Weight-based Soliris dosing regimen could save patients time, money: Study
Patients can reach therapeutic levels of the medication with fewer infusions
A weight-based regimen for administering Soliris (eculizumab) in people with atypical hemolytic uremic syndrome (aHUS) may allow patients to reach therapeutic levels of the medication with fewer infusions, saving time and money.
“We suggest to introduce this dosing schedule as the standard of care to improve therapeutic success and patient-friendliness at a lower cumulative [Soliris] dose,” researchers wrote in a study, “Prospective validation of initial eculizumab dosing in adults with atypical hemolytic uremic syndrome,” which was published as a letter to the editor in Nephrology Dialysis Transplantation.
Soliris works to block activation of complement cascade
Soliris is an approved aHUS treatment that works to block the activation of the complement cascade, a part of the immune system that’s overactive in people with the disease.
The therapy is given by an infusion into the bloodstream. Under the approved dosing regimen, patients receive infusions at a dose of 900 mg weekly for the first four weeks, then a 1,200 mg infusion on the fifth week and every other week thereafter.
Scientists in the Netherlands are pioneering an alternative initial dosing strategy based on a patient’s body weight. With this strategy, on the first day of treatment, patients weighing more than 120 kg (265 pounds) get an infusion of 2,400 mg; those weighing 90 to 120 kg (198 to 265 pounds) get an infusion of 2,100 mg; those weighing 60 to 90 kg (132 to 198 pounds) get an infusion of 1,800 mg; and those weighing 40 to 60 kg (88 to 132 pounds) get an infusion of 1,500 mg.
Two weeks after the first weight-based infusion, patients receive an infusion of 1,200 mg, and then continue to receive 1,200 mg infusions every other week, in line with the therapy’s approved maintenance dosing schedule.
In their study, the researchers measured and compared the levels of Soliris in the blood from 24 adults diagnosed with aHUS who were treated with the new weight-based regimen to those of 21 people who received the approved dosing regimen.
Soliris levels higher in patients on new dosing regimen after 1 week
Results showed that, in the first week after starting treatment, Soliris levels were significantly higher in patients given the new dosing regimen. In fact, nearly half of patients who were on standard dosing had levels below those needed to effectively control aHUS activity.
After two weeks of treatment, Soliris levels were similar in the two groups. At the end of the first month of treatment, patients given standard dosing generally had higher levels of Soliris. However, for many of these patients, the levels of the medication in the body were actually much higher than those needed to control disease activity.
As such, researchers argued that the weight-based regimen could allow patients to more quickly attain adequate therapeutic levels of the medication to keep aHUS under control. The new regimen also requires fewer infusions, so it’s less expensive and burdensome for patients, costing about 13% less than standard dosing because it requires less medication overall.
“With our new dosing regimen, we prevent [excessive Soliris] concentrations at the end (day 21-28) of the initial phase, in contrast to the standard dosing regimen. The new dosing regimen is also more patient-friendly and less expensive,” the researchers wrote.
The team suggested adopting this regimen in clinical practice, though they noted that further studies will be necessary to definitively confirm that it works as well for controlling disease activity.
About the Author
