MDA 2026: New data show Rystiggo provides consistent relief in gMG
Approved infusion therapy eased symptoms over a dozen treatment cycles
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- New data show Rystiggo consistently relieves generalized myasthenia gravis symptoms over many treatment cycles.
- The approved infusion therapy maintained its effectiveness and safety with repeated use, an analysis found.
- The researchers analyzed data from the MycarinG clinical trial and its two extension studies, which had supported the treatment's approval.
Rystiggo (rozanolixizumab-noli) provides consistent symptom relief for people with generalized myasthenia gravis (gMG) across more than a dozen treatment cycles, according to a new analysis of clinical trial data.
The approved UCB therapy is given as weekly subcutaneous, or under-the-skin, infusions in six-week cycles, with additional cycles administered as needed to control gMG symptoms. The new analysis, which involved more than 100 patients — each having received two to 13 cycles — showed that Rystiggo’s ability to ease gMG symptoms is similar across all treatment cycles. Rystiggo’s safety profile was also consistent over these cycles.
For some gMG patients in the trial, benefits from the approved therapy spanned more than one year, the data showed.
The findings were shared through a poster, titled “Efficacy and Safety of Rozanolixizumab Treatment Cycles in Patients With Generalized Myasthenia Gravis: Final Pooled Analysis of Phase 3 Studies,” at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, running March 8-11 in Orlando and virtually.
“These efficacy and safety data from [clinical] studies support the long-term use of repeated cycles of [Rystiggo] in patients with gMG,” the researchers wrote in the poster.
In gMG, self-targeting antibodies disrupt the communication between nerves and muscles, resulting in muscle weakness. Rystiggo works to reduce levels of these disease-driving antibodies by blocking a protein that prevents the breakdown of antibodies in the blood.
The therapy is approved in the U.S. and the European Union to treat adults with gMG who are positive for antibodies against acetylcholine receptor (AChR) or muscle-specific tyrosine kinase (MuSK), the two most common MG-causing antibodies. The therapy’s recommended dose is dependent on a patient’s body weight.
Researchers dive deep into MycarinG trial data
Rystiggo’s approvals were based mainly on data from the global Phase 3 MycarinG clinical trial (NCT03971422), which involved 200 adults with gMG and antibodies against AChR or MuSK.
Data showed that a six-week cycle of Rystiggo was superior to a placebo in reducing scores on the MG Activities of Daily Living (MG-ADL) scale. This scale assesses how severely MG impacts a patient’s day-to-day life, with lower scores reflecting a milder impact.
Participants who completed MycarinG could enroll in one of two sequential, open-label extension studies, the one-year MG0004 (NCT04124965) or the three-year MG0007 (NCT04650854). In both, participants received additional cycles of Rystiggo as needed to manage symptoms. Across MycarinG and the extension studies, Rystiggo was given at doses of either 7 or 10 mg/kg.
Previously reported findings from MycarinG, interim results from MG0007, and data from the first six weeks of MG0004 suggested that the therapy’s safety and effectiveness were consistent across treatment cycles one to six.
The newly presented data concerned 188 participants who received at least one treatment cycle of Rystiggo across these three trials, with some participants undergoing 13 cycles.
Participants in the studies for at least one year received a median of four cycles in the first year, which “equates to an expected treatment pattern in the first year of 6 weeks of [Rystiggo] treatment followed by a 6-8-week treatment-free interval, which can be adjusted for individual patients as needed,” the researchers wrote in the poster.
Rystiggo use led to improvements in daily living for patients
To assess the therapy’s effectiveness, the researchers compared changes in MG-ADL scores from the start to the end of each six-week cycle for the 129 gMG patients who received at least two Rystiggo cycles.
The results showed that average MG-ADL scores dropped by at least three points over the course of each Rystiggo cycle — a clinically meaningful change — with a trend toward greater score reductions with additional cycles.
Other validated disease severity measures, namely the Quantitative Myasthenia Gravis and MG Composite score, also showed clinically meaningful improvements on each cycle of Rystiggo treatment, according to the researchers.
Across all three measures, there was a rapid score change about a week after starting Rystiggo, and clinically meaningful improvements were sustained from two weeks to one month.
[Rystiggo] showed consistent improvements across multiple MG-specific outcomes up to 13 cycles and was generally well tolerated following repeated cyclic treatment.
For most cycles, the most frequent interval duration between cycles was between one to two months.
The safety profile of Rystiggo, based on 188 participants, was also generally consistent across cycles. The most commonly-reported adverse event was headache, which affected 50% of the patients. This was followed by diarrhea, experienced by 34% of patients, and COVID-19, seen for 22%. A few participants died during the study, but none of these deaths were judged to be related to Rystiggo.
Overall, the researchers concluded, Rystiggo “showed consistent improvements across multiple MG-specific outcomes up to 13 cycles and was generally well tolerated following repeated cyclic treatment.”
Note: The Myasthenia Gravis News team is providing live coverage of the 2026 MDA Clinical & Scientific Conference March 8-11 in Orlando, Florida. Go here to see the latest stories from the conference.
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