Introduction
Nail psoriasis is highly prevalent among patients with psoriasis yet remains one of the most challenging areas to treat. To better understand the treatment landscape for psoriatic nail ...disease, more studies are needed that compare the effectiveness of different biologics for patients with nail psoriasis. This study contributes to this objective by directly comparing the effectiveness of approved biologics in improving nail psoriasis for patients up to month 12 in a real-world setting.
Methods
Psoriasis Study of Health Outcomes (PSoHO) is an ongoing 3-year, prospective, non-interventional cohort study of adults with chronic moderate-to-severe plaque psoriasis initiating or switching to a new biologic. This study assessed the change in modified Nail Psoriasis Severity Index (mNAPSI) score from baseline to months 3, 6 and 12 for 763 patients and compared the effectiveness of anti-interleukin (IL)-17A biologics versus other approved biologics, as well as ixekizumab versus secukinumab, guselkumab, risankizumab and adalimumab. Comparative adjusted analyses used frequentist model averaging (FMA). Least square mean difference (LSMD) in mNAPSI scores are presented as observed.
Results
Irrespective of the severity of nail psoriasis at baseline, the anti-IL-17A cohort had greater mean mNAPSI reductions from baseline compared to the other biologics cohort through month 12, reaching significance at months 3 and 6 in the adjusted analysis. For patients with moderate-to-severe nail psoriasis, ixekizumab showed numerically higher mean reductions in mNAPSI scores compared to all other studied biologics, reaching significance versus guselkumab at all timepoints and risankizumab at month 6.
Conclusion
This real-world study showed that patients with moderate-to-severe psoriasis and any severity of concomitant nail involvement had significantly faster and more substantial improvements in nail psoriasis up to month 6 in the anti-IL-17A cohort compared to the other biologics cohort. Of the individual biologics studied, ixekizumab showed the highest numerical improvements in nail psoriasis at month 12.
Trial registration
EUPAS24207.
Introduction
Atopic dermatitis (AD) is a chronic, inflammatory skin disorder that impairs patients’ quality of life (QoL). Physician assessment of AD disease severity is determined by clinical scales ...and assessment of affected body surface area (BSA), which might not mirror patients’ perceived disease burden.
Methods
Using data from an international cross-sectional web-based survey of patients with AD and a machine learning approach, we sought to identify disease attributes with the highest impact on QoL for patients with AD. Adults with dermatologist-confirmed AD participated in the survey between July–September 2019. Eight machine learning models were applied to the data with dichotomised Dermatology Life Quality Index (DLQI) as the response variable to identify factors most predictive of AD-related QoL burden. Variables tested were demographics, affected BSA and affected body areas, flare characteristics, activity impairment, hospitalisation and AD therapies. Three machine learning models, logistic regression model, random forest and neural network, were selected on the basis of predictive performance. Each variable’s contribution was computed via importance values from 0 to 100. For relevant predictive factors, further descriptive analyses were conducted to characterise those findings.
Results
In total, 2314 patients completed the survey with mean age 39.2 years (standard deviation 12.6) and average disease duration of 19 years. Measured by affected BSA, 13.3% of patients had moderate-to-severe disease. However, 44% of patients reported a DLQI > 10, indicative of a very large to extremely large impact on QoL. Activity impairment was the most important factor predicting high QoL burden (DLQI > 10) across models. Hospitalisation during the past year and flare type were also highly ranked. Current BSA involvement was not a strong predictor of AD-related QoL impairment.
Conclusions
Activity impairment was the single most important factor for AD-related QoL impairment while current extent of AD did not predict higher disease burden. These results support the importance of considering patients’ perspectives when determining the severity of AD.
Introduction
Limited data exist on skin cancer risk in patients with psoriasis using biologics. Here, we report treatment-emergent adverse events (TEAEs) of skin cancer in patients treated with ...ixekizumab from psoriasis clinical trials.
Methods
Integrated safety databases from 17 clinical trials of adults with moderate-to-severe psoriasis treated with ≥ 1 dose of ixekizumab for ≤ 5 years were used to analyze exposure-adjusted incidence rates (IRs) per 100 patient-years of exposure (PYE) and clinically characterize dermatologist-adjudicated skin cancer TEAEs.
Results
Of 6892 patients, 58 presented with ≥ 1 skin cancer TEAE (IR 0.3) with IRs remaining stable with longer ixekizumab exposure. Non-melanoma skin cancer (NMSC) was the most common event (IR 0.3) affecting 55 patients; of those, 44 had basal cell carcinoma (IR 0.2) and 16 had squamous cell carcinoma (IR 0.1). Two treatment-emergent melanoma events were identified; neither were classified as serious AEs.
Conclusions
Incidence of skin neoplasms in patients with psoriasis treated with ixekizumab for ≤ 5 years was low, and among those events, NMSC was most common. Limitations included that longer exposure may be required to confirm risk of skin cancer and that the study exclusion criteria of several studies, which excluded patients with skin cancer events within 5 years prior to baseline, might limit interpretation of skin cancer risk in this cohort. These findings support the safety profile of ixekizumab for patients requiring long-term psoriasis control.
Fair trade, a concept that was pioneered by alternative trade activists and organisations opposed to the workings of the conventional trading system, has moved from the margins to active exchange in, ...and indeed reliance on, the mainstream market. With its origins in the early informal activities of missionaries and Non-Governmental Organisations (NGOs), Fair Trade in its infancy quickly formalised as an applied opposition to the dominance of free market principles in global markets. This was achieved through the creation of Alternative Trade Organisations (ATOs), today called Fair Trade Organisations (FTOs), as businesses actively trading with marginalised producers on the basis of a typically non-profit and socially oriented bottom line. In the 1990s, a new 'Fairtrade' labelling model emerged.1 This model sought to propel fair trade activity from the sidelines into the mainstream by inviting conventional profit-oriented businesses to participate. It differentiates from the more deeply transformative and process-oriented features of ATO trade through its emphasis on product differentiation as a mechanism for harnessing the conventional market to mainstream fair trade activity. While it preferences ethical business structures and values at the sites of production, it does so without making concomitant requirements of business structures in consumer markets, only of the terms under which they buy their fair trade product lines.
Introduction: The randomised, open-label, assessor-blinded, parallel-group SPIRIT-H2H trial (NCT03151551) demonstrated superiority of ixekizumab over adalimumab in simultaneously achieving ...improvement in joint symptoms (American College of Rheumatology ACR50) and clearance of skin lesions (Psoriasis Area and Severity Index PASI100) in biologic-naïve patients with active psoriatic arthritis (PsA) and plaque psoriasis (PsO) at Week 24. Additionally, this higher efficacy of ixekizumab versus adalimumab was maintained through Week 52.
Objective: This analysis aimed to investigate the efficacy and safety of ixekizumab and adalimumab in the subgroup of patients with PsA and moderate-to-severe PsO through W52.
Methods: Efficacy and safety outcomes were analysed in patients with PsA and moderate-to-severe PsO (PASI ≥12, Body Surface Area ≥10%, static Physician Global Assessment ≥3) through W52. Categorical and continuous outcomes were analysed using logistic regression models and mixed model for repeated measures, respectively.
Results: More ixekizumab- versus adalimumab-treated patients simultaneously achieved PASI100 and ACR50 at W24 (40.8% versus 17.6%, p=0.015) and W52 (38.8% versus 17.6%, p=0.026). Likewise, more ixekizumab- versus adalimumab-treated patients achieved PASI100 (59.2% versus 25.5%, p=0.001) and PASI90 (81.6% versus 60.8%, p=0.028) through W52, and nail PsO clearance at W24. Joint symptom improvements were comparable between treatment groups. No new safety findings were reported.
Conclusions: Ixekizumab had higher efficacy than adalimumab in simultaneous achievement of ACR50 and PASI100 at W24 and W52 in patients with PsA and moderate-to-severe PsO. Ixekizumab-treated patients also showed higher response rates for nail PsO clearance and for reporting minimal or no impact on quality of life at Week 24.
Fairness in global markets - trade, growth and inequality - locating global markets in a value chain framework - alternative trade and the creation of parallel markets - fair trade vs ‘Fairtrade’ in ...mainstream markets - free and fair trade as a response to global inequality - market-harnessing model of fair trade.
Mobile devices provide new opportunities to draw conclusions about cognitive performance in everyday situations. To gain insights into cognitive performance patterns in healthy adult populations, we ...adapted three established cognitive tests for smartphone use: the Digit Symbol Substitution Task (DSST), Sustained Attention to Response Task (SART), and Psychomotor Vigilance Task (PVT). To increase their feasibility for ambulatory assessment, we identified the minimum measurement durations that provide reliable and valid state measures of cognitive performance. Over 2 weeks, 46 participants performed each test once per day at random times, along with self-reports (e.g., on concentration, mood, and mental demands). The validity and reliability of change are promising for the 30-second PVT and 90-second DSST and SART. The DSST and SART provide fruitful outcomes for ambulatory field studies linked to mood, stress, and mental demands. We provide digital versions of the adapted DSST and SART online for free.
Background
Either a random-parameters logit (RPL) or latent class (LC) model can be used to model or explain preference heterogeneity in discrete-choice experiment (DCE) data. The former assumes ...continuous distribution of preferences across the sample, while the latter assumes a discrete distribution. This study compared RPL and LC models to explore preference heterogeneity when analyzing patient preferences for psoriasis treatments.
Methods
Using DCE data collected from respondents with moderate-to-severe plaque psoriasis, we calculated and compared preference weights derived from RPL and LC models. We then compared how RPL and LC explain preference heterogeneity by exploring differences across subgroups defined by observed characteristics (i.e., country, age, gender, marital status, and psoriasis severity).
Results
While RPL and LC models resulted in the same mean preference weights, different preference-heterogeneity patterns emerged from the two approaches. In both models, country of residence and self-reported disease severity could be linked to systematic differences in preferences. The RPL also identified gender and marital status, but not age, as sources of heterogeneity; the LC membership probability model indicated that age was a significant factor, but not gender or marital status.
Conclusions
Using data from a psoriasis patient survey to compare two widely used methods for exploring heterogeneity identified differences in results between stated-preferences: subgroup analysis in the RPL model and inclusion of subgroup characteristics in the class membership probability function of the LC model. Researchers should model data using the most adaptable approach to address the initial study question.
Driven by the massification and marketization of higher education, interest in experiential learning has grown as universities compete to demonstrate the vocational relevance of their programs. The ...authors argue that in fostering experiential learning, as opposed to simply delivering "experiences," teacher transformation can occur in tandem with transformations in student learning. To provide experiential learning, teachers do not simply assume a role of facilitator, as commonly depicted in the literature. Rather, delivering effective experiential learning can also facilitate the transformation of teachers into co-learners, a concept highlighted in transformational learning theory. This article explores the authors' journey as three tertiary educators developing and practicing a range of experiential learning models to enhance student experience and learning outcomes in their classrooms.
PDF
