A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice



Sponsor:   AstraZeneca


Sommario: Anifrolumab Study of Treatment Effectiveness in the Real World (ASTER) study will collect
real world data to obtain a good understanding of the (sustained) clinical effect and
patient quality of life outcomes among diagnosed SLE patients who initiate anifrolumab
treatment. ASTER will generate critical real-world evidence on the benefits of adding
anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform
physicians, payers and patients.




TIPOLOGIA STUDIO

 
Osservazionale




TRATTAMENTO

  
    
  






OBIETTIVO PRIMARIO


  
  • Misura: Disease activity assessed by the Physician Global Assessment (PGA)
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: The PGA is a single-item visual analogue scale that describes the physician assessment of
a patient's disease and its impact on daily functioning at the time of assessment. The
scale ranges from 0 (asymptomatic disease and no limitation of normal activities) to 3
(severe disease and limitation of normal activities).
  • Misura: Disease activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: The SLEDAI-2K is a global index and includes 24 clinical symptoms and laboratory
variables that are weighted by the type of manifestation, but not by severity or dynamic
of the individual item. The SLEDAI-2K includes scoring for antibodies and low complement,
as well as some renal and hematologic parameters. The total score ranges between 0 and
105, with higher scores representing increased disease activity.
  • Misura: Proportion of patients attaining the composite endpoint of lupus low disease activity (LLDAS)
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: The proportion of patients attaining the composite endpoint of LLDAS will be assesed.




OBIETTIVO SECONDARIO


  
  • Misura: Proportion of patients attaining Definition of Remission in SLE (DORIS)
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: The proportion of patients attaining the Definition of Remission in SLE will be assesed.
  • Misura: Clinical SLE Flares assessment by modified revised Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) flare index (rSFI)
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: Flare will be defined as any one criterion present either the Mild/Moderate Flare or
Severe Flare categories. New or worsened manifestation will only be reported for
manifestation of SLE.
  • Misura: Proportion of patients with irreversible organ damage, using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI).
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: The proportion of patients with irreversible organ damage, using the Systemic Lupus
International Collaborating Clinics/American College of Rheumatology Damage Index will be
assessed. The irreversible, accumulated organ damage from either the disease process or
disease treatment, which has been present for at least 6 months, in 12 organ systems will
be measured.
  • Misura: SLE treatment patterns prior to, concomitant with and after anifrolumab
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: SLE treatment patterns will be analyzed through prevalence and incidence in respect to
time to discontinuation.
  • Misura: Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that
assesses patient-reported fatigue and its impact upon daily activities and function over
the past 7 days. Patients will be asked to answer each question using a 5-point verbal
rating scale, with total scores ranging from 0 (most fatigued) to 52 (least fatigued).
  • Misura: Lupus Quality of Life (LupusQoL)
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: The LupusQoL is a validated SLE-specific HRQoL (health-related quality of life)
instrument consisting of 34 items across 8 domains (Physical health, Emotional health,
Body image, Pain, Planning, Fatigue, Intimate relationships, and Burden to others). The
LupusQoL has a 5-point verbal rating scale, and uses a 4-week recall period. The mean raw
domain score is transformed to scores ranging from 25 (worst HRQoL) to 125 (best HRQoL)
by dividing by 4 and then multiplying by 100.
  • Misura: Patient Global Assessment (PtGA)
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: The PtGA is a single-item question that takes into account all the ways in which illness
and health conditions may affect the patient at this time. The patient should consider
the previous week when answering this question. Responses range from 0 (Very Well) to 100
(Very Poorly) on a visual analogue scale (VAS).
  • Misura: EuroQol 5-Dimension Health Questionnaire 5 Level (EQ-5D-5L)
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: The EQ-5D-5L is a general health status measure comprising a descriptive system and the
EQ VAS. The descriptive system comprises 5 dimensions: Mobility, Self-care, Usual
activities, Pain/discomfort and Anxiety/depression. Patients are asked to rate their
current health and functional status on a 5-point verbal rating scale for each of the 5
domains. Responses are converted into an overall quality of life score via a
preference-based statistical mapping algorithm. The scores on these 5 dimensions can be
presented as a health profile or can be converted to a single summary index number
(utility) reflecting preferability compared to other health profiles. Additionally,
patients are asked to indicate how they rate their current overall health on a visual
analog scale (EQ-VAS) ranges from 100 for best imaginable health state to 0 for worst
imaginable health state.
  • Misura: Work Productivity and Activity Impairment - Lupus (WPAI:lupus)
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: The WPAI:Lupus is an SLE-specific, self-administered questionnaire, that assesses the
impact of disease on productivity. The WPAI:Lupus consists of 6 items and has a recall
period of the past 7 days. The WPAI:Lupus is divided into 4 domains: Absenteeism (work
time missed), Presenteeism (VAS [scored from 0 to 10] rating of impairment while
working), Working Productivity Loss (overall work impairment/absenteeism plus
presenteeism), and Activity Impairment (VAS [scored from 0 to 10] rating of daily
activity, other than work at a job). Scores for each domain are expressed as impairment
percentages, with higher scores indicating greater productivity impairment.
  • Misura: Pain Numerical Rating Scale (NRS)
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: The pain NRS will measure the pain severity in the past seven days on a scale of 0-10 (0:
no pain; 10: worst pain imaginable).
  • Misura: Number of outpatient hospital and emergency room visits and procedures
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: The healthcare resource utilisation (HCRU) for SLE after anifrolumab initiation as
recorded in medical records will be assessed. The number of outpatient hospital and
emergency room visits and procedures.
  • Misura: Number of hospital admissions and inpatient hospital procedures
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: The HCRU for SLE after anifrolumab initiation as recorded in medical records will be
assessed. The number of hospital admissions and inpatient hospital procedures (including
duration of hospital stay and reason for hospitalization, stratified by admission to an
intensive care unit [ICU] vs non-ICU) will be assessed.
  • Misura: Number of rheumatologist visits and procedures
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: The HCRU for SLE after anifrolumab initiation as recorded in medical records will be
assessed. The number of rheumatologist visits and procedures (including SLE-related
laboratory tests) will be assessed.
  • Misura: Number of dialysis appointments
  • Tempo: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
  • Descrizione: The HCRU for SLE after anifrolumab initiation as recorded in medical records will be
assessed. The number of dialysis appointments will be assessed.




CRITERI DI ELIGIBILITA'


    
             
  • 
        Criteri di inclusione e esclusione
        
    Inclusion Criteria:

  -  Fulfilled the 2019 EULAR (European League Against Rheumatism)/ACR (American College
     of Rheumatology) criteria for SLE at the time of study entry.

  -  Prescribed anifrolumab for their SLE treatment for the first time, according to
     approved country-specific label.

  -  The Physician's decision to prescribe anifrolumab must occur prior to any
     study-related discussion.

  -  In countries where prescription reimbursements are authorised on a case-by-case
     basis, authorisation (ie, patient access to treatment) will be required for study
     entry.

Exclusion Criteria:

  -  Currently participating in an anifrolumab early access/compassionate use program or
     an interventional clinical trial with an investigational product.

  -  Any previous exposure to anifrolumab (including as part of a clinical trial or early
     access programme).

  -  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
     (in absence of other SLE manifestations, ie. skin/joint involvement), or active
     severe or unstable neuropsychiatric lupus.

  -  Any other condition which the investigator deems to limit a patient's ability to
     understand the informed consent.
    
        
    • 
    




SESSO

  
Tutti




  


ETA' MINIMA



Età Minima: 18 Years

Età Massima: 130 Years






LUOGO


  
Research Site
Napoli, 80131
Research Site
Cona, 44124
Research Site
Udine, 33100
Research Site
Roma, 149
Research Site
Brescia, 25100
Research Site
Milano, 20122
Research Site
Torino, 10126
Research Site
Cagliari, 9042
Research Site
Ancona, 60126
Research Site
Bari, 70124
Research Site
Firenze, 50134
Research Site
Milano, 20122
Research Site
Milano, 20132
Research Site
Pisa, 56126
Research Site
Roma, 161
Research Site
Roma, 168
      


    
REFERENTE PER INFORMAZIONI

    

      AstraZeneca Clinical Study Information Center
      1-877-240-9479
      information.center@astrazeneca.com