Benzinga | Jan 21, 2022 04:31PM EST

AbbVie Reports FDA Approval For Second Indication On SKYRIZI To Treat Adults With Active Psoriatic Arthritis

- SKYRIZI(r) (risankizumab-rzaa) met the primary endpoint of ACR20 at week 24 in two pivotal studies, demonstrating significant improvement in joint symptoms, including swollen, tender and painful joints, compared to placebo[1,2,3]

- SKYRIZI also showed improvement in dactylitis and enthesitis - inflammation of fingers, toes and sites at which tendons or ligaments attach to bone[1,2,3]

- SKYRIZI is now the only IL-23 inhibitor approved for adults with moderate to severe plaque psoriasis and active psoriatic arthritis that can be administered with a single injection four times a year (after two starter doses at weeks 0 and 4)[1]

NORTH CHICAGO, Ill., Jan. 21, 2022 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI(r) (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts approximately 30 percent of patients with psoriasis.1,4-7

The FDA approval is supported by data from two pivotal studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated the efficacy and safety of SKYRIZI in adults with active PsA, including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying antirheumatic drugs (DMARDs).2,3 Across the two Phase 3 studies, SKYRIZI met the primary endpoint of ACR20 response at week 24 compared to placebo and demonstrated significant improvements across several other manifestations of PsA, including swollen, tender and painful joints.2,3

"Patients often do not suspect a connection between their psoriasis skin symptoms and the joint pain, swelling and stiffness they may be experiencing, potentially leading to a delay in diagnosis and treatment of psoriatic arthritis," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "We're proud to expand the use of SKYRIZI to patients with psoriatic arthritis who are living with the debilitating combination of skin and joint symptoms."

SKYRIZI maintains a dosing regimen for PsA that is consistent with the existing regimen for moderate to severe plaque psoriasis patients -- a single 150 mg subcutaneous injection four times a year (after two starter doses at weeks 0 and 4) -- and can be administered alone or in combination with DMARDs.1

"In the pivotal KEEPsAKE trials, SKYRIZI demonstrated improvements across a number of psoriatic arthritis symptoms, including joint pain, enthesitis and dactylitis," said Alan J. Kivitz, M.D., CPI, founder and medical director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center in Duncansville, Pa. and KEEPsAKE clinical trial investigator. "This approval provides both dermatologists and rheumatologists with an option that helps improve skin and joint symptoms in patients with active psoriatic arthritis, alongside a quarterly dosing schedule that may fit their patients' lifestyle."

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

Highlights from the Pivotal Phase 3 Program1,2,3

* In KEEPsAKE-1 and KEEPsAKE-2, 57.3 percent and 51.3 percent of patients receiving SKYRIZI achieved the primary endpoint of ACR20 response at week 24, respectively, versus 33.5 percent and 26.5 percent receiving placebo. SKYRIZI also demonstrated improvements in ACR50 and ACR70 responses compared to placebo at week 24.

* SKYRIZI showed improvements in other key manifestations of PsA compared to placebo at week 24, including improvements in dactylitis and enthesitis for patients with pre-existing dactylitis and enthesitis.

* Patients with coexistent plaque psoriasis receiving SKYRIZI saw improvements in the skin lesions of psoriasis, compared to placebo, as measured by the Psoriasis Area Severity Index (PASI 90) at week 24.

* SKYRIZI showed a statistically significant improvement in physical function, compared to placebo, as measured by the Health Assessment Questionnaire-Disability Index at week 24, with a mean difference of 0.20 in KEEPsAKE-1 and 0.16 in KEEPsAKE-2.

Safety1

* The overall safety profile observed in patients with psoriatic arthritis treated with SKYRIZI is generally consistent with the safety profile in patients with plaque psoriasis.

* SKYRIZI may cause serious side effects, including: Serious Allergic Reactions: Stop using SKYRIZI and get medical help right away if you get any symptoms of a serious allergic reaction. Infections: SKYRIZI may increase your risk of infections. Before starting treatment, your doctor should check you for infections and tuberculosis. Tell your doctor right away if you have an infection or symptoms of one.

Do not take SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI.

Also, tell your doctor if you plan to or recently received a vaccine.

Patient Access and Support

AbbVie is committed to helping people access SKYRIZI and other medicines, including offering a patient support program and co-pay card that may reduce out-of-pocket costs to as little as $5 per month for eligible, commercially-insured patients. For those with health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides SKYRIZI at no charge to those who qualify. More information about this assistance program can be found at www.AbbVie.com/myAbbVieAssist.