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Abstract: INFO36

Enlight-LN: A Prospective Observational Registry of Patients Treated With Voclosporin for Lupus Nephritis in the United States

Session Information

  • Informational Posters
    November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

  • No subcategory defined

Authors

  • Tagoe, Keith J., Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
  • Orujov, Elmar, Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
  • Baker, Matthew G., Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
  • Cipolla, Lily, Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
  • Mclemore, Jeremy, Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
  • Leher, Henry, Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
Description

Voclosporin, a novel calcineurin inhibitor, was approved in the United States in 2021 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.

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.

As of May 2022, 66 sites in 23 states have been selected to participate in the registry; Enlight-LN is currently enrolling patients.

Funding

  • Aurinia Pharmaceuticals Inc. has provided the funding for this registry.
Abstract: INFO36

Enlight-LN: A Prospective Observational Registry of Patients Treated With Voclosporin for Lupus Nephritis in the United States

Session Information

  • Informational Posters
    November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Tagoe, Keith J., Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
  • Orujov, Elmar, Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
  • Baker, Matthew G., Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
  • Cipolla, Lily, Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
  • Mclemore, Jeremy, Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
  • Leher, Henry, Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
Description

Voclosporin, a novel calcineurin inhibitor, was approved in the United States in 2021 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.

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.

As of May 2022, 66 sites in 23 states have been selected to participate in the registry; Enlight-LN is currently enrolling patients.

Abstract: INFO36

Enlight-LN: A Prospective Observational Registry of Patients Treated With Voclosporin for Lupus Nephritis in the United States

Session Information

  • Informational Posters
    November 05, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Tagoe, Keith J., Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
  • Orujov, Elmar, Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
  • Baker, Matthew G., Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
  • Cipolla, Lily, Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
  • Mclemore, Jeremy, Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
  • Leher, Henry, Aurinia Pharmaceuticals Inc, Rockville, Maryland, United States
Description

Voclosporin, a novel calcineurin inhibitor, was approved in the United States in 2021 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.

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.

As of May 2022, 66 sites in 23 states have been selected to participate in the registry; Enlight-LN is currently enrolling patients.