INVESTIGATING THE CHOLESTATIC PRURITUS OF PRIMARY SCLEROSING CHOLANGITIS (ITCH-PSC): A CROSS SECTIONAL STUDY OF PATIENTS PARTICIPATING IN THE CONSORTIUM FOR AUTOIMMUNE LIVER DISEASE (CALID)
Recommended Citation
Dean R, Yazdanfar M, Zepeda JB, Patel I, Levy C, Lammert C, Bordia R, Cosar D, Specht K, Pratt D, Gordon S, Forman L, Barry F, Li M, Assis D, McGirr A, McLaughlin M, Mukherjee S, Gungabissoon U, Bowlus C. INVESTIGATING THE CHOLESTATIC PRURITUS OF PRIMARY SCLEROSING CHOLANGITIS (ITCH-PSC): A CROSS SECTIONAL STUDY OF PATIENTS PARTICIPATING IN THE CONSORTIUM FOR AUTOIMMUNE LIVER DISEASE (CALID). Hepatology 2024; 80:S1801-S1802.
Document Type
Conference Proceeding
Publication Date
10-9-2024
Publication Title
Hepatology
Keywords
albumin, alkaline phosphatase, antihistaminic agent, bile acid, bilirubin glucuronide, biological marker, fenofibrate, resin, rifampicin, sertraline, adult, African American, aged, autoimmune liver disease, bile acid blood level, Caucasian, cholestasis, cholestatic pruritus, conference abstract, Crohn disease, cross-sectional study, drug therapy, female, human, inflammatory bowel disease, liver transplantation, major clinical study, male, numeric rating scale, off label drug use, patient-reported outcome, primary sclerosing cholangitis, pruritus, quality of life, Short Form 36, special situation for pharmacovigilance, symptom burden, ulcerative colitis
Abstract
Background: Primary Sclerosing Cholangitis (PSC) is a chronic cholestatic liver disease with no approved treatment and few effective off-label therapies to reduce the symptom burden. Pruritus is frequently reported by patients with PSC, but only limited data exist using patient-reported outcomes measures. ItCh-PSC aims to characterize the frequency and severity of pruritus and determine its impact on quality of life and relationship with biomarkers of pruritus in patients with PSC. Methods: Patients aged 18 and older, diagnosed with PSC and without a liver transplant were enrolled at 7 centers. Itch numeric rating scale (NRS), 5-D Itch, PSC-PRO, and SF-36 were completed and serum collected. For the NRS, patients reported their average and worst itch (WI) in the past 24 hours, 7 days, and 6 months. Colitis activity was assessed in patients with inflammatory bowel disease (IBD) by the Simple Clinical Colitis Activity Index (SCCAI). Total serum bile acids (TSBA) and liver biochemistries were measured. Results: A total of 200 patients were enrolled (51% male; mean (SD) age of 46.0 (15.4) years; 71% White, 11% Black/African American; 15% cirrhosis). Most patients (77%) had large duct PSC while 4% had small duct PSC and 2% had PSC-AIH. IBD was present in 79% (57% ulcerative colitis/19% Crohn's disease/3% indeterminate). WI in the past 24 hours, 7 days, and 6 months was reported as moderate-to-severe (WI-NRS > 4) by 42 (21%), 48 (24%), and 76 (38%) patients, respectively. WI-NRS in the past 7 days was greater in patients with cirrhosis (P = 0.02); and correlated with 5-D Itch (r = 0.75), PSC-PRO (r = 0.69), and SF-36 physical component (r = -0.47) and mental component (r = -0.32) scores (P < 0.0001 for all); but did not differ by age, sex, race, PSC type, or IBD status. Among patients with IBD, SCCAI was greater in those with worse WI-NRS. Average and WI-NRS scores reported at all times correlated with alkaline phosphatase, AST, albumin, total and direct bilirubin, and TSBA. Among 48 patients with an WI-NRS > 4 in the past 7 days, antihistamines were used by 19 (40%), bile acid binding resins by 12 (25%), rifampin by 7 (15%), sertraline by 4 (9%), and fenofibrate by 4 (8%). Conclusion: Patient-reported moderate-to-severe pruritus in this large cohort of patients with PSC was common and correlated with advanced liver disease; worsening cholestasis; and impaired quality of life, but medical treatment of moderate-to-severe pruritus in this group was infrequent.
Volume
80
First Page
S1801
Last Page
S1802
