P0517 - Changing Biologic Mechanism After Detection of Endoscopic Postoperative Recurrence Promotes Endoscopic Remission

Sunday, October 24, 2021

3:30 PM – 7:00 PM PT

Location: Shoreline Exhibit Hall

Has Audio

Presenting Author(s)

Salam P. Bachour, MS

Cleveland Clinic Lerner College of Medicine
Cleveland, OH, United States

Salam P. Bachour, MS¹, Ravi S. Shah, MD², Ruishen Lyu, BS³, Florian Rieder, MD⁴, Benjamin Cohen, MD, MAS⁵, Taha Qazi, MD⁶, Bret Lashner, MD², Jean-Paul Achkar, MD³, Jessica Philpott, MD³, Edward L. Barnes, MD, MPH⁷, Jordan Axelrad, MD, MPH⁸, Stefan D. Holubar, MD², Amy L. Lightner, MD², Miguel Regueiro, MD⁵, Benjamin Click, MD, MS²
¹Cleveland Clinic Lerner College of Medicine, Cleveland, OH; ²Digestive Disease Institute, Cleveland Clinic Foundation, Cleveland, OH; ³Cleveland Clinic Foundation, Cleveland, OH; ⁴Digestive Diseases and Surgery Institute, Cleveland Clinic, Cleveland, OH; ⁵Cleveland Clinic, Cleveland, OH; ⁶Cleveland Clinic Foundation, Beachwood, OH; ⁷University of North Carolina Chapel Hill, Chapel Hill, NC; ⁸New York University School of Medicine, New York, NY

Introduction: Postoperative prophylaxis with biologics following ileocecal resection (ICR) for Crohn’s disease (CD) reduces endoscopic postoperative recurrence (POR) rates. However, there is limited data regarding optimal treatment strategies of endoscopic POR. We aimed to assess the outcomes of various therapeutic regimens to treat endoscopic POR despite biologic prophylaxis.

Methods: Retrospective cohort study of adult CD patients who underwent ICR between 2009-2020 at single referral institution. Patients with bowel continuity restoration, first detection of endoscopic POR whilst on a biologic, and ≥1 postoperative colonoscopy were included. Modified Rutgeerts’ score assessed disease activity and endoscopic POR was defined as Rutgeerts’ ≥i2b. Treatment changes after POR detection were categorized as therapy optimization (steroids, immunomodulators, dose intensification of biologic, new biologic within class) or new biologic class. The primary outcome of the study was treatment failure defined as endoscopic POR at immediate follow up colonoscopy or surgical POR prior to subsequent colonoscopy. Secondary outcome was endoscopic healing at follow up endoscopy.

Results: 81 CD patients with endoscopic POR (54.6% i2b, 22.2% i3, and 22.2% i4) despite biologic prophylaxis were included. A majority (85.4%) were on anti-TNF, 8.6% vedolizumab, and 4.9% were on ustekinumab at time of POR. The predominant intervention was therapy optimization (76.3%, n=61) while 24.7%(n=20) were started on a new biologic class. 60 patients, comprised of 48 (78.7%) therapy optimization and 12 (60.0%) new biologic class, experienced treatment failure (84.6% endoscopic, 15.4% surgical) (P=0.08). On multivariable modeling, initiation of new biologic class was associated with reduced risk for treatment failure compared to therapy optimization (aOR: 0.26 [0.07-0.93]; p=0.04) (Table 1). In patients without surgical POR (n=68), 28 patients, comprised of 18 (35.3%) therapy optimization and 10 (58.9%) of new biologic class, had endoscopic healing at time of follow up endoscopy. On modeling adjusting for endoscopic severity, initiation of new biologic class was associated with endoscopic healing relative to therapy optimization (aOR: 3.3 [1.0-11.92]; p=0.05).

Discussion: In CD patients who experience POR despite biologic prophylaxis, changing mechanism of action may promote greater endoscopic healing than therapy optimization. Larger studies assessing factors associated with response and prospective trials are needed to confirm results.

Factor	Treatment Failure Adjusted Odds Ratio (95% CI)	P value	Endoscopic Healing Adjusted Odds Ratio (95% CI)	P value
Treatment Change
Therapy optimization	Reference	--	Reference
Biologic Initiated	0.26 (0.07-0.93)	0.041	3.30 (1.0-11.9)	0.05
Rutgeerts’ score at time of index POR
i2b	Reference	--	Reference
i3	0.49 (0.13-1.78)	0.28	4.97 (1.4-19.7)	0.02
i4	4.8 (1.01-37.06)	0.08	0.55 (0.12-2.10)	0.40
Tobacco Use History
Never	Reference	--	--	--
Former Tobacco Use	0.76 (0.20-2.89)	0.68	--	--
Active Tobacco Use	3.38 (0.76-19.79)	0.13	--	--
Perianal disease involvement	2.02 (0.62-7.23)	0.26	--	--
≥2 prior ICR	1.15 (0.30-5.20)	0.85	--	--

Table: Table 1: Adjusted hazard ratio of therapeutic modification for primary and secondary outcomes

Disclosures:
Salam Bachour indicated no relevant financial relationships.
Ravi Shah indicated no relevant financial relationships.
Ruishen Lyu indicated no relevant financial relationships.
Florian Rieder: AbbVie – Advisory Committee/Board Member, Consultant. Adnovate – Advisory Committee/Board Member, Consultant. Gilead – Advisory Committee/Board Member, Consultant. Pfizer – Advisory Committee/Board Member, Consultant.
Benjamin Cohen: Abbvie – Consultant, Speaker's Bureau. Bristol Myers Squibb – Advisory Committee/Board Member. Pfizer – Advisory Committee/Board Member. Sublimity Therapeutics – Consultant. Takeda – Advisory Committee/Board Member. Target RWE – Consultant.
Taha Qazi indicated no relevant financial relationships.
Bret Lashner indicated no relevant financial relationships.
Jean-Paul Achkar indicated no relevant financial relationships.
Jessica Philpott: AbbVie – Speaker's Bureau.
Edward Barnes: AbbVie – Consultant. Gilead – Consultant. Pfizer – Consultant. TARGET-RWE – Consultant.
Jordan Axelrad: Abbvie – Advisory Committee/Board Member. BioFire Diagnostics – Consultant, Grant/Research Support. Janssen – Consultant.
Stefan Holubar: Guidepoint – Consultant. Shionogi – Consultant. Takeda – Consultant.
Amy Lightner: Takeda – Consultant.
Miguel Regueiro: AbbVie – Advisory Committee/Board Member, Consultant. Janssen – Consultant. Takeda – Consultant.
Benjamin Click: Takeda – Speaker's Bureau. TARGET-RWE – Consultant.

Salam P. Bachour, MS¹, Ravi S. Shah, MD², Ruishen Lyu, BS³, Florian Rieder, MD⁴, Benjamin Cohen, MD, MAS⁵, Taha Qazi, MD⁶, Bret Lashner, MD², Jean-Paul Achkar, MD³, Jessica Philpott, MD³, Edward L. Barnes, MD, MPH⁷, Jordan Axelrad, MD, MPH⁸, Stefan D. Holubar, MD², Amy L. Lightner, MD², Miguel Regueiro, MD⁵, Benjamin Click, MD, MS². P0517 - Changing Biologic Mechanism After Detection of Endoscopic Postoperative Recurrence Promotes Endoscopic Remission, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.