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Methods to extend the strong internal validity of randomized controlled trials to reliably estimate treatment effects in target populations are gaining attention. This paper enumerates steps recommended for undertaking such extended inference, discusses currently viable choices for each one, and provides recommendations. We demonstrate a complete extended inference from a clinical trial studying a pharmaceutical treatment for Alzheimer's disease (AD) to a realistic target population of European residents diagnosed with AD. This case study highlights approaches to overcoming practical difficulties and demonstrates limitations of reliably extending inference from a trial to a real-world population. [ABSTRACT FROM AUTHOR]

There is limited real-world evidence on using ixekizumab in psoriasis patients. Therefore, we characterized patients with psoriasis initiating ixekizumab and report 6-month changes in disease and patient-reported outcomes. Adult patients with psoriasis who initiated ixekizumab and completed a 6-month follow-up visit were enrolled from the Corrona Psoriasis Registry. Disease characteristics and outcomes were assessed at ixekizumab initiation. Outcomes included the mean 6-month change in Psoriasis Area and Severity Index (PASI), body surface area (BSA), Investigator Global Assessment (IGA), and IGA*BSA. From baseline to follow-up in all patients (n = 136), means decreased for IGA*BSA (−45.5) and BSA (−12.4), and a higher % achieved an absolute PASI ≤ 5 (84.6%), BSA 0–3 (72.1%), and IGA 0/1 (50.7%). Within stratified groups, means decreased for PASI <12 for IGA*BSA (−21.1) and BSA (−6.3); PASI≥12 for IGA*BSA (−94.8) and BSA (−24.6); weight <100 kg for IGA*BSA (−45.1) and BSA (−12.4); weight ≥100 kg for IGA*BSA (−46.2) and BSA (−12.3); concomitant PsA for IGA*BSA (−56.0) and BSA (−15.3); and in no concomitant PsA for IGA*BSA (−36.9) and BSA (−10.0). We provide real-world evidence on the benefits of ixekizumab for treating psoriasis, regardless of baseline disease severity, weight, or concomitant PsA. [ABSTRACT FROM AUTHOR]

Psoriasis is characterized by thick and scaly plaques. The Dermatology Life Quality Index (DLQI) and Physician Global Assessment (PGA) can be used to define its severity. To assess the impact of complete clearance of skin versus almost clear skin across various disease measures. Data were collected in a survey of US dermatologists and patients with psoriasis from November 2016–January 2017. Dermatologists completed a 6-point PGA (0 = clear skin, 1 = almost clear skin). Patients completed the DLQI and Work Productivity and Activity Impairment questionnaire (WPAI). Patients with clear and almost clear skin were compared using analysis of covariance for continuous variables, and multivariate logistic regression analysis for categorical variables. Data for 99 and 160 patients with clear and almost clear skin, respectively, were included in the analyses. Patients with clear skin reported less frequent and lower intensity itching, lower total DLQI score (indicating better health-related quality of life), and less impairment of overall work productivity than patients with almost clear skin (all: p < 0.05). Limitations relating to general survey methodology. Patients perceived a meaningful difference between clear and almost clear skin. Clear skin is now a realistic treatment target with newer biologics approved in psoriasis. [ABSTRACT FROM AUTHOR]