NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care

Official title

Effectiveness of Subcutaneous Anifrolumab in Systemic Lupus Erythematodes - A Non-interventional, Prospective, Multicenter Study on Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care

Overview

VIOLET is a prospective, single-arm, multi-centre, non-interventional study (NIS) evaluating real-world clinical and patient-reported outcome (PRO) data in adult patients who are initiated on subcutaneous anifrolumab treatment of systemic lupus erythematosus (SLE) in line with the applicable european summary of product characteristics (SmPC) and neither having used anifrolumab subcutaneous (SC) or intravenous (IV) before.

Detailed description

This is a prospective, single-arm, multicenter, non-interventional study (NIS) to evaluate real-world clinical and patient-reported outcomes in adult patients with SLE who are initiated on anifrolumab SC therapy in line with the applicable european summary of product characteristics (SmPC) and neither having used anifrolumab SC or IV before.

This study aims to describe disease activity of SLE assessed by key treatment goals remission (DORIS) and lupus low disease activity (LLDAS), patient-reported quality of life, patterns of concomitant medication, and clinically relevant outcomes such as flares and organ damage in SLE patients treated with anifrolumab SC in a real-life setting. The 24-month observation period is chosen to capture long-term disease activity and disease control, and evaluate concomitant medication, and organ damage accrual in routine care.

Primary outcome measures

• Proportion and number of patients who fulfill criteria for definition of remission in SLE (DORIS remission) [Time frame: At month 24]

Secondary outcome measures (12)

• Proportion and number of patients in DORIS remission [Time frame: During routine visits up to 24 months]
• Proportion and number of patients who ever achieved DORIS remission [Time frame: During routine visits up to 24 months]
• Time (in months) to first DORIS remission among patients achieving DORIS criteria [Time frame: Baseline up to 24 months]
• Time (in months) spent in DORIS remission among patients achieving DORIS criteria [Time frame: Up to 24 months]
• Time (in months) spent in sustained DORIS remission if in remission for at least 2 consecutive routine visits among patients achieving DORIS criteria [Time frame: Up to 24 months]
• Proportion and number of patients attaining sustained DORIS remission among patients achieving DORIS criteria [Time frame: At month 6 and month 12]
• Proportion and number of patients who fulfill criteria of lupus low disease activity state (LLDAS) [Time frame: At month 24]
• Proportion and number of patients ever achieving LLDAS criteria [Time frame: During routine visits up to 24 months]
• Time (in months) to first achieving LLDAS criteria among patients achieving LLDAS criteria [Time frame: Up to 24 months]
• Time (in months) spent in LLDAS among patients achieving LLDAS criteria [Time frame: Up to 24 months]
• Time (in months) spent in sustained LLDAS if in LLDAS for at least 2 consecutive routine visits among patients achieving LLDAS criteria [Time frame: Up to 24 months]
• Proportion and number of patients attaining sustained LLDAS [Time frame: At month 6 and month 12]

Eligibility criteria

Inclusion criteria

• Age ≥18 years at the time of signing the informed consent
• Diagnosis of SLE
• Prescription of anifrolumab SC in line with the european summary of product characteristics (SmPC)
• Prescription of anifrolumab SC was decided prior to and independently of the study
• Signed and dated written informed consent prior to enrolment into the study
• Willing and able to participate in all study evaluations and procedures

Exclusion criteria

• Prior exposure to anifrolumab
• Treatment with concurrent biologics
• Current or planned participation in a clinical study that does not constitute routine care
• Currently experiencing a severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil \[MMF\]/cyclophosphamide + high dose steroids), isolated Class V lupus nephritis (in absence of other SLE manifestations, i.e. skin/joint involvement), or active severe or unstable neuropsychiatric lupus
• Conditions (acute or chronic) or events at the time of signing the informed consent that would limit the patient's ability to complete questionnaires or participate in this study over the period of 24 months according to the treating physician (e.g., clinically significant cognitive impairment or dementia, unstable severe psychiatric illness, uncontrolled alcohol or substance use disorder that interferes with adherence to care or other circumstances that preclude completing PROs or attending routine visits)
• Pregnancy or breast feeding at study enrolment

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

Germany · 16 centers

• Research Site — Altenburg
• Research Site — Bad Bramstedt
• Research Site — Berlin
• Research Site — Chemnitz
• Research Site — Erlangen
• Research Site — Heidelberg
• Research Site — Herne
• Research Site — Kassel
• … and 8 more centers

Identifiers

NCT: NCT07424261 · D3461R00100

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗