from baseline in HAQ-DI, as well as the achievement of PASI 90 and minimal disease activity (MDA) at week 24. The studies are ongoing, and the long-term extension remains blinded to evaluate the long-term safety, tolerability and efficacy of SKYRIZI in patients who have completed the placebo-controlled period.

More information on these trials can be found at www.clinicaltrials.gov (KEEPsAKE-1: NCT03675308; KEEPsAKE-2: NCT03671148).

About SKYRIZI^® (risankizumab)

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.^11,12 In April 2019, SKYRIZI received U.S. Food and Drug Administration approval for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The approved dose for SKYRIZI is 150 mg (two 75 mg injections), administered by subcutaneous injection at week 0 and 4, and every 12 weeks thereafter. SKYRIZI was also approved by the European Commission in April 2019. Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.^9,10,13-15 Use of SKYRIZI in psoriatic arthritis is not approved and its safety and efficacy have not been established by regulatory authorities.

About SKYRIZI^® (risankizumab-rzaa) in the United States¹²

SKYRIZI is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).