NCT07431775

Saphnelo Use in Females of Child-bearing Potential

A Non-Interventional Descriptive Multi-Country Study of Saphnelo™ (Anifrolumab-fnia) Utilization in Females of Reproductive Potential

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 26,000,000 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 15 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by substantial clinical burden-including organ damage, increased morbidity, and mortality-that often presents in young adulthood and disproportionately affects female patients. SAPHNELO™ (anifrolumab-fnia), a fully human IgG1 κ monoclonal antibody, is a novel therapeutic option approved for add-on treatment of moderate-to-severe SLE in the United States (US) on 30 July 2021 and in the European Union on 14 February 2022. To fulfill US Food and Drug Administration (FDA) post-marketing requirements for the evaluation of anifrolumab safety in pregnancy, additional evidence is needed to better understand the real-world drug utilization of anifrolumab in female patients of reproductive potential.

Detailed description

Research Questions: 1. What is the incidence and prevalence of anifrolumab use among females of reproductive potential in selected countries where anifrolumab is marketed? 2. What are the baseline characteristics and drug utilization patterns in females of reproductive potential who initiate treatment with anifrolumab in selected countries where anifrolumab is marketed? Primary Objectives: 1a. To describe trends in the annual incidence of anifrolumab utilization among females of reproductive potential overall and stratified by age group and, separately, by SLE diagnosis status. 1b. To describe trends in the annual prevalence of anifrolumab utilization among females of reproductive potential overall and stratified by age group and, separately, by SLE diagnosis status. Secondary Objectives: 2\. To describe the demographic and clinical characteristics of females of reproductive potential who initiate anifrolumab use, at the point of treatment initiation. 3\. To describe SLE treatment regimens at anifrolumab initiation among females of reproductive potential with an SLE diagnosis. 4\. To describe anifrolumab utilization patterns among females of reproductive potential who initiate anifrolumab use. 5\. To enumerate and describe pregnancies with anifrolumab exposure among females of reproductive potential who initiate anifrolumab use. This is a non-interventional, retrospective, descriptive cohort study using secondary healthcare data from selected countries where anifrolumab is marketed (specifically, Denmark, France, Germany, and the US) to assess trends in, and patterns of, anifrolumab use among females of reproductive potential. The study population for the primary objectives will be female patients of reproductive potential (defined as females aged 15 to 50 years old) who are observable during the patient identification period (country-specific; market launch date through the end of available data). The study population for the secondary objectives will be female patients of reproductive potential who newly initiated anifrolumab use during the patient identification period. Secondary Objective 3 is restricted to female patients of reproductive potential who initiate anifrolumab use and have a prior record of SLE diagnosis. Study populations will be identified separately within each country-specific secondary healthcare data source from Denmark, France, Germany, and the US. Final study report delivery is planned for April 2032.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Anifrolumab	Anifrolumab is a human monoclonal antibody that binds to subunit 1 of the type 1 interferon receptor, which was developed based on the evidence supporting the role of type 1 interferon pathway in SLE. Clinical trial evidence from TULIP 1 and TULIP 2 have showed that monthly intravenous administration of anifrolumab led to a higher percentage of patients with a response, assessed with the British Isles Lupus Assessment Group-based Composite Lupus Assessment, compared with patients receiving placebo. Moreover, the phase II MUSE study showed that administration of anifrolumab resulted in substantially reduce disease activity, as measured by the SLE Responder Index, compared to patients receiving placebo. Anifrolumab was approved by the FDA and EMA in July 2021 and February 2022, respectively, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.

Timeline

• Start date: 2026-10-01
• Primary completion: 2032-03-31
• Completion: 2032-03-31
• First posted: 2026-02-25
• Last updated: 2026-02-25

Regulatory

• FDA-regulated drug study