Drug updated on 9/4/2024
| 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
- Saphnelo (anifrolumab) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-6]
- Anifrolumab demonstrated significantly higher BICLA responses (OR = 2.071, 95% CI 1.575-2.725, p < 0.001), SRI7 responses (OR = 1.866, 95% CI 1.372-2.536, p < 0.001), and SRI8 responses (OR = 1.925, 95% CI 1.387-2.672, p < 0.001) compared to placebo in patients with systemic lupus erythematosus (SLE).
- Anifrolumab was associated with significantly higher reductions in steroid use (OR = 1.811, 95% CI = 1.308-2.506, p < 0.001) and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scores (OR = 2.245, 95% CI = 1.437-3.506, p < 0.001) compared to placebo.
- In patients with a high type I IFN gene signature, anifrolumab did not achieve a significant SRI4 response in two studies involving 450 patients.
- The incidence of adverse events was significantly higher in the anifrolumab group compared to placebo (OR = 1.815, 95% CI = 1.262-2.611, p = 0.001), while serious adverse events were significantly lower (OR = 0.679, 95% CI = 0.468-0.986, p = 0.042).
- The incidence of herpes zoster infection was significantly higher in the anifrolumab group compared to placebo (OR = 4.089, 95% CI = 1.750-9.522, p = 0.001), supported by a meta-analysis showing an increased risk of herpes zoster infection with IFNα and IFNAR inhibitors (pooled OR = 3.72, CI 1.88-7.39, p = 0.0002).
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 |