Hepatology (Baltimore, Md.) · 2025
Pruritus is common in primary sclerosing cholangitis, persists over time, and its intensity is associated with disease severity: a multicentre, prospective observational study.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Hussain Nasir, Motta Rodrigo V, Gungabissoon Usha, Casillas Linda, Mukherjee Sumanta, Ribeiro Andrea, Mclaughlin Megan M, Hagan Kaitlin, Bhandal Khushpreet, Rogers Penelope, Walmsley Martine, Ferguson James, Kremer Andreas E, Culver Emma L, Trivedi Palak J
Аннотация
BACKGROUND AND AIMS: Drug development in primary sclerosing cholangitis (PSC) is challenging, giving orphan disease status and variable rates of disease progression. A potential route for new therapies is through attenuation of symptoms. However, the epidemiology of symptomatic presentations and how they inherently fluctuate over time is not known. We conducted a prospective, multicenter study (trial registration: ISRCTN:15518794) to quantify the prevalence, intensity, and variability of pruritus in PSC.
APPROACH AND RESULTS: Participants underwent face-to-face symptom assessment through the itch numerical rating scale (NRS) and 5D-itch tool. Clinical, radiological, and biochemical factors associated with pruritus intensity were determined, alongside the impact on health-related quality-of-life [EQ-5D-5L and chronic liver disease questionnaires (CLDQ)] over 12-week intervals (up to 48±4 weeks). In all, 220 patients participated, of whom n=116 reported pruritus, with n=56 scoring NRS worst itch ≥4. Median 5D-itch was greater in people with cirrhosis (11.0 vs. 8.0), transient elastography readings >8.0 kPa (9.5 vs. 5.0), and a history of ascending cholangitis (11.0 vs. 7.0) ( p <0.01; all). 5D-itch correlated positively with serum bilirubin, ALP, ALT, and AST; and negatively with CLDQ and EQ-5D-5L. In patients scoring NRS ≥4, 61.5% reported persistent pruritus intensity over 48 weeks. Reciprocally, 46.2% experienced a spontaneous ≥2 point reduction in NRS without the addition of a new anti-pruritic agent.
CONCLUSIONS: One in 4 PSC patients experience moderate-severe pruritus, with greater symptom intensity in those with advanced disease. Our dataset is able to serve as a reference tool to aid future interventional study design, with regard to anti-pruritus therapies in PSC.
APPROACH AND RESULTS: Participants underwent face-to-face symptom assessment through the itch numerical rating scale (NRS) and 5D-itch tool. Clinical, radiological, and biochemical factors associated with pruritus intensity were determined, alongside the impact on health-related quality-of-life [EQ-5D-5L and chronic liver disease questionnaires (CLDQ)] over 12-week intervals (up to 48±4 weeks). In all, 220 patients participated, of whom n=116 reported pruritus, with n=56 scoring NRS worst itch ≥4. Median 5D-itch was greater in people with cirrhosis (11.0 vs. 8.0), transient elastography readings >8.0 kPa (9.5 vs. 5.0), and a history of ascending cholangitis (11.0 vs. 7.0) ( p <0.01; all). 5D-itch correlated positively with serum bilirubin, ALP, ALT, and AST; and negatively with CLDQ and EQ-5D-5L. In patients scoring NRS ≥4, 61.5% reported persistent pruritus intensity over 48 weeks. Reciprocally, 46.2% experienced a spontaneous ≥2 point reduction in NRS without the addition of a new anti-pruritic agent.
CONCLUSIONS: One in 4 PSC patients experience moderate-severe pruritus, with greater symptom intensity in those with advanced disease. Our dataset is able to serve as a reference tool to aid future interventional study design, with regard to anti-pruritus therapies in PSC.