AbbVie’s SKYRIZI® ▼ (risankizumab) Receives MHRA Approval For Use In Adults with Active Psoriatic Arthritis

AbbVie’s SKYRIZI^® ▼ (risankizumab) Receives MHRA Approval For Use In Adults with Active Psoriatic Arthritis

• Risankizumab is indicated 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)
• Approval is supported by data from pivotal Phase 3 studies KEEPsAKE-1 and KEEPsAKE-2,[1]^{, [2], [3]} demonstrating statistical significance for the primary endpoint of ACR20 response for efficacy and multiple secondary endpoints
• The safety profile of risankizumab in psoriatic arthritis was generally consistent with its safety profile in plaque psoriasis patients[4] 

MAIDENHEAD, UK, November 22, 2021 – AbbVie (NYSE: ABBV) today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has approved SKYRIZI^® (risankizumab), 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).[5]

Risankizumab, a humanised immunoglobulin G1 (IgG1) monoclonal antibody selective to the

IL-23 p19 subunit, is administered by injection at week 0, 4 and 12, and every 12 weeks thereafter.⁴ This is the second indication for risankizumab, which is already licensed for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy in the UK.⁴

This approval is supported by data from two Phase 3 clinical studies, KEEPsAKE-1 and KEEPsAKE-2. ^1,2,3,4 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.^1,2,3,4 The safety profile of risankizumab in psoriatic arthritis was generally consistent with its safety profile in plaque psoriasis, with no new safety risks observed.^1,2,3,4

Highlights from the pivotal Phase 3 program include: ^1,2,3

• 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).

Psoriatic arthritis is a systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin. In psoriatic arthritis, the immune system creates inflammation that can lead to skin lesions associated with psoriasis, pain, fatigue, swelling and stiffness in the joints.[6]^,[7]

Commenting on today’s decision, AbbVie UK medical director, Belinda Byrne said, “We are delighted that the MHRA has approved risankizumab for use in adults living with active psoriatic arthritis. As a leader in dermatology, AbbVie is committed to improving the quality of life for those with dermatologic comorbidities. Today’s announcement is an important step forward for patients.”

“Psoriatic arthritis is a common co-morbidity in people living with psoriasis”, explained Dr Laura Savage, Consultant Dermatologist at Leeds Teaching Hospitals NHS Trust. “The swelling and pain caused by joint inflammation can severely affect a person’s ability to carry out their normal day-to-day activities. Today’s approval is a meaningful milestone in advancing psoriatic arthritis care as we need more treatment options to manage this debilitating, life-long condition and meet the individual needs of our patients.”

About risankizumab

Risankizumab is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.⁴ IL-23 is a cytokine involved in inflammatory processes linked to psoriasis.⁴

Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Risankizumab, alone or in combination with methotrexate (MTX), is also indicated 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 antirheumatic drugs (DMARDs).⁴

The approved dose for risankizumab is 150 mg, administered by subcutaneous injection at week 0 and 4, and every 12 weeks thereafter. 

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

About KEEPsAKE-1 and KEEPsAKE-2^{1,2,3,[8],[9]}

KEEPsAKE-1 and KEEPsAKE-2 are both Phase 3, multicentre, randomised, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of risankizumab in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated risankizumab in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated risankizumab in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs. Patients were randomised to risankizumab 150 mg or placebo followed by risankizumab 150 mg at week 24. Patients randomised to risankizumab 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, but were not limited to, the achievement of minimal disease activity (MDA) as well as the change from baseline in HAQ-DI at week 24. The studies are ongoing, and the long-term extension remains blinded to the original randomisation and evaluate the long-term safety, tolerability and efficacy of risankizumab in patients who have completed the placebo-controlled period.

The safety profile of risankizumab in psoriatic arthritis was generally consistent with its safety profile in plaque psoriasis, with no new safety risks observed.⁴ 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, respectively, compared with 3.7 percent and 5.5 percent on placebo.^1,2,3 Rates of serious infections were 1.0 and 0.9 percent in risankizumab-treated patients in KEEPsAKE-1 and KEEPsAKE-2, respectively, and 1.2 and 2.3 percent in patients who received placebo.^1,2,3 In KEEPsAKE-1, there was one death in the risankizumab group not related to the study drug per investigator.^1,2 There were no deaths reported in KEEPsAKE-2.^1,3

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

About AbbVie UK
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. The company strives to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on Twitter, YouTube.

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References

[1]. Kristensen, L.E., et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 52-Week Results From the KEEPsAKE 1 and KEEPsAKE 2 Trials. 2021 EADV Virtual Congress. D1T01.4A.

[2]. Kristensen, L.E., et al. Efficacy and Safety of Risankizumab in Patients With Active Psoriatic Arthritis After Inadequate Response or Intolerance to DMARDs: 24-Week Results From the Phase 3, Randomized, Double-Blind KEEPsAKE 1 Trial.

[3]. Östör, A., et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis, Including Patients With Inadequate Response or Intolerance to Biologic Therapies: 24-Week Results From the Phase 3, Randomized, Double-blind, KEEPsAKE 2 Trial. Annals of Rheumatic Diseases. May 2021.

[4]. SKYRIZI 150 mg pre-filled pen [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.medicines.org.uk/emc. Accessed November 2021.

[5]. SKYRIZI 150 mg pre-filled syringe [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.medicines.org.uk/emc. Accessed November 2021.

[6]. Duarte GV, et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003.

[7]. Diseases & Conditions: Psoriatic Arthritis. 2019. American College of Rheumatology. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed November 2021.

[8]. Clinicaltrials.gov. A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE 2). clinicaltrials.gov; 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed November 2021.

[9]. Clinicaltrials.gov. A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1). clinicaltrials.gov; 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03675308. Accessed November 2021.