Drug updated on 3/28/2024
| Dosage Form | Injection (intravenous; 150 mg/mL) |
| Drug Class | Type I interferon receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.
Summary
- Anifrolumab (Saphnelo) is a targeted therapy specifically designed to block certain molecules, receptors, or pathways involved in the development of systemic lupus erythematosus (SLE).
- According to four Systematic Reviews / Meta-Analyses documents reviewed, anifrolumab has been evaluated for its safety and efficacy in treating adult patients with moderate to severe SLE who are receiving standard therapy.
- The systematic review indicates that anifrolumab was more effective than placebo in achieving SRI(4) response and BICLA response among patients with active SLE despite receiving standard treatment.
- In terms of safety profile, serious adverse events were less common in the anifrolumab group compared to the placebo group; however, incidences of upper respiratory tract infection, nasopharyngitis bronchitis and herpes zoster were higher among those treated with anifrolumab.
- A meta-analysis revealed that while Anifrolumab effectively treats active SLE symptoms it also increases incidence rates of herpes zoster infections when compared against placebos.
- Despite these side effects noted above such as increased risk for viral infections including herpes zoster infection, overall findings suggest that Aniforlumb (Saphnelo) is considered a well-tolerated option for treating moderate-to-severe cases of systemic lupus erythematosus(SLE).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Saphnelo (anifrolumab-fnia) Prescribing Information. | 2022 | AstraZeneca Pharmaceuticals LP, Wilmington, DE |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Clinical, pharmacoeconomic, and stakeholder input combined report. | 2023 | CADTH |
| 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 |
| Australian Public Assessment Report for Saphnelo. | 2022 | Australian Government: Department of Health |
| 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 |