Results with ZILBRYSQ

ZILBRYSQ is the first once-daily, self-administered treatment for adults with anti-AChR antibody-positive generalized myasthenia gravis (gMG).

 

ZILBRYSQ was studied in a large clinical trial specifically for adults with anti-AChR antibody-positive gMG

174 adults living with gMG enrolled in the ZILBRYSQ clinical trial

174 participants were randomly divided into 2 groups:

  • Those taking 0.3 mg/kg of ZILBRYSQ (86 participants)
  • Those taking placebo (88 participants)

Participants in the study:

  • Took 1 dose each day for 12 weeks, in addition to their current gMG treatment

UCB is grateful to all the doctors, nurses, and people living with gMG who participated in this trial.

100%.

100% of participants who completed this clinical trial opted to take ZILBRYSQ in an additional, long-term study.

166 participants completed the ZILBRYSQ clinical trial.

Results of the ZILBRYSQ clinical trial:

Individual results may vary, and not all people taking ZILBRYSQ will experience improvements.

Significant improvements in the activities of daily living

ZILBRYSQ 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 Week 12 of the study; -4.4 points in the ZILBRYSQ-treated group (86 people) vs -2.3 in the placebo group (88 people).

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 improvements in daily living

ZILBRYSQ was shown to significantly improve activities of daily living at 12 weeks. Improvements were seen in some participants as early as Week 1.

73%.

More than 7 in 10 participants responded to treatment

Among clinical trial participants receiving ZILBRYSQ, a majority experienced improvements in symptoms.

73% (63 out of 86 people) in the 0.3 mg/kg group compared to 46% (40 out of 88 people) in the placebo group, as determined by improvement in MG-ADL score from baseline without rescue therapy on Week 12 of study. Response was defined as at least a 3-point improvement in MG-ADL score from baseline without rescue therapy by Week 12.

Nearly 6 in 10 participants saw improvement in muscle strength

58% (50 out of 86 people) of clinical trial participants receiving ZILBRYSQ experienced reduced muscle weakness at 12 weeks, improving their physical functions.

Compared to 33% of people taking placebo, as determined by the Quantitative MG (QMG) total score. The QMG score assesses muscle weakness based on 13 physical functions, including looking side-to-side, looking upward, facial movements, swallowing, speaking, outstretching right arm, outstretching left arm, vital capacity, right hand grip, left hand grip, lifting head, outstretching right leg, and outstretching left leg. Response is defined as having at least a 5-point decrease in QMG score at Week 12 without rescue therapy.

Ask your doctor about ZILBRYSQ.

Our Doctor Discussion Guide can help you get the conversation started.

Safety of ZILBRYSQ in the clinical trial

The following side effects were experienced by 5% or more participants taking ZILBRYSQ and more frequently than those on placebo:

Side effect
ZILBRYSQ
(86 participants)
Placebo
(88 participants)
Side effect
Injection site reactions
29%
16%
Upper respiratory tract infections
14%
7%
Diarrhea
11%
2%
Urinary tract infection
8%
5%
Nausea or vomiting
8%
7%
Lipase increased
7%
0%
Amylase increased
5%
1%
  • ZILBRYSQ increases your chance of getting serious and life-threatening meningococcal infections. Meningococcal infections may become life-threatening or fatal if not recognized and treated early
    • You must receive vaccines for meningococcal infections at least 2 weeks before your first dose of ZILBRYSQ if you have not already received them
    • For more information about meningococcal vaccinations, click here
  • ZILBRYSQ may also increase the risk of other types of serious infections
    • ZILBRYSQ may increase your chance of getting Streptococcus pneumoniae and Haemophilus influenzae type b. Your healthcare provider will tell you if you should receive the Streptococcus pneumoniae and Haemophilus influenzae type b vaccinations
    • Certain people may have an increased risk of gonorrhea infection. Talk to your healthcare provider about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and about regular testing
  • Pancreatitis and pancreatic cysts have happened in people who use ZILBRYSQ. Your healthcare provider will do blood tests to check your pancreas before you start treatment with ZILBRYSQ
  • No participants taking ZILBRYSQ stopped treatment due to injection site reaction