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Anifrolumab to achieve LLDAS5 in people with systemic lupus erythematosus

DAHLIA: Achievement of Low Level of Disease Activity With a Dose of Corticosteroids Less Than or Equal to 5 mg (LLDAS5): a Real-life Study With Anifrolumab on Patients With Systemic Lupus Erythematosus in Italy

Observational AstraZeneca · NCT07330245

This study tests whether anifrolumab helps people with systemic lupus erythematosus reach and keep low disease activity while staying on 5 mg/day or less of corticosteroids.

Quick facts

Study typeObservational
Enrollment218 (estimated)
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsanifrolumab, cyclophosphamide
Locations19 sites (Monserrato, CA and 18 other locations)
Trial IDNCT07330245 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter observational study in Italy following adults with SLE who are starting anifrolumab per the approved label. The study will record whether patients achieve and maintain Lupus Low Disease Activity State with prednisone (or equivalent) ≤5 mg/day (LLDAS5) and will capture corticosteroid tapering strategies used in routine care. Investigators will also record DORIS remission status and changes in depressive symptoms over the study period. Patients already in LLDAS5, with prior anifrolumab exposure, or with certain severe active organ manifestations are excluded.

Who should consider this trial

Good fit: Adults (18+) with SLE meeting the 2019 EULAR/ACR criteria who are being prescribed anifrolumab for the first time and are not already in LLDAS5.

Not a fit: Patients with prior anifrolumab exposure, those already in LLDAS5, or those with severe/rapidly progressive Class III/IV nephritis, isolated Class V nephritis, or active severe neuropsychiatric lupus are unlikely to be eligible or to benefit from this observational program.

Why it matters

Potential benefit: If successful, the study could show that anifrolumab helps more patients reach and sustain low disease activity with lower steroid doses, potentially reducing steroid-related harms.

How similar studies have performed: Randomized trials of anifrolumab (e.g., the TULIP programs) showed reductions in disease activity and steroid use, and emerging real-world evidence is beginning to support these findings.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Provided informed consent to participate in the study;
* Aged 18 years or older;
* Fulfilled the 2019 EULAR/ACR classification criteria for SLE at the time of study entry;
* Prescribed anifrolumab for SLE treatment for the first time, according to the approved Italian label and reimbursement criteria;

Exclusion Criteria:

* Patients who are at LLDAS5 at the time of study entry;
* Previous exposure to anifrolumab;
* Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy \[mycophenolate mofetil (MMF)/cyclophosphamide (CYC) + high dose steroids\], isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus
* Currently participating in any interventional clinical trial with an investigational product;
* Inability to understand and sign the informed consent and to fill in patient questionnaires

Where this trial is running

Monserrato, CA and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lupus Erythematosus, SystemicLupus Erythematosus, Systemic.Anifrolumab.
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.