Anifrolumab

(Saphnelo®)

Saphnelo®

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Drug updated on 5/17/2024

Dosage FormInjection (intravenous; 150 mg/mL)
Drug ClassType 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.

Summary
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  • 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.