Saphnelo Use in Females of Child-bearing Potential

NCT07431775 | Not Yet Recruiting FDA Drug

• 1 other identifier: D3461R00086
• Study Type: observational
• Target: 26,000,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

chronic autoimmune disease; immunosuppressants; corticosteroids; human monoclonal antibody (IgG1ƙ mAb); post Marketing Requirements (PMR) study; pregnancy; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• Incidence of anifrolumab use

  Within each country, the incidence of anifrolumab will be assessed within each calendar year interval of the overall patient identification period. The follow-up period within each calendar year interval starts on the calendar year-specific index date and ends on the earliest of the following dates within that same year: (1) last date of observability (enrollment/activity), (2) death date, (3) 51st birthday, (4) end of the study period, (5) December 31st (end of calendar year), or (6) date of anifrolumab initiation (for objective 1a only). Incidence will be reported as the number of female patients of reproductive potential with incident anifrolumab use per (1) 1,000,000 females of reproductive potential (without prior anifrolumab use) in a given calendar year, with 95% CI and (2) per 1,000,000 person-years of follow-up among females of reproductive potential (without prior anifrolumab use) in a given calendar year, with 95% CI.

  1 year

• Prevalence of anifrolumab use

  Within each country, the prevalence of anifrolumab use will be assessed within each calendar year interval of the follow-up period by calculating the number and percentage with prevalent anifrolumab use among all female patients of reproductive potential in a given calendar year (with 95% CI), as well as number of female patients of reproductive potential with prevalent anifrolumab use per 1,000,000 female patients of reproductive potential in a given calendar year (with 95% CI).

  1 year

Secondary Outcomes (4)

• Baseline patient characteristics

  At anifrolumab treatment initiation (index date)

• Baseline SLE treatment characteristics

  At anifrolumab treatment initiation (index date)

• Anifrolumab treatment utilization patterns

  From anifrolumab treatment initiation (index date) up to 84 days post-initiation

• Anifrolumab-exposed pregnancies

  From anifrolumab treatment initiation (index date) up to 93 days after date of last dose

Study Arms (2)

Study population for primary objectives

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 1. 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) 2. Female sex at index date 3. Age ≥15 and ≤50 years at index date Exclusion criteria 1\. (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 Note: Cohort selection criteria for the primary objectives will be assessed repeatedly within calendar year intervals during the patient identification period to enable evaluation of annual anifrolumab use incidence and prevalence outcomes.

Drug: Anifrolumab

Study population for secondary objectives

Patients will be included in the secondary objective cohort if they satisfy the following inclusion and exclusion criteria: Inclusion criteria 1. 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) 2. Female sex at index date 3. Age ≥15 and ≤50 years at index date 4. ≥180 days of continuous observability (e.g., enrollment or activity) in the dataset prior to and including the index date. 5. (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 1\. Evidence of prior anifrolumab use in all available data prior the index date through 1 day prior to the index date

Drug: Anifrolumab

Interventions

Anifrolumab DRUG

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.

Also known as: Saphnelo

Study population for primary objectives; Study population for secondary objectives

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population for the primary objectives will be all female patients of reproductive potential (defined as females aged 15 to 50 years old) observed during the patient identification period. 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 a subset of the broader secondary objective population, and includes 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.

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead
• Aetion, Inc.: collaborator

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

anifrolumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zachary Bouck

  AstraZeneca

  STUDY DIRECTOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 25, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): March 31, 2032
• Study Completion (Estimated): March 31, 2032
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• 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 refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• 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. A signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.