Anifrolumab-fnia

(Saphnelo®)

Saphnelo®

Drug updated on 10/25/2024

Dosage FormInjection (intravenous; 300 mg/2 mL [150 mg/mL])
Drug ClassType 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
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  • 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.