63 - Treatment of Exocrine Pancreatic Insufficiency in Patients with Chronic/Recurrent Acute Pancreatitis Improves Treatment Satisfaction and Decreases Healthcare Utilization: Interim Findings from the PACT-CP Registry

Wednesday, October 25, 2023

9:50 AM – 10:00 AM PT

Location: Ballroom A

Presenting Author(s)

Jodie A. Barkin, MD, FACG

Associate Professor of Clinical Medicine
University of Miami Miller School of Medicine
Miami, FL

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Award: Outstanding Research Award in the Biliary/Pancreas Category

Jodie A. Barkin, MD, FACG¹, Yasmin G.. Hernandez-Barco, MD², Samer Al-Kaade, MD³, Rahul Pannala, MD⁴, Janine Twal, PharmD⁵, Jennifer Pack, MSN, ACNP-BC⁶, Trudi Delk, PharmD⁷, Valerie J. Powell, BS, MS⁸, David C.. Whitcomb, MD, PhD⁹
¹University of Miami, Leonard M. Miller School of Medicine, Miami, FL; ²Massachusetts General Hospital, Boston, MA; ³Mercy, Sunset Hills, MO; ⁴Mayo Clinic, Scottsdale, AZ; ⁵Aimmune Therapeutics, a Nestlé Health Science Company, Bridgewater, NJ; ⁶Nestle Health Science, Bridgewater, NJ; ⁷Aimmune Therapeutics, a Nestlé Health Science Company, Bridgewater Township, NJ; ⁸CorEvitas, LLC, Ringoes, NJ; ⁹University of Pittsburgh, UPMC, and Ariel Precision Medicine, Pittsburgh, PA

Introduction: The needs of patients (pts) with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) are poorly understood. To further characterize the challenges for pts with CP and EPI receiving pancreatic enzyme replacement therapy (PERT), a prospective, pt-driven registry was established to collect data from pts and their providers. We present interim findings from data captured in the PAtient-CenTric Chronic Pancreatitis (PACT-CP) Registry.

Methods: This longitudinal, noninterventional study (NCT05762445) in the US, follows pts up to 5 years. Eligible adults are those receiving PERT with suspected/confirmed EPI and diagnosed with CP/recurrent acute pancreatitis (RAP) at enrollment. To understand impact of clinical practices/EPI clinical course, multivariate modeling will be used to analyze effects of medical history, comorbidities, and treatments on EPI history/progression, quality of life, and healthcare resource utilization (HCRU).

Results: As of March 15, 2023, 91 pts are enrolled. Median age is 60.0 years and most pts are White (Table). Alcohol (susceptibility/progression), diabetes mellitus, and tobacco smoking are the most common CP etiologies. Pts (n=76) reported a median of 6 pills of PERT taken daily at Visit 1; median number was generally similar at subsequent visits. Most pts responding about PERT impact on symptoms at Visit 1 through the 18-month (mo) visit noted PERT greatly/somewhat improved symptoms (Visit 1, 78%; 3-mo, 71%; 6-mo, 71%; 9-mo, 77%; 12-mo, 73%; 15-mo, 50%; 18-mo, 100%). At Visit 1, 15 pts had recently been hospitalized because of abdominal pain; numbers declined at subsequent visits (2 at 3- and 6-mo visit, 1 at 15-mo visit, and 0 at 9-, 12-, and 18-mo visits). Nineteen pts needed emergency room visits over the past 3 mo at Visit 1; numbers declined to 7 at the 6-mo, 1 at the 12-mo, and 0 at the 18-mo visit. Full-time employees took a median of 2.5 days off over the past 3 mo at Visit 1 (n=28); days off at subsequent visits were ≤2.0. Mean global treatment satisfaction scores fluctuated and generally improved from Visit 1 to subsequent visits.

Discussion: Many pts with CP/EPI receiving PERT have unmet needs in their CP/EPI management with impacts on work productivity and HCRU. Treatment of EPI with PERT may mitigate overall HCRU in pts with EPI due to CP/RAP. Future analyses will continue to clarify areas of unmet needs and provide additional insights with PERT use and other aspects of disease management.

Characteristic	TotalN=91
Patient demographics^a
Age (years), median (range)	60 (27–83)
Sex, n (%)
Male	42 (53)
Female	37 (47)
Race, n (%)
White	63 (80)
Black or African American	7 (9)
Asian	2 (3)
American Indian or Alaska Native	2 (3)
Other	8 (10)
Ethnicity, n (%)
Hispanic or Latino	12 (15)
Not Hispanic or Latino	67 (85)
Chronic pancreatic etiology^b,c,d, n (%)
Toxic-metabolic
Alcohol (susceptibility/progression)	33 (37)
Tobacco smoking	19 (21)
Hyperlipidemia (fasting >300 mg/dL, nonfasting >500 mg/dL)	9 (10)
Medications	5 (6)
Toxins, other	3 (3)
Toxins, other, not otherwise specified	3 (3)
Hypercalcemia (total calcium levels >12.0 mg/dL or 3 mmol/L)	2 (2)
Toxins, chronic kidney disease (stage 5, end-stage renal disease)	2 (2)
Not applicable	43 (48)
Metabolic, other
Diabetes mellitus	28 (31)
Not applicable	62 (70)
Idiopathic
Late onset ( >35 years of age)	42 (47)
Early onset (< 35 years of age)	7 (8)
Not applicable	41 (46)
Evidence of suspected/confirmed EPI diagnosis^b,d, n (%)
Weight loss	39 (44)
Clinical steatorrhea	31 (35)
Abnormal fecal elastase-1 test	27 (30)
Vitamin deficiency	18 (20)
Pancreatic function testing	6 (7)
Other	27 (30)
Not applicable	13 (15)
Clinical manifestations of EPI^b,d, n (%)
Gastrointestinal symptoms
Diarrhea/loose stool	65 (73)
Abdominal pain	60 (67)
Bloating	46 (52)
Steatorrhea	32 (36)
Flatulence	29 (33)
Not applicable	5 (6)
Nutritional
Unintentional weight loss/difficulty gaining weight	38 (43)
Vitamin D deficiency	24 (27)
Other vitamin/mineral deficiencies	13 (15)
Malnutrition	12 (13)
Other	1 (1)
Not applicable	40 (45)

Table: Patient Demographics and Disease Characteristics at Baseline:

aData were available for 79 patients.
bData were available for 89 patients.
cSelected chronic pancreatic etiology; other categories not shown include genetic, autoimmune, recurrent and severe acute pancreatitis, obstructive, and other.
dMultiple options may be selected for individual participants.

Abbreviation: EPI, exocrine pancreatic insufficiency.

Disclosures:

Jodie Barkin: AbbVie – Advisor or Review Panel Member. Aimmune Therapeutics, a Nestlé Health Science company – Consultant. CorEvitas, LLC – Advisor or Review Panel Member. Envara Health – Advisor or Review Panel Member. Medtronic – Advisor or Review Panel Member. Organon – Advisor or Review Panel Member.

Yasmin Hernandez-Barco: Aimmune Therapeutics, a Nestlé Health Science company – Consultant. CorEvitas, LLC – Advisory Committee/Board Member.

Samer Al-Kaade: AbbVie – lectures. Aimmune Therapeutics, a Nestlé Health Science company – Consultant, medical writing. Hyde, Love & Overby, LLP – other.

Rahul Pannala: Aimmune Therapeutics, a Nestlé Health Science company – Consultant. blue star genomics – Advisor or Review Panel Member. HCL technologies – Consultant.

Janine Twal: Aimmune Therapeutics, a Nestlé Health Science company – Employee.

Jennifer Pack: Nestle Health Science – Employee.

Trudi Delk: Aimmune Therapeutics, a Nestlé Health Science company – Employee.

Valerie Powell: Aimmune Therapeutics, a Nestlé Health Science company – Consultant. CorEvitas, LLC – Employee.

David Whitcomb: Aimmune Therapeutics, a Nestlé Health Science company – Consultant. Ariel Precision Medicine – Stock Options. Collaborative Alliance for Pancreatic Education and Research – Advisory Committee/Board Member. Department of Defense – Grant/Research Support. National Pancreas Foundation – Advisory Committee/Board Member. NIH/NIDDK – Grant/Research Support. Novartis – Consultant. Provident Charter School for Dyslexia – Advisory Committee/Board Member. Regeneron Pharmaceuticals – Consultant. U.S. Application No. 15/156,063 – Intellectual Property/Patents. U.S. Patent Application No. 16/700.014 – Intellectual Property/Patents. UpToDate – Royalties.

Jodie A. Barkin, MD, FACG¹, Yasmin G.. Hernandez-Barco, MD², Samer Al-Kaade, MD³, Rahul Pannala, MD⁴, Janine Twal, PharmD⁵, Jennifer Pack, MSN, ACNP-BC⁶, Trudi Delk, PharmD⁷, Valerie J. Powell, BS, MS⁸, David C.. Whitcomb, MD, PhD⁹, 63, Treatment of Exocrine Pancreatic Insufficiency in Patients with Chronic/Recurrent Acute Pancreatitis Improves Treatment Satisfaction and Decreases Healthcare Utilization: Interim Findings from the PACT-CP Registry, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.