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  • A significantly higher proportion of patients with moderately to severely active ulcerative colitis treated with risankizumab achieved the primary endpoint of clinical remissiona (per Adapted Mayo Score) compared to placebo at week 12 in the Phase 3 INSPIRE induction study
  • All secondary endpoints, including clinical, endoscopic and histologic outcomes, were met
  • Safety results in this study were consistent with the known safety profile of risankizumab, with no new safety risks observed1
  • Building on AbbVie’s growing gastroenterology portfolio, risankizumab is an IL-23 inhibitor being evaluated as a treatment for adults with moderate to severe ulcerative colitis and approved for Crohn’s disease, psoriatic arthritis, and psoriasis1

NORTH CHICAGO, IL, USA I March 23, 2023 I AbbVie (NYSE: ABBV) today announced positive top-line results from INSPIRE, a Phase 3 induction study, showing risankizumab (SKYRIZI®,1200 mg intravenous [IV], at weeks 0, 4 and 8) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 12, as well as all secondary endpoints in adult patients with moderately to severely active ulcerative colitis.1 In the study, 20.3% of patients receiving risankizumab achieved clinical remission compared to 6.2% of patients receiving placebo (p<0.00001).1 The INSPIRE study enrolled patients that demonstrated intolerance or inadequate response to conventional therapies and/or advanced therapies (biologics, JAK inhibitors and S1P receptor modulators).1 

“Our commitment to people living with gastroenterological conditions continues to grow,” said Roopal Thakkar, M.D., senior vice president, development, regulatory affairs and chief medical officer, AbbVie. “These encouraging results help support the potential risankizumab has to improve clinical, endoscopic and histologic outcomes in patients with ulcerative colitis.”

A significantly greater proportion of patients treated with risankizumab achieved endoscopic improvement at week 12 compared to placebo (36.5% vs 12.1%; p<0.00001).1 Furthermore, 24.5% of patients treated with risankizumab achieved histologic-endoscopic mucosal improvement at week 12 vs 7.7% of those receiving placebo (p<0.00001).1 

“It is impressive to see the meaningful responses that were achieved in the INSPIRE study, which demonstrates the potential of risankizumab to serve as an option across inflammatory bowel diseases,” said Edouard Louis, M.D., Ph.D., professor and head of the department of gastroenterology, University Hospital CHU of Liège Belgium, INSPIRE study investigator. “These results suggest that risankizumab may help patients coping with the challenging symptoms of ulcerative colitis, which include abdominal pain, bowel urgency and fecal incontinence.”

  Efficacy Results at Week 12*,1
   

Risankizumab 1200 mg IV

(n=650)

Placebo

(n=325)
  Clinical Remission (Adapted Mayo Score)a 20.3 % 6.2 %
  Clinical Response (Adapted Mayo Score)b 64.3 % 35.7 %
  Endoscopic Improvementc 36.5 % 12.1 %
  Histologic-Endoscopic Mucosal Improvementd 24.5 % 7.7 %
   

* Primary endpoint was clinical remission (per Adapted Mayo Score). Clinical response (per Adapted Mayo Score), endoscopic improvement and histologic-endoscopic mucosal improvement were secondary endpoints. Not all secondary endpoints are shown. All primary and secondary endpoints in this study achieved statistical significance under the overall type I error rate at 0.05 (2-sided).

a Clinical remission per Adapted Mayo Score is defined as stool frequency subscore (SFS) ≤1 and not greater than baseline, rectal bleeding subscore (RBS) of 0 and endoscopic subscore ≤1 without friability.

  
b Clinical response per Adapted Mayo Score is defined as a decrease from baseline in the Adapted Mayo score ≥2 points and ≥30% from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1.  

c Endoscopic improvement is defined as endoscopic subscore ≤1 without friability.

d Histologic-endoscopic mucosal improvement is defined as Geboes score ≤3.1 and endoscopic subscore ≤1 without friability.

  

During the 12-week, double-blind, placebo-controlled period, the safety profile of risankizumab 1200 mg IV was consistent with the safety profile observed in previous studies across other indications, with no new safety risks observed.1 The most common adverse events observed in the risankizumab group were COVID-19, anemia and arthralgia. Serious adverse events occurred in 2.3% of patients in the risankizumab 1200 mg IV group compared to 10.2% of patients in the placebo group.1 Rates of serious infections were 0.6% in those treated with risankizumab 1200 mg IV and 1.2% in patients who received placebo.1 There was one death in the risankizumab 1200 mg group due to COVID-19 pneumonia on study day 33. There were no adjudicated major adverse cardiac events (MACE), no adjudicated anaphylactic reaction events and no malignancy events reported in the risankizumab group.1

Use of risankizumab in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities. The maintenance study for ulcerative colitis is ongoing.

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

About Ulcerative Colitis

Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon.2,3 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.3,4 The disease course of ulcerative colitis varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or complications, including cancer or death.4,5 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease.6

About INSPIRE1

INSPIRE is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of risankizumab 1200 mg IV administered every four weeks as induction therapy in subjects with moderately to severely active ulcerative colitis.

The primary endpoint is clinical remission (per adapted Mayo Score, defined as SFS ≤1 and not greater than baseline, RBS of 0 and endoscopic subscore ≤1 without friability) at week 12. Secondary endpoints include clinical response (decrease from baseline in the Adapted Mayo score ≥2 points and ≥30% from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1), endoscopic improvement (endoscopic subscore ≤1 without friability), and histologic endoscopic mucosal improvement (HEMI, endoscopic subscore of 0 or 1 without friability and Geboes score ≤3.1) at week 12. More information can be found on www.clinicaltrials.gov (NCT03398148).

About Risankizumab (SKYRIZI®)

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.7 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 (FDA) and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease. Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis are ongoing.8,9,10

U.S. Indications and Important Safety Information about SKYRIZI® (risankizumab-rzaa)11
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.

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, LinkedIn or Instagram.

References:

  1. AbbVie. Data on file: ABVRRTI75696.
  2. Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019 Dec;65(12):100851. doi: 10.1016/j.disamonth.2019.02.004
  3. The facts about inflammatory bowel diseases. Crohn’s & Colitis Foundation of America. Accessed March 8, 2023.  https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
  4. Ulcerative colitis. Mayo Clinic. Accessed March 3, 2023. https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326
  5. Monstad, I, Hovde O, Solberg IC, A Moum B. Clinical course and prognosis in ulcerative colitis: results from population-based and observational studies. Ann Gastroenterol. 2014; 27(2): 95–104.
  6. Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016;22(3 Suppl):s51-60.
  7. Duvallet E, Sererano L, Assier E, Falgarone G, Boissier MC. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011;43(7):503-11. doi:10.3109/07853890.2011.577093
  8. Pipeline. AbbVie. 2021. Accessed March 3, 2023. https://www.abbvie.com/our-science/pipeline.html
  9. 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. Updated February 28, 2023. Accessed March 3, 2023. https://clinicaltrials.gov/ct2/show/NCT03671148
  10. 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. ClinicalTrials.gov. Updated March 10, 2023. Accessed March 12, 2023. https://clinicaltrials.gov/ct2/show/record/NCT03398148
  11. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.; 2022.

SOURCE: AbbVie

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