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Oral Paper Presentation

Annual Scientific Meeting

Session: Presidential Plenary Session 2

9 - Biologic and Small Molecule Therapies Are Not Associated with Increased Major Adverse Cardiovascular Events (MACE) in IBD: A Propensity Matched Cohort Study

Monday, October 23, 2023
9:54 AM – 10:06 AM PT
Location: Ballroom B
Livestream On-Demand Video
Thabet Qapaja, MD1, Khaled Alsabbagh Alchirazi, MD1, Ahmad Naser, MD2, Motasem Alkhayyat, MD1, Serge Baroud, MD3, Miguel Regueiro, MD4
1Cleveland Clinic, Cleveland, OH; 2Jacobi Medical Center, Albert Einstein College of Medicine, New York, NY; 3MetroHealth Medical Center, Cleveland, OH; 4Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH

Introduction: Patients with IBD are at an increased risk of cardiovascular (CV) complications, i.e., atherosclerotic cardiovascular disease and thromboembolic events, collectively referred to as MACE. This risk is likely a result of chronic inflammation and endothelial dysfunction. While biologic and small molecule therapies are effective at treating IBD, some of these medications have been implicated in an increased risk of MACE. Our study evaluates the impact of biologic and small molecule therapies on cardiovascular events in IBD patients.

Methods: We utilized the TrinNetX multi-institutional database to investigate MACE in adult patients with IBD who were receiving biologics, Infliximab, Adalimumab, Golimumab, Certolizumab, Vedolizumab, Natalizumab, or Ustekinumab, and compared them to IBD patients who did not receive biologics. Additionally, we identified IBD patients who received oral small molecule therapies, Tofacitinib, Upadacitinib, or Ozanimod, and compared them to those who did not receive these treatments. We performed 1:1 propensity score matching for age, race, sex, cardiovascular risk factors, and medications including immunomodulators, 5-ASAs, and steroids. MACE were assessed at least 30 days after initiation of therapy.

Results: IBD patients on biologics had lower risk of coronary artery disease (CAD) (OR 0.69, 95% CI 0.66-0.72, p< 0.0001), myocardial infarction (MI) (OR 0.66, 95% CI 0.61-0.72, p< 0.0001), stroke (OR 0.71, 95% CI 0.65-0.77, p< 0.0001), and venous thromboembolism (VTE) (OR 0.85, 95% CI 0.81-0.89, p< 0.0001) compared to IBD patients not on biological therapy. IBD patients receiving an oral small molecule did not have increased risk of CAD (OR 1.05, 95% CI 0.82-1.33, p= 0.7148), MI (OR 1.04, 95% CI 0.60-1.78, p= 0.8903), stroke (OR 0.87, 95% CI 0.57-1.33, p= 0.5148), or VTE (OR 1.07, 95% CI 0.83-1.39, p= 0.5957) compared to patients not treated with small molecule therapy. There was a nonsignificant lower risk of stroke in IBD patients taking oral small molecules.

Discussion: Patients treated with biologics had a lower risk of CV and thromboembolic diseases. Oral small molecules did not increase the risk of MACE. Although further study is needed, it is possible that adequate treatment of bowel inflammation in IBD patients results in a decreased risk of MACE.
Cardiovascular Outcomes in IBD on Biologics vs No Biologics 
OutcomeIBD on biologicsN=67,607IBD not on biologicsN=67,607OR95% CIp-value
Coronary artery disease3,206 (4.74%)4,541 (6.71%)0.691(0.66,0.724)< 0.0001
Myocardial infarction896 (1.33%)1,344 (1.98%)0.662(0.608,0.721)< 0.0001
Stroke985 (1.46%)1,380 (2.04%)0.71(0.653,0.771)< 0.0001
Venous thromboembolism (DVT or PE)3,001 (4.44%)3,512 (5.2%)0.848(0.806,0.891)< 0.0001
Peripheral arterial disease938 (1.39%)1,437 (2.13%)0.648(0.596,0.704)< 0.0001 
Carotid artery stenosis672 (0.99%)1,003 (1.48%) 0.667(0.604,0.736)< 0.0001 
Abdominal aortic aneurysm246 (0.36%)369 (0.55%)0.665(0.566,0.782)< 0.0001 
Cardiovascular Outcomes in IBD on Small Molecules vs No Small Molecules 
OutcomeIBD on small moleculesN=3,194IBD not on small moleculesN=3,194OR95% CIp-value
Coronary artery disease144 (4.5%)138 (4.32%)1.046(0.823,1.328)0.7148
Myocardial infarction27 (0.84%)26 (0.81%)1.039(0.605,1.784)0.8903
Stroke40 (1.25%)46 (1.44%)0.868(0.567,1.33)0.5148
Venous thromboembolism (DVT or PE)122 (3.82%)114 (3.57%) 1.073(0.827,1.392)0.5957

Table: Table: Cardiovascular Outcomes in IBD Patients on Biologics or Small Molecule Therapy


Disclosures:
Thabet Qapaja indicated no relevant financial relationships.
Khaled Alsabbagh Alchirazi indicated no relevant financial relationships.
Ahmad Naser indicated no relevant financial relationships.
Motasem Alkhayyat indicated no relevant financial relationships.
Serge Baroud indicated no relevant financial relationships.
Miguel Regueiro: AbbVie – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Alfasigma – Advisory Committee/Board Member, Consultant. Allergan – Advisory Committee/Board Member, Consultant. Amgen – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Celgene – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Eli Lilly – Advisory Committee/Board Member, Consultant. Genentech – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Gilead Sciences – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Janssen – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Miraca Labs – Advisory Committee/Board Member, Consultant. Pfizer Inc – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Prometheus – Advisory Committee/Board Member, Consultant. Salix – Advisory Committee/Board Member, Consultant. Seres – Advisory Committee/Board Member, Consultant. Takeda – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Target RWE – Advisory Committee/Board Member, Consultant. UCB – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Wolters Kluwer Health – Royalties.


Thabet Qapaja, MD1, Khaled Alsabbagh Alchirazi, MD1, Ahmad Naser, MD2, Motasem Alkhayyat, MD1, Serge Baroud, MD3, Miguel Regueiro, MD4, 9, Biologic and Small Molecule Therapies Are Not Associated with Increased Major Adverse Cardiovascular Events (MACE) in IBD: A Propensity Matched Cohort Study, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.