Introduction
Pruritus associated with primary biliary cholangitis (PBC) affects sleep and, social and emotional wellbeing. The impact of itch severity on quality of life (QoL) using the EuroQol-5-Dimension 5-Level (EQ-5D-5L) health utility score was explored and quantified in a post hoc analysis of the Phase 2b GLIMMER study of linerixibat for the treatment of pruritus in PBC (NCT02966834). Pruritus (particularly severe pruritus) was previously found to have a significant negative impact on QoL and health utility: mean (standard deviation [SD]) baseline utility was 0.69 (0.23); patients with mild or moderate pruritus at baseline had similar utilities (0.75 [0.17] and 0.76 [0.17], respectively) whereas patients with severe pruritus at baseline had notably worse utility (0.49 [0.28]).
Aims & Methods
Here we look in detail at factors impacting QoL in patients with PBC and pruritus. Patients in GLIMMER completed the EQ-5D-5L and Beck Depression Inventory (BDI-II) at baseline, which followed a 4-week single-blind placebo run-in period. EQ-5D-5L is a generic, standardised and simple health-related QoL instrument. Scores range from 1 “perfect health” to 0 “death”. BDI is a 21-item, self-rated scale that evaluates key symptoms of depression. An overall score of 0–9 is classed as minimal depression, 10–18 mild, 19–29 moderate, and 30–63 severe depression. Patients were classified as having mild (<4, at baseline all mild were ≥3 to <4), moderate (≥4 to <7) or severe pruritus (≥7 to 10) using the mean worst daily itch score. Sleep disturbance severity was based on the same numerical rating scale thresholds as those used for pruritus.
Results
There were striking associations between itch severity, sleep disturbance and health utility, and between itch severity, depression and health utility. Overall mean (SD) health utility was highest in those with mild sleep disturbance 0.83 (0.126). Those with severe sleep disturbance had a much lower score and those with severe itch and severe sleep disturbance even lower (0.52 [0.30] and 0.47 [0.31], respectively). For patients with mild itch, 60% had mild sleep disturbance; the remaining 40% of patients had moderate sleep disturbance. In patients with severe itch, 34% experienced moderate sleep disturbance, while 66% had severe sleep disturbance. Thus, no patients with mild itch had severe sleep disturbance and no patients with severe itch had mild sleep disturbance. As might be expected, health utility was lower with worse depression; from 0.81 (0.18) with minimal depression to 0.39 (0.31) for those with severe depression; amongst those with moderate or severe depression the incremental impact of severe pruritus on health utility was striking, with utilities of 0.32 and 0.26, respectively. In mild and moderate itch, the distribution of depression severity was similar, with over 80% having minimal or mild depression. However, in the group with severe itch, 49% had moderate or severe depression.
Conclusion
Pruritus in PBC significantly impacts QoL. Severe sleep disturbance and moderate and severe depression were far more common in patients with severe pruritus. In patients suffering with both severe pruritus and moderate to severe depression, health utility was severely impaired.
Funding: GSK (201000).
Encore statement: This abstract was previously presented at the European Association for the Study of the Liver (EASL) 2023 congress, held 21–24 June, 2023. This encore is presented on behalf of the original authors with their permission.
References
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Disclosure
HTS, MMM, AR, and PJFT are employees of, and hold shares in GSK. SD is an employee of GSK. AEK has received grant/research support from Intercept Pharmaceuticals and provided paid consultancy for AbbVie, Bristol Myers Squibb, CymaBay Therapeutics, Eisai, Escient, Falk, Gilead, GSK, Intercept Pharmaceuticals, Janssen, Lilly, Mirum, MSD, Vifor, Zambon. DJ has received grant/research support from GSK, Intercept Pharmaceuticals, Falk, Pfizer, Abbott, Novartis.
