Drug updated on 5/17/2024
Dosage Form | Injection (intravenous; 150 mg/mL) |
Drug Class | Type I interferon receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.
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Summary
- Anifrolumab (Saphnelo) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. The medication has shown significant improvement in BICLA responses, SRI-4, SRI-5, SRI-6, SRI-7, and SRI-8 responses compared to placebo.
- Five systematic reviews/meta-analyses highlighted anifrolumab's efficacy over placebo in various efficacy endpoints critical for managing systemic lupus erythematosus.
- Anifrolumab's use is associated with an increased incidence of certain adverse events such as herpes zoster infection, despite having lower serious adverse events compared to a placebo. This trade-off poses a significant safety consideration.
- Anifrolumab’s effectiveness is notably superior to placebos, particularly in achieving Systemic Lupus Erythematosus Responder Index (SRI) and British Isles Lupus Assessment Group-based Composite LupuS Endpoint (BICLA) responses. However, it also increases the risk of infections like herpes zoster, similar to other interferon-pathway inhibitors.
- The efficacy of Anifrolumab appears consistent across different patient populations suffering from active disease, even while on standard therapy. Some studies, however, showed no improved response among patients with a high type I IFN gene signature, indicating possible subgroups that may not benefit significantly from its use.
- Regarding therapeutic options, the unique mechanism by which Anifrolumab inhibits the type I interferon receptor offers a novel approach, particularly beneficial for those unresponsive or insufficiently responsive to other treatments. However, further research would be beneficial towards fine-tuning its application within broader context management strategies for systemic lupus erythematosus and exploring comparative effectiveness against other treatments currently available.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Saphnelo (anifrolumab-fnia) Prescribing Information. | 2023 | AstraZeneca Pharmaceuticals LP, Wilmington, DE |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Model-based meta-analysis using latent variable modeling to set benchmarks for new treatments of systemic lupus erythematosus. | 2024 | CPT: Pharmacometrics & Systems Pharmacology |
New biologics and targeted therapies in systemic lupus: from new molecular targets to new indications. A systematic review. | 2023 | Joint Bone Spine |
Safety and efficacy of anifrolumab for systemic lupus erythematosus: network meta-analysis. | 2023 | American Journal of Therapeutics |
Evaluation of anifrolumab safety in systemic lupus erythematosus: a meta-analysis and systematic review. | 2022 | Frontiers in Immunology |
Anifrolumab for the treatment of active systemic lupus erythematosus: a meta-analysis of randomized controlled trials. | 2021 | Zeitschrift für Rheumatologie |
Biologics targeting type I interferons in SLE: a meta-analysis and systematic review of randomised controlled trials. | 2020 | Lupus |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. | 2023 | Annals of the Rheumatic Diseases |
A practical overview of the articular manifestations of systemic lupus erythematosus. | 2023 | Cureus |