Burden, impact and variability of pruritus in primary sclerosing cholangitis (psc) over time: a prospective observational study

Pruritus is a recognised symptom of PSC, although the prevalence, persistence and impact on quality of life (QoL) are unknown. The study aims are to (A) quantify the proportion of patients with PSC who experience pruritus, (B) identify factors associated with symptom intensity, (C) determine the association between pruritus and overall health related QoL, and (D) assess the variability in pruritus over time.

Methods

Patients with a diagnosis of PSC (age >16 years; non-transplant) were invited to complete specific QoL tools: 5D itch, itch numerical rating scale (NRS), chronic liver disease questionnaire (CLDQ) and the EQ-5D-5L. Measures were obtained at 0, 3, 6, 9 and 12 months, alongside clinical and laboratory data. This prospective observational study began recruitment in Aug ‘21. Follow-up is ongoing, and interim results are presented herein.

Results

Between Aug ‘21 and Feb ‘23, we accrued data from 200 patients. Most had large duct disease (n=18), were men (n=115), with a median age of 39yrs (IQR 28–57), a history of inflammatory bowel disease (IBD, n=170) and a median MELD score of 7 (IQR 6–8). (A) Median baseline 5D itch score was 8 (IQR 5–12), with 100/200 pts (50%) reporting any degree of itch according to the NRS. The latter included 41 patients who report the intensity of itch as moderate or severe (20.5%). (B) 5D itch scores negatively correlated with age, positively correlated with serum bilirubin, ALT, ALP, GGT and bile acid values. Pruritus was greater in patients with previous episodes of acute cholangitis, those with advanced fibrosis, and people with cirrhosis (figure 1). (C) Pruritus was associated with worse health utility, which worsened as itch intensity increased. Mean (SD) CLDQ scores in patients with no, mild, moderate, and severe itch were 5.6 (1.0), 5.1 (1.2), 4.4 (1.2) and 3.7 (1.3), respectively. Mean EQ-5D scores for no, mild, moderate, and severe itch were 0.81 (0.21), 0.77 (0.24), 0.70 (0.19), 0.68 (0.23) respectively. (D) At time of writing, 49/100 patients reporting itch at baseline, undertook repeat assessment at 12 months. 25/49 pts (51%) reported itch was unchanged or had worsened (including 9 who were taking symptom-specific therapy).

Conclusion

Pruritus is common in PSC, with more than 20% reporting pruritus as moderate or severe. Pruritus persists over time and has negative connotations on QoL. Those with a history of recurrent cholangitis, advanced fibrosis and cirrhosis have the greatest need for anti-pruritic therapy and must be prioritised for symptom-directed interventional trials.