Background/Purpose: Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease that causes connective tissue inflammation and can result in multiple organ damage. Registries may be a valuable source of real-world data that complements randomized clinical trial data. 

To 1) identify SLE registries, 2) determine what measures are collected within the registries, and 3) determine which registries capture metric(s) and/or endpoints which have been collected within a SLE clinical trial. 

Methods: Utilizing the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISM) guidelines, we conducted a systematic review of the literature search using PubMed, EMBASE, and Scopus databases between 2012 to the present and a gray literature search to identify SLE registries.  We reviewed each registry for the following criteria: 1) population diagnosed with SLE, who were 16 years or older; 2) published in English language; and 3) contained content on any of the following measures or endpoints; Short-Form(SF)-36, SRI (SLE responder index), SLEDAI (SLE Disease Activity Index), PGA (physician global assessment), BILAG (British Isles Lupus Activity Group), Systemic Lupus Collaborating Clinics (SLICC) damage index, Lupus Quality of Life (LupusQoL), Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue, healthcare utilization, clinical outcomes (e.g. flares) or biobank information.

Results: A total of 41 SLE registries were identified.  No registry captures all the components of the SRI-4, the SLEDAI, BILAG, and PGA.  Ten registries collect 2 components of the SRI-4 (Table 1).  Four SLE registries capture the SF-36 and 3 registries collect biobank data (Table 1).    There is at least 1 SLE registry in each of the 4 main regions of the world; North America, Europe, Asia Pacific, and Latin America. 

Conclusion: There is variability among the measures collected by SLE registries.  Many of the SLE registries capture a subset of measures common to those collected by SLE clinical trials.  It appears that measures collected by SLE clinical trials are not necessarily the same as those captured in real world settings.  Additional research is needed to develop validated measures which may be captured within clinical trials as well as within real world settings such as registries.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/systemic-lupus-erythematosus-registries-are-the-measures-captured-in-the-real-world-similar-to-those-in-clinical-trials/