Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs

Study Overview
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Brief Summary
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The ERYTHRO study is a retrospective medical chart review study of patients in the AMANA and ATUc Early Access Programs (EAPs) across a number of countries, to assess anifrolumab usage and patient experience in treating SLE in a real-world setting. Since patient safety data are already collected and reported according to regulatory requirements through EAPs, this study will not collect safety data.

Detailed Description
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This is a multi-country, multi-site retrospective chart review study that will use data extracted from the medical charts of SLE patients who participated in the anifrolumab EAPs AMANA or ATUc in France, Germany, Greece, Israel, Italy, Portugal, Spain, and the UK. Patient level data will be captured longitudinally for each patient over a 12- to 18-month period. The study period will include retrospective data collection covering a minimum 6- month baseline period prior to the index date and retrospective data collection covering a minimum 6-month FU period from the first Anifrolumab infusion. The index date is defined as the date of first anifrolumab infusion during the indexing period. The indexing period is between the earliest date of patient enrolment into the EAP and the date of last new patient enrolment into EAP. The EAPs have closed by end of February 2023 in all countries included in the ERYTHRO study. One data extraction will be performed per patient.

Official Title
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ERYTHRO Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Other: None (Observational study)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years at time of enrolment into AMANA or France ATUc program, and Have at least 6 months of data from medical charts available prior to the initiation of anifrolumab through the EAP, and Have been initiated on anifrolumab at least 6 months before enrolment into ERYTHRO study, and Informed consent obtained to participate in ERYTHRO Exclusion Criteria: Participated in anifrolumab clinical trials, NCT02794285 (D3461C00009) and / or NCT01753193 (D3461C00003), prior to enrolment into AMANA or France ATUc program, or Participated in any SLE clinical trial during the baseline period and / or the FU period of ERYTHRO, or Patients who were pregnant during the baseline period and / or the FU period of ERYTHRO

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br>SLE patients who participated in the anifrolumab EAPs (AMANA or ATUc). | Other: None (Observational study)<br>* Not applicable since this is observational study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) or any of its components at 6 months from the date of first anifrolumab infusion | The SLEDAI-2K stands for Systemic Lupus Erythematosus Disease Activity Index -2000. It measures disease activity in the 28 days prior to and at the time point of the assessment. It is a global index and includes 24 clinical symptoms and laboratory variables that are weighted by the type of manifestation, but not by severity or dynamic of the individual item. The SLEDAI-2K includes scoring for antibodies (anti-dsDNA positive or negative) and low complement, as well as some renal and hematologic parameters. The total score ranges between 0 and 105, with higher scores representing increased disease activity. In practice it is expected that SLEDAI scores will be skewed towards 0, with scores higher than 20 being rare. | 6-month longitudinal data capture | 
| Disease activity assessed by the Physician Global Assessment (PGA) at 6 months from the date of first anifrolumab infusion | The PGA is a single-item visual analogue scale that describes the physician assessment of a patient's disease and its impact on daily functioning at the time of assessment. The scale ranges from 0 (asymptomatic disease and no limitation of normal activities) to 3 (severe disease and limitation of normal activities). 0 - none - mild - moderate - severe | 6-month longitudinal data capture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Proportion of patients achieving clinical remission at 6 months from the date of first anifrolumab infusion | Remission: defined as clinical SLEDAI 2K =0, plus PGA score <0.5 | 6-month longitudinal data capture | 
| 2. Proportion of patients achieving all four criteria for low disease activity (LLDAS) at 6 months from first anifrolumab infusion | LLDAS assessment requires all of the following criteria to be met: SLEDAI-2K score ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, or fever), No new SLEDAI-2K assessed disease activity compared with the previous visit, PGA score ≤ 1, Prednisone or equivalent dosage ≤ 7.5 mg/day, and No non-standard immunosuppressant dosing, with antimalarials allowed. | 6-month longitudinal data capture | 
| 3. The frequency overall and by intensity (mild / moderate and severe) of flares as assessed by the Revised Safety of Estrogens in Lupus National Assessment - SLE Disease Activity Index Flare Index (rSFI) at baseline and during follow up. | Worsening of symptoms, referred to as flares, will be defined based on the the Revised Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index Flare Index (rSFI). Flares will be categorized into mild/moderate and severe flares as per the rSFI definitions. | 6-month longitudinal data capture | 
| 4. The extent of skin manifestations over time as described by Cutaneous LE Disease Area and Severity Index (CLASI) during baseline and at 6 months after the data of first anifrolumab infusion | The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) consists of 2 scores; the first summarizes the activity of the disease and the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hypertrophy of skin and mucous membranes, acute hair loss, and nonscarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. Study participants are asked whether dyspigmentation due to cutaneous lupus erythematosus lesions usually remains visible for more than 12 months, which is taken to be permanent. If the dyspigmentation lasts longer than 12 months after the active lesion has resolved, then the score is doubled. The scores are calculated by simple addition and range from 0-70 for activity and 0-56 for damage, with higher scores indicating worse disease activity/damage. | 6-month longitudinal data capture | 
| 5. SLE treatments used before, during and after Anifrolumab, especially oral corticosteroids (OCS) | Pre- Anifrolumab treatment/ OCS usage before anifrolumab initiation Treatment concomitant with Anifrolumab / OCS usage concomitant with Anifrolumab Post-Anifrolumab treatment/ OCS usage after anifrolumab end/discontinuation. | 12- to 18-month longitudinal data capture | 
| 6. Usage of anifrolumab, including adherence | Adherence is the actual number of infusions received out of the expected number of infusions during a specified duration | 12- to 18-month longitudinal data capture | 
| 7. Usage of anifrolumab, including persistence | Persistence is the time on treatment as per indicated treatment interval | 12- to 18-month longitudinal data capture | 
| 8. Baseline patient characteristics | Demographics (age, gender, ethnicity) Patients medical history Family history of autoimmune diseases Baseline comorbid conditions SLE treatment history Lifestyle (smoking history, alcohol consumption history) | 12- to 18-month longitudinal data capture | 
| 9. Describe baseline comorbidities described by Charlson Comorbidity Index (CCI) or any of its components | Charlson Comorbidity Index (CCI) predicts the mortality for a patient who may have a range of concurrent conditions, includes 17 chronic diseases in estimating the CCI. The CCI predicts 10- year mortality risk from chronic comorbidities. | 12- to 18-month longitudinal data capture | 
| 10. SLE related tests performed during baseline and FU, respectively | Whole blood tests | 12- to 18-month longitudinal data capture | 
| 11. SLE related tests performed during baseline and FU, respectively | Biochemical | 12- to 18-month longitudinal data capture | 
| 12. SLE related tests performed during baseline and FU, respectively | Serological | 12- to 18-month longitudinal data capture | 
| 13. SLE related tests performed during baseline and FU, respectively | Urine test | 12- to 18-month longitudinal data capture | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic autoimmune disease, immunosuppressants, corticosteroids, human monoclonal antibody (IgG1ƙ mAb), Real World