An observational study in Lupus Erythematosus, Systemic, sponsored by AstraZeneca. Active, not recruiting at 11 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by AstraZeneca · Observational
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).
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 105 is below the median of 140 across 283 observational studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Consecutive adult (aged ≥18 year old) patients with SLE who received anifrolumab treatment in the frames of NDP in Poland.
Exclusion Criteria:
Open-lable arm with SLE patients who received anifrolumab treatment in the frames of NDP in Poland.
Drug: Anifrolumab
Anifrolumab 300 mg concentrate for solution for infusion
Also known as: Saphnelo
Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
Time frame: at month 12
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
Change from index date in corticosteroids dose
Time frame: at month 6, 12, 18, 24
Proportion of steroid-free patients at every 6 months
Time frame: every 6 months
Proportion of patients able to reach ≤5 mg/day of prednisolone equivalent dose at month 6, 12, 18, 24
Time frame: at month 6, 12, 18, 24
Proportion of patients with 0-25%; 26-50%; 51-75%; 76-100% glucocorticoids (GCS) dose reduction
Time frame: at month 6, 12, 18, 24
Anifrolumab treatment adherence
Comparison of actual and expected number of infusions (%) evaluate
Time frame: very 6 months
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic→
AstraZeneca