SOLIRIS®: a treatment option with the potential to improve symptom control1,2 SOLIRIS® (eculizumab) is indicated for the treatment of refractory generalised myasthenia gravis (gMG) in patients aged 6 years and above who are anti-acetylcholine receptor (AChR) antibody-positive.3 Please consult the Summary of Product Characteristics prior to prescribing.
This website describes data on adult patients treated with SOLIRIS® (eculizumab) for the treatment of gMG who are AChR antibody-positive.

To reduce the risk of infection, all patients must be vaccinated against meningococcal infections at least 2 weeks prior to initiating SOLIRIS® unless the risk of delaying SOLIRIS® therapy outweighs the risk of developing a meningococcal infection. Patients who initiate SOLIRIS® treatment less than 2 weeks after receiving a tetravalent meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Patients must receive vaccination according to current national vaccination guidelines for vaccination use.3


Please consult the Summary of Product Characteristics prior to prescribing.

* Primary objective was not met.1,4

† Supportive safety data were obtained from 33 clinical studies that included 1,555 patients exposed to eculizumab in complement-mediated disease populations, including PNH, aHUS, refractory gMG and NMOSD.3

* In the REGAIN study, refractory gMG patients were defined as: 1) Patients who failed treatment for at least one year with 2 or more immunosuppressant therapies (either in combination or as monotherapy), i.e., patients continued to have impairment in activities of daily living despite immunosuppressant therapies. OR 2) Patients who have failed at least one immunosuppressant therapy and required chronic plasma exchange or IVIg to control symptoms, i.e., patients require PLEX or IVIg on a regular basis for the management of muscle weakness at least every 3 months over previous 12 months.3


† ICU admission: at Year 2: OR = 3.498 (1.514, 8.081) P = 0.0034; feeding tube use: At Year 2: OR = 84.639; (3.328, 2152.581); P = 0.0072.8
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AChR, acetylcholine receptor; aHUS, acute haemolytic uraemic syndrome; C5, complement component 5; gMG, generalised myasthenia gravis; ICU, intensive care unit; IVIg, intravenous immunoglobulin; MG-ADL, Myasthenia Gravis Activities of Daily Living; MG, myasthenia gravis; NMJ, neuromuscular junction; OR, overall response; PLEX, plasma exchange; paroxysmal nocturnal haemoglobinuria. 
Healthcare professionals are asked to report any suspected adverse reactions. Please report any adverse reactions via your national reporting system. Adverse events should also be reported to Alexion pharmaceuticals by the following link: https://contactazmedical.astrazeneca.com/
Muppidi S, et al. Long-term safety and efficacy of eculizumab in generalized myasthenia gravis. Muscle Nerve. 2019;14–24. Howard JF, et al. Long-term efficacy of eculizumab in refractory generalized myasthenia gravis: responder analyses. Ann Clin Transl Neurol. 2021;8(7):1398–1407. SOLIRIS® (eculizumab) EU Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/soliris-epar-product-information_en.pdf. Last accessed: March 2024. Howard JF, et al. Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study. Lancet Neurol. 2017;16(12):976–986 (main article and supplementary appendix). Schneider-Gold C, et al. Understanding the burden of refractory myasthenia gravis. Ther Adv Neurol Disord. 2019;12:1–16. Suh J, et al. Clinical characteristics of refractory myasthenia gravis patients. Yale J Biol Med. 2013; 86:255–260. Engel-Nitz NM, et al. Burden of illness in patients with treatment refractory myasthenia gravis. Muscle Nerve. 2018;58(1):99–105. Harris L, et al. Longitudinal analysis of disease burden in refractory and nonrefractory generalized myasthenia gravis in the United States. J Clin Neuromuscl Disease. 2020;22(1):11–21. Farrugia ME, et al. A practical approach to managing patients with myasthenia gravis – opinions and a review of the literature. Front Neurol. 2020;11:604.