Lupus Erythematosus, Systemic
Conditions
Keywords
Anifrolumab, systemic lupus erythematosus, SLE, observational
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).
Interventions
DRUGAnifrolumab
Anifrolumab 300 mg concentrate for solution for infusion
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score | at month 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Poland
Outcome results
None listed