ObjectiveAssess ustekinumab efficacy (week 24/week 52) and safety (week 16/week 24/week 60) in patients with active psoriatic arthritis (PsA) despite treatment with conventional and/or biological anti-tumour necrosis factor (TNF) agents.MethodsIn this phase 3, multicentre, placebo-controlled trial, 312 adults with active PsA were randomised (stratified by site, weight (≤100 kg/>100 kg), methotrexate use) to ustekinumab 45 mg or 90 mg at week 0, week 4, q12 weeks or placebo at week 0, week 4, week 16 and crossover to ustekinumab 45 mg at week 24, week 28 and week 40. At week 16, patients with <5% improvement in tender/swollen joint counts entered blinded early escape (placebo→45 mg, 45 mg→90 mg, 90 mg→90 mg). The primary endpoint was ≥20% improvement in American College of Rheumatology (ACR20) criteria at week 24. Secondary endpoints included week 24 Health Assessment Questionnaire-Disability Index (HAQ-DI) improvement, ACR50, ACR70 and ≥75% improvement in Psoriasis Area and Severity Index (PASI75). Efficacy was assessed in all patients, anti-TNF-naïve (n=132) patients and anti-TNF-experienced (n=180) patients.ResultsMore ustekinumab-treated (43.8% combined) than placebo-treated (20.2%) patients achieved ACR20 at week 24 (p<0.001). Significant treatment differences were observed for week 24 HAQ-DI improvement (p<0.001), ACR50 (p≤0.05) and PASI75 (p<0.001); all benefits were sustained through week 52. Among patients previously treated with ≥1 TNF inhibitor, sustained ustekinumab efficacy was also observed (week 24 combined vs placebo: ACR20 35.6% vs 14.5%, PASI75 47.1% vs 2.0%, median HAQ-DI change −0.13 vs 0.0; week 52 ustekinumab-treated: ACR20 38.9%, PASI75 43.4%, median HAQ-DI change −0.13). No unexpected adverse events were observed through week 60.ConclusionsThe interleukin-12/23 inhibitor ustekinumab (45/90 mg q12 weeks) yielded significant and sustained improvements in PsA signs/symptoms in a diverse population of patients with active PsA, including anti-TNF-experienced PsA patients.
BackgroundThe collection and consumption of wild edibles is an important part in livelihood strategies throughout the world. There is an urgent need to document and safeguard the wild food knowledge, especially in remote areas. The aims of this study are to accomplish detailed investigation of wild edibles used by the Naxi in Baidi village and evaluate them to identify innovative organic food products. Also, we aim to explore the characteristics of distribution and transmission of the traditional knowledge (TK) on wild edibles among the Naxi.MethodsData was collected through a semi-structured interview of key informants above the age of 20 years, chosen carefully by a snowball sampling. The interviews were supplemented by free lists and participatory observation methods. Informants below 20 years were interviewed to test their knowledge of traditional practices. A quantitative index like Cultural Importance Index (CI) was used to evaluate the relative importance of the different wild edibles. Linear regression and t-test were performed to test variation in the TK among the informants of different age groups and genders.ResultsAltogether 173 wild edible plant species belonging to 76 families and 139 genera were recorded in the study. Cardamine macrophylla, C. tangutorum and Eutrema yunnanense, have traditionally been consumed as an important supplement to the diet, particularly during food shortages as wild vegetables. The age was found to have a significant effect on TK, but there was no significant difference between male and female informant in knowledge abundance. The traditional food knowledge was dynamic and affected by social factors. Also, it was descending partly among younger generations in Baidi.ConclusionBaidi village is a prime example of a rapidly changing community where local traditions compete with modern ways of life. Overall, this study provides a deeper understanding of the Naxi peoples’ knowledge on wild edibles. Some wild edibles might have an interesting dietary constituent, which need in-depth studies. Such detail studies can help to promote the market in one hand and protect TK in the other. Protecting TK from disappearing in succeeding generations is necessary, and understanding the dynamics of TK is one important solution to this dilemma.
Over the past two decades, the Chinese domestic security apparatus has expanded dramatically. “Stability maintenance” operations have become a top priority for local Chinese authorities. We argue that this trend goes back to the early 1990s, when central Party authorities adopted new governance models that differed dramatically from those of the 1980s. They increased the bureaucratic rank of public security chiefs within the Party apparatus, expanded the reach of the Party political-legal apparatus into a broader range of governance issues, and altered cadre evaluation standards to increase the sensitivity of local authorities to social unrest. We show that the origin of these changes lies in a policy response to the developments of 1989–1991, namely the Tiananmen democracy movement and the collapse of communist political systems in Eastern Europe. Over the past twenty years, these practices have developed into an extensive stability maintenance apparatus, whereby local governance is increasingly oriented around the need to respond to social unrest, whether through concession or repression. Chinese authorities now appear to be rethinking these developments, but the direction of reform remains unclear.
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