Dupilumab is effective in easing symptoms in adolescents with moderate to severe atopic dermatitis, according to research published in JAMA Dermatology.
A phase 3 randomised controlled trial compared 16 weeks of fortnightly (200 or 300 mg) or monthly (300 mg) dupilumab monotherapy with placebo in 250 adolescents, 12 to 18 year old.
The study found a significantly higher proportion of patients in all dupilumab groups (41.5% with fortnightly dosing; 38.1% with monthly dosing) reached EASI-75 by the end of treatment period compared to controls (8.2%).
The proportions of patients reaching the Investigator’s Global Assessment (IGA) score of 0 or 1 was also significantly higher with fortnightly (24.4%) and monthly treatment (17.9%) compared to placebo (2.4%).
Secondary outcomes including Peak Pruritus NRS, patient reported itch and sleep, and quality of life also favoured the monoclonal antibody.
“In addition, the proportion of patients requiring rescue medication was higher in the placebo group than the dupilumab groups (every 2weeks, 20.7%; every 4weeks, 32.1%; placebo, 58.8%),” the study authors said.
“Both dupilumab groups showed reductions from baseline in blood eosinophil count and significant suppression of blood lactate dehydrogenase level, serum thymus and activation regulated chemokine (TARC) (also known as CCL17), and total IgE concentrations compared with placebo.”
Patients with comorbid asthma or allergic rhinitis also experienced greater improvement in their symptoms with dupilumab treatment.
Conjunctivitis and injection site reactions were higher in the treatment groups than controls, as previously reported in adult populations.
There were no serious adverse events and none leading to discontinuation of treatment.
“While the every-2-week and every-4-week regimens had similar safety, the every-2-week regimen was numerically superior in most categorical efficacy end points, including the proportion of patients with IGA 0 or 1.”
“Pharmacokinetic data support the every-2-week dosing approval, as this dose provided higher dupilumab trough concentrations—a factor associated with greater efficacy.”
“Dupilumab had an acceptable safety profile and the placebo adjusted efficacy and safety in adolescents with moderate to severe AD were similar to those in adults,” the study concluded.
PBS listing wait
With more evidence for the effectiveness of dupilumab in atopic dermatitis, the community will be keen to see more support in the form of a PBS listing.
PBAC has twice rejected submissions for dupilumab for the treatment of adult patients who are inadequately controlled on topical therapies.
“The PBAC acknowledged the effectiveness of dupilumab in a therapeutic area of high clinical need, however considered that dupilumab was not cost-effective at the price proposed in the resubmission,” the outcome statement from the July 2019 PBAC meeting said.
“The PBAC also considered that the criteria for defining the patient population for initial and continuing treatment did not appropriately consider the extent of disease in terms of the body surface area affected.”
“The PBAC considered that the estimated financial implications were very high and uncertain, and that a risk sharing arrangement would be necessary to manage the uncertainty in patient estimates, likely treatment duration and the potential for use outside the proposed restriction.”
Melbourne dermatologist Dr Gayle Ross told the limbic she was hopeful dupilumab would receive a PBS listing in the next year or so given its effectiveness.
“I think it is absolutely life-changing. The vast majority of patients who have taken it have no itch and they are able to lead a normal life.”
While private access was available, the cost of about $20,000 per year was prohibitive for most patients.
A Change.org petition supporting the PBS listing of dupilumab for this indication has been started by patients with dermatitis saying they will otherwise have to pay tens of thousands of dollars for the only treatment that has worked for them.