Filsuvez cuts time, money spent on EB dressing changes: Trial data
Changes needed less often, take less time with topical therapy
Filsuvez (birch triterpenes) reduced the burden of wound dressing changes for people with dystrophic epidermolysis bullosa (DEB) and junctional epidermolysis bullosa (JEB). The frequency of changes — along with the time and estimated money spent on them — went down with the topical therapy.
That’s according to new analyses from EASE (NCT03068780), the Phase 3 study that supported Filsuvez’s regulatory approvals for DEB and JEB in the U.S. and elsewhere.
“[Filsuvez] significantly reduced dressing frequency and time burden, with potential to ease the intensive demands of EB wound care,” the researchers wrote.
The study, “Reduction in Dressing Change Burden in Patients With Epidermolysis Bullosa—Impact of Oleogel-S10,” was published in The Journal of Dermatology. It was funded by Amryt Pharma, the company that was developing Filsuvez before being acquired by Chiesi Global Rare Diseases. One of the study authors was affiliated with Amryt and two with Chiesi at the time of the analysis.
DEB and JEB are rare genetic diseases characterized by fragile skin that easily tears and blisters. People with these forms of epidermolysis bullosa (EB) have open wounds that are slow to heal and often become infected.
Dressing changes a big part of EB management
Wound care is a major part of EB management. Wounds can require frequent dressing changes that are time-consuming, painful, and expensive, placing a substantial burden on patients and families.
“Alongside the imperatives to heal wounds and prevent re-injury and infection, EB patients and their caregivers have described decreasing time for dressing change as among one of the most important factors for EB therapies,” the researchers wrote.
Filsuvez, formerly known as Oleogel-S10, contains a tree bark extract that’s believed to ease inflammation and promote the growth of skin cells. When administered as a topical gel onto wounds during dressing changes, it is expected to help expedite healing.
The medication is approved in the U.S. to treat wounds in people with DEB or JEB, ages 6 months and older, with similar approvals elsewhere. It’s particularly intended for treating partial thickness wounds, or those that don’t extend past the top two layers of skin.
These approvals were supported by data from EASE, which involved more than 200 people with DEB and JEB who were randomly assigned to apply Filsuvez or a placebo control gel to their partial-thickness wounds during standard dressing changes for about three months (90 days).
Trial results showed that Filsuvez led to significantly higher rates of target wound closure than the placebo within 45 days, meeting the study’s main goal. In the subsequent open-label phase (OLP), where all participants used Filsuvez for two more years, Filsuvez was associated with sustained reductions in wound burden.
In the latest study, scientists examined whether Filsuvez eased the burden of dressing changes for participants who had been undergoing daily dressing changes at the study’s start (baseline). This included 43% of the Filsuvez group (47 people) and 46% of the placebo group (53 people).
Results showed that at day 90, significantly more people on Filsuvez no longer required daily dressing changes compared with the placebo group (35.6% vs. 10.6%).
People on Filsuvez also had a significantly greater reduction in the number of required weekly dressing changes compared to the placebo. The difference “equates to almost three fewer dressing changes every 2 weeks for [Filsuvez] versus only one fewer for control gel,” the researchers said.
At baseline, participants in either group were spending around 2.5 hours a day on dressing changes. This was reduced to an average of 1.6 hours per day with Filsuvez and 2.2 hours with the control gel.
Ultimately, the switch to Filsuvez saved an estimated 10.7 hours each week — 6.4 hours for the patient and 4.3 hours for the caregiver. By comparison, four hours per week were saved with the placebo — 2.4 hours for patients and 1.6 hours for caregivers.
The reductions in dressing changes were associated with about a 60% reduction in the estimated cost of dressing changes. Without treatment, dressing changes were estimated to cost more than $63,000 per patient over the 27 months (a little over two years) spanning the main trial and its OLP. With Filsuvez, this went down to around $25,900.
This reflects $16,700 in annualized cost savings per patient, according to the authors. “In the EASE cohort, this could have translated to a $3.3 million saving throughout the study for patients who required daily dressing changes at baseline,” they wrote.
The data show Filsuvez “has the potential to reduce the burden of dressing changes, a painful, distressing, and costly procedure that is a constant challenge for those living with EB,” the team concluded.
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