In clinical trials, Soliris improved activities of daily living and muscle weakness in patients with 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.

In a clinical trial of 125 patients with anti-AchR+ gMG, Soliris was shown to improve activities of daily living and muscle weakness in patients with unresolved symptoms, despite multiple treatments. Of patients receiving Soliris:

  • 60% reported an improvement in activities of daily living compared with 40% of those taking placeboa
  • 45% had a clinically meaningful improvement in muscle weakness compared with 19% of those taking placebob
Bar graph of clinical trial results of Soliris vs placebo
Bar graph of clinical trial results of Soliris vs placebo

Patients in the placebo-controlled gMG clinical trial continued to receive immunosuppressant and anticholinesterase therapies while on Soliris treatment.

aClinical response defined as ≥3-point improvement from baseline in MG-ADL total score at 26 weeks of treatment.
bClinical response defined as ≥5-point improvement from baseline in QMG total score at 26 weeks of treatment.

Soliris is thought to reduce the activity of complement at the muscle surface in patients with anti-AchR+ gMG.

Soliris doesn’t work for everyone. If you and your doctor decide to begin treatment with Soliris, it may take up to 12 weeks to know if it is helping to improve your gMG symptoms. Speak with your doctor to help determine if Soliris is right for you.

The 125 patients included in the gMG placebo-controlled clinical trial had a range of demographic characteristics

Demographics

  • Female: 66%
  • ≥65 years: 20.8% (26/125)
  • Mean MG duration (min, max): 9.55 years (1.0, 33.8)
  • Mean age at first study dose (min, max): 47.2 years (19.0, 79.0)
    • Female: 42.0 years (19.0, 74.0)
    • Male: 57.0 years (22.0, 79.0)

Prior treatments

  • Approximately 50% of patients had been treated with ≥3 immunosuppressants since diagnosisa
  • Use of IVIg or PLEX
    • IVIg: 28.0% chronic,b 63.2% acute setting
    • PLEX: 11.2% chronic,b 43.2% acute setting
  • 54.4% of patients had undergone thymectomy

Immunosuppressants at baseline and during clinical trialc

  • 80.0% (n = 100) received corticosteroids
  • 85.6% (n = 107) received immunosuppressants other than prednisone

MGFA Clinical Classificationd (N = 125)

  • Class IIa or IIIa: 49.6% (n = 62)
  • Class IIb or IIIb: 40.8% (n = 51)
  • Class IVa: 4.8% (n = 6)
  • Class IVb: 4.8% (n = 6)

During the gMG placebo-controlled clinical trial, the majority of patients were receiving corticosteroids or other immunosuppressants.

aImmunosuppressants used prior to enrollment included but were not limited to AZA, MMF, MTX, cyclosporine, tacrolimus, cyclophosphamide, corticosteroids, and rituximab. Use of rituximab within 6 months prior to screening was an exclusion criterion.
bChronic PLEX or IVIg is defined as ≥4 treatments in a year (at least every 3 months over the previous 12 months).
cOn stable dosages prior to screening, defined as: AZA: on drug for ≥6 months, on a stable dose for ≥2 months; MMF, MTX, cyclosporine, tacrolimus, or cyclophosphamide: on drug for ≥3 months, on stable dosage for ≥1 month; oral steroids: on stable dosage for ≥28 days.
dAt randomization stratification. MGFA class I encompasses ocular muscle weakness only (excluded from gMG clinical trial); classes II, III, or IV refer to mild, moderate, or severe weakness, affecting muscles other than ocular, but may also include ocular weakness of any severity; class a: weakness predominantly affecting limb and/or axial muscles; class b: predominantly affecting oropharyngeal and/or respiratory muscles; class V refers to patients in MG crisis (excluded from gMG clinical trial).

Soliris was approved for the treatment of adults with anti-AchR+ gMG in 2017.

Because Soliris works by blocking a part of your immune system, it increases your chance of getting meningococcal infections, including those that may be serious and quickly life-threatening, causing death if not recognized and treated early.

The most common side effects in people with gMG treated with Soliris include: muscle and joint (musculoskeletal) pain.

Soliris has been prescribed to treat other rare diseases for more than 10 years in nearly 50 countries.

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Abbreviations:

anti-AchR+, anti-acetylcholine receptor antibody positive; AZA, azathioprine; IVIg, intravenous immunoglobulin; MG-ADL, Myasthenia Gravis-Activities of Daily Living; MGFA, Myasthenia Gravis Foundation of America; MMF, mycophenolate mofetil; MTX, methotrexate; PLEX, plasma exchange; QMG, Quantitative Myasthenia Gravis.

INDICATION & IMPORTANT SAFETY INFORMATION FOR SOLIRIS® (eculizumab)

 

INDICATION

 

What is SOLIRIS?

SOLIRIS is a prescription medicine called a monoclonal antibody. SOLIRIS is used to treat:

  • adults with a disease called generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive

It is not known if SOLIRIS is safe and effective in children with gMG.

IMPORTANT SAFETY INFORMATION

 

What is the most important information I should know about SOLIRIS?

SOLIRIS is a medicine that affects your immune system. SOLIRIS can lower the ability of your immune system to fight infections.

  • SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early.
  1. You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you have not already had this vaccine.

  2. If your doctor decided that urgent treatment with SOLIRIS is needed, you should receive meningococcal vaccination as soon as possible.

  3. If you have not been vaccinated and SOLIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.

  4. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting SOLIRIS. Your doctor will decide if you need additional meningococcal vaccination.

  5. Meningococcal vaccines reduce the risk of meningococcal infection but do not prevent all meningococcal infections. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection:

  • headache with nausea or vomiting
  • headache and fever
  • headache with a stiff neck or stiff back
  • fever
  • fever and a rash
  • confusion
  • muscle aches with flu-like symptoms
  • eyes sensitive to light

Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last SOLIRIS dose. Your risk of meningococcal infection may continue for several weeks after your last dose of SOLIRIS. It is important to show this card to any doctor or nurse who treats you. This will help them diagnose and treat you quickly.

SOLIRIS is only available through a program called the SOLIRIS REMS. Before you can receive SOLIRIS, your doctor must:

  • enroll in the SOLIRIS REMS program
  • counsel you about the risk of meningococcal infection
  • give you information about the symptoms of meningococcal infection
  • give you a Patient Safety Card about your risk of meningococcal infection, as discussed above
  • make sure that you are vaccinated with a meningococcal vaccine

SOLIRIS may also increase the risk of other types of serious infections. If your child is treated with SOLIRIS, make sure that your child receives vaccinations against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Certain people may be at risk of serious infections with gonorrhea. Talk to your doctor about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing. Certain fungal infections (Aspergillus) may also happen if you take SOLIRIS and have a weak immune system or a low white blood cell count.

Who should not receive SOLIRIS?

Do not receive SOLIRIS if you:

  • have a meningococcal infection.
  • have not been vaccinated against meningitis infection unless your doctor decides that urgent treatment with SOLIRIS is needed. See “What is the most important information I should know about SOLIRIS?”

Before you receive SOLIRIS, tell your doctor about all of your medical conditions, including if you:

  • have an infection or fever.
  • are pregnant or plan to become pregnant. It is not known if SOLIRIS will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if SOLIRIS passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIRIS and other medicines can affect each other causing side effects.

It is important that you:

  • have all recommended vaccinations before you start SOLIRIS
  • receive 2 weeks of antibiotics if you immediately start SOLIRIS
  • stay up-to-date with all recommended vaccinations during treatment with SOLIRIS

Know the medications you take and the vaccines you receive. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of SOLIRIS?

SOLIRIS can cause serious side effects including:

  • See “What is the most important information I should know about SOLIRIS?”
  • Serious allergic reactions. Serious allergic reactions can happen during your SOLIRIS infusion. Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion:
    • chest pain
    • trouble breathing or shortness of breath
    • swelling of your face, tongue, or throat
    • feel faint or pass out

If you have an allergic reaction to SOLIRIS, your doctor may need to infuse SOLIRIS more slowly, or stop SOLIRIS. See “How will I receive SOLIRIS?” in the Medication Guide.

The most common side effects in people with gMG treated with SOLIRIS include:

  • muscle and joint (musculoskeletal) pain

Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of SOLIRIS. For more information, ask your doctor or pharmacist.

 

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.

 

Please see the full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections.

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