The FDA’s approval of a new weight-based secukinumab (Cosentyx) formulation offers adolescents with moderate-to-severe hidradenitis suppurativa (HS) a new treatment option for the condition, also known as acne inversa.
A chronic inflammatory skin disease characterized by painful lumps, cysts, and skin tunnels; HS affects areas with sweat glands such as the armpits, groin, and buttocks, causing lesions that can become inflamed, rupture, and lead to scarring. While the FDA previously approved secukinumab as the first IL-17A inhibitor for the treatment of HS in adults in 2023, it is now the first IL-17A inhibitor approved for patients aged 12 and older.
Key takeaways:
- The FDA approved secukinumab (Cosentyx) for adolescents aged 12 and older with HS.
- It is the first IL-17A inhibitor approved for this age group.
Age (and Weight) Matters
HS affects approximately 1% to 4% of people in the United States, and more than half of patients develop symptoms during adolescence. Female patients are more likely to develop HS than males, and factors such as ethnicity, race, and family history may influence risk. Often associated with conditions like obesity and metabolic syndrome, HS can be difficult to diagnose and treat. While the exact cause is not fully understood, it is believed to involve an autoimmune component. Treatment options may include medications, lifestyle changes, and in some cases, surgery.
“HS often begins after puberty and the diagnosis is also commonly delayed, in some cases by as much as a decade,” explained Alexa B. Kimball, MD, MPH, president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, and professor of dermatology at Harvard Medical School. Dr. Kimball was the lead investigator of the SUNSHINE and SUNRISE clinical trials in adult patients with HS that contributed to this FDA approval. “Having options with established profiles for younger patients can help clinicians know how to treat them earlier in their disease course.”
The use of secukinumab in adolescents aged 12 years and older and weighing at least 30 kg is supported by well-controlled adult studies and pharmacokinetic modeling extrapolated from adult HS and psoriasis trials, along with pediatric data from other approved indications. The approval is also supported by dosing analysis predicting that weight-based dosing in pediatric patients can achieve exposure levels comparable to those seen in adult patients.
Related Trials
This latest approval is further supported by clinical data from other FDA-approved pediatric indications. Secukinumab is already approved for moderate-to-severe plaque psoriasis in children aged 6 years and older, enthesitis-related arthritis in children aged 4 years and older, and active psoriatic arthritis in children aged 2 years and older.
For patients aged 12 years and older, the TNF inhibitor adalimumab (Humira) was previously approved by the FDA for moderate-to-severe HS in 2018; the biosimilar adalimumab-aaty (Yuflyma) followed in 2023.
This most recent FDA approval for adolescent HS is based primarily on data extrapolated from the SUNSHINE and SUNRISE clinical trials, which included 676 and 687 adult patients, respectively, with a mean age of 36.1 years. Patients were randomly assigned to 300 mg subcutaneous secukinumab every two weeks, every four weeks, or placebo. Significantly more patients receiving secukinumab achieved clinical response compared with placebo, with results sustained up to 52 weeks and no new safety signals reported.
Because HS can lead to secondary complications that significantly impact quality of life — including pain, scarring, impaired movement, and psychological distress — this approval is particularly encouraging for both clinicians and patients.
“Having options with known doses and established safety profiles will hopefully increase access to medications,” Dr. Kimball noted, “and provide reassurance for patients and clinicians and their families as they consider their options.”
