Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus (SLE-ARTEMIS)

Anifrolumab Real-world Treatment Outcomes in Polish Patients With Systemic Lupus Erythematosus (SLE). Multicenter, Non-interventional Study

The Polish multicentre observational (non-interventional) study aiming to collect data on the characteristic of patients with systemic lupus erythematosus and clinical outcomes of anifrolumab administered in the scope of routine clinical practice.

Study Overview

• Status: Active, not recruiting
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Drug: Anifrolumab

Detailed Description

This is multicenter, observational, cohort study designed to collect longitudinal data on the management and clinical outcomes of patients with SLE that received anifrolumab in the scope of routine clinical practice within the frames of National Drug Program (NDP) for up to 30 months (~ 6 months baseline and ~24 months follow-up date).

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Poland
  • Bydgoszcz, Poland
    • Research Site
  • Bytom, Poland
    • Research Site
  • Gdansk, Poland
    • Research Site
  • Katowice, Poland
    • Research Site
  • Krakow, Poland
    • Research Site
  • Lodz, Poland
    • Research Site
  • Lublin, Poland
    • Research Site
  • Poznan, Poland
    • Research Site
  • Rzeszów, Poland
    • Research Site
  • Warsaw, Poland
    • Research Site
  • Wroclaw, Poland
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult (aged ≥18 year old) patients with SLE who received anifrolumab treatment in the frames of NDP in Poland.

Description

Inclusion Criteria:

1. Adult (aged ≥18 years old) patients with SLE who received anifrolumab treatment in the frames of NDP in Poland.
2. Patients willing to participate in the study and signed Informed Consent Form (ICF).

Exclusion Criteria:

1. Those who participated in anifrolumab clinical trial in the past, and/or those who participated/plans to participate in clinical trial on/after the date of first anifrolumab infusion through NDP.
2. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SLE Patients; Open-lable arm with SLE patients who received anifrolumab treatment in the frames of NDP in Poland.	Drug: Anifrolumab; Anifrolumab 300 mg concentrate for solution for infusion; Other Names: Saphnelo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score	at month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients achieving the composite endpoint of remission	Disease activity index (cSLEDAI)=0, PGA <0.5 (0-3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives, and biologics.	at month 6, 12, 18,24
Change from index date in corticosteroids dose		at month 6, 12, 18, 24
Proportion of steroid-free patients at every 6 months		every 6 months
Proportion of patients able to reach ≤5 mg/day of prednisolone equivalent dose at month 6, 12, 18, 24		at month 6, 12, 18, 24
Anifrolumab treatment adherence	Comparison of actual and expected number of infusions (%) evaluate	very 6 months
Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score		at month 6, 18, 24;
Change from index date in Physician Global Assessment (PGA) score		at month 6, 12, 18, 24;
Proportion of patients attaining the composite endpoint of modified SLE Responder Index (mSRI)	mSRI defined as: a reduction in SLEDAI-2K ≥4 points with no worsening in PGA ≥0.3 points	at month 6, 12, 18, 24;
Proportion of patients attaining the composite endpoint of Lupus Low Disease Activity State (LLDAS)	LLDAS defined as: 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; PGA ≤1; current prednisone(-equivalent) dose ≤7.5mg/day; well-tolerated standard maintenance dose of immunosuppressive drugs and biologics if any.	at month 6, 12, 18, 24
Proportion of patients receiving antimalarials, immunosuppressives, Non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids		every 6 months
Proportion of patients with 0-25%; 26-50%; 51-75%; 76-100% glucocorticoids (GCS) dose reduction		at month 6, 12, 18, 24

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 17, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: systemic lupus erythematosus; SLE; observational; Anifrolumab
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; anifrolumab
• Other Study ID Numbers: D3461R00082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No