SAT0644 OUTCOME MEASURES IN NEUROPSYCHIATRIC SYSTEMIC LUPUS ERYTHEMATOSUS. (June 2019) - Bortoluzzi, Alessandra
Abstract : Background: Neuropsychiatric involvement in Systemic Lupus Erythematosus (NPSLE) is one of the most complex and severe expressions of the disease consisting of a variety of neurological and psychiatric syndromes. To date the NPSLE spectrum is lacking in validated disease activity instruments to support specific interventions. This absence of standardization for defining response to therapy is one of the most important barriers to test new therapeutic strategies or drugs in controlled clinical trials in NPSLE. Objectives: To identify the instruments used to assess NPSLE in published studies according to the OMERACT (Outcome Measures in Rheumatology) Filter 2.0 [Ref]. Methods: This systematic review was conducted in accordance with the Preferred Reporting Items for systematic reviews and Meta-analysis (PRISMA) statement. All articles available in English, published from June 1967 to March 1, 2018, in Pubmed, EMBASE, PsycINFO, Cochrane Library and EULAR Library for Outcome Measure were screened as well as extensive hand search. Study selection and data collection were performed by four independent reviewers. All data were extracted using a standardized template designed for this review. Each outcome was characterized according to the OMERACT Filter 2.0 considering core areas (pathophysiological manifestations, life impact, death, resource use) and domains [Ref]. Results: Results: Of 2, 625 abstracts, we included in the review 62 studies of which 1 randomised clinical trial (1.6%, 32 patients), 4 systematic literature reviews (6.4%, 8, 024 patients), 21 cohort studies (33.8%, 2, 684 patients) and 36 observational studies (58.1%, 1, 534 patients), with a total of 12, 274 patients. Patients were predominantly female (89.6%) with a mean±SD age of 34.9±5.8 years. The mean disease duration was 5.1±2.2 years (range 1 - 9.6). The most frequent included events were seizures (34 studies, 54.8%), cerebrovascular disease (30 studies, 48.4%), psychosis and myelopathy (29 studies, 46.8%), mood disorders (28 studies, 45.1%), headache (27 studies, 43.5%), cognitive dysfunction and cranial neuropathy (24 studies, 38.7%), polyneuropathy (22 studies, 35.5%). Four studies did not define the neuropsychiatric manifestation. Studies identified in this literature review include outcomes and instruments pertinent to all core areas defined by OMERACT, except resource use. The core areas most represented are pathophysiological manifestations and life impact which included a total of 8 domains for each [Table 1 ]. Conclusion: Our study revealed that a great heterogeneity exists in the assessment of NPSLE and this supports the development of a core outcome set in order to promote clinical research in this field and enhance comparability of studies. References: [1] Boers M, Kirwan JR, Wells G, et al. Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol 2014;67:745–53. doi:10.1016/j.jclinepi.2013.11.013 Disclosure of Interests: Alessandra Bortoluzzi: None declared, Francesca Bergossi: None declared, Elisabetta Chessa: None declared, Maria Ester D'Amico: None declared, Matteo Piga: None declared, Carlo Alberto Scirè: None declared, Ettore Silvagni: None declared, Marcello Govoni Paid instructor for: Pfizer, Roche, Speakers bureau: Pfizer, Abbvie, MSD, Roche, Eli-Lilly, Celgene, Sanofi, Janssen