Eculizumab

(Soliris®)

Eculizumab

Drug updated on 5/17/2024

Dosage FormInjection (intravenous; 300 mg/30 mL [10 mg/mL])
Drug ClassComplement inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
  • Indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
  • Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive.
  • Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Summary
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  • Eculizumab (Soliris) is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor antibody positive, and neuromyelitis optica spectrum disorder in adults who are anti-aquaporin-4 antibody positive.
  • Twelve studies were reviewed to gather information about Soliris. These documents compared Soliris's safety and effectiveness across different indications including gMG, aHUS, NMOSD, PNH, and transplant-associated thrombotic microangiopathy.
  • In treating gMG, eculizumab was ranked second in efficacy when compared to ten targeted drugs. Its safety profile regarding adverse events was not significantly different from placebo.
  • For aHUS treatment, eculizumab showed comparable safety and efficacy as ravulizumab but had disadvantages concerning financial burden and dosing frequency. However, it improved renal function significantly reducing the need for dialysis among renal transplant patients with aHUS.
  • When used for NMOSD treatment alongside other FDA-approved monoclonal antibodies like satralizumab or inebilizumab, eculizumab demonstrated significant efficacy by reducing relapse risks compared to standard treatments.
  • As per one study on the PNH indication, eculizumab effectively reduced lactate dehydrogenase levels and transfusion rates while being well-tolerated among PNH patients.
  • In case of Transplant Associated Thrombotic Microangiopathy (TA-TMA), eculizumab has shown to improve survival rates and overall response rate, suggesting its tolerability despite infection being the primary adverse event.
  • The drug's general tolerance across various indications is good with most studies reporting adverse events comparable to or lower than placebo. However, vigilant monitoring for infections, particularly meningococcal infection, is necessary.

Product Monograph / Prescribing Information

Document TitleYearSource
Soliris (eculizumab) Prescribing Information.2024Alexion Pharmaceuticals, Inc., Boston, MA, USA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
The efficacy and safety of different targeted drugs for the treatment of generalized myasthenia gravis: a systematic review and Bayesian network meta-analysis.2024CNS drugs
Eculizumab versus ravulizumab for the treatment of atypical hemolytic uremic syndrome: a systematic review.2023Cureus
New findings in preventing recurrence and improving renal function in AHUS patients after renal transplantation treated with eculizumab: a systemic review and meta-analyses.2023Renal failure
Efficacy of innovative therapies in myasthenia gravis: a systematic review, meta-analysis and network meta-analysis.2023European Journal of Neurology
Efficacy and safety of monoclonal antibody therapy in patients with neuromyelitis optica spectrum disorder: A systematic review and network meta-analysis.2023Frontiers in Neurology
Practical management for use of eculizumab in the treatment of severe, refractory, non-thymomatous, achr + generalized myasthenia gravis: a systematic review.2022Therapeutics and Clinical Risk Management
Efficacy and safety of eculizumab in the treatment of transplant-associated thrombotic microangiopathy: a systematic review and meta-analysis.2021Frontiers in Immunology
Efficacy and safety of eculizumab for paroxysmal nocturnal hemoglobinuria: a systematic review and meta-analysis.2021Journal of Pediatric Hematology Oncology
Interventions for atypical haemolytic uraemic syndrome.2021The Cochrane Database of Systematic Reviews
Clinical efficacy and safety of eculizumab for treating myasthenia gravis.2021Frontiers in Immunology
A systematic review of the role of eculizumab in systemic lupus erythematosus-associated thrombotic microangiopathy.2020BMC Nephrology
Efficacy and safety of monoclonal antibody therapy in neuromyelitis optica spectrum disorders: evidence from randomized controlled trials.2020Multiple Sclerosis and Related Disorders

Clinical Practice Guidelines