Saphnelo Use in Females of Child-bearing Potential

Official title

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

Overview

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.

Interventions

• 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 place

Primary outcome measures

• Incidence of anifrolumab use [Time frame: 1 year]
• Prevalence of anifrolumab use [Time frame: 1 year]

Secondary outcome measures (4)

• Baseline patient characteristics [Time frame: At anifrolumab treatment initiation (index date)]
• Baseline SLE treatment characteristics [Time frame: At anifrolumab treatment initiation (index date)]
• Anifrolumab treatment utilization patterns [Time frame: From anifrolumab treatment initiation (index date) up to 84 days post-initiation]
• Anifrolumab-exposed pregnancies [Time frame: From anifrolumab treatment initiation (index date) up to 93 days after date of last dose]

Eligibility criteria

Patients will be included in the primary objective cohort for a given calendar year interval, if they satisfy the following inclusion and exclusion criteria within that year:

Inclusion criteria

• Observability (enrollment or activity) in the data source for at least one day during the patient identification period within that calendar year (set earliest qualifying date as "index date" for primary objectives)
• Female sex at index date
• Age ≥15 and ≤50 years at index date

Exclusion criteria

• (Primary Objective 1a only) Evidence of prior anifrolumab use in all available data prior to the index date through 1 day prior to the index date

Patients will be included in the secondary objective cohort if they satisfy the following inclusion and exclusion criteria:

Inclusion criteria

• Receipt of anifrolumab therapy during the patient identification period (identify earliest record of anifrolumab in this period and set as "index date" for secondary objectives).
• Female sex at index date.
• Age ≥15 and ≤50 years at index date.
• ≥180 days of continuous observability (e.g., enrollment or activity) in the dataset prior to and including the index date.
• (For Secondary Objective 3 only) SLE diagnosis, defined as having at least one unique health care encounter record with an International Classification of Diseases, 10th Revision (ICD-10) code of M32\* (excluding M32.0: drug-induced SLE) within the 180-day baseline period prior to and including the index date.

Exclusion criteria

• Evidence of prior anifrolumab use in all available data prior the index date through 1 day prior to the index date.

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

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07431775 · D3461R00086

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗