Saphnelo Use in Females of Child-bearing Potential

Conditions

• Systemic Lupus Erythematosus

Eligibility Criteria

Sex

FEMALE

Age

15 Years - 50 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

First listed

Feb 25, 2026

Start date

Oct 1, 2026

Status verified

Feb 2026

Primary completion

Mar 31, 2032

Completion

Mar 31, 2032

Study Design

Enrollment

26,000,000 participants (estimated)

Arms

• Arm: 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.
• Arm: 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

Primary Outcome Measure

Incidence of anifrolumab use [ Time Frame: 1 year ]

Central Contacts

• AstraZeneca Clinical Study Information Center
  1-877-240-9479
  [email protected]

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