Abstract
BackgroundLimited information exists about the very early forms of psoriatic arthritis. In particular, differences and responsiveness of patient-reported outcomes (PROs) in very early as compared to established PsA have not been investigated to date.MethodsCross-sectional and prospective longitudinal evaluation of PROs related to pain (VAS), physical function (HAQ-DI, SF-36 physical), mental function (SF-36 mental), impact of psoriatic skin (DLQI), joint (PsAID), and global disease (VAS) in two small prospective observational studies on secukinumab 300 mg over 6 months in very early disease patients (IVEPSA study, N = 20) and established PsA (PSARTROS study, N = 20). Cluster analysis was performed at baseline and 24-weeks of follow-up.ResultsWhile responses in pain and physical activity-related PROs to secukinumab were more pronounced in established PsA than a very early disease, effects on PROs related to general health perception, as well as those related to emotional and mental well-being, were modified in a similar way in very early disease and established PsA. Cluster analysis based on global disease activity and PROs showed that baseline clusters reflected very early disease and established PsA, while after secukinumab treatment these clusters were abolished and new clusters based on differential responses to physically and mentally oriented PROs formed.ConclusionsInhibition of IL-17A by secukinumab leads to comprehensive improvement of general health perception and mental well-being in very early and established PsA, while overall responses in pain and physical activity are more pronounced in established disease. Most importantly, treatment restructures the original patients’ clusters based on disease stage and leads to the formation of new clusters that reflect their response in physical and mental-orientated PROs.Trial registrationNCT02483234, registered 26 June 2015, retrospectively registered.
Highlights
Limited information exists about the very early forms of psoriatic arthritis
Quality of life (QOL) is considerably impaired in patients with immune-mediated inflammatory disease and improvement of life quality is a central aim of treatment
Aside from measuring objective manifestations of psoriatic skin (e.g., psoriasis Area and Severity Index (PASI)) and/or joint (DAPSA) disease, patient-reported outcomes (PROs) are valuable tools to complement the vision on the effect of disease on QOL and the potential of therapy to improve QOL [2]
Summary
Limited information exists about the very early forms of psoriatic arthritis. In particular, differences and responsiveness of patient-reported outcomes (PROs) in very early as compared to established PsA have not been investigated to date. PROs used in psoriatic disease are visual analog scales (VAS) for pain and global disease activity and function and quality of life questionnaires Among the latter, the 36-Item Short Form Survey (SF-36) and the Health Assessment Questionnaire Disability Index (HAQ-DI) were not initially developed for PsA patients and may not fully reflect the influence of PsA on the health status of the patients. The 36-Item Short Form Survey (SF-36) and the Health Assessment Questionnaire Disability Index (HAQ-DI) were not initially developed for PsA patients and may not fully reflect the influence of PsA on the health status of the patients Additional indices such as the Psoriatic Arthritis Impact of Disease Questionnaire (PsAID) were developed for PsA [3], while the Dermatology Life Quality Index (DLQI) was created with an input from several different skin diseases, including psoriasis [4]
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