Suchergebnisse

Geng Wang,1 Rong Mu,2 Huji Xu1 1Department of Rheumatology and Immunology, Changzheng Hospital, The Second Military Medical University, Shanghai, 2Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, People's Republic of China Abstract: The prevalence of rheumatoid arthritis (RA) is 0.19%–0.41% in Chinese population. RA exerts profound influence on health-related quality of life (HRQoL), which imposed huge burdens on patients physically, mentally, and economically. As a developing country, People's Republic of China faces enormous challenges in management of RA. Conventional-synthesized disease-modifying antirheumatic drugs (csDMARDs) remain the most selective therapeutic options for RA in People's Republic of China owing to their affordable price and fair efficacy as well as tolerability. Unfortunately, there are substantial RA patients who are poor responders to csDMARDs, even to subsequently combined therapy with tumor necrosis factor antagonist (anti-TNF). Tocilizumab (TCZ) has been approved as a subsequent-line biological agent in patients with moderate-to-severe RA worldwide including People's Republic of China. TCZ is the first biological agent approved for the treatment of RA inhibiting interlukin-6 (IL-6) by blocking both membrane-bound and soluble IL-6 receptors. Open-label studies in real-life practice and strictly controlled clinical trials demonstrated its high efficacy and safety profile in treatment of patients with RA who have inadequate responses to csDMARDs and anti-TNF. HRQoL of RA patients was improved in various measurements. TCZ was associated with 1.2 times the risk of adverse events, such as infections, dyslipidemia, and hepatic transaminases elevation, compared with pooled placebo. A relatively long half-life allowing for monthly intravenous administration and a newly developed subcutaneous injection make TCZ more acceptable. However, data are not enough so far comparing TCZ to anti-TNF. Lack of evidence in Chinese patients and high cost of TCZ limit its prescription in People's Republic of China being a developing country. Further clinical trials and post-marketing surveillance may offer a comprehensive assessment of patient satisfaction and acceptability, which may help us define the optimal role for TCZ in therapeutic strategy. Keywords: rheumatoid arthritis, IL-6, tocilizumab, People's Republic of China, health-related quality of life

Xiao Zhang,1 Huji Xu,2 Zhiyi Zhang,3 Yang Li,4 Lynne Pauer,5 Shanmei Liao,6 Fengchun Zhang7 1Department of Rheumatology, Guangdong General Hospital, Guangdong, People's Republic of China; 2Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, People's Republic of China; 3School of Clinical Medicine, The First Affiliated Hospital of Harbin Medical University, Harbin, People's Republic of China; 4Department of Rheumatology and Immunology, The Second Affiliated Hospital of Harbin Medical University, Harbin, People's Republic of China; 5Global Research and Development, Pfizer, Groton, CT, USA; 6Pfizer China Statistics Department, Global Innovative Pharma Business, Shanghai, People's Republic of China; 7Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Beijing, People's Republic of ChinaCorrespondence: Fengchun ZhangPeking Union Medical College Hospital, No. 9, Dongdan Santiao, Dongcheng District, Beijing, People's Republic of ChinaTel/Fax +8610-69155416Email zhangfccra@aliyun.comPurpose: Fibromyalgia (FM) may go underdiagnosed and untreated in China in part due to a lack of awareness and understanding of the condition, and limited available treatments.Patients and Methods: This randomized, double-blind, Phase III local registration trial compared the efficacy and safety of pregabalin (flexibly dosed 300– 450 mg/day) versus placebo for the management of pain in Chinese adults diagnosed with FM according to American College of Rheumatology 1990 criteria, across 22 centers within China. Patients reported pain score of ≥ 40 mm on 100-mm scale (from 0 "no pain" to 100 "worst possible pain"). The primary efficacy endpoint was change from baseline to Week 14 in mean pain score (MPS). Secondary endpoints included measures of sleep and sleep interference. Safety and tolerability were monitored throughout.Results: Median pregabalin dose was 335 mg/day. A significant reduction from baseline to Week 14 in weekly MPS was seen for patients treated with pregabalin (n=170) versus placebo (n=164) (least-squares mean difference [95% confidence interval]: – 0.73 [– 1.10 to – 0.36]; P=0.0001). Significantly greater proportions of patients experienced ≥ 30% and ≥ 50% reductions in MPS at Week 14 with pregabalin versus placebo. Pregabalin-treated subjects demonstrated improvements in measures of sleep and sleep interference. Pregabalin was generally well tolerated. The most common adverse events were dizziness and somnolence; no serious adverse events (SAEs) occurred in pregabalin-treated subjects. Nine placebo-treated subjects experienced SAEs.Conclusion: Pregabalin (300– 450 mg/day) is a safe and effective treatment for reducing pain and improving sleep in native Chinese subjects with FM.ClinicalTrials.gov Identifier: NCT01387607.Keywords: China, chronic pain, FM, Lyrica, pain management, sleep

Objectives: Anti-tumor necrosis factor (TNF) agents have been regarded as the most effective treatment for ankylosing spondylitis (AS) so far. However, economic factors limited the prescription of original biologicals in China. Yisaipu® is a biosimilar for etanercept as pre fill syringes (PFS), which has entered China's national medical insurance catalog for more than 10 yr and was widely used because it greatly reduced the economic burden of AS patients. Yisaipu® is provided subcutaneous injection in hospital setting only. We collected clinical data of AS patients before, during and after COVID-19 epidemic, in an attempt to investigate the advantages and disadvantages of original biologicals and Yisaipu® during regular follow up and COVID-19 epidemic.Methods: AS patients who received original biologicals or Yisaipu® in our department for more than 1 yr were included in our study. General data, demographic characteristics, disease activity, quality of life and medical compliance were collected from regular visits. The patients were followed up through telephone interviews from April 20th to 27th, 2020 about the overall impact of the COVID-19 epidemic.Results: There was no significant difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score-CRP (ASDAS-CRP) between the two groups. Health Assessment Questionnaire for Spondyloarthropathies (HAQ-s) showed that Yisaipu® group was superior to original biological group in terms of eating, gripping and driving. In addition, the medical cost of Yisaipu® was lower than that of original biologicals. The overall impact of the COVID-19 epidemic on patients of original biological group was comparatively smaller than that on Yisaipu® group.Conclusions: Yisaipu® provided AS patients with an economical selection during regular follow-up, while original biologicals had certain advantages in the COVID-19 epidemic setting, including a longer time interval between two drug administrations and the self-injection dose form of medication.

Since the outbreak of the coronavirus disease 2019 (COVID-19) pandemic, the international medical device trade has received extensive attention. To maintain the domestic supply of medical devices, some countries have sought multilateral trade cooperation or simply implemented export restrictions, which has exacerbated the instability and fragility of the global medical device market. It is crucial for government policymakers to identify the most influential countries in the international medical device trade and nip exports in the bud. However, few efforts have been made in previous studies to explore various countries' influence on the international medical device trade in light of their intricate trade relationships. To fill these research gaps, this study constructs a global medical device trade network (GMDTN) and explores the criticality of various countries from a network-based perspective. The evolution patterns and geographical distribution of influence among countries in the GMDTN are revealed. Details on the ways in which the influence of some crucial countries has formed are provided. The results show that the global medical device trade market is export oriented. The formation of some countries' strong influence may be due to their large number of trading partners or the deep dependence of some of those trading partners on that country (namely, breadth- or depth-based patterns). It is worth noting that the US has a dominant position in the international medical device trade in terms of both breadth and depth. In addition, some countries play a critical role as intermediate points in the influence formation process of other countries, although these countries are not critical direct trading partners. The findings of this study provide implications for policymakers seeking to understand the influence of countries on the international medical device trade and to proactively prepare responses to unexpected changes in this trade.