AbbVie Presents Integrated Efficacy and Safety Data From Two Phase 3 Trials on Risankizumab (SKYRIZI®) in Psoriatic Arthritis at ACR Convergence 2021

Rhea-AI Summary

AbbVie presented integrated data from two Phase 3 trials, KEEPsAKE 1 and KEEPsAKE 2, showing that treatment with risankizumab (SKYRIZI) significantly improved signs and symptoms of psoriatic arthritis (PsA) after 24 weeks compared to placebo. Patients receiving risankizumab achieved an ACR20 response rate of 55.5% versus 31.3% for placebo. No new safety signals were reported, with serious treatment-emergent adverse events at 3.0% for risankizumab and 4.4% for placebo. Regulatory reviews for approval in the U.S. and EU are ongoing.

Positive

• Risankizumab showed a significant ACR20 response rate of 55.5% at week 24 compared to 31.3% for placebo.
• Higher improvements observed in key endpoints including HAQ-DI, PASI 90, and resolution of dactylitis.
• No new safety signals were identified, maintaining a safety profile similar to that seen in psoriasis patients.
• European Medicines Agency's CHMP has adopted a positive opinion for risankizumab's approval in PsA.

Negative

• Use of risankizumab is still not approved in the U.S. or EU, pending regulatory review.
• Risankizumab's safety and efficacy are currently under ongoing scrutiny, delaying its market potential.

NORTH CHICAGO, Ill., Nov. 5, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the presentation of integrated data from two Phase 3 clinical trials, KEEPsAKE 1 and KEEPsAKE 2, evaluating the efficacy and safety of risankizumab (SKYRIZI^®) in adult patients with active psoriatic arthritis (PsA). The data showed that 24-weeks of treatment with risankizumab resulted in greater improvements in PsA signs and symptoms compared with placebo with no new safety signals.¹ These results will be featured in an American College of Rheumatology (ACR) Convergence 2021 plenary session on Saturday, Nov. 6, from 9:45-10 a.m. CT (Abstract #0453).

"Psoriatic arthritis is a chronic, progressive and debilitating disease. These results support the potential of risankizumab to help improve joint and skin symptoms for people living with this disease and assist more people in their pursuit of reaching their treatment goals," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie.

Patients receiving risankizumab achieved higher rates of ACR20 (55.5%) than patients receiving placebo (31.3%) at week 24.¹ Additionally, patients receiving risankizumab showed greater improvements in the key clinical and patient-reported outcome endpoints compared to patients receiving placebo.¹

Efficacy at Week 241***
	Risankizumab 150 mg (N=707)	Placebo (N=700)
ACR20, %	55.5	31.3
HAQ-DIa, change from baseline	-0.27	-0.08
PASI 90b, %	53.2	10.0
MDA, %	25.2	10.6
Resolution of enthesitisc, %	48.4	34.8
Resolution of dactylitisd, %	68.1	51.0

ACR20, ≥ 20 improvement in American College of Rheumatology score; HAQ-DI, Health Assessment Questionnaire-Disability Index; PASI 90, ≥90% reduction in Psoriasis Area Severity Index; MDA, minimal disease activity; PBO, placebo; RZB, risankizumab.

*** P-value <0.001

a Non-missing data at baseline RZB N=706; PBO N=6

b For patients with involved body surface area ≥ 3% at baseline (RZB N=396; PBO N=391).

c For patients with enthesitis at baseline (RZB N=444; PBO N=448).

d For patients with dactylitis at baseline (RZB N=188; PBO N=204).

"Many people living with psoriatic arthritis continue to experience burdensome symptoms, including joint pain, red and scaly skin and other manifestations of the disease," said Andrew Östör, M.D., study author, associate professor and consultant rheumatologist at Cabrini Hospital, Monash University and Emeritus Research, Melbourne, Australia. "The data in this analysis show risankizumab could be a valuable treatment option to help patients find meaningful relief from the signs and symptoms of psoriatic arthritis."

Across these integrated week 24 data, the safety profile of risankizumab was generally similar to that observed in patients with psoriasis, and no new safety signals were identified.¹ Serious treatment-emergent adverse events (TEAE) occurred in 3.0% of patients treated with risankizumab compared with 4.4% on placebo.¹ Serious infections occurred in 1% of patients treated with risankizumab and 1.6% of patients treated with placebo.¹ The rates of adverse events leading to discontinuation of the study drug were 0.8% of patients treated with risankizumab compared with 1.4% on placebo.¹ In the risankizumab group, there was one death not related to the study drug per investigator and one major adverse cardiac event (MACE) was reported.¹

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

Use of risankizumab in psoriatic arthritis is not approved in the U.S. or EU, and its safety and efficacy are currently under review by the respective regulatory authorities. Recently, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of risankizumab for the treatment of active psoriatic arthritis.

The ACR Convergence 2021 abstracts can be found here.

About Psoriatic Arthritis

Psoriatic arthritis (PsA) is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin.² In PsA, the immune system causes inflammation that can lead to skin lesions associated with psoriasis, pain, fatigue and stiffness in the joints.^2,3 PsA affects about 30% of people with psoriasis.^4,5

About KEEPsAKE 1 and KEEPsAKE 2^6-9

KEEPsAKE 1 and KEEPsAKE 2 are both Phase 3, multicenter, randomized, 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 disease modifying anti-rheumatic drug (DMARD). KEEPsAKE 2 evaluated risankizumab in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs. Patients were randomized to risankizumab 150 mg or placebo followed by risankizumab 150 mg at week 24.

The primary endpoint for both studies was the achievement of ACR20 response at week 24. Ranked secondary endpoints included, but were not limited to, change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI), resolution of enthesitis and dactylitis, as well as the achievement of PASI 90 and 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 risankizumab 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 Risankizumab-rzaa (SKYRIZI^®) in the United States¹⁰
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).

Important Safety Information

What is the most important information I should know about SKYRIZI^® (risankizumab-rzaa)?
SKYRIZI may cause serious side effects, including infections. SKYRIZI is a prescription medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.

• Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
• fever, sweats, or chills
• muscle aches
• weight loss
• cough
• warm, red, or painful skin or sores on your body different from your psoriasis
• diarrhea or stomach pain
• shortness of breath
• blood in your mucus (phlegm)
• burning when you urinate or urinating more often than normal

Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?"
• have an infection that does not go away or that keeps coming back.
• have TB or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). Medications that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine.
• are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?"

The most common side effects of SKYRIZI include upper respiratory infections, feeling tired, fungal skin infections, headache, and injection site reactions.

These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects.

Use SKYRIZI exactly as your healthcare provider tells you to use it. SKYRIZI is available in a 150 mg/mL prefilled syringe and pen.

This is not a complete summary of all safety information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please click here for Full Prescribing Information and Medication Guide for SKYRIZI.

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

About AbbVie in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals. For more information on AbbVie in rheumatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.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 2020 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. Östör A, et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-Week Integrated Results from 2 Phase 3, Randomized, Double-blind Clinical Trials for CsDMARD-IR and Bio-IR Patients. 2021 American College of Rheumatology Convergence; 0453.
2. 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.
3. 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.
4. Rodrigo Valdes-Rodriguez MD, et al. (2018). Itch in Psoriasis: From Basic Mechanisms to Practical Treatments. Psoriasis Forum, Volume: 18a issue: 3,page(s): 110-117.
5. Mease PJ, et al. (2013). Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol, 69(5), 729-735.
6. Kristensen LE, 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. Annals of the Rheumatic Diseases 2021;80:1315-1316.
7. 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 the Rheumatic Diseases 2021;80:138-139.
8. 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. Available at: https://clinicaltrials.gov/ct2/show/NCT03675308. Accessed: November 2021.
9. 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. Available at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed: November 2021.
10. SKYRIZI^® (risankizumab-rzaa) [Package Insert]. North Chicago, Ill.: AbbVie Inc.

 

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SOURCE AbbVie

FAQ

What were the results of the Phase 3 trials for ABBV's risankizumab?

The Phase 3 trials showed a significant ACR20 response rate of 55.5% for risankizumab compared to 31.3% for placebo at week 24.

What is the safety profile of risankizumab in the recent trials?

The safety profile of risankizumab was similar to that observed in psoriasis patients, with serious treatment-emergent adverse events at 3.0%.

What regulatory status does ABBV's risankizumab have in the U.S. and EU?

Risankizumab is not yet approved for use in the U.S. or EU, but the European Medicines Agency's CHMP has issued a positive opinion for its approval for psoriatic arthritis.

When were the trial results for ABBV's risankizumab presented?

The trial results were presented at the ACR Convergence 2021 on November 6, 2021.