• Higher rates of endoscopic remission and ulcer-free endoscopy were observed following subcutaneous SKYRIZI^® (risankizumab-rzaa)treatment versus placeboⁱ
• Results build on previously reported week 12 findings in which SKYRIZI achieved superiority in the co-primary endpoints of clinical remission and endoscopic response versus placebo
• These data support the application to the U.S. Food and Drug Administration seeking approval of a subcutaneous induction dosing regimen for SKYRIZI for patients with moderately to severely active Crohn's disease

NORTH CHICAGO, Ill., Oct. 13, 2026 /PRNewswire/ -- AbbVie today announced new findings from the Phase 3 AFFIRM study evaluating a new option for induction treatment with SKYRIZI^® (risankizumab-rzaa) in adults with moderately to severely active Crohn's disease (CD). Presented at the American College of Gastroenterology 2026 Annual Scientific Meeting, the findings build on the previously reported efficacy results of subcutaneous (SC) SKYRIZI^® treatment, showing new endoscopic remissionⁱⁱ and ulcer-free endoscopyⁱⁱⁱ outcomes for patients receiving SKYRIZI subcutaneously.ⁱ 

After treatment with SKYRIZI, 35.8% of patients achieved endoscopic remission, or the healing of the intestinal lining with little to no visible inflammation.ⁱ Across subgroups, 36.6% of patients who had ulcers at the start of the study achieved the complete absence of ulcers, known as ulcer-free endoscopy, after induction and maintenance treatment.ⁱ Among advanced therapy-naïve patients, rates were higher, with 45.1% achieving endoscopic remission and 49.0% achieving ulcer-free endoscopy, representing the highest rates observed across the evaluated subgroups.ⁱ

Evaluating subcutaneous SKYRIZI against stringent endoscopic outcomes demonstrates its potential to help CD patients achieve deeper control of underlying inflammation with a fully patient-administered regimen. Subcutaneous induction with SKYRIZI for adults with moderately to severely active CD is currently under regulatory review with the U.S. Food and Drug Administration and European Medicines Agency.

"Controlling underlying inflammation can limit the amount of time people living with Crohn's disease spend experiencing debilitating flares," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "The findings reported in AFFIRM are important because not only were the endoscopic outcomes higher with SKYRIZI, but they were achieved after induction, demonstrating the potential of subcutaneous SKYRIZI for helping patients achieve disease control early in their treatment journey."

AFFIRM included patients with longstanding, difficult-to-treat CD; 65% had previously experienced an inadequate response to advanced therapies. Patients had lived with the disease for an average of more than seven years and had substantial intestinal inflammation at study entry.ⁱ

"In clinical practice, we're making treatment decisions for patients at very different points in their disease, from those starting their first advanced therapy to those who have already cycled through several," said Millie D. Long, M.D., MPH, chief, division of gastroenterology and hepatology, University of North Carolina at Chapel Hill, and lead investigator of AFFIRM. "Seeing the endoscopic improvements in both advanced therapy-naïve and treatment-experienced patients observed in AFFIRM gives clinicians meaningful evidence to inform decisions across the treatment journey."

Safety findings through week 24 were consistent with the known safety profile of risankizumab, with lower rates of treatment-emergent adverse events observed in the risankizumab treatment groups versus placebo during both induction and maintenance.ⁱ Rates of adverse events of special interest remained low, and no new safety signals were identified.ⁱ

About Crohn's Disease 
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, most commonly in the area between the small intestine (ileum) and the colon, causing persistent diarrhea and abdominal pain.^v,vi It is a progressive disease, meaning it gets worse over time and may lead to life-threatening complications or surgery.^vii,viii Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically but also emotionally and economically.^ix

About the AFFIRM Studyⁱ
AFFIRM is a global, Phase 3, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of risankizumab subcutaneous (SC) as an induction treatment in adult patients with moderately to severely active Crohn's disease. Co-primary endpoints were percentage of participants with CDAI Clinical Remission (CDAI < 150) and percentage of participants with endoscopic response at week 12. A total of 289 patients were randomized in a 2:1 ratio to risankizumab SC or placebo. Key demographics and baseline characteristics were generally balanced between the risankizumab SC and placebo groups; 65% had failed advanced therapies for the treatment of CD before. The study consists of three treatment periods: a placebo-controlled Period A (baseline to week 12) to evaluate the efficacy and safety of risankizumab SC induction treatment, an extended Period B (week 12 to 24) where patients receive blinded or open-label treatments based on their clinical response at week 12, and a 52-week open-label extension Period C where all patients receive the approved risankizumab maintenance treatment.ⁱ More information on this trial can be found at www.clinicaltrials.gov (NCT06063967).^x

About SKYRIZI^® (risankizumab)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that blocks IL-23 by selectively binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.^xi SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderately to severely active ulcerative colitis, plaque psoriasis, psoriatic arthritis and Crohn's disease.^xi,xii

SKYRIZI^® (risankizumab-rzaa) U.S. Uses and Important Safety Information^xi
SKYRIZI is a prescription medicine used to treat:

• moderate to severe plaque psoriasis in adults and children 6 years of age and older who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
• active psoriatic arthritis in adults and children 6 years of age and older.
• moderate to severe Crohn's disease in adults.
• moderate to severe ulcerative colitis in adults.

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:

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:

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). 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.
• 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 may happen while being treated for Crohn's disease or ulcerative colitis: 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 at least 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 and ulcerative colitis include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, urinary tract infection, and rash.

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 (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 55 mg/0.37 mL prefilled syringe, 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.

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

About AbbVie in Immunology
AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For nearly 30 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of action and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.

Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 20+ immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit www.abbvie.com/immunology.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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 and uses of future or conditional verbs, 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 expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. 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 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 

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