P0702 - Risk of Opportunistic Infections Among Inflammatory Bowel Disease Patients on Biologics: A Nationwide Database Study

Sunday, October 22, 2023

3:30 PM – 7:00 PM PT

Location: Exhibit Hall

Presenting Author(s)

TQ

Thabet Qapaja, MD

Cleveland Clinic
Cleveland, OH

Thabet Qapaja, MD¹, Khaled Alsabbagh Alchirazi, MD¹, Motasem Alkhayyat, MD¹, Almaza Albakri, MD², Ahmed Nadeem, MD¹, Serge Baroud, MD³, Miguel Regueiro, MD⁴
¹Cleveland Clinic, Cleveland, OH; ²King Hussein Medical Center, Amman, 'Amman, Jordan; ³MetroHealth Medical Center, Cleveland, OH; ⁴Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH

Introduction: Biological therapy in IBD, particularly TNF-alpha inhibitor, has been associated with an increased risk of serious infections such as pneumonia, zoster, tuberculosis, and opportunistic infection. However available data regarding some opportunistic infections are conflicting as some of these studies are small and confounded by the simultaneous use of several immunosuppressive agents. Our study aimed to assess the risk of various opportunistic infections among IBD patients treated with biologics, utilizing a large database.

Methods: We conducted a retrospective cohort study using the TrinNetX database, a multi-institutional database, that included all adult patients (18 years and older) diagnosed with IBD (CD or UC) on biological therapy (Infliximab, Adalimumab, Golimumab, Certolizumab, Vedolizumab, Natalizumab, or Ustekinumab), as well as patients not treated with biological therapy. The aim was to compare the risk of selected infectious diseases between the two groups, at least one month after therapy initiation. To minimize confounding and ensure balanced groups, we employed 1:1 propensity score matching for factors such as age, gender, race, tobacco use, alcohol use, diabetes, HIV, organ transplant, and medications including azathioprine, mercaptopurine, methotrexate, 5-ASA medications, and steroids.

Results: After matching, there were 79,960 IBD patients in each cohort. Patients on biologics had a higher risk of Legionella (OR 2.85, 95% CI 1.55-5.25, P 0.0004), Tuberculosis (OR 1.98, 95% CI 1.60-2.45, P < 0.0001), Clostridium difficile (OR 1.85, 95% CI 1.75-1.95, P < 0.0001), sepsis (OR 1.11, 95% CI 1.05-1.16, P < 0.0001), Histoplasmosis (OR 2.66, 95% CI 1.81-3.91, P < 0.0001), Candidiasis (OR 1.22, 95% CI 1.17-1.28, P < 0.0001), CMV (OR 1.21, 95% CI 1.05-1.40, P 0.0062), HSV (OR 1.11, 95% CI 1.03-1.20, P 0.0040), and VZV (OR 1.28, 95% CI 1.195-1.38, P < 0.0001) infections compared to those not on biologics. The risk of Streptococcus pneumoniae pneumonia, Actinomycosis, Nocardiosis, Cryptococcosis, Aspergillosis, Pneumocystis, influenza, and HPV was not significantly different between the two cohorts.

Discussion: Our study revealed that IBD patients on biologics are at a higher risk of certain opportunistic infections compared to those not treated with biologics. This study underscores the importance of close monitoring for infections in IBD patients on biologics, particularly for those at high risk.

Outcome	IBD on biologics N= 79,960	IBD not on biologics N= 79,960	OR	95% CI	p-value
Bacterial
Legionella	40 (0.05%)	14 (0.02%)	2.858	(1.555,5.253)	0.0004
Streptococcus pneumoniae pneumonia	77 (0.1%)	81 (0.1%)	0.951	(0.696,1.299)	0.6691
Tuberculosis	256 (0.32%)	129 (0.16%)	1.988	(1.608,2.457)	< 0.0001
Nocardiosis	20 (0.03%)	19 (0.02%)	1.053	(0.562,1.972)	0.8728
Actinomycosis	52 (0.06%)	38 (0.05%)	1.369	(0.901,2.08)	0.1399
Clostridium difficile	3,704 (4.63%)	2,045 (2.56%)	1.851	(1.752,1.955)	< 0.0001
Sepsis	3,583 (4.48%)	3,245 (4.06%)	1.109	(1.056,1.164)	< 0.0001
Fungal
Histoplasmosis	96 (0.12%)	36 (0.05%)	2.669	(1.819,3.915)	< 0.0001
Cryptococcosis	16 (0.02%)	19 (0.02%)	0.842	(0.433,1.638)	0.6121
Aspergillosis	89 (0.11%)	88 (0.11%)	1.011	(0.753,1.358)	0.9401
Candidiasis	4,329 (5.41%)	3,563 (4.46%)	1.227	(1.173,1.284)	< 0.0001
Pneumocystis	48 (0.06%)	41 (0.05%)	1.171	(0.772,1.776)	0.4580
Viral
Human Papillomavirus (HPV)	460 (0.58%)	465 (0.58%)	0.989	(0.869,1.126)	0.8690
Influenza	1,446 (1.81%)	1,518 (1.9%)	0.952	(0.885,1.023)	0.1819
Cytomegalovirus (CMV)	426 (0.53%)	349 (0.47%)	1.219	((1.058,1.405))	0.0062
Herpes Simplex Virus (HSV)	1,436 (1.79%)	1,286 (1.61%)	1.118	(1.036,1.202)	0.0040
Varicella-Zoster Virus (VZV)	1,680 (2.1%)	1,313 (1.64%)	1.286	(1.195,1.383)	< 0.0001

Table: Risk of Selected Opportunistic Infections in IBD Patients on Biologics vs No Biologics

Disclosures:

Thabet Qapaja indicated no relevant financial relationships.

Khaled Alsabbagh Alchirazi indicated no relevant financial relationships.

Motasem Alkhayyat indicated no relevant financial relationships.

Almaza Albakri indicated no relevant financial relationships.

Ahmed Nadeem 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, Motasem Alkhayyat, MD¹, Almaza Albakri, MD², Ahmed Nadeem, MD¹, Serge Baroud, MD³, Miguel Regueiro, MD⁴. P0702 - Risk of Opportunistic Infections Among Inflammatory Bowel Disease Patients on Biologics: A Nationwide Database Study, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.