Illinois Gastroenterology Group Gurnee, IL, United States
Jonathan Rosenberg, MD1, Chris LaVallee, MS2, Manchikanti Nagarjuna Reddy, BPharm, MS (Pharm)3, Prafullakumar Seelam, BE4, Olivia Li, BSc5, Jennifer Pack, MSN, ACNP-BC6, Dennis L. Decktor, PhD, FACG7 1Illinois Gastroenterology Group, Gurnee, IL; 2Decision Resources Group, Austin, TX; 3DRG Clarivate, Huzurnagar, Telangana, India; 4DRG Clarivate, Bangalore, Karnataka, India; 5DRG Clarivate, Toronto, ON, Canada; 6Aimmune Therapeutics, a Nestle Health Science Company, Bridgewater, NJ; 7Aimmune Therapeutics, a Nestle Health Science Company, Dresher, PA
Introduction: Data describing real-world outcomes of patients with chronic pancreatitis (CP) or type 2 diabetes (T2D) receiving pancreatic enzyme replacement therapies (PERTs) are limited. In addition, the effect of patient compliance with PERT on exocrine pancreatic insufficiency (EPI)-driven symptoms is unknown. This study evaluated clinical and HCP characteristics of symptom profiles over time in pancrelipase (PL)-treated patients with CP and T2D.
Methods: Data were obtained from the Decision Resources Group Real World Evidence US Data Repository. Using medical claims data, the cohort (aged ≥18 years) was defined by patients receiving PL (ZENPEP) at an index date between August 01, 2015 and June 30, 2020. Gastrointestinal (GI) symptoms were assessed at 6, 12 and 18 months post-index vs baseline. Patients were classified into mutually exclusive CP and T2D cohorts based on relevant ICD‑10-CM diagnosis codes. Univariate descriptive statistics were calculated for study variables.
Results: The study identified 10,656 patients with CP (n=3,215) or T2D (n=7,441) treated with PL over the post-index period (PIP). Sixty percent of patients with CP (n=1,927) and 83% of patients with T2D (n=6,164) were aged ≥55 years. Higher proportions of females were observed in both cohorts (CP: 1,984 [62%]; T2D: 4,607 [62%]). Compared with baseline, significant and sustained reductions in GI symptoms (abdominal pain, nausea & vomiting and diarrhea & steatorrhea) were observed following PL treatment in both cohorts (p< 0.05 across each symptom subset). Patients with CP who complied with the prescribed PL regimen for >270 days (n=1,553) over the PIP had significantly lower rates of abdominal pain (p< 0.0001) and nausea & vomiting (p< 0.05) vs those who used PL for < 90 days (n=1,115). Patients with T2D who complied with PL for >270 days (n=2,964) had significantly lower rates of abdominal pain (p< 0.0001) and diarrhea &steatorrhea (p< 0.05) vs those who used PL for < 90 days (n=2,959). Importantly, results were consistent regardless of prescribing HCP specialty.
Discussion: The sustained impact of PERT on reducing GI symptoms in patients with CP or T2D has not been previously described. These results suggest that PL treatment reduces GI symptoms and greater PL compliance leads to an improved GI symptom profile. Treatment effectiveness was similar among patients treated by various HCPs. These findings provide important information on the effects of PL on GI symptom profiles and highlight the importance of patient compliance.
Jonathan Rosenberg: Nestle – Consultant, Speaker's Bureau.
Chris LaVallee indicated no relevant financial relationships.
Manchikanti Nagarjuna Reddy indicated no relevant financial relationships.
Prafullakumar Seelam indicated no relevant financial relationships.
Olivia Li indicated no relevant financial relationships.
Jennifer Pack indicated no relevant financial relationships.
Dennis Decktor: Aimmune Therapeutics, Nestle Health Science – Employee.
Jonathan Rosenberg, MD1, Chris LaVallee, MS2, Manchikanti Nagarjuna Reddy, BPharm, MS (Pharm)3, Prafullakumar Seelam, BE4, Olivia Li, BSc5, Jennifer Pack, MSN, ACNP-BC6, Dennis L. Decktor, PhD, FACG7. P1085 - Real World Evidence Evaluation of the Characteristics of Chronic Pancreatitis and Type 2 Diabetes Patients Treated With Pancrelipase in the United States, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.