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.