PSS22 - Real World, Prospective, Observational, Patient Reported Outcome Study of Hydroxyzine Hydrochloride in Indian Patients with Chronic Pruritis

Abstract

To assess effectiveness & tolerability of hydroxyzine hydrochloride in management of Indian patients with chronic pruritus in real world setting A prospective, observational, patient reported outcomes study of 400 patients across 7 centres (179 male, 221 female), >18 years of age, having chronic pruritus due to dermatological cause and treated with hydroxyzine hydrochloride as per clinician's discretion upto period of 12 weeks. Primary outcome was improvement from baseline in quality of life, assessed using 10-point Dermatology Quality of Life Index (DLQI) after 12 weeks of study period. Secondary outcomes were improvement in the pruritus scores (5D-Itch scale) after 12 weeks, improvements in DLQI and 5D-Itch scores at 2, 4, and 8 weeks, and clinical safety during the study period were recorded. Wilcoxon test is used to compare baseline and follow-up data for DLQI and pruritus scores. The per-protocol set (PPS) included 177 patients and full-analysis set (FAS) had 391 patients. There was significant improvement (p<0.0001) in DLQI scores at 2 weeks (13.10%), 4 weeks (37.40%), 8 weeks (57.01%) and 12 weeks (76.33%) period in PPS patients. Similar significant improvement in DLQI was noted in FAS at 2, 4, 8 & 12 weeks (p<0.0001). The pruritus scores also decreased significantly (p<0.0001) at 2 weeks (10.56%), 4 weeks (26.32%), 8 weeks (37.71%) and 12 weeks (57.76%) period in PPS patients. Similar significant reduction in pruritus scores was observed in FAS patients at 2, 4, 8 & 12 weeks (p<0001). Total 10 (2.5%) patients reported mild to moderate adverse events (total 11 events) which were dizziness (4), constipation (2), drowsiness (2), dry mouth (2) and sedation (1). All events resolved without any intervention. This real world, observational, patient reported outcome study demonstrates hydroxyzine hydrochloride to significantly decrease symptoms of pruritus and improve quality of life in patients with chronic pruritus over 12 weeks treatment period