U.S. FDA Approves Subcutaneous Induction Regimen for AbbVie's SKYRIZI® (risankizumab-rzaa) for Adults With Moderately to Severely Active Crohn's Disease

The new regimen allows patients to begin SKYRIZI treatment at home rather than starting with intravenous administration.

Rhea-AI Summary

AbbVie (ABBV) received FDA approval for subcutaneous SKYRIZI induction treatment in adults with moderately to severely active Crohn's disease. Patients can now start treatment at home using an on-body injector. Induction dosing is 720 mg at weeks 0, 2, 4 and 8, followed by maintenance starting at week 12 and continuing every eight weeks.

In the Phase 3 AFFIRM trial, week-12 clinical remission was 56% with subcutaneous SKYRIZI versus 30% with placebo; endoscopic response, a measure of improvement seen during intestinal examination, was 43% versus 15%. Among patients without prior advanced therapy failure, these rates were 74% versus 27% and 60% versus 15%, respectively. No new safety risks were observed. The FDA also approved label changes across all approved indications allowing clinicians to determine whether pretreatment tuberculosis testing is needed using clinical judgment.

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Positive

• Major pointAFFIRM week-12 clinical remission reached 56% versus 30% with placebo, meeting a co-primary endpoint.
• Major pointAFFIRM week-12 endoscopic response reached 43% versus 15% with placebo, meeting the other co-primary endpoint.
• Moderate pointFDA approval adds subcutaneous induction for adults with moderately to severely active Crohn's disease.
• Moderate pointThe week-12 fatigue-score secondary endpoint was also met versus placebo.
• Minor pointAFFIRM week-12 endoscopic remission reached 26% versus 11% with placebo.

8 minor points

• Minor pointPatients without prior advanced therapy failure achieved week-12 clinical remission of 74% versus 27% with placebo.
• Minor pointPatients without prior advanced therapy failure achieved week-12 endoscopic response of 60% versus 15% with placebo.
• Minor pointPatients without prior advanced therapy failure achieved week-12 endoscopic remission of 43% versus 9% with placebo.
• Minor pointPatients with prior advanced therapy failure achieved week-12 clinical remission of 45% versus 31% with placebo.
• Minor pointPatients with prior advanced therapy failure achieved week-12 endoscopic response of 33% versus 15% with placebo.
• Minor pointPatients with prior advanced therapy failure achieved week-12 endoscopic remission of 17% versus 11% with placebo.
• Minor pointSubcutaneous induction showed no new safety risks, with safety generally consistent with SKYRIZI's established Crohn's disease profile.
• Minor pointFDA-approved tuberculosis label changes remove mandatory pretreatment testing across approved indications, allowing clinical judgment.

Negative

• None.

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• Now with a new route of induction administration, subcutaneous SKYRIZI supports early symptomatic and endoscopic control with an on-body injector (OBI) device throughout the course of treatment
• In the pivotal Phase 3 AFFIRM study, subcutaneous (SC) SKYRIZI^® achieved superior clinical remissionⁱ and endoscopic responseⁱⁱ at week 12 compared with placebo in patients with Crohn's disease; results were particularly strong in patients without prior advanced therapy failureⁱⁱⁱ
• The safety profile of subcutaneous induction was generally consistent with the established SKYRIZI profile in Crohn's disease, with no new safety risks identified
• FDA also approved an update to the U.S. Prescribing Information warning and precautions across all indications to allow healthcare providers to use clinical judgment when determining whether tuberculosis (TB) testing is needed

NORTH CHICAGO, Ill., Oct. 23, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration has approved a subcutaneous (SC) induction regimen for SKYRIZI^® (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease (CD)^iv. Patients now have the option to start SKYRIZI treatment at home, with induction doses delivered by an on-body injector (OBI) induction pack and then continue using an OBI once every eight weeks throughout the course of maintenance treatment.

"People living with Crohn's disease need treatments that can deliver meaningful disease control from the start," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "With the approval of subcutaneous induction, we are building on the strong efficacy of SKYRIZI while giving patients and physicians greater flexibility in how treatment is initiated. This is one more example of how AbbVie continues to advance treatment to better meet the needs of people living with Crohn's disease."

Subcutaneous SKYRIZI Shows High Rates of Clinical Remission and Endoscopic Response by Week 12ⁱⁱⁱ 
This FDA approval is supported by positive results from the Phase 3 AFFIRM trial evaluating the efficacy and safety of SC SKYRIZI versus placebo in patients with moderately to severely active CD.ⁱⁱⁱ SKYRIZI achieved superiority of the co-primary endpoints of clinical remission and endoscopic response at week 12.ⁱⁱⁱ Although the study enrolled a primarily treatment-refractory population, these Phase 3 results were particularly strong within patients without prior advanced therapy failure (advanced therapy-naïve).ⁱⁱⁱ By week 12, nearly three-quarters (74%) of advanced therapy (AT)-naïve patients were in clinical remission (vs. 27% placebo) and these AT-naïve patients achieved endoscopic response at four times the rate of placebo (60% vs. 15%, respectively).ⁱⁱⁱ SC SKYRIZI also had a higher efficacy response in patients who had previously failed advanced therapy.ⁱⁱⁱ

SC SKYRIZI also met secondary endpoints including endoscopic remission and FACIT fatigue scores at week 12 vs. placebo.ⁱⁱⁱ The safety profile of SC SKYRIZI for induction was generally consistent with its known profile in CD, with no new safety risks observed.ⁱⁱⁱ

Together, these results demonstrate market-leading clinical and endoscopic outcomes in advanced therapy-naïve patients that set a high bar in CD. Furthermore, the strength of these subcutaneous results provides a compelling foundation for future clinical trials.

AFFIRM Phase 3 Proportion of Patients Meeting Efficacy Endpoints at Week 12iii
	Total Population		Prior Advanced Therapy Failurea		Without Prior Advanced Therapy Failureb  (Advanced Therapy-Naïve)
Proportion of Patients	Placebo N=94	Skyrizi SCc N=180	Placebo N=61	Skyrizi SCc N=115	Placebo N=33	Skyrizi SCc N=65
Clinical Remissiond,e	30 %	56 %h	31 %	45 %	27 %	74 %
Endoscopic Responsed,f	15 %	43 %h	15 %	33 %	15 %	60 %
Endoscopic Remissiong	11 %	26 %h	11 %	17 %	9 %	43 %
a. Prior advanced therapy failure includes inadequate response, loss of response, or intolerance to one or more biologic or Janus Kinase inhibitor (JAKi) treatments for CD b. Without prior advanced therapy failure includes patients who were naïve to biologics or JAKi, or patients who had never failed or demonstrated intolerance to biologics or JAKi c. SKYRIZI 720 mg as a subcutaneous injection at Week 0, Week 2, Week 4, and Week 8 d. Co-primary endpoints e. Defined as Crohn's disease activity index (CDAI) < 150 f.  Defined as a decrease in Simplified Endoscopic Activity Score for Crohn's disease (SES-CD) > 50% from baseline, or a decrease of at least 2 points for subjects with a baseline     score of 4 and isolated ileal disease, based on central reading g. SES-CD ≤ 4 and at least a 2-point reduction from baseline, with no individual subscore greater than 1, based on central reading h. p <0.001 compared to placebo in total population.

Subcutaneous Treatment With SKYRIZI Offers Fully Self-Administered Therapy From the Start 
The induction dosing regimen with SC SKYRIZI is 720 mg delivered by OBI induction pack at weeks 0, 2, 4 and 8.ⁱⁱⁱ Patients also have the option to start treatment intravenously with 600 mg delivered at weeks 0, 4 and 8.ⁱⁱⁱ Patients can then continue with maintenance dosing starting at week 12 administered by OBI every eight weeks.ⁱⁱⁱ

"When patients and I discuss treatment, they want to know two things: will it work? And how will it fit into their lives?" 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. "AFFIRM answered the first question, with superior rates of clinical remission and endoscopic response versus placebo during induction with subcutaneous SKYRIZI, particularly in patients new to advanced therapy. This approval answers the second. As a physician who has used the SKYRIZI OBI, I've seen firsthand the convenience it can offer patients. Now with this approval, patients can start treatment at home and continue the same way through maintenance."

Patients Report Satisfaction and Ease of Use in Real World Experience With SKYRIZI OBI
First introduced in 2022 for CD maintenance treatment, the SKYRIZI OBI has demonstrated strong user experience. In a real-world survey of 186 people living with CD, 88% reported AbbVie's OBI easy to use.^v In evaluating alternative routes of administration, a patient-reported survey of 352 adults living with IBD found 87% were satisfied or highly satisfied with OBI compared to 71% with an autoinjector^vi, demonstrating patient preference for OBI.

FDA Also Approved Update to Tuberculosis (TB) Language in U.S. Prescribing Information
Additionally, the FDA approved an update to the SKYRIZI prescribing information's warning and precautions language across all approved indications.ⁱⁱⁱ The revised label advises healthcare providers to consider TB evaluation prior to treatment initiation based on clinical judgment.ⁱⁱⁱ This change gives healthcare providers greater flexibility in patient assessment before starting SKYRIZI treatment. There is no mandatory TB test prior to initiating SKYRIZI.

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.^vii,viii It is a progressive disease, meaning it gets worse over time and may lead to life-threatening complications or surgery.^ix,x 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.^xi

About the AFFIRM Study^xii
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 274 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.^xii More information on this trial can be found at www.clinicaltrials.gov (NCT06063967).^xii

Patient Access and Support
AbbVie is committed to helping people access SKYRIZI and other medicines, including offering a patient support program and co-pay card that may reduce out-of-pocket costs to as little as $0 per month for eligible, commercially insured patients. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides SKYRIZI at no charge to those who qualify. More information about this assistance program can be found at www.AbbVie.com/myAbbVieAssist.

About SKYRIZI^® (risankizumab-rzaa)
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.ⁱⁱⁱ 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.ⁱⁱⁱ

SKYRIZI^® (risankizumab-rzaa) U.S. Uses and Important Safety Informationⁱⁱⁱ
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.
• moderately to severely active Crohn's disease in adults.
• moderately to severely active 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:
  • 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 may 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). 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 or visit http://glowpregnancyregistry.com 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit 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/PatientAccessSupport to learn more.

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

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.

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, 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.

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. 

U.S. Media: Jasmine Farley +1 (847) 309-2779 Jasmine.Farley@abbvie.com Global Media: Giovanna Chandler +1 (571) 867-1967 Giovanna.Chandler@abbvie.com

Investors: Liz Shea +1 (847) 935-2211 Liz.Shea@abbvie.com

References: 
i. Co-primary endpoint defined as Crohn's Disease Activity Index (CDAI) score <150.
ii. Co-primary endpoint defined as decrease in SES-CD > 50% from baseline (or for patients with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline), as scored by a central reviewer.
iii. SKYRIZI [Package Insert]. North Chicago, IL: AbbVie Inc. 
iv. Defined as CDAI of 220 to 450 and SES-CD ≥ 6 (or ≥ 4 for isolated ileal disease).
v. Keefer L, Griffith JM, Yang M, et al. Treatment satisfaction and patients' experiences with risankizumab on-body injector among adults with Crohn's disease in clinical practice: initial results from the ASPIRE-CD study. Poster P5425. Presented at: American College of Gastroenterology Annual Scientific Meeting; October 24-29, 2025; Phoenix, AZ. 
vi. Data on file, AbbVie Inc. Source: ZS Associates; December 2024-February 2025.
vii. Crohn's & Colitis Foundation. The facts about inflammatory bowel diseases. Crohn's & Colitis Foundation. Published November 2014. Accessed October 13, 2026. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf.
viii. Mayo Clinic. Crohn's disease - Symptoms and causes. Mayo Clinic. Accessed February 23, 2026. https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304.
ix. Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016 Mar;22(3 Suppl):s51-60.
x. Kaplan G. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150.
xi. Gajendran M, et al. A comprehensive review and update on Crohn's disease. Dis Mon. 2018 Feb;64(2):20-57. doi: 10.1016/j.disamonth.2017.07.001.
xii. ClinicalTrials.gov. A Study to Evaluate Efficacy and Safety of Risankizumab Subcutaneous Induction in Participants With Moderately to Severely Active Crohn's Disease (AFFIRM). NCT06063967. Available at: https://clinicaltrials.gov/study/NCT06063967. Accessed October 13, 2026.

 

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SOURCE AbbVie

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did the FDA approve for AbbVie's SKYRIZI in Crohn's disease?

The FDA approved subcutaneous induction for adults with moderately to severely active Crohn's disease. Patients can begin treatment at home with an on-body injector, receiving 720 mg at weeks 0, 2, 4 and 8, then begin maintenance at week 12 with dosing every eight weeks.

What were SKYRIZI's main results in the AFFIRM trial?

At week 12, subcutaneous SKYRIZI achieved clinical remission in 56% of patients versus 30% with placebo, and endoscopic response in 43% versus 15%. Both co-primary endpoints demonstrated superiority to placebo.

Can patients still start SKYRIZI intravenously for Crohn's disease?

Patients retain the option to start SKYRIZI with 600 mg intravenously at weeks 0, 4 and 8. Maintenance treatment can then begin at week 12 using an on-body injector every eight weeks.

How was AbbVie's SKYRIZI AFFIRM trial designed?

AFFIRM is a randomized, placebo-controlled, double-blind Phase 3 study evaluating subcutaneous induction in adults with moderately to severely active Crohn's disease. It randomized 274 patients in a 2:1 ratio to SKYRIZI or placebo; 65% had previously failed advanced therapies.