Anifrolumab for Lupus

(PRIMULA Lac Trial)

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: AstraZeneca

Must be taking: Anifrolumab

Must not be taking: Investigational compounds, Biologics

Disqualifiers: Lupus nephritis, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 4 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how anifrolumab, a treatment for lupus, affects breast milk and the health of both the mother and her infant. The goal is to gather information about the presence of the drug in breast milk and in the blood of both the mother and the infant. It targets mothers with moderate to severe lupus who are already taking anifrolumab and are breastfeeding. Participants should be breastfeeding exclusively or mostly and willing to continue throughout the study. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires ongoing treatment with anifrolumab. It is best to discuss your current medications with the trial team to ensure they are compatible with the study requirements.

What is the safety track record for Anifrolumab?

Research has shown that anifrolumab is generally safe for treating systemic lupus erythematosus (SLE) and has received FDA approval for this use. However, some important safety points require attention.

Anifrolumab can weaken the immune system, making it harder for the body to fight infections, which increases the risk of serious infections. Some patients have experienced serious infections while on this treatment. Monitoring for signs of infection, such as fever or chills, and consulting a doctor if they occur is crucial.

While anifrolumab helps reduce disease symptoms, awareness of these possible side effects is important. Discuss any concerns and the treatment's benefits and risks with a healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Anifrolumab is unique because it specifically targets the type I interferon receptor, which plays a key role in the inflammatory process of lupus. Unlike traditional treatments, which often include corticosteroids or immunosuppressants like hydroxychloroquine and methotrexate, anifrolumab acts on a different pathway, offering a more targeted approach. This could potentially lead to fewer side effects and more effective management of lupus symptoms. Researchers are excited about anifrolumab because it may provide a new option for patients who don't respond well to existing therapies.

What is the effectiveness track record for Anifrolumab in treating lupus?

Research has shown that anifrolumab effectively treats systemic lupus erythematosus (SLE), a type of lupus. In one study, 47.8% of patients taking anifrolumab experienced significant improvement compared to 31.5% of those taking a placebo. Over four years of treatment with anifrolumab, patients reported better health and quality of life. Anifrolumab has also reduced symptoms, particularly those affecting the skin and joints. These findings support its effectiveness in managing lupus symptoms. ^{1 4 6 7 8}

Who Is on the Research Team?

Darin Brimhall, MD

Principal Investigator

PPD, Las Vegas, US

Are You a Good Fit for This Trial?

This study is for breastfeeding individuals at least 18 years old with moderate/severe Systemic Lupus Erythematosus (SLE), who are on anifrolumab treatment and have been pumping or breastfeeding for at least 4 weeks. Participants must be willing to exclusively breastfeed/pump, use only lanolin nipple cream during sampling, and continue milk feeding throughout the study.

Inclusion Criteria

Maternal: Ongoing treatment with anifrolumab

Maternal: Has reached or will reach steady state with anifrolumab by the time of study Day 1

Maternal: Established lactation in the index post-partum period

Exclusion Criteria

My infant has a notable health issue or significant medical condition.

Maternal: Received any investigational compound or approved biologic or biosimilar within 30 days or 5 half-lives prior to enrollment

I was diagnosed with lupus nephritis in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive anifrolumab and undergo milk and serum collection at specified timepoints

4 weeks

14 milk collection visits, 3 maternal serum collection visits, 1 infant serum collection visit

Follow-up

Participants are monitored for maternal and infant adverse events and pharmacokinetic analysis

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Anifrolumab

Trial Overview The PRIMULA Lac trial is examining if the lupus medication anifrolumab can be found in human breast milk and blood serum of both mother and infant. It's a post-marketing study required by the FDA to gather more information after the drug has been approved.

How Is the Trial Designed?

Group I: Anifrolumab Experimental Treatment 1 Intervention

Lactating individuals 18 years of age or older receiving anifrolumab therapeutically who provide consent to participate will be included in the study. Milk collection will occur at a series of 14 timepoints, 1 pre-dose (spot) and 13 post-dose: Day 1 \[0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, 18-24 hours\], Day 3 \[48 hours, spot\], Day 4 (spot), Day 6 (spot), Day 8 (spot), Day 12 (spot), Day 16 (spot), Day 22 (spot), and Day 29 (prior to next dose, spot). Maternal serum will be collected Day 1 (pre-dose and 0-4 hours post-dose), Day 12, and approximately Day 29 (immediately preceding subsequent dose). Infant serum will be collected on approximately Day 30 following the next dose and after 24 hours of breast feeding.

Anifrolumab is already approved in United States, European Union for the following indications:

Approved in United States as Saphnelo for:

• Moderate to severe systemic lupus erythematosus (SLE)

Approved in European Union as Saphnelo for:

• Moderate to severe systemic lupus erythematosus (SLE)

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

PPD DEVELOPMENT, LP

Industry Sponsor

Trials

167

Recruited

38,000+

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

PPD Development, LP

Industry Sponsor

Published Research Related to This Trial

In a 3-year study involving 218 patients with moderate-to-severe systemic lupus erythematosus (SLE), long-term treatment with anifrolumab showed an acceptable safety profile, with only 6.9% of patients discontinuing due to adverse events.

Patients experienced sustained improvements in SLE disease activity and health-related quality of life, with no new safety concerns identified, indicating that anifrolumab effectively manages SLE over an extended period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Safety and Efficacy of Anifrolumab in Adults With Systemic Lupus Erythematosus: Results of a Phase II Open-Label Extension Study. Chatham, WW., Furie, R., Saxena, A., et al.[2021]

In the TULIP-LN trial involving 147 patients with active lupus nephritis, the intensified regimen of anifrolumab (900 mg followed by 300 mg) showed a higher rate of complete renal response at Week 104 compared to the basic regimen and placebo (27.3% vs 18.6% and 17.8%).

The safety profile of anifrolumab remained consistent over two years, with 72% of patients reporting at least one adverse event, but serious adverse events were relatively low, suggesting that anifrolumab is a tolerable treatment option for lupus nephritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial. Jayne, D., Rovin, B., Mysler, E., et al.[2023]

Belimumab and anifrolumab are two targeted biological drugs approved for treating systemic lupus erythematosus (SLE), with belimumab primarily affecting adaptive immune responses and anifrolumab potentially causing organ-specific effects due to its action on the IFNAR1 receptor.

Safety data indicate that anifrolumab may increase the risk of certain viral infections, while belimumab appears to have a more favorable safety profile, suggesting that careful patient selection and monitoring are essential to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belimumab or anifrolumab for systemic lupus erythematosus? A risk-benefit assessment. Kirou, KA., Dall Era, M., Aranow, C., et al.[2022]

Anifrolumab is a monoclonal antibody that targets the type 1 interferon receptor and has been approved in the USA for treating moderate to severe systemic lupus erythematosus (SLE) in adults, marking a significant advancement in autoimmune disorder therapies.

The drug is currently being evaluated in ongoing clinical studies and is under regulatory review in the EU and Japan, indicating its potential for broader use in managing SLE and related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anifrolumab: First Approval. Deeks, ED.[2022]

Anifrolumab, a monoclonal antibody targeting the type I interferon receptor, has shown significant efficacy in treating moderately to severely active systemic lupus erythematosus (SLE), with over 16% improvement compared to placebo in response rates after 52 weeks in phase 3 studies (TULIP-1 and TULIP-2).

The safety profile of anifrolumab is comparable to placebo, although there is a higher incidence of herpes zoster in patients receiving the treatment (up to 7% vs. 2% for placebo), indicating that while effective, monitoring for this specific side effect is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anifrolumab, a monoclonal antibody to the type I interferon receptor subunit 1, for the treatment of systemic lupus erythematosus: an overview from clinical trials. Tanaka, Y., Tummala, R.[2021]

In a phase IIb trial involving 305 patients with moderate-to-severe systemic lupus erythematosus (SLE), anifrolumab significantly improved disease activity compared to placebo, particularly in patients with a high interferon gene signature, with 34.3% of patients on the 300 mg dose achieving a response at week 24.

Anifrolumab's safety profile was generally similar to placebo, but it was associated with a higher incidence of herpes zoster and influenza-like symptoms, indicating a need for monitoring these potential side effects in treated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interferon Inhibition for Lupus with Anifrolumab: Critical Appraisal of the Evidence Leading to FDA Approval. Loncharich, MF., Anderson, CW.[2022]

Anifrolumab, a treatment for systemic lupus erythematosus (SLE), was found to have a lower incidence of serious adverse events compared to placebo in a meta-analysis of 1160 patients from four randomized controlled trials, indicating good safety.

Common adverse events associated with anifrolumab included upper respiratory infections and herpes zoster, but overall, it is considered a well-tolerated option for patients with moderate to severe SLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of anifrolumab safety in systemic lupus erythematosus: A meta-analysis and systematic review. Liu, Z., Cheng, R., Liu, Y.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40324450/

Long-term effect of anifrolumab on patient-reported ... Over 4 years of treatment, patients reported improvements in health status and health-related quality of life, including differences favouring anifrolumab ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1912196

Trial of Anifrolumab in Active Systemic Lupus Erythematosus A BICLA response at week 52 occurred in 86 of 180 patients (47.8%) receiving anifrolumab and in 57 of 182 (31.5%) receiving placebo (adjusted difference, 16.3 ...

3. astrazeneca-us.com astrazeneca-us.com/media/press-releases/2025/SAPHNELO-self-administration-TULIP-SC-Phase-III-trial-meets-primary-endpoint-in-patients-with-systemic-lupus-erythematosus-based-on-an-interim-analysis.html

SAPHNELO self-administration TULIP-SC Phase III trial ... Positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial in patients with systemic lupus erythematosus ...

4. jrheum.org jrheum.org/content/52/Suppl_1/254

REAL-WORLD EFFICACY AND SAFETY DATA OF ... ANI showed promising results, reducing overall and organ-specific disease activity, confirming its efficacy in cutaneous and joint manifestations.

5. saphnelohcp.com saphnelohcp.com/clinical-data.html

Clinical Data - SAPHNELO For HCPs The reduction in disease activity seen in BICLA and SRI-4 was related primarily to improvement in the mucocutaneous and musculoskeletal organ systems.

6. saphnelo.com saphnelo.com/safety

Safety | SAPHNELO® (anifrolumab-fnia) Injection for ... SAPHNELO may cause serious side effects, including: Serious infections: SAPHNELO can lower the ability of your immune system to fight infections.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12278508/

Post-marketing safety signals of anifrolumab in systemic ... This study provides valuable safety data on the real-world application of anifrolumab, confirming known AEs and revealing additional potential risks.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/761123s000lbl.pdf

SAPHNELO (anifrolumab-fnia) injection, for intravenous use Serious Infections: Serious and sometimes fatal infections have occurred in patients receiving SAPHNELO. SAPHNELO increases the.