Clinical and Demographic Features of Patients With Moderate to Severe Active Systemic Lupus Erythematosus in Russia

Inclusion Criteria:

Inclusion criteria for the retrospective phase are:

1. Patients with the diagnosis of SLE (ICD code: M32) confirmed by medical records;
2. Patients with availability of data of at least one visit to the clinic in the medical records in the last 24 months prior to inclusion;
3. Age ≥ 18 years at the time of last patient's visit to the clinic.

   Additional inclusion criteria for the prospective phase are:
4. Signed and dated written informed consent in accordance with ICH-GCP and local law prior to inclusion in the prospective phase of the study;
5. Disease activity measured with SLEDAI-2K ≥ 6 despite of standard treatment at the time of inclusion in the prospective phase of the study

Exclusion Criteria:

Exclusion criteria for the retrospective phase are:

1. Regular use of genetically engineered biological drugs for SLE treatment within the last 24 months prior to inclusion;
2. Participation in any interventional trial since the last patient's visit to the clinic;
3. Presence of lupus nephritis class III/IV ± V at the moment of the last patient's visit to the clinic;
4. Presence of neuropsychiatric lupus at the moment of the last patient's visit to the clinic.

   Additional exclusion criteria for the prospective phase are:
5. Current use of genetically engineered biological drugs for SLE treatment;
6. Current participation in any interventional trial;
7. Presence of lupus nephritis Class III/IV ± V at the moment of patient's visit;
8. Presence of neuropsychiatric lupus at the moment of patient's visit;
9. An acute or chronic disease that, in the opinion of the investigator, limits the ability of patient to provide data on his/her health or participate in this study or influence the interpretation of the results.