Health-related quality of life and lifestyle changes in patients with chronic kidney disease and hyperkalaemia: Real-world data from the US, five European countries and China.

BACKGROUND: Chronic kidney disease patients have impaired health-related quality of life and an increased risk of hyperkalaemia. AIMS: The objective was to evaluate the impact of hyperkalaemia on health-related quality of life, and investigate lifestyle change recommendations, in these patients. METHODS: The Adelphi Real World Chronic Kidney Disease Specific Programme™ was used. Data were collected from physicians and patients with non-dialysis dependent stage 3a, 3b and 4 chronic kidney disease from the US, France, Germany, Spain, Italy, the UK and China. Patients completed the Kidney Disease Quality of Life Instrument and EuroQol-5D-3L. Analyses compared data between hyperkalaemic (serum potassium >5.0 mmol/L) and normokalaemic (serum potassium 3.5-5.0 mmol/L) patients. RESULTS: Overall, 1149 patients were included (hyperkalaemic: n = 216, normokalaemic: n = 933; US: n = 376, Europe: n = 490, China: n = 283). Hyperkalaemic vs normokalaemic patients experienced more symptoms (P < .001) and had numerically lower scores, indicating poorer health-related quality of life, in all Kidney Disease Quality of Life domains, with significant differences for three/five domains. Hyperkalaemic patients reported numerically lower EuroQol-5D-3L utility index and visual analogue scores, indicating poorer health status, than normokalaemic patients. A higher proportion of hyperkalaemic than normokalaemic patients were recommended to reduce dietary potassium (P < .05). More normokalaemic than hyperkalaemic patients reported making a radical change in five/six recommended lifestyle changes, with the difference significant for four/six recommendations. CONCLUSIONS: Hyperkalaemia is associated with an incremental impairment of the health-related quality of life in chronic kidney disease patients. A better understanding of the impact of hyperkalaemia in these patients could improve patient outcomes.

Living with Ulcerative Colitis in Japan: Biologic Persistence and Health-Care Resource Use.

OBJECTIVE: The aim of the study was to improve understanding of adherence and persistence to biologics, and their association with health-care resource utilization (HCRU), in Japanese patients with moderate to severe ulcerative colitis (UC). METHODS: Data were from Medical Data Vision, a secondary care administrative database. A retrospective, longitudinal cohort analysis was conducted of data from UC patients initiating biologic therapy between August 2013 and July 2016. Data collected for 2 years prior (baseline) and 2 years after (follow-up) the index date were evaluated. Patients completing biologic induction were identified, and adherence/persistence to biologic therapy calculated. HCRU, steroid, and immunosuppressant use during baseline and follow-up were assessed. Biologic switching during the follow-up was evaluated. Descriptive statistics (e.g., means and proportions) were obtained and inferential analyses (from Student's t tests, Fisher's exact tests, χ2 tests, the Cox proportional hazard model, and negative binomial regression) were performed. RESULTS: The analysis included 649 patients (adalimumab: 265; infliximab: 384). Biologic induction was completed by 80% of patients. Adherence to adalimumab was higher than that to infliximab (p < 0.001). Persistence at 6, 12, 18, and 24 months was higher with infliximab than with adalimumab (p < 0.05). Overall, gastroenterology outpatient visits increased, and hospitalization frequency and duration decreased, from baseline to follow-up. UC-related hospitalizations were fewer and shorter, and endoscopies fewer, in persistent than in nonpersistent patients, although persistent patients made more outpatient visits than nonpersistent patients. Hospitalization duration was lower in persistent than nonpersistent patients. Approximately 50% of patients received an immunosuppressant during biologic therapy; 5% received a concomitant steroid during biologic therapy. Overall, 17% and 3% of patients, respectively, received 2nd line and 3rd line biologics. CONCLUSIONS: Poor biologic persistence was associated with increased non-medication-associated HCRU. Effective treatments with high persistence levels and limited associated HCRU are needed in UC.

The association between disease activity and patient-reported outcomes in patients with moderate-to-severe ulcerative colitis in the United States and Europe.

BACKGROUND: Patients with ulcerative colitis (UC) experience periods of recurring and episodic clinical signs and symptoms. This study sought to establish the association between disease activity and health-related quality of life (HRQoL) and other patient-reported outcomes. METHODS: United States (US) and European Union 5 ([EU5]; i.e., France, Germany, Italy, Spain, and the United Kingdom) data from the 2015 and 2017 Adelphi Inflammatory Bowel Disease-Specific Programme (IBD-DSP) were used. The IBD-DSP is a database of retrospective patient chart information integrated with patient survey data (EuroQoL-5 Dimensions [EQ-5D], Short Quality of Life in Inflammatory Bowel Disease Questionnaire [SIBDQ], and Work Productivity and Activity Impairment-Ulcerative Colitis [WPAI-UC] questionnaire). Using available chart information, physicians classified their moderate-to-severe patients into one of the following categories: remission with a Mayo endoscopic score = 0 ("deep remission"), remission without a Mayo endoscopic score = 0 ("remission"), or active disease. Differences among disease activity categories with respect to patient-reported outcomes were analyzed using generalized linear models, controlling for confounding variables. RESULTS: N = 289 and N = 1037 patient charts with linked surveys were included from the US and EU5, respectively. The disease activity distribution was as follows: active disease = 40.1% (US) and 33.6% (EU5); remission = 48.0 and 53.0%; deep remission = 11.9 and 13.3%. Patients with active disease reported significantly lower levels of EQ-5D health state utilities (adjusted mean [AdjM] = 0.87 [US] and 0.78 [EU5]) compared with remission (AdjM = 0.92 and 0.91) and deep remission (AdjM = 0.93 and 0.91) (all P < 0.05 compared with active disease within each region). Similar findings were observed with the scores from the SIBDQ and the WPAI-UC. No significant differences were observed between remission categories. CONCLUSIONS: Among patients with moderate-to-severe UC in the US and EU5, active disease was associated with significant impairments in HRQoL, work and leisure activities. These results reinforce the importance, to both the patient and society, of achieving some level of remission to restore generic and disease-related HRQoL and one's ability to work productively.

Treatment patterns among patients with moderate-to-severe ulcerative colitis in the United States and Europe.

OBJECTIVE: The aim of the present study is to examine how moderate-to-severe ulcerative colitis (UC) is currently managed in real-world clinical practice across the United States (US) and European Union Five (EU5; France, Germany, Italy, Spain, and the United Kingdom). METHODS: Data from the 2017 Adelphi Inflammatory Bowel-Disease Specific Programme (IBD-DSP) were used. The IBD-DSP is a database of patient chart information abstracted by selected gastroenterologists across the US and EU5. Eligible gastroenterologists who agreed to participate were asked to complete patient record forms for the next seven consecutive eligible adult patients with UC. Only charts from patients with moderate-to-severe UC were included in the analysis (defined as those with documented administration of either an immunosuppressant [IM] or a biologic). Treatment patterns were reported descriptively. RESULTS: 411 and 1191 patient charts were included in the US and EU5 (mean ages 44.2 and 39.6 years; 53.0% and 43.5% female), respectively. For those with complete treatment history, 40.7% and 52.9% used either an IM or biologic as their first treatment (with or without steroids). Usage of these therapies increased in subsequent lines. The percentage of patients treated with combination therapy (i.e., biologic therapy with a concomitant IM) in first line generally varied between 10-20% (e.g., US: adalimumab (ADA), 10.8%; infliximab (IFX), 18.2%; EU5: ADA, 12.5%; IFX, 19.9%), though increased in later lines in the EU5. Among patients currently using a biologic therapy, between 10-40% of patients used a higher than indicated dose or greater than indicated dosing frequency during maintenance (e.g., US: IFX, 37.1%; ADA, 13.4%; EU5: IFX, 39.1%; ADA, 36.1%). In both the US and EU5, the primary reason for switching therapy was efficacy-related. CONCLUSIONS: In this analysis, many patients with moderate-to-severe UC use an IM or biologic as their first therapy after diagnosis. Combination therapy and dose escalation are also common, and underscore the challenges with managing this patient population.