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

AstraZeneca46 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

None (Observational study)OTHER

Not applicable since this is observational study.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

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 (where required as per country regulations) 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

Locations (15)

Research Site

Brest, France

Research Site

Caen, France

Research Site

Dijon, France

Research Site

Outcomes

Primary Outcomes

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.

Time frame: 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 1. \- mild 2. \- moderate 3. \- severe

Time frame: 6-month longitudinal data capture

Secondary Outcomes

1. Proportion of patients achieving SLE remission at 6 months from the date of first anifrolumab infusion

Remission: defined as clinical SLEDAI = 0, and PGA \< 0.5. The patients may be on antimalarials, low-dose glucocorticoids (prednisolone ≤ 5 mg/day), and/or stable immunosuppressives, including biologics

Time frame: 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: 1. SLEDAI-2K score ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, or fever), 2. No new SLEDAI-2K assessed disease activity compared with the previous visit, 3. PGA score ≤ 1, 4. Prednisone or equivalent dosage ≤ 7.5 mg/day, and 5. No non-standard immunosuppressant dosing, with antimalarials allowed.

Data from ClinicalTrials.gov

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Research Site

Paris, France

Research Site

Toulouse, France

Research Site

Athens, Greece

Research Site

Ramat Gan, Israel

Research Site

Tel Aviv, Israel

Research Site

Pisa -PI-, Italy

...and 5 more locations

Time frame: 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.

Time frame: 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.

Time frame: 6-month longitudinal data capture

5. SLE treatments used before, during and after Anifrolumab, especially oral corticosteroids (OCS)

1. Pre- Anifrolumab treatment/ OCS usage before anifrolumab initiation 2. Treatment concomitant with Anifrolumab / OCS usage concomitant with Anifrolumab 3. Post-Anifrolumab treatment/ OCS usage after anifrolumab end/discontinuation.