AbbVie Announces Late-Breaking Results of Study Evaluating 52-Week Efficacy and Safety of SKYRIZI® (risankizumab) in Plaque Psoriasis Patients With a Prior Suboptimal Response to IL-17 Inhibitor Therapy

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Mar 18, 2023, 10:03 ET

Treatment with SKYRIZI (risankizumab) demonstrated short- and long-term efficacy of psoriasis signs and symptoms (sPGA 0/1) at week 16 and week 52 in a difficult-to-treat population, with no new safety signals observed in an open-label, single-arm phase 3b study
Patients with moderate to severe psoriasis previously received at least six months of treatment with secukinumab or ixekizumab with a suboptimal response, defined as a static Physician's Global Assessment (sPGA) score of 2 or 3 and body surface area of 3% to <10%, before switching to risankizumab

NORTH CHICAGO, Ill., March 18, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new 52-week data from an open-label, single-arm study demonstrating improved plaque psoriasis signs and symptoms among a difficult-to-treat patient population who received SKYRIZI^® (risankizumab), an IL-23 inhibitor. These moderate to severe plaque psoriasis patients previously had a suboptimal response to treatment with secukinumab or ixekizumab, both IL-17A inhibitor therapies, for at least six months before switching to risankizumab. The data were presented at a Late-Breaking Research session during the 2023 American Academy of Dermatology (AAD) Annual Meeting in New Orleans, Louisiana.

"The evidence presented at the AAD meeting underscores the important role of SKYRIZI in helping patients in a difficult-to-treat population achieve skin clearance and a resolution of their burdensome psoriasis symptoms," said Nicole Selenko-Gebauer, M.D., MBA, vice president, global medical affairs, AbbVie. "Science is at the core of our work, and our continuing research represents our steady commitment to improving the standards of care, now and in the future, for patients with serious immune-mediated conditions like plaque psoriasis."

Findings from this phase 3b, open-label single-arm study showed that 56.3% of patients who received risankizumab, without a washout period following a suboptimal response to secukinumab or ixekizumab achieved the week 16 primary endpoint of reduced signs and symptoms of psoriasis (sPGA 0/1). A suboptimal response was defined as a static Physician's Global Assessment (sPGA) score of 2 or 3 and body surface area of 3% to <10% after at least six months of treatment with secukinumab or ixekizumab. The mean duration of treatment was 2.6 years for patients receiving secukinumab, and 2.1 years for patients receiving ixekizumab.

Highlights from this new aIMM 52-week analysis include:

The majority of patients (63.0%) achieved clear or almost clear skin (sPGA 0/1) at the week 52 primary endpoint
Patients achieved completely clear skin (sPGA score of 0) at week 16 (19.8%) and week 52 (26.2%), a secondary endpoint
Patients reported no symptoms such as pain, itching, redness and burning, as shown by a Psoriasis Symptom Scale (PSS) score of 0 at week 16 (20.2%) and week 52 (27.4%), a secondary endpoint

No new safety signals were observed in this analysis.

"Advanced therapies represent an important option in the treatment of plaque psoriasis, but as a physician, it's critically important to continually assess if patients are having an optimal response to treatment, as residual psoriasis can still have a significant impact on a patient's life," said Professor Richard Warren from the University of Manchester and Norten Care Alliance, UK. This study showed that risankizumab was able to improve clinical signs and symptoms of patients who had a suboptimal response with the anti-IL-17 therapies secukinumab and ixekizumab, contributing to the whole of evidence supporting risankizumab use in moderate to severe plaque psoriasis."

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

About Psoriasis
Psoriasis is a chronic, immune-mediated, inflammatory skin condition that produces thickened, scaling skin due to rapid growth of skin cells.¹ It affects an estimated 7.5 million people in the U.S.,² with approximately 80-90% having plaque psoriasis.¹ People with psoriasis also experience a significant emotional, psychological and social burden that can negatively impact their quality of life.⁴

About the Phase 3b, Open-Label Study
The findings presented today are part of a Phase 3b, multicenter, interventional, open-label, single-arm study of adults ages 18 years or older with moderate to severe plaque psoriasis. The trial included 252 participants who had been treated with secukinumab or ixekizumab for at least six months and experienced a suboptimal response, defined as sPGA score of 2 or 3 and body surface area of 3% to <10%.

Participants received SKYRIZI 150mg at weeks 0, 4, and once every 12 weeks for 52 weeks without a washout period. The primary endpoint was the percentage of participants achieving an sPGA score of 0/1 at week 16. The secondary endpoints were sPGA 0/1 at week 52, and sPGA 0, DLQI 0/1 and PSS 0 at weeks 16 and 52. The mean duration of treatment was 2.6 years for patients receiving secukinumab and 2.1 years for ixekizumab-treated patients. This finding was previously reported at the European Academy of Dermatology and Venereology (EADV) 2022 Congress.

Efficacy results were assessed by non-responder imputation. Limitations of this analysis include lack of placebo control or active comparator; definition of suboptimal response has been based on expert feedback and to reflect clinical practice. Safety was monitored throughout the study.

More information on these trials can be found at www.clinicaltrials.gov (NCT04102007).

About SKYRIZI^® (risankizumab-rzaa)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.⁵ IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.⁵ Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.^6-11

SKYRIZI U.S. Uses and Important Safety Information¹²

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).
active psoriatic arthritis (PsA).
moderate to severe Crohn's disease.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SKYRIZI^® (risankizumab-rzaa)?

SKYRIZI is a prescription medicine that may cause serious side effects, including:

Serious allergic reactions:

Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:
- fainting, dizziness, feeling lightheaded (low blood pressure)
- swelling of your face, eyelids, lips, mouth, tongue, or throat
- trouble breathing or throat tightness
- chest tightness
- skin rash, hives
- itching

Infections:
SKYRIZI 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
- cough
- shortness of breath
- blood in your mucus (phlegm)
- muscle aches
- warm, red, or painful skin or sores on your body different from your psoriasis
- weight loss
- diarrhea or stomach pain
- burning when you urinate or urinating more often than normal

Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

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). Medicines 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.
become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry.

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?"

Liver problems in Crohn's disease: A person with Crohn's disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and up to 12 weeks of treatment and may stop treatment with SKYRIZI if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine.

The most common side effects of SKYRIZI in people treated for Crohn's disease include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, and urinary tract infection.

The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections.

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, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector.

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
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, LinkedIn or Instagram.

AbbVie 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:

AAD. Psoriasis: Overview. https://www.aad.org/public/diseases/psoriasis/what/overview. Accessed February 16, 2023.
National Psoriasis Foundation. About Psoriasis. https://www.psoriasis.org/about-psoriasis/. Accessed February 16, 2023.
National Psoriasis Foundation. Statistics. https://www.psoriasis.org/content/statistics. Accessed February 16, 2023.
Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11.
A Study on the long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03047395. Accessed on February 17, 2023.
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03105128. Accessed on March 8, 2022.
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03398135. Accessed on March 8, 2022.
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. Available at: https://clinicaltrials.gov/ct2/show/NCT03398148. Accessed on March 8, 2022.
BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. Available at: https://clinicaltrials.gov/ct2/show/NCT03675308. Accessed on March 8, 2022.
BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. Available at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed on March 8, 2022.
SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.