Switching to Ultomiris from Soliris found safe, effective in real world
No reports of new side effects or worsening of symptoms for up to year
Adults with atypical hemolytic uremic syndrome (aHUS) who switched from Soliris (eculizumab) to long-acting Ultomiris (ravulizumab) in a real-world setting experienced no new side effects or worsening of symptoms for up to a year, a study has found.
Switching to Ultomiris may be more convenient for patients because it requires fewer infusions than Soliris, which may reduce the frequency of hospital visits and lower the overall costs associated with treatment.
The study, “Clinical efficacy and safety of switching from eculizumab to ravulizumab in adult patients with aHUS– real-world data,” was published in the journal BMC Nephrology.
aHUS occurs when the complement system becomes overactive and causes clots to form in small blood vessels, blocking blood flow and damaging the kidneys and other organs. The complement system is a part of the immune system that normally helps the body fight off infections.
Soliris and Ultomiris block C5 complement protein
Both Soliris and Ultomiris keep the complement system in check by blocking the C5 complement protein, thereby easing aHUS symptoms. Unlike Soliris, which is infused into the bloodstream every other week, Ultomiris is infused in intervals of up to two months because it stays in the body up to four times longer.
While many patients on long-term treatment with Soliris may have been transitioning to Ultomiris to take advantage of fewer infusions, few studies have reported on how safe this switch is and how well it works to keep symptoms under control.
In the new study, a team of researchers in Germany reviewed the clinical records of 32 adults with aHUS, including 10 who had received kidney transplants, to check how well they did after switching from Soliris to Ultomiris. These patients, who were a mean age of 41.4 years, had been on Soliris for at least three months and for up to 10 years before switching to Ultomiris.
Genetic testing revealed most patients (71.9%) carried at least one known disease-causing mutation in genes coding for complement proteins. The researchers noted “this proportion is in line with [the] literature,” but was higher than that seen in Phase 3 clinical testing of Ultomiris.
For the switch, a loading dose of Ultomiris was infused two weeks after the last dose of Soliris. Another dose of Ultomiris was given two weeks later, followed by additional doses every eight weeks. Dosing was adjusted according to the patient’s body weight, as recommended in its prescribing information.
No patients had episodes of thrombotic microangiopathy during follow-up
During follow-up, which lasted up to 12 months after the switch, none of the patients experienced episodes of thrombotic microangiopathy, which is characterized by the destruction of red blood cells, low numbers of platelets, and organ damage due to the formation of blood clots.
There were no signs of kidney function worsening, and none of the patients progressed to end-stage kidney disease, when the kidneys stop functioning. This suggests that Ultomiris was as effective as Soliris in keeping aHUS symptoms under control.
The most common side effects reported with Ultomiris were urinary tract infection, upper respiratory tract infection, and headache or dizziness. No serious side effects related to treatment were reported, and no meningococcal infections, a potential serious side effect of Ultomiris.
“Switching to [Ultomiris] was safe and efficient resulting in sustained hematological [blood] stability and preservation of renal [kidney] function,” the researchers wrote.
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