Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus

N/AActive Not RecruitingNCT06673043

AstraZeneca105 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

105

Conditions

Lupus Erythematosus, Systemic

Interventions

AnifrolumabDRUG

Anifrolumab 300 mg concentrate for solution for infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Research Site

Bydgoszcz, Poland

Research Site

Bytom, Poland

Research Site

Gdansk, Poland

Research Site

Katowice, Poland

Outcomes

Primary Outcomes

Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score

Time frame: at month 12

Secondary Outcomes

Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score

Time frame: at month 6, 18, 24;

Change from index date in Physician Global Assessment (PGA) score

Time frame: at month 6, 12, 18, 24;

Proportion of patients attaining the composite endpoint of modified SLE Responder Index (mSRI)

mSRI defined as: a reduction in SLEDAI-2K ≥4 points with no worsening in PGA ≥0.3 points

Time frame: at month 6, 12, 18, 24;

Proportion of patients attaining the composite endpoint of Lupus Low Disease Activity State (LLDAS)

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.

Time frame: at month 6, 12, 18, 24

Proportion of patients achieving the composite endpoint of remission

Disease activity index (cSLEDAI)=0, PGA \<0.5 (0-3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives, and biologics.

Time frame: at month 6, 12, 18,24

Proportion of patients receiving antimalarials, immunosuppressives, Non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids

Time frame: every 6 months

Data from ClinicalTrials.gov

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