C0385 - Comparison of Surgical Rates in Biologic Naive Crohn's Disease Patients on Ustekinumab and Vedolizumab

Monday, October 24, 2022

3:00 PM – 5:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

Abdul S. Mohammed, MD

Cleveland Clinic
Orlando, FL

Abdul Mohammed, MD¹, Khaled Alsabbagh Alchirazi, MD¹, Osama Hamid, MD, MRCPI¹, Ahmed Eltelbany, MD, MPH¹, Rajat Garg, MD², Neethi Paranji, MD³, Ernesto Robalino Gonzaga, MD⁴, Amandeep Singh, MD², Susan Kais, MD⁵, Miguel Regueiro, MD⁶
¹Cleveland Clinic, Cleveland, OH; ²Cleveland Clinic Foundation, Cleveland, OH; ³MetroHealth Medical Center, Cleveland, OH; ⁴Johns Hopkins University, Baltimore, MD; ⁵AdventHealth Orlando, Orlando, FL; ⁶Cleveland Clinic Main Campus, Cleveland, OH

Introduction: Between 25% to 45% of patients with Crohn’s Disease (CD) require surgical treatment of their disease between 5 and 10 years of diagnosis. Anti-tumor necrosis factor (anti-TNF) therapy has been associated with lower surgical rates in IBD. However, the rate of surgical intervention in ustekinumab- and vedolizumab-treated biologic naïve CD to date patients is unknown. We aimed to investigate the effect of ustekinumab and vedolizumab on intestinal resection rates in bio-naïve CD patients.

Methods: A commercial database (Explorys Inc, Cleveland, OH) was utilized, which included electronic health record data from 26 major integrated US healthcare systems. We identified bio-naïve CD patients. The primary outcome was to examine the association between anti-tumor necrosis factor (anti-TNF) medications, ustekinumab, and vedolizumab therapy and the rate of bowel resection in bio-naïve CD patients after at least 12 weeks of treatment. Secondary endpoints were factors associated with increased risk of surgical intervention in these bio-naïve CD patients.

Results: The database included over 70 million individuals in which we identified 249,300 (0.35%) adult ( >18 years) patients with CD. Among all CD patients, 1.7% received ustekinumab, 2.4% received vedolizumab, and 16% received anti-TNF as first-line biologic therapy. The rate of intestinal resection was lower among ustekinumab-treated compared to vedolizumab-treated bio-naïve CD patients (11.8% vs. 13.9%, p = 0.001). The rate of intestinal resection was higher among vedolizumab-treated compared to anti-TNF-treated bio-naïve CD patients (13.9% vs. 12.5%, p < 0.0001). However, intestinal resection rates did not significantly differ between ustekinumab-treated compared to anti-TNF-treated bio-naïve CD patients (11.8% vs. 12.5%, p = 0.15). Compared to anti-TNF, tobacco smoking, fistulas, and abscesses were more commonly associated with intestinal resection in ustekinumab- and vedolizumab-treated bio-naïve CD patients. Age < 65 years and intestinal fistulas were commonly associated with ustekinumab-treated bio-naïve CD patients compared to vedolizumab.

Discussion: In this large cohort of bio-naïve CD patients, the rate of intestinal resection was lower in ustekinumab-treated and anti-TNF treated patients compared to Vedolizumab after at least 12 weeks of therapy. Further prospective studies are needed to compare the effectiveness and safety of first-line Ustekinumab and Vedolizumab therapy in IBD patients.

Figure: Comparison of intestinal resection rates in bio-naive CD patients after at least 12 weeks of ustekinumab, vedolizumab, and anti-TNF.

Factors	Ustekinumab N = 510 (%)	Vedolizumab N = 850 (%)	Odds ratio (95% confidence interval), P value
Age
Adults (18-65y)	460 (90%)	710 (84%)	1.81 (1.28-2.55), 0.0007
Seniors ( >65y)	50 (10%)	140 (16%)	0.55 (0.39-0.77), 0.0007
Race
White	460 (90%)	760 (89%)	1.08 (0.75-1.56), 0.64
Non-white	50(10%)	90 (11%)	0.91 (0.63-1.32), 0.64
Gender
Female	300 (59%)	460 (54%)	1.21 (0.97-1.51), 0.90
Male	210 (41%)	390 (46%)	0.82 (0.66-1.03), 0.90
Clinical characteristics
Tobacco user (current and former)	490 (96%)	820 (96%)	0.89 (0.50-1.59), 0.71
Clostridium difficile infection	70 (14%)	150 (18%)	0.74 (0.54-1.01), 0.05
Small bowel obstruction	10 (2%)	30 (4%)	054 (0.26-1.12), 0.10
Fistula of intestine	230 (45%)	330 (38%)	1.29 (1.03-1.61), 0.02
Anorectal fistula	150 (20%)	230 (27%)	1.12 (0.88-1.43), 0.34
Perianal abscess	100 (20%)	140 (16%)	1.23 (0.93-1.64), 0.14
Anorectal abscess	80 (16%)	130 (15%)	1.03 (0.76-1.39), 0.84
Neoplasm of colon	70 (14%)	160 (19%)	0.68 (0.54-0.93), 0.01
Malignant neoplasm of colon	10 (2%)	30 (4%)	0.54 (0.26-1.12), 0.10

Table: Characteristics of biologic naive CD patients requiring intestinal resection after at least 12 weeks of ustekinumab and vedolizumab

Disclosures:

Abdul Mohammed indicated no relevant financial relationships.

Khaled Alsabbagh Alchirazi indicated no relevant financial relationships.

Osama Hamid indicated no relevant financial relationships.

Ahmed Eltelbany indicated no relevant financial relationships.

Rajat Garg indicated no relevant financial relationships.

Neethi Paranji indicated no relevant financial relationships.

Ernesto Robalino Gonzaga indicated no relevant financial relationships.

Amandeep Singh indicated no relevant financial relationships.

Susan Kais: Abbvie – Advisory Committee/Board Member, Speakers Bureau. BMS – Advisory Committee/Board Member, Speakers Bureau. Pfizer – Speakers Bureau. Takeda – Speakers Bureau.

Miguel Regueiro: Abbvie – Advisory Committee/Board Member, Consultant. Abbvie – Grant/Research Support. ALFASIGMA, S.p.A. – Advisory Committee/Board Member. Allergan – Advisory Committee/Board Member. Amgen – Advisory Committee/Board Member. BMS – Grant/Research Support. Bristol Meyer Squibb – Advisory Committee/Board Member, Consultant. CC360 – Royalties. Celgene – Advisory Committee/Board Member. CME Outfitters – CME Companies. Cornerstones – CME Companies. Crohn’s and Colitis Foundation as Editor-in-Chief – Royalties. Genentech – Advisory Committee/Board Member. Genentech – Grant/Research Support. Gilead – Advisory Committee/Board Member. Gilead – Grant/Research Support. HMPGlobal – CME Companies. Imedex, GI Health Foundation (GiHF) – CME Companies. Janssen – Advisory Committee/Board Member, Consultant. Janssen – Grant/Research Support. Lilly – Grant/Research Support. MDEducation – CME Companies. Medscape – CME Companies. Miraca Labs – Advisory Committee/Board Member. MJH life sciences – CME Companies. Pfizer – Advisory Committee/Board Member, Consultant. Prometheus – Advisory Committee/Board Member. Remedy – CME Companies. Salix – Advisory Committee/Board Member. Seres – Advisory Committee/Board Member. Takeda – Advisory Committee/Board Member, Consultant. TARGET Pharma Solutions – Advisory Committee/Board Member. UCB – Grant/Research Support. WebMD – CME Companies. Wolters Kluwer Health as Author/Editor of UpToDate – Royalties.

Abdul Mohammed, MD¹, Khaled Alsabbagh Alchirazi, MD¹, Osama Hamid, MD, MRCPI¹, Ahmed Eltelbany, MD, MPH¹, Rajat Garg, MD², Neethi Paranji, MD³, Ernesto Robalino Gonzaga, MD⁴, Amandeep Singh, MD², Susan Kais, MD⁵, Miguel Regueiro, MD⁶. C0385 - Comparison of Surgical Rates in Biologic Naive Crohn's Disease Patients on Ustekinumab and Vedolizumab, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.