Results with RYSTIGGO
RYSTIGGO is FDA-approved to treat both anti-AChR and anti-MuSK antibody-positive gMG
Results with RYSTIGGO
RYSTIGGO is FDA-approved to treat both anti-AChR and anti-MuSK antibody-positive gMG
RYSTIGGO was studied in a large clinical trial (200 participants) specifically for people with gMG
The RYSTIGGO clinical trial included adults with gMG who were anti-AChR or anti-MuSK antibody positive.
of people with gMG are anti-AChR or anti-MuSK antibody positive
of people with gMG are anti-AChR or anti-MuSK antibody positive
200 people were divided into 3 groups:
- Those taking 7 mg/kg of RYSTIGGO (66 people)
- Those taking 10 mg/kg of RYSTIGGO (67 people)
- Those taking placebo (67 people)
People in the study:
- Received 1 dose each week for 6 weeks, in addition to their current gMG treatment
- Underwent a 6-week treatment period followed by an observation period of up to 8 weeks
UCB is grateful to all the doctors, nurses, and people living with gMG who participated in this trial.
Results of the RYSTIGGO clinical trial:
Significant improvement in the activities of daily living
RYSTIGGO significantly improved activities of daily living such as breathing, talking, swallowing, and being able to rise from a chair.*
*As determined by improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline on Day 43 of the study; -3.4 points in the RYSTIGGO-treated group (133 people) vs -0.8 in the placebo group (67 people).
Individual results may vary, and not all people taking RYSTIGGO will experience improvements.
These results were measured using the Myasthenia Gravis Activities of Daily Living scale (MG‑ADL)
Study participants scored themselves on 8 functional activities commonly
affected by gMG. A total MG-ADL score ranges from 0-24, with higher scores indicating more
impairment.
Rapid improvement by the end of Week 6
RYSTIGGO was shown to significantly improve activities of daily living by the end of the 6-week treatment period. Improvements were seen in some participants as early as 1 week after the first dose.†
†35% (23 out of 66 people) of the 7 mg/kg group and 38% (25 out of 66) of the 10 mg/kg group, compared to 24% (16 out of 67) of the placebo group, as determined by improvement in MG-ADL score.
Up to 72% of people responded to treatment
Among clinical trial participants receiving RYSTIGGO, a majority experienced improvements in symptoms.‡ Caution must be used when interpreting as conclusions cannot be drawn. Results may vary.
‡72% (46 out of 64 people) in the 7 mg/kg group and 69% (43 out of 62) in the 10 mg/kg group, compared to 31% (20 out of 64) in the placebo group, as determined by improvement in MG-ADL score from baseline on Day 43 of study. Response was defined as at least a 2-point improvement in MG-ADL score from baseline by Day 43.
The first treatment of its kind for anti-MuSK antibody-positive gMG
All 12 participants with anti-MuSK antibody-positive gMG who received RYSTIGGO showed improvement in activities of daily living.§ Caution must be used when interpreting as conclusions cannot be drawn. Results may vary.
§As determined by improvement in their MG-ADL score. The study did not compare improvements in anti-MuSK antibody-positive participants to those who were anti-AChR antibody positive and received RYSTIGGO (120 participants).
Ask your doctor if RYSTIGGO may be right for you.
The Doctor Discussion Guide can help you get the conversation started.
The safety of RYSTIGGO in the clinical trial
The following side effects were experienced by 5% or more people taking RYSTIGGO, and more often than in those on placebo.
(133 people)
(67 people)
RYSTIGGO may cause serious side effects, including:
- Infection: RYSTIGGO may increase the risk of infection. Your healthcare provider should check you for infections before starting and during treatment with RYSTIGGO. Tell your healthcare provider if you have any history of infections. Tell your healthcare provider right away if you have signs or symptoms of an infection during treatment with RYSTIGGO. Some of the signs and symptoms may include fever, chills, frequent and/or painful urination, cough, runny nose, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.
- Aseptic Meningitis: RYSTIGGO could cause aseptic meningitis. Tell your healthcare provider right away if you develop any signs or symptoms of meningitis during treatment with RYSTIGGO such as severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting.
- Hypersensitivity Reactions: RYSTIGGO can cause swelling and rash. Your healthcare provider should monitor you during and after treatment and discontinue RYSTIGGO if needed. Tell your healthcare provider immediately about any undesirable reactions you experience after administration.
