Adaptations in the PURE registry in response to the COVID 19 pandemic: The impact of well-designed modifications in real-world data collection in a psoriasis registry

ABSTRACT

Introduction: PURE is an international registry of adult patients with moderate-to-severe psoriasis treated with secukinumab (Cohort 1) vs other approved therapies (Cohort 2). The SARS-CoV-2 (COVID-19) pandemic necessitated adaptations in the collection of data enabling continued, successful monitoring of patients in the registry. This presents an overview of these changes and their impact on the PURE registry. Materials and methods: This ongoing registry enrolled 2362 adult patients with moderate to severe psoriasis (11 ratio;secukinumab other treatments) from 81 community and hospital sites. As a noninterventional study, PURE registry allowed for flexibility in the visit schedule and type of visit (remote visits vs face-to-face) per routine practice. This enabled monitoring of patient outcomes during the pandemic at sites where appropriate resources and capabilities were available to perform virtual visits (video teleconferencing, or through phone calls with photographs). The video conference/photographs should have ensured that the investigator was able to assess the disease activity and its extent. The eCRF was modified to record the type of visit (Remote or On-site) and COVID-19 related adverse events (AE). This included diagnostic testing, symptoms, and concomitant medications. Clear definitions for suspected/confirmed and symptomatic/asymptomatic COVID-19 diagnoses, and the associated data entry instructions with clear illustrative examples were provided. COVID-19 related outcomes are being reported separately at this congress. Conclusions: Adaptations to PURE registry successfully enabled continued follow-up of psoriasis patients through the COVID-19 pandemic. The COVID-19 AE data provides us with the opportunity to explore the impact of the pandemic on patients with psoriasis treated with secukinumab.