E0369 - Treatment Preferences in Crohn’s Disease Perianal Fistula: Patient Perspectives

Tuesday, October 25, 2022

3:00 PM – 5:00 PM ET

Location: Crown Ballroom

Has Audio

Presenting Author(s)

AA

Amod Athavale, BPharm, MS, PhD

Trinity Partners, LLC
Waltham, MA

Amod Athavale, BPharm, MS, PhD¹, Josiah Edelblut, MBA¹, Minghua Chen, MD, MPH², Susan E. Cazzetta, PharmD², Pradeep P. Nazarey, MD³, Tao Fan, PhD², Nandini Hadker, MA¹, Jeanne Jiang, MS²
¹Trinity Partners, LLC, Waltham, MA; ²Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA; ³Takeda Pharmaceuticals U.S.A., Inc., Shrewsbury, MA

Introduction: Crohn’s perianal fistulas (CPFs) are a common complication of Crohn’s disease, and patients with CPF have a high treatment burden that can negatively affect their quality of life (QoL). This study aimed to assess patient satisfaction with current CPF treatments and preferences for future CPF treatment attributes.

Methods: A US observational study was conducted among patients aged ≥21 and ≤89 years with self-reported physician-diagnosed CPF (±CPF-related surgery). Using a web-enabled questionnaire, patient satisfaction with CPF treatments and treatment attribute importance over the past 12 months were rated using a 1–9 scale (1=not at all satisfied, 9=extremely satisfied). A discrete choice experiment (DCE) evaluated patient preferences for future CPF treatment attributes. Data were analyzed using descriptive statistics and hierarchical Bayesian modeling for DCE.

Results: In total, 100 patients were recruited, with a mean (standard deviation [SD]) age of 40.0 [12.2] years. Mean number of unique CPFs was 2.7 [2.4], mean disease duration since diagnosis was 9.1 [9.9] years and 53% reported having complex fistula.

For those who had CPF-related surgery and/or seton placement, treatment satisfaction was highest for fistulectomy/fistulotomy and ligation of the intersphincteric fistula tract and lowest for fibrin glue, short- and long-term setons (Table). Biologics were used by 90% of patients, infliximab having the highest overall satisfaction (6.6 [2.5]). Patient attitudes toward current CPF treatments identified a need for new treatment options (7.1 [1.8]).

For all patients, improvement in QoL (60%) and avoidance of future surgery (50%) were the most important treatment goals. A lower risk of symptom recurrence (8.2 [1.1]), quick improvement in QoL (8.1 [1.1]), reduction in fistula/no large abscess (8.0 [1.4]) and better symptom control (8.0 [1.3]) were the most important current treatment attributes.

The DCE identified symptom control/fistula closure, then post-operative discomfort as the most important attributes for therapies (Figure). Patients considered low fecal incontinence important and preferred procedures with minimal cutting/puncturing and those where treatments were injected into the anal area.

Discussion: Improvements in patient CPF treatment satisfaction and new treatments are required. Clinical development of CPF treatments should consider patient-centric attributes for clinical trial endpoints and when assessing treatment effectiveness.

Figure: Figure: Mean relative attribute importance of future CPF treatments. a = Numbers above columns represent mean relative attribute importance. Mean relative attribute importance is a measure of how important an attribute is when selecting a procedure for CPF, in the context of all attributes tested in the DCE design. It is presented as a normalized score summing to 100 across all attributes tested. A higher value for an attribute indicates higher importance when selecting a procedure for CPF, and a lower value indicates lower importance. CPF, Crohn’s perianal fistula; DCE, discrete choice experiment; FI, fecal incontinence.

	All CPF N = 100
Satisfaction with CPF-related procedures/surgeries (mean [SD])^a
Fistulectomy/fistulotomy^b	7.6 (1.8)
Ligation of the intersphincteric fistula tract (LIFT)^b	7.6 (1.5)
Endorectal/anal advancement flap^b	7.2 (2.3)
Anal fistula plug^b	7.0 (1.4)
Long-term seton placement^c	6.5 (2.1)
Short-term seton placement^c	6.3 (2.3)
Fibrin glue^b	6.2 (1.9)
Satisfaction with medications (mean [SD])^a,b,c
Remicade (infliximab)	6.6 (2.5)
Stelara (ustekinumab)	6.5 (2.6)
Prednisolone or methylprednisolone	6.3 (2.3)
Imuran (azathioprine)	5.9 (2.8)
Humira (adalimumab)	5.8 (2.7)
Rheumatrex, Trexall (methotrexate)	5.4 (2.7)
Entocort EC (budesonide)	5.4 (2.6)
Flagyl (metronidazole)	5.3 (2.6)
Cipro (ciprofloxacin)	5.2 (2.4)
Purinethol (mercaptopurine)	4.9 (2.6)
Asacol, Delzicol, Pentasa, Lialda, Apriso (mesalamine)	4.8 (2.9)
Azulfidine (sulfasalazine)	4.7 (2.6)

Table: Table: Satisfaction with CPF-related procedures/surgeries and medication. a = Satisfaction scores were assessed using a 1–9 scale (1 = not at all satisfied, 9 = extremely satisfied). b = Patients with CPF who have undergone surgery. c = Patients with CPF who have and have not undergone surgery. CPF, Crohn’s perianal fistulas; LIFT, ligation of the intersphincteric fistula tract; SD, standard deviation.

Disclosures:

Amod Athavale: Takeda Pharmaceuticals – Grant/Research Support.

Josiah Edelblut: Takeda – Grant/Research Support.

Minghua Chen: Takeda Pharmaceuticals – Employee.

Susan Cazzetta: Takeda – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).

Pradeep Nazarey: Takeda Pharmaceuticals LTD – Employee. Takeda Pharmaceuticals LTD – Employee, Stock Options. Takeda Pharmaceuticals LTD – Stock Options.

Tao Fan: Takeda Pharmaceuticals U.S.A., Inc – Employee, Stock Options.

Nandini Hadker indicated no relevant financial relationships.

Jeanne Jiang: Takeda – Employee, Stock-publicly held company(excluding mutual/index funds).

Amod Athavale, BPharm, MS, PhD¹, Josiah Edelblut, MBA¹, Minghua Chen, MD, MPH², Susan E. Cazzetta, PharmD², Pradeep P. Nazarey, MD³, Tao Fan, PhD², Nandini Hadker, MA¹, Jeanne Jiang, MS². E0369 - Treatment Preferences in Crohn’s Disease Perianal Fistula: Patient Perspectives, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.