Phase III Results on Dupixent in Adolescents
Many adolescent patients with moderate-to-severe atopic dermatitis (AD) find themselves with limited treatment options, especially when topical medications fail, or aren’t feasible to treat the patient’s condition.1 While there are some treatments available, they aren’t always the best options for long-term treatment, or they aren’t safe to use for extended periods.1 AD in adolescents can be a source of embarrassment, lead to bullying and can lower self-esteem at a critical point in a child’s development.2
Adolescent clinical trial
Researchers at Regeneron-Sanofi have been conducting a Phase III clinical trial using the medication Dupixent (generic name: dupilumab) in an adolescent (12-17 years) population. Dupixent is an immunotherapy that targets a group of proteins known as interleukin-4 (IL-4) and interleukin-13 (IL-13).3Interleukins are a part of the immune system and are created by white blood cells; IL-4 and IL-13 specifically play a part in the inflammation that leads to moderate-to-severe AD.3
Who participated in the clinical trial?
Researchers enrolled 251 patients, 12-17 years old with moderate-to-severe AD whose disease couldn’t be controlled with topicals, or who couldn’t receive treatment for other reasons.3 The patients were split into three groups. The first group of patients received treatment based on weight (200-300 mg of Dupixent with a first dose of 400-600 mg) every two weeks. The second group received a set dose of 300 mg of Dupixent (with a first dose of 600mg) every four weeks. The last group received a placebo every two weeks.3
Of the first group, who were dosed based on weight, 41.5% of patients had a skin improvement of 75% or greater, and 24% had clear or almost clear skin.4 In the second group, who received a standard dose, 38% had a skin improvement of 75% or greater, and 18% had clear or almost clear skin. The placebo group had 8% of patients with a skin improvement of 75% or greater, and 2% who achieved clear or almost clear skin.
Were the results better for those treated with Dupixent?
Patients in the weight-based group and in the standard dose groups reported a 66% and 65% change in their Eczema Area and Severity Index (EASI) Scores, while patients in the placebo group only reported a 24% change in their scores.3 Patients also reported about a 45% reduction in itch.1 Importantly, there was a significant improvement in the reported quality of life for patients treated with Dupixent versus the placebo.3
The medication is not without side effects. 72% of patients in the weight-based group, 64% of patients in the standard dose group and 69% of placebo patients reported adverse events.3 None of these adverse events were serious, and the most commonly reported events in patients treated with Dupixent were injection site reactions and conjunctivitis. No patients discontinued treatment due to their reactions.1 The most common adverse events in patients treated with the placebo were skin infections and AD flares.1
While this trial is promising, Dupixent has not been approved by any regulatory agency, either in the United States or Europe. The medication will likely have to go to Phase IV trial to prove safety and efficacy before the FDA approves it in the United States. If it is approved, Dupixent will be able to fill an unmet need in adolescent AD patients, improving quality of life, and helping patients during an important time in their life.
Have you been diagnosed with atopic dermatitis?