AbbVie Presents New Late-Breaking Data Analyses Showing Risankizumab Achieves Clinical Remission and Endoscopic Response at Week 12 in Patients with Moderate to Severe Crohn's Disease

Late-breaking data analyses presented by ABBVie (NYSE: ABBV) at Digestive Disease Week ® (DDW) Virtual Conference 2021 showed significantly greater proportions of patients with moderately to severely active Crohn's disease treated with both doses of investigational risankizumab (600 mg or 1200 mg) met the co-primary endpoints of clinical remission and endoscopic response at week 12 compared to placebo (p

The ADVANCE study included patients with past intolerance or inadequate response to conventional therapy (non-bio-IR) and/or biologic therapy (bio-IR). The MOTIVATE trial evaluated only bio-IR patients. In the ADVANCE study, risankizumab showed efficacy regardless of prior treatment status by subgroup analysis in patients with moderate to severe Crohn's disease, and non-bio-IR patients had numerically higher rates of efficacy compared to bio-IR patients. ^1*

"Many people with Crohn's disease, an unpredictable condition that can cause significant physical, emotional and economic burden, do not achieve disease control with current treatments," said Remo Panaccione , M.D., professor of medicine and director of the IBD unit, University of Calgary . "We are pleased to present data at DDW that demonstrates risankizumab helps significantly more patients to achieve clinical remission and endoscopic response at week 12 compared to placebo."

These and additional data were presented at DDW 2021 as part of the "Clinical Science Late-Breaking Abstract Plenary" session (Abstract #775a) on Sunday, May 23, 2:32 pm - 2:46 p.m. CT.

* All differences between the overall risankizumab dose groups and placebo are statistically significant, with p-values ^a Clinical remission per CDAI (Crohn's Disease Activity Index) is defined as CDAI score of ^b Clinical remission per SF (stool frequency)/AP (abdominal pain) (also referred to as PRO-2) is defined as average daily SF score of ≤2.8 and daily AP score of ≤1, not worse than baseline for both.
^c Endoscopic response is defined as a decrease in simple endoscope score for Crohn's disease (SES-CD) >50 percent from baseline (or for patients with isolated ileal disease and a baseline SES-CD of 4, ≥2-point reduction from baseline).

During the 12-week induction period, the safety profile of risankizumab in both studies was generally consistent with the known safety profile of risankizumab from previous clinical trials. ¹ No new safety risks were observed.

In ADVANCE, serious adverse events (SAEs) occurred in 7.2 percent of patients in the risankizumab 600 mg group and 3.8 percent of patients in the risankizumab 1200 mg group compared to 15.1 percent of patients in the placebo group. ¹ The most common adverse events (AEs) observed in the risankizumab treatment groups were headache, nasopharyngitis and fatigue. ¹ Rates of serious infections were 0.8 and 0.5 percent in those treated with risankizumab 600 mg or 1200 mg, respectively, and 3.8 percent in patients who received placebo. ¹ The rates of AEs leading to discontinuation of the study drug were 2.4 and 1.9 percent of patients treated with risankizumab 600 mg or 1200 mg, respectively, compared with 7.5 percent on placebo. ¹ In ADVANCE, there were two deaths reported in the placebo group. ¹ There were no adjudicated major adverse cardiac events (MACE) or adjudicated anaphylactic reaction events reported. ¹

In MOTIVATE, SAEs occurred in 4.9 percent of patients in the risankizumab 600 mg group and 4.4 percent of patients in the risankizumab 1200 mg group compared to 12.6 percent of patients in the placebo group. ¹ The most common AEs observed in the risankizumab treatment groups were headache, arthralgia and nasopharyngitis. Rates of serious infections were 0.5 and 1.0 percent in those treated with risankizumab 600 mg or 1200 mg, respectively, and 2.4 percent in patients who received placebo. ¹ The rates of AEs leading to discontinuation of the study drug were 1.0 and 2.4 percent of patients treated with risankizumab 600 mg or 1200 mg, respectively, compared with 8.2 percent on placebo. ¹ There was one death in the risankizumab 1200 mg group due to squamous cell carcinoma of the lung diagnosed on study day 8, which was assessed as unrelated to the study drug by the investigator. There were no adjudicated MACE or adjudicated anaphylactic reaction events reported. ¹

Results from these studies are being submitted to journals for publication. Use of risankizumab in Crohn's disease is not approved and its safety and efficacy have not been evaluated by regulatory authorities. The maintenance study for Crohn's disease is ongoing and once completed will be submitted to regulatory authorities with the induction studies.

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

About Crohn's Disease  
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea, abdominal pain, and rectal bleeding. ^2,4,5 It is a progressive disease, meaning it gets worse over time. ^2,3 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. ⁴

About the ADVANCE and MOTIVATE Studies ^1,6,7  
The ADVANCE and MOTIVATE studies are Phase 3, multicenter, randomized, double-blind, placebo-controlled induction studies designed to evaluate the efficacy and safety of risankizumab in adults with moderate to severe Crohn's disease. The objective of the two Phase 3 induction studies is to evaluate the efficacy and safety of two doses of risankizumab, 600 mg and 1200 mg, compared to placebo. The ADVANCE study included a mixed population of patients who had responded inadequately or are intolerant to conventional and/or biologic therapy. The MOTIVATE study evaluated patients who had responded inadequately or were intolerant to biologic therapy.

Both studies included slightly different sets of primary and secondary endpoints for U.S. protocol and outside U.S. (OUS) protocol. The primary endpoints were achievement of clinical remission (per CDAI for the U.S. protocol, which was measured by a CDAI score less than 150, and per PRO-2 for the OUS protocol, which was measured by daily stool frequency and abdominal pain score) and endoscopic response (for both protocols) at week 12. Endoscopic response is defined as a decrease in SES-CD of greater than 50 percent from baseline (or at least a greater than or equal to 50 percent decrease from baseline in patients with isolated ileal disease and a baseline SES-CD of 4), as scored by a central reviewer. More information can be found on www.clinicaltrials.gov (ADVANCE: NCT03105128; MOTIVATE: NCT03104413).

About risankizumab (SKYRIZI ^® )

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. ^8,9 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including Crohn's disease. ^8,9 In April 2019, SKYRIZI received U.S. Food and Drug Administration approval for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The approved dose for SKYRIZI is 150 mg (two 75 mg injections), administered by subcutaneous injection at week 0 and 4, and every 12 weeks thereafter. SKYRIZI was also approved by the European Commission in April 2019. Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing. ^6,7,10,11 Use of SKYRIZI in Crohn's disease is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About SKYRIZI ^® (risankizumab-rzaa) in the United States ⁹

SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Important Safety Information ⁹

Infection

SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves.

Pre-Treatment Evaluation for Tuberculosis (TB)

Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB.

Immunizations  
Prior to initiating SKYRIZI, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with SKYRIZI.

Adverse Reactions  
Most common (≥1%) adverse reactions associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

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 https://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 Gastroenterology

With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.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. D'Haens G, Panaccione R, Colombel JF, et al. Risankizumab induction therapy in patients with moderate-to-severe Crohn's disease: results from the ADVANCE and MOTIVATE phase 3 studies. Presented at Digestive Disease Week ^® (DDW) Virtual Conference 2021, May 21–23.
2. The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf . Accessed on April 9, 2021 .
3. Crohn's disease. Symptoms and Causes. Mayo Clinic. 2020. Available at: https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304 . Accessed on April 9, 2021 .
4. The Economic Cost of Crohn's Disease and Ulcerative Colitis. Access Economics Pty Limited. 2007. Available at: https://www.crohnsandcolitis.com.au/site/wp-content/uploads/Deloitte-Access-Economics-Report.pdf . Accessed April 9, 2021 .
5. 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.
6. 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://www.clinicaltrials.gov/ct2/show/NCT03105128 . Accessed on April 9, 2021 .
7. A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment. ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT03104413 . Accessed on April 9, 2021 .
8. Duvallet E, Sererano L, Assier E, et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11.
9. SYRIZI (risankizumab) [Package Insert]. North Chicago, Ill. : AbbVie Inc.
10. A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS). ClinicalTrials.gov 2021. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03047395 . Accessed on April 9, 2021 .
11. A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE2). ClinicalTrials.gov 2021. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03671148 . Accessed on April 9, 2021 .

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