AbbVie Releases New Data Demonstrating Breadth of Its Gastroenterology Portfolio at 2023 Digestive Disease Week®

NORTH CHICAGO, Ill., May 6, 2023

-  Twenty-nine abstracts showcase AbbVie's vast portfolio and continued commitment to changing the way patients living with gastrointestinal disorders manage their condition

NORTH CHICAGO, Ill., May 6, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will present 29 abstracts during the 2023 Digestive Disease Week (DDW) Annual Meeting, May 6-9, 2023, being held in Chicago and virtually.

"Our abstracts showcase our comprehensive, well-researched gastroenterology portfolio," said Celine Goldberger, M.D., vice president, and head of U.S. medical affairs, AbbVie. "This collective evidence underscores data across a range of digestive and inflammatory bowel diseases and reinforces our commitment to improving patient care."

The oral and poster presentations from AbbVie feature research across the company's gastroenterology portfolio, including data on Crohn's disease, ulcerative colitis, and functional constipation. Notable data presentations will include:

• Two oral presentations and several posters evaluating investigational upadacitinib in adults with moderately to severely active Crohn's disease, including data on fistulas and fissures and among patients who previously failed biologic or conventional treatment.
• Several posters of risankizumab in adults with moderately to severely active Crohn's disease, including results from three Phase 3 studies (ADVANCE, MOTIVATE, and FORTIFY) assessing risankizumab as induction therapy for patients who did not previously achieve a clinical response to therapy, as well as long-term efficacy and safety data.
• An oral presentation and posters assessing investigational linaclotide in pediatric patients (ages 6 to 17 years) with functional constipation, including efficacy and safety data from a Phase 3 trial and an interim analysis of long-term safety from an open-label trial.

Select AbbVie abstracts at 2023 DDW are outlined below. The full list of 2023 DDW Annual Meeting e-Posters is available here.

Abstract Title ARIVA.DE Börsen-Geflüster Kurse AbbVie Inc. 164,66 $ 0,00%	Presentation Details All times CDT
Crohn's Disease
Efficacy and Safety of Upadacitinib for the Treatment of Fistulas and Fissures in Patients with Crohn's Disease	Oral Presentation #947 AGA IBD: Real World Data and Clinical Trials to Guide Care (Research Forum) May 9, 2023 8:30 – 8:45 AM
Upadacitinib Improves Endoscopic Outcomes in Patients with Moderate to Severely Active Crohn's Disease Irrespective of Previous Failure to Respond to Biologics or Conventional Therapies	Oral Presentation #1031 AGA Controlled Clinical Trials in IBD (Research Forum) May 9, 2023 11:00 – 11:15 AM
Delayed Clinical Responders in Patients with Crohn's Disease Receiving Upadacitinib Therapy	Poster #Tu1705 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Upadacitinib Pharmacokinetic and Exposure-Response Relationships in Subjects with Crohn's Disease - Analyses of Phase 3 Studies	Poster #Tu1733 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Additional Risankizumab Treatment Is Effective in Patients with Moderately to Severely Active Crohn's Disease Who Did Not Achieve CDAI Clinical Response with the Initial 12 Week Induction Treatment: Results From the ADVANCE, MOTIVATE, and FORTIFY Studies	Poster #Tu1710 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Long-Term Efficacy and Safety of Risankizumab Treatment in Patients with Moderately to Severely Active Crohn's Disease: 104-Week Results from the FORTIFY Study	Poster #Tu1730 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Safety Profile of Risankizumab in Crohn's Disease Patients by Age: Post-hoc Analysis of the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies	Poster #Tu1717 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Functional Constipation
Efficacy and Safety of Linaclotide in Treating Functional Constipation in Pediatric Patients aged 6-17 years: a Phase 3 Pivotal Randomized Placebo-Controlled Trial	Oral Presentation: #145 AGA Pediatric Functional and Motility Disorders (Research Forum) May 6, 2023 10:15 – 10:30 AM
Time to Response of Linaclotide in Treating Functional Constipation in Pediatric Patients aged 6-17 years: Data from a Phase 3 Randomized Placebo-Controlled Trial	Poster #Mo2008 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Efficacy of Linaclotide in Treating Symptoms of Incomplete Evacuation and Straining in Pediatric Patients with Functional Constipation	Poster #Mo2007 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Long-term Safety of Linaclotide in Treating Functional Constipation in Pediatric Patients aged 6-17 years: Interim Analysis of an Open Label, Phase 3, Extension Trial	Poster #Mo2016 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Safety of Linaclotide in Pediatric Patients with Functional Constipation: A Pooled Analysis of Placebo-Controlled, Randomized Controlled Trials	Poster #Mo2015 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Exocrine Pancreatic Insufficiency
Development, Generalizability of a Clinical Screening Tool for Exocrine Pancreatic Insufficiency (EPI) in Patients with Definite Chronic Pancreatitis	Poster #Mo1419 AGA Exocrine Pancreatic Diseases and Diabetes (Poster Session) May 8, 2023 12:30 – 1:30 PM
Disease State
Patients with Crohn's Disease and Ulcerative Colitis Cycle Through Multiple Medications Prior To Starting Advanced Therapy: A Retrospective Study	Poster #Sa1814 May 6, 2023 12:30 – 1:30 PM
Food Security in Hispanics with IBD: A Barrier to Dietary Management	Poster #EP141 AGA Diet and IBD (ePoster section) May 6, 2023 9:30 AM – 4:00 PM
Incidence Rates of Gastrointestinal Perforation Among Patients with Inflammatory Bowel Disease: Real-world Evidence from a Large US Nationwide Claims Database	Poster #Su1769 IBD: Diagnostics in IBD (Poster Section) May 7, 2023 12:30 – 1:30 PM

SKYRIZI^® (risankizumab-rzaa) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally.

LINZESS^® (linaclotide) is part of a collaboration between AbbVie and Ironwood Pharmaceuticals to share development and commercialization of LINZESS in the United States.

The use of upadacitinib in Crohn's disease is not approved by the U.S. Food and Drug Administration (FDA). Its safety and efficacy are under evaluation as part of ongoing registrational studies.

RINVOQ^® (upadacitinib) U.S. Uses and Important Safety Information¹

RINVOQ is a prescription medicine used to treat:

• Adults with moderate to severe rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used and did not work well or could not be tolerated.
• Adults with active psoriatic arthritis when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated.
• Adults with moderately to severely active ulcerative colitis when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated.
• Adults with active ankylosing spondylitis when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated.
• Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used and did not work well or could not be tolerated.

It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.

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