Registry data back Soliris, Ultomiris as safe, effective for gMG
Both treatments show long-term effectiveness for patients in real world
Soliris (eculizumab) and Ultomiris (ravulizumab-cwvz) are generally safe and effective for easing symptoms of generalized myasthenia gravis (gMG) when used in everyday clinical practice.
That’s according to data from the MG SPOTLIGHT Registry (NCT04202341), which was established to assess the long-term effectiveness of both therapies in adults with gMG in real-world clinical practice.
The study, “First analysis of the Myasthenia Gravis SPOTLIGHT Registry: outcomes with eculizumab and ravulizumab,” was published in the Journal of the Neurological Sciences. The work was funded by Alexion, AstraZeneca Rare Disease, which markets both Soliris and Ultomiris.
Myasthenia gravis (MG) is caused by antibodies that interfere with the communication between nerve and muscle cells, resulting in MG symptoms such as muscle weakness and fatigue. The most common type of MG-driving antibodies target the acetylcholine receptor (AChR), a protein found on muscle cells.
Soliris and Ultomiris are both widely approved to treat gMG, a more severe and widespread form of MG, in patients who are positive for antibodies against AChR. Both therapies block the activation of the complement cascade, a group of immune proteins involved in driving MG. While they share the same mechanism of action, Soliris is an older therapy administered by infusion every other week, while the newer Ultomiris is given by infusion every other month.
Looking at results in the real world
Clinical trials have shown that both Soliris and Ultomiris can help ease symptoms of gMG in patients who are positive for anti-AChR antibodies. But clinical trials are carefully controlled studies with strict enrollment criteria that may not perfectly reflect the real world.
The researchers analyzed data from a registry that recorded outcomes from the two therapies in clinical practice.
“The objectives of this Registry study were to evaluate the safety and effectiveness of [Soliris] and [Ultomiris] for the treatment of patients with gMG in clinical practice and to assess whether treatment effects were maintained after transitioning from [Soliris to Ultomiris],” the researchers wrote.
They looked at the cases of 189 gMG patients who started treatment with Soliris. Slightly more than half of these patients were men, and more than 80% were white, with a mean age of 61.3 at the time of enrollment. Most patients had lived with MG for more than two years before starting on Soliris.
The median duration of Soliris treatment was slightly less than two years. Some patients stopped taking Soliris after the first infusion, whereas others had been on the therapy for more than seven years as of the latest follow-up. About a third of the patients switched from Soliris to Ultomiris, and 16.9% stopped taking Soliris due to lack of efficacy.
To assess the effectiveness of treatment on MG symptoms, researchers mainly looked at scores on two standardized measures: the MG-Activities of Daily Living (MG-ADL), which assesses how much MG affects day-to-day life, and the Revised MG Quality of Life-15 (MG-QOL15r), which assesses the extent to which MG is affecting a patient’s quality of life.
MG-ADL data were available for 110 patients. Scores improved by a mean of 4.2 points after patients started Soliris. At the first assessment after starting Soliris, more than a third of these patients had an MG-ADL score of 1 or 0, meaning they had minimal or no MG symptoms.
MG-QOL15r data, available for 40 patients, likewise showed improvements following Soliris initiation, with scores improving by a mean of 7.5 points. MGFA class, another assessment of disease severity, also improved for many patients after they started Soliris.
Among patients who switched from Soliris to Ultomiris, scores on these disease severity measures generally remained stable after switching to the newer therapy.
Safety data from the registry study were consistent with the known safety profiles of Soliris and Ultomiris. Serious side effects were reported in two patients given Soliris and in one given Ultomiris. One of these serious events, an infection in a patient on Soliris, was fatal.
Overall, the data “demonstrate the effectiveness of [Soliris] on daily function and overall disease status, [quality of life] benefits, and its safety profile in patients with gMG in a clinical practice setting,” the researchers wrote. “In addition, these analyses showed that these benefits are sustained following a transition from [Soliris to Ultomiris].”
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