Soliris benefits maintained after patients switch to Ultomiris: Study
Survey finds patients prefer Ultomiris six months after switching
The initial treatment benefits of Soliris (eculizumab) were maintained after people with generalized myasthenia gravis (gMG) switched over to Ultomiris (ravulizumab-cwvz), a small real-world study confirmed.
Most patients who completed a survey almost six months after switching said they preferred Ultomiris due to treatment convenience, lower frequency of infusions. the ability to plan activities, and better quality of life.
The study, “Real-world experience with eculizumab and switching to ravulizumab for generalized myasthenia gravis,” was published in the Annals of Clinical and Translational Neurology.
Soliris is approved for people with hard-to-treat gMG who are positive for self-reactive antibodies targeting the acetylcholine receptor (AChR), the most common type of MG-causing antibody. Administered via an infusion into the bloodstream, Soliris is designed to block the activation of the complement cascade, a part of the immune system that plays a key role in driving MG, by targeting a complement protein called C5.
Some Soliris-treated patients switch to a different medication due to lack of effectiveness, side effects, or the desire for a more convenient treatment regimen. Ultomiris is also a complement inhibitor that works by targeting C5, but is designed to be more stable in the bloodstream, allowing for less frequent dosing compared with Soliris.
Describing real-world patient experiences with Soliris treatment
Researchers in Japan noted that the “clinical effectiveness of the switch from [Soliris] to [Ultomiris] in the real-world experience is not described.” In an effort to learn more, they conducted a study in which they drew on data from a Japan MG registry to analyze the clinical outcomes of gMG patients receiving Soliris, as well as of those who eventually switched over to Ultomiris.
Of the 1,106 gMG patients with anti-AChR antibodies in the Japan MG registry, 36 (3%) were treated with Soliris.
All but one of the Soliris-treated patients were categorized as being MGFA class III, meaning they had eye muscle involvement of any severity and moderate weakness affecting other muscles, or worse.
Twelve patients had experienced a myasthenic crisis, a life-threatening event marked by weakness in the muscles that control breathing. All participants were receiving immunosuppressive therapy in the form of oral prednisolone.
Over an average of 35 months (nearly three years), Soliris reduced the overall severity of MG symptoms and their impact on daily life, as assessed by the patient-reported MG Activities of Daily Living (MG-ADL) scale.
Among the 36 Soliris-treated patients, 25 (70%) were considered responders, meaning they saw an improvement of three or more points in the MG-ADL score. Soliris treatment also led to a reduction in the doses of prednisolone in 20 patients (56%).
Before Soliris treatment, two patients were classified as having minimal disease manifestations, or the absence or very low level of MG symptoms. After treatment with Soliris, the number of patients attaining this status had increased to 13 (36%).
The number of patients who experienced positive changes in their condition after receiving Soliris rose from seven to 15. Still, the health status of eight patients remained unchanged or had worsened.
Patients younger than 50 had the most significant MG-ADL gains, compared with those ages 50 and older and those in whom MG was associated with tumors in the thymus gland.
“To our knowledge, there have been no reports that showed [Soliris] was effective particularly in early onset MG compared with late-onset MG and thymoma-associated MG,” the researchers wrote.
Soliris was discontinued in 13 patients (36%) due to lack of effectiveness (in six) and side effects (in two). While two patients died (one from stroke and one from cervical cancer), both were considered Soliris responders. The remaining patients no longer required treatment due to achieving a minimal disease manifestation status.
Among the remaining 23 patients, 15 switched from Soliris to Ultomiris. MG-ADL scores in these patients remained generally stable over 26 weeks (almost six months). Three patients saw their MG-ADL scores improve by at least three or more points, including one who achieved a status of minimal manifestation.
After 26 weeks of Ultomiris treatment, nine of 14 patients (64%) who completed a questionnaire said they preferred Ultomiris over Soliris. Reasons for this preference included the frequency of infusions, the ability to plan activities, the convenience of receiving treatment, and quality of life.
“[Soliris] and switching to [Ultomiris] showed to be effective for refractory AChR-[positive] gMG patients in clinical settings,” the researchers wrote.
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