Biologics use in sle in 23 centers – data from the international registry for biologics in SLE

Backgroundand objectives There is only one biologic agent approved for use in SLE, but some are used off-label in various settings. To obtain information systematically regarding this, members of the SLICC group initiated the International Registry for Biologics in SLE (IRBIS). The objective of this study was to analyse the use of biologics in SLE, and assess results achieved with the most commonly used off-label biologic, rituximab (RTX). Materials and methods IRBIS investigators were asked to provide retrospective data on all patients treated with a biologic for SLE at their center. Standardised case report forms were used to collect demographic, disease-specific and treatment data at the time of biologic initiation and at yearly follow-up. Data from the first 23 reporting centers are presented. Results Three hundred and fifty-nine patients were treated off-label with RTX, and additional groups of patients were exposed to belimumab (n=44), epratuzumab (n=21), abatacept (n=4), etanercept (n=3) and adalimumab (n=1). For the RTX treated group, age (mean±SD) was 41.3±13.3 and 91% were female. The majority (76%) were Caucasian, and smaller proportions were Southeast Asian, Asian/Indian, African-American, Latino, Afro-Caribbean or other (each Conclusions RTX was the off-label biologic most commonly used in this multi-center international lupus cohort and was used for LN as well as for other SLE manifestations. At one-year-follow-up both lupus activity and concomitant glucocorticoid dosage had decreased even when no other IS treatments had been introduced. The two RTX dosing regimes appeared equally effective for LN treatment, but firm conclusions cannot be made from these observational data.