RT Journal Article
SR Electronic
T1 PO.7.160 Enlight-LN: a prospective observational registry of patients treated with voclosporin for lupus nephritis in the united states
JF Lupus Science & Medicine
JO Lupus Sci Med
FD Lupus Foundation of America
SP A117
OP A118
DO 10.1136/lupus-2022-elm2022.180
VO 9
IS Suppl 2
A1 N Slawny
A1 A Pavlova-Wolf
A1 C Collins
A1 R Gluck
A1 L Hodge
A1 H Leher
YR 2022
UL http://lupus.bmj.com/content/9/Suppl_2/A117.abstract
AB Purpose Voclosporin, a novel calcineurin inhibitor, was approved in January 2021 in the United States for the treatment of adult patients with active lupus nephritis in combination with background immunosuppressive therapy. Voclosporin has a favorable metabolic profile and a consistent dose-concentration relationship, eliminating the need for therapeutic drug monitoring associated with other calcineurin inhibitors. Pivotal Phase 2 and Phase 3 studies showed that the addition of voclosporin to mycophenolate mofetil (MMF) and low-dose steroids significantly increased complete renal response (CRR) rates in patients with lupus nephritis at approximately one year of treatment (48 weeks in AURA-LV, 52 weeks in AURORA 1).Here we describe an actively enrolling prospective observational registry, designed to characterize the real world effectiveness profile and utilization patterns of voclosporin in the United States.Methods Patients enrolled in Enlight-LN will receive standard care in accordance with usual clinical practice at each site, with no mandatory visits or assessments required by the protocol. Data will be extracted from patient medical records approximately every 3 months for up to 36 months; collected data will include demographics, disease characteristics, response to therapy, safety, and treatment patterns and utilization. The registry will enroll patients who are initiating or who have already initiated treatment with commercial voclosporin within 3 months prior to consent. Patients ≥18 years of age with biopsy-confirmed lupus nephritis are eligible (Table 1). Secondary objectives include describing at baseline and during the study period the clinical characteristics, treatment and response patterns of patients treated with voclosporin.To date, 36 sites in 16 states have been selected to participate in the registry; Enlight-LN is currently enrolling patients.View this table:Abstract PO.7.160 Table 1 Enlight-LN registry inclusion and exclustion criteria