Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anifrolumab.
- Who it may be relevant to
- Registry conditions: Lupus Erythematosus, Systemic. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
Detailed description
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.
Interventions
- Biological Anifrolumab
anifrolumab - fully human monoclonal antibody target type I INF
Primary outcome measures
- Number and percentage of patients achieving LLDAS5 [Time frame: 52 weeks]
Secondary outcome measures (11)
- Number and percentage of patients reaching LLDAS5 at each time point [Time frame: week 24, 76 and 104]
- Number and percentage of patients achieving a GCS (Glucocorticosterioids) dose reduction [Time frame: week 4, 12, 24, 52, 76, 104 vs baseline]
- 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]
- Mean(SD) change in tender and swollen joint count [Time frame: week 4, 12, 24, 52, 76 and 104 vs week 0]
- mean (SD) change in Power Doppler (PD) Signal Total score [Time frame: week 4, 12, 24, 52, 76 and 104 vs week 0]
- mean (SD) change in Synovial Hypertrophy (SH) Total score [Time frame: week 4, 12, 24, 52, 76 and 104 vs week 0]
- Annualize flaire rate [Time frame: week 52 and week 104]
- Number and percentage of patients meeting the DORIS clinical remission [Time frame: week 12, 24, 52, 76 and 104]
- Number and percentage of patients with sustained DORIS remission [Time frame: week 104]
- Mean (SD) HDRS (Hamilton Depression Rating Scale) total score [Time frame: week 12, 24, 52 and 104 vs week 0]
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 22 centers
- Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato — Monserrato
- Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'Anna — Cona
- IRCCS Casa Sollievo della Sofferenza — San Giovanni Rotondo
- IRCCS Humanitas Research Hospital — Rozzano
- AOU Ospedali Riuniti di Ancona - Presidio Torrette — Ancona
- Azienda Ospedaliero-Universitaria Policlinico di Bari — Bari
- ASST Spedali Civili di Brescia — Brescia
- Azienda Ospedaliero-Universitaria Careggi — Florence
- … and 14 more centers
Identifiers
NCT: NCT07330245 · D3461R00093