P0391 - Clinical Outcomes Before and After the Initiation of Prucalopride Treatment: A Real World Study in Patients With Constipation in the USA

Sunday, October 24, 2021

3:30 PM – 7:00 PM PT

Location: Shoreline Exhibit Hall

Has Audio

Presenting Author(s)

Anthony Lembo, MD

Beth Israel Deaconess Medical Center
Boston, MA, United States

Anthony Lembo, MD¹, Brooks D. Cash, MD, FACG², Mei Lu, MSc, MD³, Emi Terasawa, PhD⁴, Brian Terreri, PharmD, MBA⁵, Shawn Du, PhD⁴, Rajeev Ayyagari, PhD⁶, Paul Feuerstadt, MD⁷, Baha Moshiree, MD⁸, Mena Boules, MD⁵, Linda Nguyen, MD⁹
¹Beth Israel Deaconess Medical Center, Boston, MA; ²University of Texas Health Science Center at Houston, Houston, TX; ³Takeda Development Center Americas, Inc., Lexington, MA; ⁴Analysis Group, Inc., New York, NY; ⁵Takeda Pharmaceuticals USA, Inc., Lexington, MA; ⁶Analysis Group, Inc., Boston, MA; ⁷Yale University School of Medicine and PACT-Gastroenterology Center, Hamden, CT; ⁸Atrium Health, Charlotte, NC; ⁹Stanford University, Redwood City, CA

Introduction: Prucalopride is a selective high-affinity serotonin type-4 receptor agonist that was approved in 2019 by the US Food and Drug Administration for the treatment of chronic idiopathic constipation (CIC) in adults. Patients with CIC commonly experience a significant symptom burden; however, real-world data on the effectiveness of prucalopride on constipation-related symptoms in patients in the USA are limited. The aim of this real-world study was to compare constipation-related symptoms and complications before and after initiation of prucalopride in the USA.

Methods: An observational retrospective cohort study was conducted using insurance claims data from the MarketScan Commercial Claims and Encounters database and the Medicare Supplemental database (2015–Q2, 2020). This included patients ≥18 years old with ≥1 prescription fill for prucalopride, who had continuous database enrolment for ≥6 months before initiation of prucalopride (baseline) and ≥6 months post-initiation (study period). The first prescription fill for prucalopride was defined as the index date. The proportions of patients who experienced constipation-related symptoms and complications were measured using ICD‑10/Current Procedural Terminology (CPT) codes, and compared during the 6 months before and the 6 months after prucalopride initiation using McNemar’s test.

Results: Overall, 690 patients were included in the study; the mean age was 48 years and most patients were women (87.5%). In total, 63.2% of patients had previously received other prescription CIC treatments (Table). After treatment with prucalopride, there were significant reductions compared with baseline in the proportions of patients with ICD-10 diagnosis codes of abdominal pain (33.3% vs 50.4%, p< 0.001), abdominal distention/bloating (13.3% vs 23.9%, p<0.001) and nausea (17.7% vs 22.6%, p<0.01) (Figure). In addition, after treatment with prucalopride, a significantly lower proportion of patients had ICD-10/CPT codes of hemorrhoids (7.0% vs 10.7%, p< 0.05) or intestinal obstruction (2.0% vs 4.9%, p< 0.001) compared with baseline (Figure).

Discussion: This real-world study indicates that treatment with prucalopride is associated with a reduction in the coding of constipation-related symptoms and complications. Additional studies are needed to confirm that these findings are associated with an improvement in constipated-related symptoms and complications.

Figure: Figure. Constipation-related symptoms (A) and complications‡ (B) in patients with constipation before and after treatment initiation with prucalopride

***p<0.001; **p<0.01; *p<0.05. All p-values were generated using McNemar’s test.
‡Other CIC-related complications that were evaluated include anal fissure and fistula; fecal impaction; impaction of intestine; rectal prolapse; peri-anal thrombosis; and peri-anal/peri-rectal abscess. These were not included in the analyses owing to few occurrences.

Demographic/characteristic	All patients (N = 690)	18–64 years old (n = 634)	≥ 65 years old (n = 56)
Age, years, mean (SD)	48 (14.7)	45.7 (12.8)	74.4 (7.1)
Women, n (%)	604 (87.5)	563 (88.8)	41 (73.2)
Initial dose of prucalopride (mg), mean (SD)	1.9 (0.3)	1.9 (0.3)	1.8 (0.4)
1.0 mg	76 (11.0)	66 (10.4)	10 (17.9)
2.0 mg	614 (89.0)	568 (89.6)	46 (82.1)
Any constipation-related comparator prescription treatment any time before the index date, n (%)^†	436 (63.2)	399 (62.9)	37 (66.1)
Prior CIC prescription treatments during baseline
Lubiprostone	69 (10.0)	63 (9.9)	6 (10.7)
Linaclotide	212 (30.7)	194 (30.6)	18 (32.1)
Plecanatide	84 (12.2)	80 (12.6)	4 (7.1)
None	379 (54.9)	349 (55.0)	30 (53.6)

Table: Table. Demographics and Characteristics of Patients with Constipation*.

*The baseline period was defined as the 6 months before the index date; †Includes lubiprostone, linaclotide and plecanatide.
CIC, chronic idiopathic constipation; SD, standard deviation.

Disclosures:

Anthony Lembo: Aeon – Consultant. Allakos – Consultant. Arena – Consultant. Bayer – Consultant. Bellatrix – Consultant. Bristol Myer Squibb – Stockholder/Ownership Interest (excluding diversified mutual funds). Gemilli biotech – Consultant. Ironwood – Consultant. Johnson and Johnson – Stockholder/Ownership Interest (excluding diversified mutual funds). Mylan – Consultant. OrphoMED – Consultant. Shire, a Takeda company – Consultant. Takeda – Consultant. Vibrant – Consultant.

Brooks Cash: Takeda Pharmaceuticals – Consultant, Speaker's Bureau.

Mei Lu: Takeda Development Center Americas, Inc. – Employee. Takeda Pharmaceutical Company Limited – Stockholder/Ownership Interest (excluding diversified mutual funds).

Emi Terasawa: Analysis Group Inc. – Employee. Takeda Pharmaceuticals USA, Inc. – Grant/Research Support.

Brian Terreri: Takeda Development Center Americas, Inc. – Employee. Takeda Pharmaceutical Company Limited – Stockholder/Ownership Interest (excluding diversified mutual funds).

Shawn Du: Analysis Group Inc. – Employee. Takeda Pharmaceuticals USA, Inc. – Grant/Research Support.

Rajeev Ayyagari: Analysis Group Inc. – Employee. Takeda Pharmaceuticals USA, Inc. – Grant/Research Support.

Paul Feuerstadt: Ferring/Rebiotix – Consultant, Speaker's Bureau. Merck and Co. – Consultant, Speaker's Bureau. SERES Therapeutics – Consultant, Speaker's Bureau. Takeda Pharmaceuticals – Advisory Committee/Board Member.

Baha Moshiree: AbbVie Pharmaceuticals – Advisory Committee/Board Member, Grant/Research Support. Allergan – Advisory Committee/Board Member, Grant/Research Support. Alnylam Pharmaceuticals – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speaker's Bureau. Medotronic – Advisory Committee/Board Member, Grant/Research Support. Progenity – Advisory Committee/Board Member, Grant/Research Support. Salix/Bausch Pharmaceuticals – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speaker's Bureau. Takeda Pharmaceuticals – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speaker's Bureau. University of Miami/Atrium Health – Patent Holder.

Mena Boules: Takeda Development Center Americas, Inc. – Employee. Takeda Pharmaceutical Company Limited – Stockholder/Ownership Interest (excluding diversified mutual funds).

Linda Nguyen: Alnylam – Consultant. Bold Health – Grant/Research Support. Eli Lilly – Consultant. Gamelli Biotech – Advisory Committee/Board Member. Ironwood – Consultant. Neurogastx – Consultant. Pendulum – Consultant. Phathom – Consultant. Takeda Pharmaceuticals – Consultant. Vanda – Grant/Research Support.

Anthony Lembo, MD¹, Brooks D. Cash, MD, FACG², Mei Lu, MSc, MD³, Emi Terasawa, PhD⁴, Brian Terreri, PharmD, MBA⁵, Shawn Du, PhD⁴, Rajeev Ayyagari, PhD⁶, Paul Feuerstadt, MD⁷, Baha Moshiree, MD⁸, Mena Boules, MD⁵, Linda Nguyen, MD⁹. P0391 - Clinical Outcomes Before and After the Initiation of Prucalopride Treatment: A Real World Study in Patients With Constipation in the USA, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.