scholarly journals Effect of Certolizumab Pegol on Multiple Facets of Psoriatic Arthritis as Reported by Patients: 24-Week Patient-Reported Outcome Results of a Phase III, Multicenter Study

2014 ◽  
Vol 66 (7) ◽  
pp. 1085-1092 ◽  
Author(s):  
D. Gladman ◽  
R. Fleischmann ◽  
G. Coteur ◽  
F. Woltering ◽  
P. J. Mease
Keyword(s):  
Psoriatic Arthritis ◽  
Multicenter Study ◽  
Certolizumab Pegol ◽  
Patient Reported Outcome ◽  
Phase Iii ◽  
Patient Reported

Psoriatic arthritis

2013 ◽  
pp. 890-900
Author(s):  
Laura C. Coates ◽  
Philip S. Helliwell
Keyword(s):  
Psoriatic Arthritis ◽  
Skin Condition ◽  
Patient Reported Outcome ◽  
New Drugs ◽  
Screening Tools ◽  
North Americans ◽  
The Metabolic Syndrome ◽  
Patient Reported ◽  
Chronic Skin ◽  
The Impact

Psoriasis is a chronic skin condition affecting about 3% of Europeans and North Americans. About 15% of people afflicted with psoriasis will develop psoriatic arthritis—cutaneous risk factors for this are psoriasis of the nails, scalp, and flexures. Since most cases of arthritis develop in people with psoriasis, new screening tools, both clinical and imaging, are available. Some genetic factors may also explain susceptibility and severity. Historically, five clinical subgroups have been described but these may be simplified to axial and peripheral involvement, the latter dividing into oligo- and polyarticular patterns. The importance of these clinical subdivisions is still under debate and research but it is clear that there is marked heterogeneity in all manifestations of this disease. In recent times the importance of extra-articular features has gained prominence such that the metabolic syndrome and cardiovascular morbidity are now seen as important features of ’psoriatic disease’. The diverse changes seen in bone on imaging reflect both the underlying pathogenic mechanisms and the ways in which the disease progresses. Recent work with animal models and immunohistochemistry has further advanced our understanding of these features. In the biologic era renewed interest in psoriatic arthritis has stimulated research into outcome assessment and permitted clearer understanding of how these new drugs work on the different aspects of the disease. In addition, improved recognition of the impact of the disease on the person has stimulated the development of new patient-reported outcome tools.

scholarly journals Development of a patient-reported outcome questionnaire for aplastic anemia and paroxysmal nocturnal hemoglobinuria (PRO-AA/PNH)

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Kimmo Weisshaar ◽  
Hannah Ewald ◽  
Jörg Halter ◽  
Sabine Gerull ◽  
Sandra Schönfeld ◽  
...  
Keyword(s):  
Aplastic Anemia ◽  
Paroxysmal Nocturnal Hemoglobinuria ◽  
Patient Reported Outcome ◽  
Phase Iii ◽  
Specific Patient ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
Core Symptoms ◽  
Missing Items

Abstract Background The introduction of new therapy modalities has significantly improved the outcome of aplastic anemia (AA) and paroxysmal nocturnal hemoglobinuria (PNH) patients. However, relatively little is known about the exact disease burden of AA/PNH since standardized assessments of symptoms including health-related quality of life (HRQoL) are frequently missing or inadequately designed for this rare patient group. We aimed to develop AA/PNH-specific questionnaires for self-reporting of symptoms, which could be included in electronic platforms for data collection and patient care. Methods By scoping review, we extracted any reported symptoms in AA/PNH and their prevalence from the literature (Phase I). Consensus rounds with patients and medical experts were conducted to identify core symptoms reported in the literature and to add missing items (Phase II). Ultimately, AA/PNH-specific patient-reported outcome (PRO) questionnaires including the selected measures were designed (Phase III). Results AA symptoms from 62 and PNH symptoms from 45 observational studies were extracted from the literature. Twenty-four patients and seven medical experts identified 11 core symptoms including HRQoL issues after three consensus rounds. Significant differences in the symptom ranking of patients versus medical experts could be observed. Therefore, patient- as well as expert-centered PRO questionnaires in AA and PNH were created following the concepts of validated instruments. Conclusion The development of symptom self-reporting questionnaires for AA and PNH was feasible and the disease-specific PRO questionnaires can now be validated within a web-based workflow in a subsequent feasibility study.

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