SOLIRIS® for gMG

In gMG, uncontrolled complement activation leads to damage at the neuromuscular junction (NMJ)1

Chronic, uncontrolled complement activation leads to postsynaptic membrane damage, which impairs neuromuscular transmission.1,2

SOLIRIS® targets terminal complement activity at the NMJ3

  • SOLIRIS® specifically targets complement protein C5 to block its cleavage to C5a and C5b, preventing the formation of MAC (C5b-9)3
  • Ongoing SOLIRIS® administration results in immediate, targeted, complete, and sustained inhibition of terminal complement activity3
  • SOLIRIS® inhibits MAC formation, which is known to cause damage to the postsynaptic membrane at the NMJ2,3
SOLIRIS® MOA Video

When to consider SOLIRIS®

Refractory gMG patients are defined as those who:3

  • Have failed treatment with two or more immunosuppressive therapies (ISTs) either in combination or as monotherapy
  • Have failed treatment with at least one IST and required chronic plasmapheresis, plasma exchange (PE), or intravenous immunoglobulin (IVIg) to control symptoms

Recognizing refractory gMG in your practice

The MG-ADL assessment questionnaire can be a quick and easy tool ideal for tracking improvement of gMG in your clinical practice.4

  • Clinical trials frequently use a 2 or 3-point improvement in MG-ADL score to indicate clinical improvement4
  • As an absolute measure of minimal symptom activity, an MG-ADL score ≤2 has been considered indicative of patients feeling a global state of wellbeing that is “well enough”4

Treatment Goals in gMG: Minimal Manifestation Status5

The MGFA Task Force Post-Intervention Status (PIS) classifies Minimal Manifestation Status (MMS) as:

No symptoms or functional limitations from MG but has some weakness on examination of some muscles. This class recognizes that some patients who otherwise meet the definition of remission have mild weakness.

 

See the clinical trial data supporting SOLIRIS®

SOLIRIS® (eculizumab) is indicated in adult patients with generalized Myasthenia Gravis (gMG).

SOLIRIS® was studied in clinical trials in patients who were anti-acetylcholine receptor (AChR) antibody positive and refractory, defined as failure of treatment with two or more immunosuppressive therapies (ISTs) either in combination or as monotherapy, or failed at least one IST and required chronic plasmapheresis, plasma exchange (PE), or intravenous immunoglobulin (IVIg) to control symptoms. Patients continued to receive standard therapy throughout the pivotal clinical trial.

SOLIRIS® should be administered by a qualified healthcare professional.

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Cases of serious or fatal meningococcal infections have been reported in patients treated with SOLIRIS®. Meningococcal infections may become rapidly life-threatening or fatal if not recognized and treated early.

  • Comply with the most current National Advisory Committee on Immunization (NACI) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • All patients must be vaccinated with meningococcal vaccines prior to, or at the time of, initiating SOLIRIS®, unless the risks of delaying SOLIRIS® therapy outweigh the risks of developing a meningococcal infection; revaccinate according to current medical guidelines for vaccine use.
  • All patients must be monitored for early signs of meningococcal infections, evaluated immediately if infection is suspected, and treated with antibiotics, if necessary.

Vaccination may not prevent all meningococcal infections.

Contraindications

Do not initiate SOLIRIS® therapy in patients:

  • With unresolved Neisseria meningitidis infection.
  • Who are not currently vaccinated against Neisseria meningitidis (unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination).
1. Conti-Fine BM, Milani M, Kaminski HJ. Myasthenia gravis: past, present, and future. J Clin Invest. 2006;116(11):2843-2854.
2. Kusner LL, Kaminski HJ. The role of complement in experimental autoimmune myasthenia gravis. Ann NY Acad Sci. 2012;1274(1):127-132.
3. SOLIRIS® Product Monograph. Alexion Pharmaceuticals Inc. March 25, 2021.
4. Muppidi S, Silvestri NJ, Tan R, et al. Utilization of MG-ADL in myasthenia gravis clinical research and care. Muscle & Nerve. 2022;1-10.
5. Sanders, DB et al. International consensus guidance for management of myasthenia gravis. Neurology. Jul 2016, 87 (4) 419-425; DOI: 10.1212/ WNL.0000000000002790.