Overview
The purpose of the OBSErve-LN study is to assess the real-world use and effectiveness of belimumab in routine practice for the treatment of adults with active LN in multiple countries of interest. This study aims to provide the first long-term (up to 5 years) assessment of renal function preservation in belimumab treated participants.
Eligibility
Inclusion Criteria:
- Participants to provide a signed informed consent at the time of enrollment per protocol,
- Male or female aged 18 or over at initiation of belimumab,
- Participants received belimumab for the treatment of active LN prescribed as per local label in combination with standard immunosuppressive therapy/ies at initiation of belimumab,
- Participants initiated belimumab 6 to 24 months prior to study enrollment,
- Accessibility of medical records starting at belimumab initiation (including accessibility of medical records for the prior 12 months and confirmatory biopsy within the prior 24 months from belimumab initiation),
- Biopsy-confirmed diagnosis of active LN in the two-years prior to the initiation of
belimumab
- Class III (focal LN) with or without Class V (membranous LN),
- Class IV (diffuse LN) with or without Class V,
- Class V.
Exclusion Criteria:
- Participants receiving renal replacement therapy at initiation of belimumab,
- Participant is concomitantly receiving another biologic at initiation of belimumab,
- Participants in a clinical trial during the observation period (with the exception of allowing participation in other non-interventional studies),
- Participant is pregnant at the initiation of belimumab,
- Participant with a kidney transplant at the initiation of belimumab,
- Participants will be excluded from the study if they are planning to become pregnant or are pregnant at study enrollment.