Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus

Recruiting

• Conditions: Lupus Erythematosus, Systemic
• Interventions: Drug: Anifrolumab

• Registration Number: NCT06673043
• Lead Sponsor: AstraZeneca

Brief Summary

The Polish multicentre observational (non-interventional) study aiming to collect data on the characteristic of patients with systemic lupus erythematosus and clinical outcomes of anifrolumab administered in the scope of routine clinical practice.

Detailed Description

This is multicenter, observational, cohort study designed to collect longitudinal data on the management and clinical outcomes of patients with SLE that received anifrolumab in the scope of routine clinical practice within the frames of National Drug Program (NDP) for up to 30 months (\~ 6 months baseline and \~24 months follow-up date).

Study Timeline

• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Study First Posted: 2024-11-04
• Study Start: 2025-02-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Adult (aged ≥18 years old) patients with SLE who received anifrolumab treatment in the frames of NDP in Poland.
2. Patients willing to participate in the study and signed Informed Consent Form (ICF).

Exclusion Criteria

1. Those who participated in anifrolumab clinical trial in the past, and/or those who participated/plans to participate in clinical trial on/after the date of first anifrolumab infusion through NDP.
2. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SLE Patients	Anifrolumab	Open-lable arm with SLE patients who received anifrolumab treatment in the frames of NDP in Poland.

Primary Outcome Measures

Name	Time	Method
Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score	at month 12

Secondary Outcome Measures

Name	Time	Method
Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score	at month 6, 18, 24;
Change from index date in Physician Global Assessment (PGA) score	at month 6, 12, 18, 24;
Proportion of patients attaining the composite endpoint of modified SLE Responder Index (mSRI)	at month 6, 12, 18, 24;	mSRI defined as: a reduction in SLEDAI-2K ≥4 points with no worsening in PGA ≥0.3 points
Proportion of patients attaining the composite endpoint of Lupus Low Disease Activity State (LLDAS)	at month 6, 12, 18, 24	LLDAS defined as: SLEDAI-2K ≤4, with no activity in major organ systems and no haemolytic anaemia or gastrointestinal activity; no new lupus disease activity compared with previous assessment; PGA ≤1; current prednisone(-equivalent) dose ≤7.5mg/day; well-tolerated standard maintenance dose of immunosuppressive drugs and biologics if any.
Proportion of patients achieving the composite endpoint of remission	at month 6, 12, 18,24	Disease activity index (cSLEDAI)=0, PGA \<0.5 (0-3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives, and biologics.
Proportion of patients receiving antimalarials, immunosuppressives, Non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids	every 6 months
Change from index date in corticosteroids dose	at month 6, 12, 18, 24
Proportion of steroid-free patients at every 6 months	every 6 months
Proportion of patients able to reach ≤5 mg/day of prednisolone equivalent dose at month 6, 12, 18, 24	at month 6, 12, 18, 24
Proportion of patients with 0-25%; 26-50%; 51-75%; 76-100% glucocorticoids (GCS) dose reduction	at month 6, 12, 18, 24
Anifrolumab treatment adherence	very 6 months	Comparison of actual and expected number of infusions (%) evaluate

Trial Locations

Locations (1)

Research Site; 🇵🇱 Wroclaw, Poland