C0386 - Comparison of Colectomy Rates in Biologic Naive Ulcerative Colitis 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, Ahmed Eltelbany, MD, MPH¹, Osama Hamid, MD, MRCPI¹, Ernesto Robalino Gonzaga, MD², Rajat Garg, MD³, Neethi Paranji, MD⁴, Amandeep Singh, MD³, Susan Kais, MD⁵, Miguel Regueiro, MD⁶
¹Cleveland Clinic, Cleveland, OH; ²Johns Hopkins University, Baltimore, MD; ³Cleveland Clinic Foundation, Cleveland, OH; ⁴MetroHealth Medical Center, Cleveland, OH; ⁵AdventHealth Orlando, Orlando, FL; ⁶Cleveland Clinic Main Campus, Cleveland, OH

Introduction: Between 10% to 20% of patients with Ulcerative Colitis (UC) 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 UC patients is unknown. We aimed to investigate the effect of ustekinumab and vedolizumab on colectomy rates in bio-naïve UC 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 UC patients. The primary outcome was to examine the association between anti-tumor necrosis factor (anti-TNF) medications, ustekinumab, and vedolizumab therapy and the colectomy rate in bio-naïve UC patients after at least 12 weeks of treatment. Secondary endpoints were factors associated with increased risk of surgical intervention in these bio-naïve UC patients.

Results: The database included over 70 million individuals in which we identified 208,880 (0.30%) adult ( >18 years) patients with UC. Among all UC patients, 0.7% received ustekinumab, 2.3% received vedolizumab, and 9.4% received anti-TNF as first-line biologic therapy. The rate of colectomy was lower among ustekinumab-treated compared to vedolizumab-treated (11.8% vs. 14.1%, p = 0.01) and anti-TNF-treated (111.8% vs. 14.0%, p = 0.01) bio-naïve UC patients. However, colectomy rates did not significantly differ between vedolizumab-and anti-TNF-treated bio-naïve UC patients (14.0% vs. 14.0%, p = 0.77). Females were more commonly associated with colectomy in ustekinumab-treated than vedolizumab- and anti-TNF-treated bio-naïve UC patients. Age < 65 years was more commonly associated with colectomy in ustekinumab- and vedolizumab-treated than anti-TNF-treated UC patients. Neoplasm of the colon was more commonly associated with colectomy in vedolizumab-treated than anti-TNF-treated UC patients. However, the rate of malignant neoplasm was not significantly different.

Discussion: In this large cohort of biologic naïve UC patients, the colectomy rate was lower in ustekinumab-treated compared to vedolizumab- and anti-TNF treated patients 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 UC.

Figure: Comparison of Colectomy rates in biologic naive UC patients requiring colectomy after at least 12 weeks of ustekinumab, vedolizumab, and anti-TNF.

Factors	Ustekinumab	Vedolizumab	Odds ratio (95% confidence interval), P value
Age
Adults (18-65y)	160 (84%)	560 (80%)	1.33 (0.86-2.05), 0.19
Seniors ( >65y)	30 (16%)	140 (21%)	0.75 (0.48-1.15), 0.19
Race
White	170 (89%)	630 (90%)	0.94 (0.55-1.59), 0.83
Non-white	20 (11%)	70 (11%)	1.05 (0.62-1.78), 0.83
Gender
Female	110 (58%)	330 (47%)	1.54 (1.11-2.13), 0.008
Male	80 (42%)	370 (53%)	0.64 (0.46-0.89), 0.008
Clinical characteristics
Tobacco user (current and former)	178 (94%)	660 (94%)	0.65 (0.36-1.1), 0.17
Clostridium difficile infection	40 (21%)	140 (20%)	1.06 (0.71-1.58), 0.74
Neoplasm of colon	60 (32%)	240 (34%)	0.88 (0.62-1.24), 0.48

Table: Characteristics of biologic naive UC patients requiring colectomy 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.

Ahmed Eltelbany indicated no relevant financial relationships.

Osama Hamid indicated no relevant financial relationships.

Ernesto Robalino Gonzaga indicated no relevant financial relationships.

Rajat Garg indicated no relevant financial relationships.

Neethi Paranji 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, Ahmed Eltelbany, MD, MPH¹, Osama Hamid, MD, MRCPI¹, Ernesto Robalino Gonzaga, MD², Rajat Garg, MD³, Neethi Paranji, MD⁴, Amandeep Singh, MD³, Susan Kais, MD⁵, Miguel Regueiro, MD⁶. C0386 - Comparison of Colectomy Rates in Biologic Naive Ulcerative Colitis Patients on Ustekinumab and Vedolizumab, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.