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Saphnelo Use in Females of Child-bearing Potential

Not Yet RecruitingN/A

Sponsor: AstraZeneca

Conditions: Systemic Lupus Erythematosus

Interventions: Anifrolumab

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.

Eligibility overview

Sex: FEMALE

Age: 15 Years to 50 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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.