Drug updated on 10/25/2024
Dosage Form | Injection (intravenous; 300 mg/2 mL [150 mg/mL]) |
Drug Class | Type I interferon (IFN) 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
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- Anifrolumab demonstrated significant efficacy in treating non-renal systemic lupus erythematosus (SLE), providing better disease control compared to the standard of care in high-quality randomized controlled trials (RCTs).
- In lupus nephritis (LN), higher doses of anifrolumab (900 + 300 mg) were more effective in achieving renal complete remission compared to the 300 mg dose and placebo, ranking well among other biologics for overall renal remission.
- Comparative analysis highlighted that belimumab was superior in renal complete remission, while obinutuzumab showed high effectiveness for overall renal remission, and low-dose IL-2 demonstrated the highest probability of achieving complete remission in LN.
- Anifrolumab was generally well-tolerated in non-renal SLE, with fewer serious adverse events compared to placebo. Common adverse events included upper respiratory tract infections, nasopharyngitis, bronchitis, and herpes zoster.
- Increased risk of herpes zoster infections was observed with anifrolumab and rituximab compared to other biologics. Serious infections were more frequent in placebo-treated patients, especially in lupus nephritis trials involving belimumab and rituximab.
- Effectiveness in achieving remission varied among subgroups, with patients having a high type I IFN (IFNAR) gene signature showing reduced response to anifrolumab compared to those with lower gene signatures. Some studies excluded patients with active severe lupus nephritis or central nervous system lupus.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Saphnelo (anifrolumab-fnia) Prescribing Information. | 2024 | AstraZeneca Pharmaceuticals LP, Wilmington, DE |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. | 2024 | Annals of the Rheumatic Diseases |