Safety and efficacy of Soliris in adult patients with anti-AchR+ gMG have been evaluated in multinational, prospective studies1,2

REGAIN (gMG Study 1) is the only prospective study performed to date in patients who did not adequately respond to appropriate immunosuppressant treatments3

REGAIN (gMG Study 1) (ECU-MG-301)a and Extension study (ECU-MG-302)1,2

aClinicalTrials.gov identifier NCT01997229.
bA total of 126 patients were randomized, 125 of whom received treatment and were analyzed.1
cOr received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.1
dPatients underwent a 4-week induction. In the Extension study, a similar induction phase was performed in order to maintain the blinded treatment assignment of REGAIN.1
eOn stable doses prior to screening, defined as: AZA: on drug for ≥6 months, on stable dose for ≥2 months; MMF, MTX, cyclosporine, tacrolimus, or cyclophosphamide: on drug for ≥3 months, on stable dose for ≥1 month; oral steroid: on stable dose for ≥28 days.1
fDue to intolerance or if medically indicated, at the discretion of the Investigator.1

Key inclusion criteria for REGAIN clinical trial 2,3

Sex and age Male or female patients ≥18 years old3
Antibody status Positive serologic test for anti-AchR autoantibodies2
Treatment history At least 1-year failure of

  • ≥2 immunosuppressive agents, including steroids and/or other immunosuppressants2,g

Failed ≥1 immunosuppressive agent and required chronic plasmapheresis, PLEX, or IVIg2,g,h

Disease burden A total score of ≥6 on the patient-reported MG activities of daily living (MG-ADL) assessment at screening2
Therapies at study entry On a stable dose of immunosuppressants or other concomitant medications3,i
MGFA classification Clinical classification II-IV (class I and V excluded)2

Explore more baseline characteristics of the REGAIN trial patients.

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gImmunosuppressant failure was defined as continued impairment of activities of daily living (persistent weakness, experienced crisis, or inability to tolerate immunosuppressants).3
hChronic PLEX or IVIg is defined as ≥4 treatments in a year (at least every 3 months over the previous 12 months).3
iOn stable doses prior to screening, defined as: AZA: on drug for ≥6 months, on stable dose for ≥2 months; MMF, MTX, cyclosporine, tacrolimus, or cyclophosphamide: on drug for ≥3 months, on stable dose for ≥1 month; oral steroid: on stable dose for ≥28 days. For patients receiving a cholinesterase inhibitor, must have been on a stable dose for ≥2 weeks prior to screening.1

During REGAIN, 98% of patients in each group were receiving immunosuppressant therapies (ISTs).2

A broad array of validated MG instruments measured the effect of Soliris in adult patients with anti-AchR+ gMG in REGAIN and Extension study1,2

The use of physician- and patient-reported MG instruments provided a comprehensive picture of Soliris treatment experience.3

jThe proportion of patients with a ≥3-point change in MG-ADL total score from baseline at 26 weeks and no rescue therapy was a secondary endpoint.1
kThe proportion of patients with a ≥5-point change in QMG total score from baseline at 26 weeks and no rescue therapy was also a secondary endpoint.1

Learn more about MG instruments you can use in your practice to assess your patients with gMG.

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Clinical trial baseline characteristics

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Greater improvements in activities of daily living (MG-ADL) were reported with Soliris vs placebo at 26 weeks.2

See the data

INDICATION & IMPORTANT SAFETY INFORMATION FOR SOLIRIS® (eculizumab)

INDICATION

Generalized Myasthenia Gravis (gMG)

Soliris is indicated for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive.

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.

 

  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  •  
  • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection. (See Serious Meningococcal Infections for additional guidance on the management of the risk of meningococcal infection)
  •  
  • Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

 

Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com.

 

Contraindications

Soliris is contraindicated in:

  • Patients with unresolved serious Neisseria meningitidis infection
  • Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Soliris treatment outweigh the risks of developing a meningococcal infection

 

Warnings and Precautions

 

Serious Meningococcal Infections

 

Risk and Prevention

 

See Boxed WARNING for additional information on serious meningococcal infections.

 

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis).

 

Vaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Revaccinate patients in accordance with ACIP recommendations, considering the duration of Soliris therapy.

 

Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If urgent Soliris therapy is indicated in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide patients with 2 weeks of antibacterial drug prophylaxis.

 

The benefits and risks of antibiotic prophylaxis for prevention of meningococcal infections in patients receiving Soliris have not been established.

 

Vaccination reduces, but does not eliminate, the risk of meningococcal infections.

 

Closely monitor patients for early signs and symptoms of meningococcal infection, and evaluate patients immediately if an infection is suspected. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections.

 

REMS

Because of the risk of meningococcal infections, Soliris is available only through a restricted program under a REMS. Under the Soliris REMS, prescribers must enroll in the program.

 

Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s).

 

Other Infections

Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported.

 

Soliris blocks terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with Soliris may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP guidelines. Use caution when administering Soliris to patients with any systemic infection.

 

Infusion Reactions

Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion reaction that required discontinuation of Soliris. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

 

Adverse Reactions

The most frequently reported adverse reaction in the gMG placebo-controlled clinical trial (≥10%) is: musculoskeletal pain.

 

Please see full prescribing information for Soliris, including boxed WARNING regarding serious meningococcal infections.

Abbreviations: anti-AchR+, acetylcholine receptor antibody positive; AZA, azathioprine; gMG, generalized myasthenia gravis; IVIg, intravenous immunoglobulin; MG, myasthenia gravis; MGFA, Myasthenia Gravis Foundation of America; MMF, mycophenolate mofetil; MTX, methotrexate; PLEX, plasma exchange; REGAIN, Eculizumab for Refractory Generalized Myasthenia Gravis.

References

  1. Data on file. Alexion Pharmaceuticals, Inc.
  2. Soliris [prescribing information]. Boston, MA: Alexion Pharmaceuticals Inc; 2018.
  3. Howard JF Jr, Utsugisawa K, Benatar M, 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. doi:10.1016/S1474-4422(17)30369-1.
  4. Muppidi S, Wolfe GI, Conaway M, Burns TM; MG Composite and MG-QOL15 Study Group. MG-ADL: still a relevant outcome measure. Muscle Nerve. 2011;44(5):727-731. doi:10.1002/mus.22140.
  5. Wolfe GI, Herbelin L, Nations SP, Foster B, Bryan WW, Barohn RJ. Myasthenia gravis activities of daily living profile. Neurology. 1999;52(7):1487-1489. doi:10.1212/WNL.52.7.1487.
  6. Howard JF Jr, Freimer M, O'Brien F, et al; for MG (Phase 2) Study Group. QMG and MG-ADL correlations: study of eculizumab treatment of myasthenia gravis. Muscle Nerve. 2017;56(2):328-330. doi:10.1002/mus.25529.
  7. Burns TM, Conaway MR, Sanders DB; for MG Composite and MG-QOL15 Study Group. The MG composite: a valid and reliable outcome measure for myasthenia gravis. Neurology. 2010;74(18):1434-1440. doi:10.1212/WNL.0b013e3181dc1b1e.
  8. Educational Materials. Myasthenia Gravis Foundation of America website. http://www.myasthenia.org/HealthProfessionals/EducationalMaterials.aspx. Accessed September 8, 2017.
  9. Burns TM, Conaway MR, Cutter GR, Sanders DB; Muscle Study Group. Less is more, or almost as much: a 15-item quality-of-life instrument for myasthenia gravis. Muscle Nerve. 2008;38(2):957-963. doi:10.1002/mus.21053.