SO002INTERIM RESULTS FROM ACQUIRE: A STUDY MEASURING QUALITY OF LIFE, TREATMENT PREFERENCE AND TREATMENT SATISFACTION OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE PATIENTS IN EUROPE

Abstract

Abstract Background and Aims Data suggest the health-related quality of life (HRQoL) of autosomal dominant polycystic kidney disease (ADPKD) patients (pts) may be lower than the general population [1,2]. In this ‘real life’ cohort of ADPKD pts with chronic kidney disease (CKD) stages 1–3 and rapidly progressing disease, we aimed to describe pt demographics, treatment patterns and pt reported outcome measures (PROMs). Method ACQUIRE (NCT02848521) is a prospective, non-interventional, real-world observational study ongoing in 7 European countries. Rapidly progressing ADPKD pts (CKD stages 1–3) completed validated PROMs at enrolment (baseline), Month 1, Month 3 and every 3 months to Month 18. This abstract reports results through 9 months. The primary objective was change in Physical Health Composite Scale (PCS) scores of the 12-item Short Form Health Survey (SF-12). Other objectives included changes in SF-12 Mental Health Composite Scale (MCS) scores, ADPKD-specific PROMs including the ADPKD-Impact Scale (IS), -Urinary Impact Scale (UIS) and -Pain & Discomfort Scale (PDS), and treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM-9). Treatment preferences will be measured using a discrete choice experiment on study completion. Results Pt demographics and changes from baseline in SF-12, ADPKD-IS and TSQM-9 at Month 9 are presented in Table 1; no changes were observed in ADPKD-UIS or ADPKD-PDS. Conclusion The study population is relatively young and in full-time employment. During this interim analysis, pts reported reduced scores in the PCS component of SF-12, increased ADPKD-IS scores and reduced treatment satisfaction. These data suggest that disease progression over 9 months negatively impacts pts with early stages of ADPKD. The final analyses will further investigate the contribution of different factors on PROMs and treatment satisfaction. Table 1.Patient demographics and changes in SF-12, ADPKD-IS and TSQM-9 at Month 9 by CKD stageCKD stageTotal (N=402)Parameter, mean (SD)*1 (n=79)2 (n=123)3 (n=200)Patient demographics and disease characteristicsSex, female, n (%)49 (62.0)56 (45.5)89 (44.5)194 (48.3)Age, years34.0 (10.2)40.7 (8.4)47.8 (9.2)42.9 (10.6)Any chronic condition, n (%)31 (39.2)40 (32.5)95 (47.5)166 (41.3)Hypertension, n (%)41 (51.9)92 (74.8)169 (84.5)302 (75.1)Age of ADPKD symptom onset24.0 (12.2)28.6 (9.3)32.5 (12.7)29.6 (12.1)Employed full-time, n (%)48 (66.7)90 (78.3)137 (73.3)275 (73.5)Prescribed tolvaptan, n (%)33 (41.8)70 (56.9)137 (68.5)240 (59.7)Changes from Baseline at Month 9SF-12 (range: 1–100)N223964125PCSBL53.9 (7.3)55.8 (5.3)51.4 (8.3)53.3 (7.5)Mth 9 CfB-2.4 (8.06)-0.9 (5.13)-2.2 (5.61)-1.8 (5.96)p value#0.1800.3020.0020.001MCSBL46.1 (10.9)50.0 (6.9)47.2 (9.2)47.8 (9.1)Mth 9 CfB0.8 (7.48)0.0 (8.73)2.5 (8.76)1.4 (8.55)ADPKD-IS (range: 1–5)N193763119PhysicalBL1.50 (0.65)1.37 (0.59)1.70 (0.75)1.56 (0.70)Mth 9 CfB0.33 (0.64)-0.04 (0.56)0.06 (0.48)0.07 (0.54)EmotionalBL2.08 (0.83)1.94 (0.75)2.16 (0.81)2.08 (0.80)Mth 9 CfB-0.22 (0.38)-0.27 (0.62)-0.04 (0.66)-0.14 (0.61)FatigueBL1.92 (1.01)1.64 (0.79)2.00 (0.92)1.87 (0.91)Mth 9 CfB0.29 (0.56)0.10 (0.59)0.05 (0.65)0.11 (0.62)TSQM-9 (range: 1–100)N173361111Global satisfactionBL57.7 (23.1)67.2 (19.7)67.1 (23.2)65.4 (22.4)Mth 9 CfB-7.1 (16.4)0.4 (17.4)-3.4 (19.1)-2.8 (18.2)Baseline demographics: Full Analysis Set (all patients fulfilling inclusion criteria); CfB: Primary Analysis Set (all patients providing a baseline SF-12 measurement; CKD1: n=63; CKD2: n=93; CKD3: n=149). *Unless otherwise stated. #paired t-test, reported for primary endpoint only. Where range is 1–100, 1 is lowest; 100 is highest. Where range is 1–5, 1 is not difficult/bothered; 5 is extremely difficult/bothered. BL: baseline; CfB: change from baseline; MCS: mental component score; Mth: month; PCS: physical component score; SD: standard deviation.