Challenges for Synthesising Data in a Network of Registries for Systemic Psoriasis Therapies

Abstract

Background: Large disease registries are the preferred method to assess long-term treatment safety. If psoriasis registries collaborate in a network, their power to assess safety is increased. Objective: To identify heterogeneity in psoriasis registries and methodological challenges for synthesising the data they provide. Methods: We surveyed the registries in PSONET and identified and addressed the challenges to collaborative analysis for the network in several round table meetings. Results: Eight out of 10 registries had a prospective comparator cohort with similar disease characteristics but not on biologics. Registries differed in the coding and validation or follow-up of adverse events and in the way they sampled their population. Fifteen challenges to registries collaborating were identified in the areas of operational governance, structural conduct, bias and analysis. Conclusions: Participation in PSONET, a network of psoriasis registries, helps identify and solve common issues, enhancing the individual registries, and provides larger sets of more powerful safety data in a diverse population. Challenges to interpreting data collectively include heterogeneity in sampling, variable penetration of biologics and compatibility of different datasets.

Erythroderma: A Clinical and Prognostic Study

“…In our study, psoriasis was the most common (55%) underlying etiology of pre-existing dermatosis, which was much higher than all the previous reports. As a result, we concluded that there might be a higher frequency of psoriasis or a greater tendency for its generalization in our district [10]; furthermore, unlike in western reports [11], injudicious use of medications, either by the individual or prescribed by physicians, may partly be responsible for the higher rate of psoriasis (the most frequently suspected trigger factors were upper respiratory tract infections and withdrawal of oral medicines including systemic corticosteroids or Chinese traditional herbal medicines). In our study, we also found bullous pemphigoid, hypereosinophilic syndrome and dermatomyositis as causes of erythroderma, which have never or rarely been mentioned in previous reports.…”

Prevalence of Phototherapy in the Age of Biologics

“…Cut-off PASI value ≥10 [10] PASI score was assessed independently by 2 physicians after attending a PASI training course [3]. In case of discordance, the 2 investigators reviewed the scores together with a third physician Who failed to respond to Patients were clinically evaluated at monthly intervals, and they underwent the necessary laboratory and instrumental tests at baseline and at recommended intervals [10].…”

“…Moreover, the same registries showed wide differences in the rates of patients treated with the biologics [3][4][5][6]. A possible explanation is that the European Medicines Agency (EMA) did not describe in detail the eligibility criteria for biologics and systemic conventional therapies [7][8][9][10], and therefore they left a margin of discretion in their interpretation.…”

Multinational Registries: Challenges and Opportunities

“…The registries agreed on the Psonet protocol and a common set of variables and procedures; recent work has focused on understanding heterogeneity in patient populations. 17 The IRHLT (described previously) is another example of a registry that uses the network model. This registry incorporates data from 16 national-level transplantation registries as well as data submitted directly from 80 institutions.…”