Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements. The study will collect data about the presence of anifrolumab in human breast milk and serum (maternal and infant) among lactating individuals who are receiving anifrolumab therapeutically via intravenous (IV) or subcutaneous (SC) administration and evaluate exposure and effects on the breastfed infant.
18 years or older
Signed informed consent to participate
Diagnosis of moderate/severe SLE
Ongoing treatment with anifrolumab
Received any investigational compound or approved biologic or biosimilar within 30 days or 5 half-lives (whichever is longer) prior to enrollment in the study
Diagnosis of lupus nephritis in the last 12 months
History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts
History of malignancy in the last 10 years
Single group
Anifrolumab
DrugAnifrolumab 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 (Furie et al., 2017). Clinical trial evidence from TULIP 1, 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 (Furie et al., 2019; Morand et al., 2020). The phase II MUSE study showed that administration of anifrolumab resulted in substantially reduced disease activity, measured by the SLE Responder Index, compared to patients receiving placebo (Furie et al., 2017). These data resulted with applications to the FDA and the EMA, leading to approvals in July 2021 and February 2022, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.
Area under the milk concentration-time curve during a dosing interval
Area under the milk concentration-time curve during a dosing interval is a component used to assess pharmacokinetic (PK) of anifrolumab in milk of lactating individuals. Milk PK parameters of anifrolumab will be derived using non-compartmental analysis methods and will be determined using the concentration-time data for all evaluable participants included in the PK population
Area under the milk concentration-time curve from time 0 to last quantifiable concentration
Area under the milk concentration-time curve from time 0 to last quantifiable concentration is a component used to assess PK of anifrolumab in milk of lactating individuals. Milk PK parameters of anifrolumab will be derived using non-compartmental analysis methods and will be determined using the concentration-time data for all evaluable participants included in the PK population
Average milk concentration at steady state
Average milk concentration at steady state is a component used to assess PK of anifrolumab in milk of lactating individuals. It will be calculated dividing "Area under the milk concentration-time curve during a dosing interval" by the dosing interval for anifrolumab
Observed milk concentration at end of dosing interval
Observed milk concentration at end of dosing interval is a component used to assess PK of anifrolumab in milk of lactating individuals. Milk PK parameters of anifrolumab will be derived using non-compartmental analysis methods and will be determined using data for all evaluable participants included in the PK population
Total amount of drug excreted in milk over 24 hours
Variable used to assess total amount of drug excreted in milk of lactating individuals. Total amount of drug excreted in milk (mg) over 24 hours calculated as: Σ(total drug concentration in each milk collection x milk volume in each milk collection)
Fraction of dose excreted in milk
Variable used to assess fraction of anifrolumab dose excreted in milk of lactating individuals. Fraction of dose excreted in milk, calculated as (Total amount of drug excreted in milk over 24 hours)/Administered dose
Maternal serum pharmacokinetic (PK) concentrations
Variable used to assess maternal serum pharmacokinetic (PK) concentrations
Estimates of infant exposure
Variable used to assess infant anifrolumab exposure (daily infant dosage; relative infant dosage; infant serum anifrolumab concentration)
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AstraZeneca
Lead sponsor
PPD Development, LP
Collaborator
