How SOLIRIS (eculizumab) was studied
SOLIRIS was studied in a clinical trial called REGAIN
125 patients total
- 62 received SOLIRIS
- 63 received Placebo
After 26 weeks, patients had the option to participate in an open-label extension study.
REGAIN was a 26-week clinical trial that studied the safety and efficacy of SOLIRIS compared to placebo* in adults with anti-AChR antibody-positive generalized myasthenia gravis (gMG).
The primary endpoint† was average change in MG-ADL total score from the start of the trial to Week 26.
REGAIN also looked at how many patients achieved a clinically meaningful†† improvement in MG-ADL total score.
After 26 weeks, patients had the option to participate in an open-label extension study.
During the trial, patients were able to keep taking certain medications, like steroids.
*Placebo is an inactive substance or treatment that looks the same as, and is given in the same way as, the investigational medication being studied.
†Primary Endpoint: The primary result measured at the end of a study to determine whether a treatment is effective.
††Clinically meaningful in this trial was defined as ≥3-point improvement from baseline in MG-ADL total score at 26 weeks of treatment.
When the REGAIN trial began...
91%
of participants were MGFA
class II or III
Patients’ MG-ADL score had to be
6
or more
98%
of participants had tried 2 or more immunosuppressive treatments
MGFA Class
The Myasthenia Gravis Foundation of America (MGFA) classifications range from I to V, with V being the most severe.
Class I
Any ocular muscle weakness. May have weakness of eye closure. All other muscle strength is normal.
Class II
Mild weakness in muscles other than in the eye; may also impact eye
Class III
Moderate weakness in muscles other than in the eye; may also impact eye
Class IV
Severe weakness affecting muscles other than ocular muscles. May also have ocular weakness of any severity.
Class V
Intubation, with or without medical ventilation, except when used during postoperative management.
The results from the REGAIN trial
SOLIRIS showed improvement in MG-ADL total score from baseline to Week 26.
SOLIRIS
4.2
point average improvement in MG-ADL total score
PLACEBO
2.3
point average improvement in MG-ADL total score
Average MG-ADL total score before starting the clinical trial was 10.5 for the SOLIRIS group and 9.9 for the Placebo group.
SELECT IMPORTANT SAFETY INFORMATION
What are the possible side effects of SOLIRIS?
SOLIRIS can cause serious side effects including serious infusion-related reactions. 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; and feel faint or pass out. If you have an infusion-related reaction to SOLIRIS, your doctor may need to infuse SOLIRIS more slowly, or stop SOLIRIS.
Please see additional Important Safety Information, including Boxed WARNING regarding serious and life-threatening meningococcal infections, below.
Most patients improved their MG-ADL total score by 3 points or more by 26 weeks
In this trial a clinically meaningful response was defined as ≥ 3-point improvement in MG-ADL total score after 26 weeks of treatment.
60%
of patients who received SOLIRIS experienced a clinically meaningful response
More than one-third of patients (34%) taking SOLIRIS experienced an improvement of
7
points
or more
7
points
or more
SELECT IMPORTANT SAFETY INFORMATION
What are the possible side effects of SOLIRIS? (cont'd)
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 additional Important Safety Information, including Boxed WARNING regarding serious and life-threatening meningococcal infections, below.
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Sign up todayWhat is the most important information I should know about SOLIRIS?
SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.
- SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early.
- You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you are not vaccinated.
- If your doctor decided that urgent treatment with SOLIRIS is needed, you should receive meningococcal vaccination as soon as possible.
- If you have not been vaccinated and SOLIRIS therapy must be initiated immediately, you should also receive two weeks of antibiotics with your vaccinations.
- If you had a meningococcal vaccine in the past, you might need additional vaccination. Your doctor will decide if you need additional vaccination.
- Meningococcal vaccines reduce 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, and 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. It is important to show this card to any doctor or nurse to 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 and a Patient Safety Card about the symptoms and your risk of meningococcal infection (as discussed above); and make sure that you are vaccinated with the meningococcal vaccine and, if needed, get revaccinated with the meningococcal vaccine. Ask your doctor if you are not sure if you need to be revaccinated.
SOLIRIS may also increase the risk of other types of serious infections. Certain people may be at risk of serious infections with gonorrhea. Certain fungal infections (Aspergillus) may occur 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 or have not been vaccinated against meningitis infection unless your doctor decides that urgent treatment with SOLIRIS is needed.
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, and are breastfeeding or plan to breastfeed. It is not known if SOLIRIS will harm your unborn baby or if it passes into your breast milk.
Tell your doctor about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. It is important that you have all recommended vaccinations before you start SOLIRIS, receive 2 weeks of antibiotics if you immediately start SOLIRIS, and stay up-to-date with all recommended vaccinations during treatment with SOLIRIS.
What are the possible side effects of SOLIRIS?
SOLIRIS can cause serious side effects including serious infusion-related reactions. 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, and feel faint or pass out. If you have an infusion-related reaction to SOLIRIS, your doctor may need to infuse SOLIRIS more slowly, or stop SOLIRIS.
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.
INDICATION
What is SOLIRIS?
SOLIRIS is a prescription medicine 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.
Please see the full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections.
What is the most important information I should know about SOLIRIS?
SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.
- SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early.
- You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you are not vaccinated.
- If your doctor decided that urgent treatment with SOLIRIS is needed, you should receive meningococcal vaccination as soon as possible.
- If you have not been vaccinated and SOLIRIS therapy must be initiated immediately, you should also receive two weeks of antibiotics with your vaccinations.
- If you had a meningococcal vaccine in the past, you might need additional vaccination. Your doctor will decide if you need additional vaccination.
- Meningococcal vaccines reduce 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, and 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. It is important to show this card to any doctor or nurse to 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 and a Patient Safety Card about the symptoms and your risk of meningococcal infection (as discussed above); and make sure that you are vaccinated with the meningococcal vaccine and, if needed, get revaccinated with the meningococcal vaccine. Ask your doctor if you are not sure if you need to be revaccinated.
SOLIRIS may also increase the risk of other types of serious infections. Certain people may be at risk of serious infections with gonorrhea. Certain fungal infections (Aspergillus) may occur 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 or have not been vaccinated against meningitis infection unless your doctor decides that urgent treatment with SOLIRIS is needed.
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, and are breastfeeding or plan to breastfeed. It is not known if SOLIRIS will harm your unborn baby or if it passes into your breast milk.
Tell your doctor about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. It is important that you have all recommended vaccinations before you start SOLIRIS, receive 2 weeks of antibiotics if you immediately start SOLIRIS, and stay up-to-date with all recommended vaccinations during treatment with SOLIRIS.
What are the possible side effects of SOLIRIS?
SOLIRIS can cause serious side effects including serious infusion-related reactions. 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, and feel faint or pass out. If you have an infusion-related reaction to SOLIRIS, your doctor may need to infuse SOLIRIS more slowly, or stop SOLIRIS.
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.
INDICATION
What is SOLIRIS?
SOLIRIS is a prescription medicine 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.
Please see the full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections.