Rapid and Sustained Effect of Ixekizumab on Patient Global, Spinal Pain, Stiffness, and Fatigue in Chinese Patients with Radiographic Axial Spondyloarthritis.

INTRODUCTION: Ixekizumab, an interleukin 17A (IL-17A) inhibitor, has demonstrated rapid and sustained improvement in the signs and symptoms in patients with active radiographic axial spondyloarthritis (r-axSpA) in global and Chinese populations. We studied the effect of ixekizumab on patient-reported outcomes (PROs) (including patient global, spinal pain, stiffness, and fatigue) and overall health-related quality of life (HRQoL) of ixekizumab in the phase 3 study in China. METHODS: In this Chinese phase 3, randomized, double-blind, placebo-controlled study, patients with r-axSpA were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W; starting dose 160 mg) or placebo for 16 weeks. At week 16, patients receiving placebo were switched to IXEQ4W, and those receiving IXEQ4W continued, until week 52. Data for patient global, spinal pain, spinal pain at night, stiffness, and fatigue were collected through week 52. Minimally clinical important differences (MCIDs) were determined for spinal pain and spinal pain at night. The subgroup analyses by baseline disease duration since diagnosis and baseline C-reactive protein (CRP) level were conducted post hoc. RESULTS: Compared with placebo, patients treated with IXEQ4W reported significantly greater improvement with a rapid onset in changes from baseline of PROs (patient global, spinal pain, spinal pain at night, stiffness, and fatigue) through week 16. Improvements were maintained through week 52. A similar trend of improvement was also observed in MCID response in spinal pain and spinal pain at night. The improvement in overall HRQoL was supported by EQ-5D-5L assessment. Subgroup analyses demonstrated that IXEQ4W provided significantly greater efficacy at week 16 compared with placebo, irrespective of baseline disease duration or baseline CRP level. CONCLUSION: IXEQ4W provided rapid and sustained improvement in clinically relevant PROs and overall HRQoL through 1-year treatment in Chinese patients with r-axSpA. Regardless of the baseline disease duration or baseline CRP level, consistent efficacy was observed. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04285229.

Effectiveness of Ixekizumab in Chinese Patients with Moderate-Severe Plaque Psoriasis with Special Area Involvement: Subanalysis of a Prospective, Multicenter, Observational Real-World Study.

INTRODUCTION: Ixekizumab, a monoclonal antibody against interleukin-17A, demonstrated effectiveness in the treatment of psoriasis in a Chinese real-world study that was consistent with previous randomized controlled trials. Here, we report further analyses from this study to explore the effectiveness of ixekizumab for treating patients with psoriasis and the involvement of special body areas (scalp, nail, joint, palmoplantar, or genital areas). METHODS: A multicenter, prospective, observational, single-arm, post-marketing surveillance study was conducted in patients aged ≥ 18 years with moderate-to-severe plaque psoriasis and prescribed with ixekizumab in 26 Chinese hospitals. Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores were compared between patients with versus without psoriasis in special body areas in the overall study population and across subgroups by body area. RESULTS: In total, 612 patients were included. At baseline, most patients (93.6%) had psoriasis involvement in at least one special body area. Overall, patients with psoriasis in special body areas reported a worse quality of life (QoL) than those without. Patients with versus without psoriasis in special body areas achieved a comparable mean reduction from baseline in PASI score (10.9 vs. 9.2 at week 2, and 16.9 vs. 14.7 at week 12, respectively) and DLQI score (6.0 vs. 4.4 at week 2, and 9.9 vs. 7.5 at week 12, respectively); a similar proportion of patients also achieved PASI 50 at week 2, and PASI 75 and PASI 90 at week 12, and a DLQI (0/1) at weeks 2 and 12. Several significantly different results were reported between subgroups, the majority of which favored patients with special body area involvement. CONCLUSION: Most patients had psoriasis involvement in a special body area which was associated with worse QoL. Ixekizumab is similarly effective in reducing disease severity and improving QoL in patients with plaque psoriasis across different special body areas.

Outcomes of Biologic Use in Asian Compared with Non-Hispanic White Adult Psoriasis Patients from the CorEvitas Psoriasis Registry.

INTRODUCTION: Real-world data are limited comparing Asian and White patients with psoriasis using biologic therapy. This study compared the 6-month effectiveness of biologic therapy between Asian and White plaque patients with psoriasis in the CorEvitas Psoriasis Registry. METHODS: Analyses included biologic initiations and 6-month follow-up visits from self-identified Asian (n = 293) and White (n = 2314) patients in the USA/Canada (4/2015-4/2020). Outcomes included: Psoriasis Area Severity Index (PASI) 75, disease activity measures [body surface area (BSA) ≤ 1, BSA ≤ 3, PASI90, PASI100, Investigator's Global Assessment (IGA) 0/1], and patient-reported outcomes [Dermatology Life Quality Index (DLQI) 0/1, itch, fatigue, skin pain, EuroQoL visual analog scale (EQ-VAS), patient global assessment, Work Productivity Activity and Impairment (WPAI) domains]. Unadjusted regression models were used to calculate odds ratios (OR) and 95% confidence intervals (CI) for achievement of binary outcomes and difference in mean change in continuous outcomes (ß, 95% CI) at 6 months, followed by adjustment for age, sex, body mass index, alcohol, smoking, health insurance, education, comorbidities, scalp psoriasis morphology, psoriatic arthritis, biologic class, previous biologics, and baseline outcome value. RESULTS: Asians had lower proportions of women (32.8% versus 49.1%) and obesity (27.3% versus 54.5%), and higher proportions on Medicaid (19.9% versus 8.8%), graduated college (50.9% versus 40.1%) and never smoked (67.1% versus 44.1%). In unadjusted analyses, Asians had 52% higher odds of achieving PASI75 versus White patients (OR 1.52; 95% CI 1.15, 2.02). After adjustment, the association was attenuated (OR 1.11; 0.81, 1.52). Secondary outcomes experienced similar patterns except for DLQI: Asians had 33% lower odds of achieving DLQI 0/1 in both the unadjusted (OR 0.67; 0.50, 0.90) and adjusted (OR 0.67; 0.49, 0.92) models. CONCLUSION: Unadjusted differences in biologic therapy effectiveness between Asians compared with White patients were likely explained by differences in demographic, lifestyle, and psoriatic disease characteristics between groups. However, Asians still experienced lesser improvements in skin-related quality of life, even after adjustment.

Patient Preference for Biologic Treatments of Psoriasis in the Chinese Setting.

Objective: Assessments of patients' preferences can support in clinical decision-making regarding biologic therapies for psoriasis. Our objective was to investigate patient preference for biologic treatments in patients with psoriasis in China. Methods: From October 2020 to January 2021, psoriasis patients were recruited for a survey that included demographic and disease-related questions, as well as a discrete choice experiment to measure their preferences for biologic therapy. A discrete-choice experiment was used in which respondents selected psoriasis treatments based on benefits (ie, early onset of efficacy, long-term efficacy, sustained efficacy) and treatment costs. We analyzed choice data using conditional logit model. Results: This study included 236 patients with moderate-to-severe psoriasis. The relative importance of the cost of biologic treatments, probability of keeping PASI100 at 5 years, probability of achieving PASI100 at 3 months and time to achieve PASI50 after initiation the biologic treatment were 0.593, 0.137, 0.185 and 0.085. Over 50% of patients regarded the cost of biologic treatments as the most important attribute. High-income and low-income subgroups had higher preference weight in probability of achieving PASI100 at 3-month and monthly cost. Conclusion: The cost of biologic treatments was found as the most important attribute for Chinese patients with psoriasis. Among efficacy attributes, the probability of achieving PASI100 at 3 months showed most sensitive. These results may be helpful to understand patient preference for biologic treatments used for psoriasis in China.

Anatomy of provincial level inequality in maternal mortality in China during 2004-2016: a new decomposition analysis.

BACKGROUND: The maternal mortality ratio (MMR) is an important indicator of maternal health and socioeconomic development. Although China has experienced a large decline in MMR, substantial disparities across regions are still apparent. This study aims to explore causes of socioeconomic related inequality in MMR at the province-level in China from 2004 to 2016. METHODS: We collected data from various issues of the China Health Statistics Yearbook, China Statistics Yearbook, and China Population and Employment Statistics Yearbook to construct a longitudinal sample of all provinces in China. We first examined determinants of the MMR using province fixed-effect models, accounted for socioeconomic condition, health resource allocation, and access to health care. We then used the concentration index (CI) to measure MMR inequality and employed the direct decomposition method to estimate the marginal impact of the determinants on the inequality index. Importance of the determinants were compared based on logworth values. RESULTS: During our study period, economically more deprived provinces experienced higher MMR than better-off ones. There was no evidence of improved socioeconomic related inequality in MMR. Illiteracy proportion was positively associated with the MMR (p < 0.01). In contrast, prenatal check-up rate (p = 0.05), hospital delivery rate (p < 0.01) and rate of delivery attended by professionals (p = 0.02) were negatively associated with the MMR. We also find that higher maternal health profile creation rate (p < 0.01) was associated with a pro-poor change of MMR inequality. CONCLUSION: Access to healthcare was the most important factor in explaining the persistent MMR inequality in China, followed by socioeconomic condition. We do not find evidence that health resource allocation was a contributing factor.

Impact of the Global Budget Payment System on Expenditure of Cardiovascular Diseases: An Interrupted Time Series Analysis in Shanghai, China.

Since few studies evaluated the impact of the global budget payment system (GBPS) over time, and by expenditure type, this paper aims to evaluate the impact of the GBPS on expenditure of inpatients, and explores how hospitals curb the expenditure in patients with cardiovascular diseases (CVDs) in Shanghai. We built a time series model with the monthly expenditure of CVDs from 2009 to 2012. We evaluated the instant impact and trends impact of the GBPS and analyzed results based on medical expenditure types (e.g., drug, examination, cure, unclassified items), discharge number, and expenditure per capita. We found GBPS instantly dropped the medical expenditure by Chinese Yuan (CNY) 55.71 million (p < 0.001), and decreased the monthly increasing trend by CNY 4.23 million (p = 0.011). The discharge number had 10.4% instant reduction and 225.55 monthly decrease (p = 0.021) while the expenditure per capita experienced fewer changes. Moreover, the expenditure of drug and cure had an instant reduction of CNY 28.31 million and 16.28 million (p < 0.001). In conclusion, we considered the GBPS is an effective solution to control the expenditure of CVDs by decreasing the discharge number, and a focus on the drug and cure expenditures lead to greater spend reduction than other types of expenditures.

Reducing the medical economic burden of health insurance in China: Achievements and challenges.

The aims of this study were to describe health insurance reforms initiated by the Chinese government over the past two decades, to review their achievements in reducing the medical economic burden, and to summarize the challenges that still exist regarding a further reduction in out-of-pocket expenditures in this country. China has successfully attained the goal of providing health insurance coverage to almost the entire population by developing a mixed health insurance system, which consists of Urban Employees Basic Medical Insurance (UEBMI), Urban Resident Basic Medical Insurance (URBMI), New Rural Cooperative Medical Scheme (NCMS), and supplementary Catastrophic Health Insurance. Despite this achievement, China is still facing the challenges of a disparity in the medical economic burden by region and by health insurance scheme, relatively little protection from financial risk compared to developed countries, as well as low efficiency and quality of care under current payment systems. To further reduce the disparity in the medical economic burden and to increase the overall protection from financial risk in China, the Government should increase central government transfers to NCMS and URBMI enrollees in poor regions and increase the total amount of government subsidies to NCMS. In addition, China should improve the efficiency and quality of health insurance by further reforming the payment system.

Does the leading pharmaceutical reform in China really solve the issue of overly expensive healthcare services? Evidence from an empirical study.

BACKGROUND: Healthcare system reform of Sanming city has become a leading healthcare reform model in China. It has developed a rigorous pharmaceutical reform consisted of the Zero Mark-up Drug Policy and the Centralized Procurement of Medicine Policy to bring down drug expenses and total health expenditures. However, despite the credit and much attention have been given to Sanming's pharmaceutical reform, its impact still remains unclear. Therefore, the purpose of this study was to explore the impact of the pharmaceutical reform of Sanming on both drug and total health expenditures. METHODS: Interrupted time series analysis with three segments divided by two intervention points was employed to evaluate the impact of the pharmaceutical reform. Segment 1 was the pre-reform period which captured the baseline information. Segment 2 occurred after the first intervention point when the Zero Mark-up Drug Policy was implemented, whereas Segment 3 was after the implementation of the Centralized Procurement of Medicine Policy. Primary outcomes are outpatient drug expenditure, outpatient total health expenditure, inpatient drug expenditure, and inpatient total health expenditure. Data spanning from May 2012 to May 2014 are included. RESULTS: Both drug and total health expenditures exhibited rising trends before any policy was carried out. The launch of Zero Mark-up Drug Policy led to significant instant reductions in levels of outpatient drug expenditure (coefficient = -6,602.99, p<0.01), outpatient total health expenditure (coefficient = -9,958.58, p<0.05), inpatient drug expenditure (coefficient = -7,520.90, p<0.01), and inpatient total health expenditure (coefficient = -16,737, p<0.01). Moreover, the previous upward trends were changed into downward trends for inpatient drug expenditure (coefficient = -2,747.02, p = 0.00) and total health expenditure (coefficient = -3,069.29, p = 0.12). However, after the implementation of Centralized Procurement of Medicine Policy, we observed no significant instant level changes and also, the inpatient drug expenditure (coefficient = 372.95, p = 0.01) and total health expenditure (coefficient = 788.76, p = 0.06) resumed upward trends again. CONCLUSIONS: Although the pharmaceutical reform could control or reduced drug expenditure and total health expenditure in short term, expenditures gradually resumed growing again and reached or even exceeded their baseline levels of pre-reform period, indicating the effect became weakened or even faded out in long term. In all, the pharmaceutical reform as a whole failed to meet its goal of combating sharp growth of drug and total health expenditure.