Secukinumab (Cosentyx, Novartis) should be available on the NHS in England as a treatment option for moderate-to-severe hidradenitis suppurativa, the National Institute for Health and Care Excellence (NICE) said.
Hidradenitis suppurativa (HS) — also known as acne inversa — is a painful chronic inflammatory skin disease that causes abscesses and scarring. It is thought to affect about 1 in 100 people, according to estimates from the NHS, which said symptoms ranged from mild to severe.
The exact cause of HS is unknown, and there is no cure. Existing treatments focus primarily on wound and pain management. The condition is more common in women than men, and it is particularly common in people of childbearing age, people with a higher body weight, and smokers.
"The impact of HS is multifaceted and complex," highlighted Angela Gibbons, patient and HS advocate, in the foreword to a report published earlier this year, The Burden of Hidradenitis Suppurativa on Patients, the NHS and Society, who noted there were "many ways in which HS can significantly reduce quality of life".
People with HS faced an average diagnostic delay of 10 years, and more than 70% of patients already exhibited moderate-to-severe disease when first diagnosed, according to the authors of the report, which was funded by Novartis Pharmaceuticals UK. Also, patients might see multiple physicians and face more than three misdiagnoses, it noted.
Final Draft Guidance
In final draft guidance, NICE recommended secukinumab as an option for treating active moderate-to-severe hidradenitis suppurativa in adults when it has not responded well enough to conventional systemic treatment, but only if adalimumab is not suitable, did not work, or has stopped working.
Patients' response to secukinumab should be assessed after the first 16 weeks, and treatment should only continue if there was "clear evidence of a response", defined as a reduction of 25% or more in the total abscess and inflammatory nodule count, and no increase in abscesses and draining fistulas, the appraisal committee stated.
In addition, NICE emphasised that its recommendation depended on the manufacturer providing secukinumab according to an agreed-upon commercial arrangement. Patients already receiving the treatment outside of the recommendation may continue without a change to the funding arrangements put in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Improved Symptoms More Than Placebo
NICE experts highlighted that evidence from two identically designed phase 3, randomised, double-blind, placebo-controlled, parallel-group trials — SUNSHINE and SUNRISE (the SUNNY trials) — showed that secukinumab generally improved symptoms of moderate-to- severe hidradenitis suppurativa more than placebo.
NICE cautioned that in severe HS, it could be "difficult to accurately and objectively measure the extent and severity of the condition". However, the regulator concluded that it was "plausible" that secukinumab improved outcomes compared with placebo.
NICE explained that if HS was not well controlled with medication, then major surgery might be needed, which incurred a 3- to 6-month recovery period. "Targeting inflammation early with effective treatments can prevent major surgery and scarring," the guidance said.
The real-world, prospective global VOICE study of people with HS had found that about 46% of people with moderate-to-severe HS were not satisfied with their current treatments because of poor efficacy and side effects.
"People with HS have lost faith in medicine because of the lack of treatment options," alerted NICE, and it stressed that "alternatives to surgery and existing biological treatment are needed".
In an emailed comment to Medscape News UK, a NICE spokesperson stressed that HS could have a "substantial effect" on people's quality of life. The condition affected career prospects, family relationships, and the decision to have children. "There is a high unmet need for alternatives to surgery and existing biological treatment," the spokesperson said.
Final guidance is expected from NICE on 6 December, 2023.