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NCT Number: NCT07330245

Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.

This is an observational, multicenter, prospective study on patients with systemic lupus erythematosus treated with anifrolumab in Italy aimed at evaluating the achievement of LLDAS5

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Key information

Conditions

Lupus Erythematosus, Systemic Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato, Monserrato, CA, Italy

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About this study

DAHLIA study aims to expand real-world evidence on anifrolumab role in clinical practice, specifically evaluating its effectiveness in achieving and maintenance of LLDAS with a dose of corticosteroids less than or equal to 5 mg/day (LLDAS5). Moreover it will provide data on corticosteroid tapering strategies. Additionally, will be also evaluated the Definitions Of Remission In SLE (DORIS) remission during the study period, as well as the depressive symptoms of these patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anifrolumab

Biological

anifrolumab - fully human monoclonal antibody target type I INF

Other names: Saphnelo

Primary outcomes

  1. Number and percentage of patients achieving LLDAS5

    Time frame: 52 weeks

    proportion of patients with LLDAS5 at 52 weeks, defined as:

    LLDAS5 is defined as follows:

    • Systemic Lupus Erythematosus Disease Activity Index 2000 (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 as defined per protocol;
    • Physician's Global Assessment (PGA) ≤1;
    • Current prednisone (-equivalent) dose ≤ 5mg/day;
    • Well-tolerated standard maintenance dose of immunosuppressive drugs and biologics if any.

Secondary outcomes

  1. Number and percentage of patients reaching LLDAS5 at each time point

    Time frame: week 24, 76 and 104

    Proportion of patients with LLDAS5, according the following definition:

    LLDAS5 is defined as follows:

    • Systemic Lupus Erythematosus Disease Activity Index 2000 (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 as defined per protocol;
    • Physician's Global Assessment (PGA) ≤1;
    • Current prednisone (-equivalent) dose ≤ 5mg/day;
    • Well-tolerated standard maintenance dose of immunosuppressive drugs and biologics if any.

  2. Number and percentage of patients achieving a GCS (Glucocorticosterioids) dose reduction

    Time frame: week 4, 12, 24, 52, 76, 104 vs baseline

    Number and percentage of patients achieving a GCS dose reduction (to ≤ 5 mg/day; to 0 mg/day) at different timepoints (T1, T2, T3, T4, T5, T6) compared to T0

  3. Median (range) cumulative dose of GCS

    Time frame: from week 0 to week 24; from week 24 to week 52; from week 52 to week 76; from week 76 to week 104

    Median cumulative dose of GCS calculated at each 6 month period following T0

  4. Mean(SD) change in tender and swollen joint count

    Time frame: week 4, 12, 24, 52, 76 and 104 vs week 0

    Mean change in tender and swollen joint count using Disease Activity Score 28 (DAS28) map at different timepoints compared to baseline (w0). DAS28 ranges from 0 (no-activity) to 10 (high disease activity)

  5. mean (SD) change in Power Doppler (PD) Signal Total score

    Time frame: week 4, 12, 24, 52, 76 and 104 vs week 0

    Mean change in Power Doppler (PD) Signal at each time point vs baseline. PD Signal ranges from 0 (low) to 84 (high)

  6. mean (SD) change in Synovial Hypertrophy (SH) Total score

    Time frame: week 4, 12, 24, 52, 76 and 104 vs week 0

    Mean change in synovial hypertrophy at each time point vs baseline. Synovial hypertrophy ranges from 0 (low) to 84 (high).

  7. Annualize flaire rate

    Time frame: week 52 and week 104

    Annualized flare rate in the first and second years

  8. Number and percentage of patients meeting the DORIS clinical remission

    Time frame: week 12, 24, 52, 76 and 104

    Number and percentage of patients meeting the DORIS clinical remission definition at each timepoints, according to:

    • Clinical SLEDAI-2K = 0;
    • PGA < 0.5;
    • Prednisolone ≤ 5 mg/day

  9. Number and percentage of patients with sustained DORIS remission

    Time frame: week 104

    Number and percentage of patients with sustained DORIS remission, defined as remaining in remission at or greater than 12 weeks after having met the DORIS definition

  10. Mean (SD) HDRS (Hamilton Depression Rating Scale) total score

    Time frame: week 12, 24, 52 and 104 vs week 0

    Change in HDRS total score at different timepoints compared to T0. HDRS ranges from 0 (no depression) to 54 (severe)

  11. Mean (SD) PROMIS Depression Short Form 8b (Patient-Reported Outcomes Measurement Information System) total score

    Time frame: week 12, 24, 52 and 104 vs week 0

    Change in PROMIS Depression Short Form 8b total score at different timepoints compared to week 0 (baseline). PROMIS raw scores ranges from 8 (no depression) to 40 (severe)

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: DAHLIA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 9, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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