AbbVie Announces Positive Topline Results from Phase 3 AFFIRM Study Evaluating SKYRIZI® (Risankizumab) Subcutaneous Induction in Patients with Crohn's Disease
- In the Phase 3 AFFIRM study in adults with moderately to severely active Crohn's disease, risankizumab (SKYRIZI®) achieved superiority for the co-primary and ranked secondary endpoints at week 12 for induction delivered by subcutaneous (SC) injection versus placebo1
- These data support strong efficacy of risankizumab in Crohn's disease while providing potential for an induction choice for patients1
- The safety profile of risankizumab SC induction was consistent with its known profile in Crohn's disease, with no new safety risks observed1
NORTH CHICAGO, Ill., March 2, 2026 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced positive topline results from the Phase 3, randomized, placebo-controlled, double-blind AFFIRM study evaluating the efficacy and safety of risankizumab (SKYRIZI®) subcutaneous (SC) induction treatment versus placebo in adult patients with moderately to severely active Crohn's disease (CD).1
The AFFIRM study results show significantly greater proportions of patients treated with risankizumab SC induction achieved the co-primary endpoints of Crohn's Disease Activity Index (CDAI) clinical remissiona (55% vs. 30%; p<0.0001) and endoscopic responseb (44% vs. 14%; p<0.0001) at week 12 compared to placebo.1 Among patients with clinical responsec after 12 weeks of risankizumab SC induction treatment followed by 12 weeks of maintenance, 67% achieved CDAI clinical remission at week 24 and 57% achieved endoscopic response at week 24.1
This Phase 3 study enrolled a predominantly treatment-refractory population** (65%) with 50% of those patients having failed two or more advanced therapies and 23% having failed ustekinumab and 12% having failed a Janus kinase inhibitor (JAKi).1
"This study evaluated a difficult-to-treat Crohn's disease patient population, including a majority with a prior failure to advanced therapy, and these data reinforce risankizumab as a leading, effective treatment for patients," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "The level of endoscopic response is a particularly meaningful achievement for Crohn's disease patients; and for AbbVie, these results underscore our continued innovation and research to raise the standard of care."
AFFIRM Phase 3 Co-Primary Endpoints Results at Week 12 | ||||||
Overall Population (N=289) | Advanced Therapy Naïve* (N=100) | Prior Advanced Therapy Failure** (N=189) | ||||
Proportion | PBO | RZB SC | PBO | RZB SC | PBO | RZB SC |
CDAI | 29.6 % | 55 % | 27.3 % | 73.1 % | 30.8 % | 45.2 % |
Endoscopic | 14.3 % | 44 % | 15.2 % | 61.2 % | 13.8 % | 34.7 % |
RZB= risankizumab; PBO=placebo | ||||||
* | Defined as patients without prior advanced therapy failure.1 |
** | Defined as patients with prior failure to at least one advanced therapy for CD.1 |
a | Defined as Crohn's Disease Activity Index (CDAI) <150 at week 12.1 |
b | Defined as decrease in Simple Endoscopic Score for Crohn's disease (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 blinded central reviewer at week 12.1 |
c | Defined as at least a 100-point reduction from baseline in CDAI.1 |
"Crohn's disease is a complex, often debilitating condition that affects far more than a patient's digestive health, disrupting work, relationships and daily life," said Millie D. Long, M.D., MPH, chief, Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, and lead investigator of the AFFIRM study. "These high endoscopic response rates across populations, in particular among those who have not failed an advanced therapy, demonstrate the potential of subcutaneous induction risankizumab as an effective therapy for Crohn's disease."
During the 12-week, double-blind, placebo-controlled period, the safety profile of risankizumab SC was consistent with the safety profile observed in Crohn's disease with no new safety risks observed. The most common adverse events observed among patients receiving risankizumab were upper respiratory tract infection, abdominal pain and arthralgia. Serious adverse events occurred in 0.5% of patients in the risankizumab SC group compared to 3.1% in the placebo group.1
Full results will be published in an upcoming medical journal and shared at future medical congresses.
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.2,3 It is a progressive disease, meaning it gets worse over time and may lead to life-threatening complications or surgery.4,5 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.6
About the AFFIRM Study1
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.1 More information on this trial can be found at www.clinicaltrials.gov (NCT06063967).7
About SKYRIZI® (risankizumab)
SKYRIZI is an interleukin (IL)-23 inhibitor that selectively blocks IL-23 by 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.8 SKYRIZI is approved by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.8,9
SKYRIZI® (risankizumab-rzaa) U.S. Uses and Important Safety Information8
Indications
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.
- moderate to severe Crohn's disease.
- moderate to severe ulcerative colitis.
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 | |
• fainting, dizziness, feeling | |
• swelling of your face, eyelids, lips,
• 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 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 | – muscle aches – warm, red, or painful – weight loss
| – diarrhea or stomach – burning when you |
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 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 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.
This is the most important information to know about SKYRIZI. For more information, talk to your HCP.
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.
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 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 2024 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.
References
- AbbVie. Data on file ABVRRTI82775
- Crohn's & Colitis Foundation. The facts about inflammatory bowel diseases. Crohn's & Colitis Foundation. Published November 2014. Accessed February 23, 2026. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
- 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
- Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016 Mar;22(3 Suppl):s51-60.
- 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.
- 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.
- A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. (AFFIRM). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06063967. Accessed February 23, 2026.
- SKYRIZI [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025.
- SKYRIZI. Summary of Product Characteristics. AbbVie. Accessed February 23, 2026.
Global Media: Giovanna Chandler
U.S. Media: Stephanie Tennessen | Investors: Liz Shea |
View original content:SOURCE AbbVie