New Late-Breaking Results from Phase 3 Trials of SKYRIZI® (risankizumab) Evaluating Long-term Effect on Skin and Joint Symptoms in Patients with Psoriatic Arthritis at Week 100

- Analyses included 100-week efficacy and safety data from the four-year, open-label extension period of KEEPsAKE 1 and 2 evaluating SKYRIZI in patients with active psoriatic arthritis1

- Ongoing treatment with SKYRIZI demonstrated consistent long-term efficacy in psoriatic arthritis with similar rates of improvement in skin (PASI 90) and joint (ACR, enthesitis, dactylitis) symptoms at week 100 as those reported at week 521

- No new safety signals were observed through 100 weeks1-4

NORTH CHICAGO, Ill., Sept. 10, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced new, long-term data analyses of KEEPsAKE 1 and 2, Phase 3 trials evaluating SKYRIZI® (risankizumab, 150 mg) in adult patients with active psoriatic arthritis. Results showed that at week 100 of the open-label extension period, patients receiving SKYRIZI reported improvement in skin and joint symptoms, with more than half of patients in KEEPsAKE 1 and 2 achieving a 90 percent reduction in the Psoriasis Area and Severity Index (PASI 90) and an American College of Rheumatology 20 (ACR20) response. Additionally, the data demonstrated no new observed safety signals through 100 weeks.1-4 These results were featured during the "Late Breaking News" session at the 31st European Academy of Dermatology and Venereology (EADV) Hybrid Congress onsite in Milan and online.

"We're pleased to share these new, nearly two-year analyses, which showed SKYRIZI maintained improvements across joint and skin measures of psoriatic arthritis over time," said Doina Cosma-Roman, M.D., vice president and global head, Clinical Development, Immunology, AbbVie. "It is critically important for physicians to have treatment options that demonstrate lasting efficacy, as we know people living with psoriatic arthritis discontinue therapies due to loss of efficacy or tolerability."

The new data from the open-label extension period showed that at 100 weeks, 64 and 57 percent of patients initially treated with SKYRIZI achieved ACR20 response in KEEPsAKE 1 and 2, respectively.1 Additionally, at week 100, 71 and 67 percent of patients from KEEPsAKE 1 and 2, respectively, initially treated with SKYRIZI and who had a body surface area involvement greater than or equal to ≥3 percent at baseline, achieved PASI 90.1

Furthermore, at week 100, pooled results from KEEPsAKE 1 and 2 showed that 76 and 57 percent of patients, respectively, initially treated with SKYRIZI achieved resolution of dactylitis and enthesitis.1 For patients in KEEPsAKE 1 with nail psoriasis at baseline and who were initially treated with SKYRIZI, mean scores for Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and modified Nail Psoriasis Severity Index (mNAPSI) were maintained at week 100 compared with week 52.1

"Psoriatic arthritis often presents with musculoskeletal symptoms, including pain and swelling in the knees, wrists, ankles and fingers, as well as pain in the hips and heels, which can significantly reduce a person's quality of life," said Lars Erik Kristensen, M.D., Ph.D., consultant and head of science at the Parker Institute in Copenhagen, Denmark and associate professor, SUS University Hospital in Lund, Sweden. "These results highlight SKYRIZI's potential to relieve symptoms in both biologic-naïve and -experienced patients with active psoriatic arthritis in the long-term."

SKYRIZI was generally well-tolerated, and no new safety signals were noted in both KEEPsAKE 1 and 2 at 100 weeks of treatment.1-4 Serious treatment-emergent adverse events (TEAEs) occurred at 7.6 events/100 patient-years (E/100PY) and 9.9 E/100PY in KEEPsAKE 1 and 2, respectively.1 Rates of serious infections in KEEPsAKE 1 and 2 were 2.3 and 1.6 E/100PY, respectively.1 Major adverse cardiac events (MACE) occurred at 0.1 E/100PY in KEEPsAKE 1 and 0.5 E/100PY in KEEPsAKE 2.1 The rates of TEAEs leading to discontinuation of the study drug in KEEPsAKE 1 was 2.1 E/100PY and 1.2 E/100PY in KEEPsAKE 2.1 There were six deaths in KEEPsAKE 1, which were not related to the study drug, per investigator.1* In KEEPsAKE 2, there was one death not related to the study drug, per investigator.1

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

About Psoriatic Arthritis

Psoriatic arthritis is a heterogeneous, systemic and inflammatory disease with hallmark manifestations across multiple domains including joints and skin.5,6 In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue, stiffness in the joints and cause a red, scaly rash.5,6

About KEEPsAKE 1 and 21-4,7,8

KEEPsAKE 1 and 2 are both Phase 3, multicenter, randomized, double-blind and placebo-controlled studies designed to evaluate the safety and efficacy of SKYRIZI in adult patients with active psoriatic arthritis. KEEPsAKE 1 included patients with an inadequate response or intolerance to one or more conventional synthetic disease modifying antirheumatic drugs (csDMARD-IR), while KEEPsAKE 2 included patients with an inadequate response to csDMARD-IR and/or with an inadequate response or intolerance to one or two biologic therapies. In the first phase of the studies (Period 1), patients were randomized to SKYRIZI or placebo through week 24. At week 24, the open-label extension (Period 2) began, and all patients were treated with SKYRIZI.

The two studies are ongoing to evaluate the long-term safety, tolerability and efficacy of SKYRIZI in patients with psoriatic arthritis.

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.9,10 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic, immune-mediated diseases, including psoriasis.9 SKYRIZI is approved in the U.S. to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, as well as to treat active psoriatic arthritis in adults.11 In the EU, SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy; SKYRIZI, alone or in combination with methotrexate (MTX), 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 antirheumatic drugs (DMARDs).10 The approved dose for SKYRIZI is 150 mg (one 150 mg pre-filled pen or pre-filled syringe) administered by subcutaneous injections at week 0 and 4 and every 12 weeks thereafter.10 Phase 3 trials of SKYRIZI in psoriatic arthritis, psoriasis, Crohn's disease and ulcerative colitis are ongoing.12-14

EU Indications and Important Safety Information about SKYRIZI® (risankizumab)10

Indications

Skyrizi (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Skyrizi, alone or in combination with methotrexate (MTX), 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 antirheumatic drugs (DMARDs).

Important Safety Information

Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.

The most frequently reported adverse reactions were upper respiratory infections. Commonly (≥ 1/100 to < 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.

This is not a complete summary of all safety information.

See SKYRIZI full summary of product characteristics (SmPC) at www.ema.europa.eu.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Dermatology

For more than a decade, AbbVie has worked to uncover new solutions and improve care for people with serious skin diseases, including psoriasis, psoriatic arthritis, hidradenitis suppurativa and atopic dermatitis. With a broad clinical trial program, we continue to actively research and adapt to the evolving needs of the dermatology community and advance our pipeline to help people achieve their treatment goals and live beyond their skin disease. For more information on AbbVie in dermatology, visit  https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/dermatology.html. 

About AbbVie

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

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

1. Kristensen, L.E., et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE 1 and KEEPsAKE 2 Trials. 2022 European Academy of Dermatology and Venereology (EADV) Hybrid Congress.
2. 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 European Academy of Dermatology and Venereology Virtual Congress.
3. 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. 2021 World Psoriatic and Arthritis Conference.
4. 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.
5. Duarte G.V., et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003.
6. 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 August 17, 2022.
7. 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 August 17, 2022.
8. 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 August 17, 2022.
9. Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11.
10. SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu/en/documents/product- information/skyrizi-epar-product-information_en.pdf. Accessed August 17, 2022.
11. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.; 2022.
12. A Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease. clinicaltrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed August 17, 2022.
13. A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants with Moderately to Severely Active Ulcerative Colitis. clinicaltrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03398148. Accessed August 17, 2022.
14. Pipeline – Our Science | AbbVie. AbbVie. 2021. Available at: https:// www.abbvie.com/our-science/pipeline.html. Accessed August 17, 2022.

* In KEEPsAKE 1, there were six subjects with fatal events, but seven different events were reported.

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