22 February 2023
Monoclonal antibody hope for hidradenitis suppurativa
Biologic Treatments Used in Dermatology dermatology Hidradenitis Suppurativa
A drug used to treat plaque psoriasis, psoriatic arthritis and active ankylosing spondylitis could be the answer for this devastating disease.
A monoclonal antibody used to treat plaque psoriasis and a range of inflammatory diseases is shaping up as a lifeline for patients suffering from “probably the most devastating disease in dermatology”.
Two clinical trials conducted across 40 countries found secukinumab showed great promise in treating hidradenitis suppurativa.
Secukinumab is also used to treat conditions such as psoriatic arthritis and active ankylosing spondylitis.
Hidradenitis suppurativa is a chronic inflammatory skin disease characterised by pain, disability and the potential for progression to scarring.
However, few therapeutic options exist for the treatment of moderate-to-severe disease. Adalimumab, a TNFα inhibitor, is the only biologic therapy approved for treating adolescents and adults with moderate-to-severe hidradenitis suppurativa.
Secukinumab is a fully human monoclonal antibody that selectively neutralises interleukin (IL)-17A, and has previously been reported to improve clinical signs and symptoms of hidradenitis suppurativa in open-label studies and case reports.
But now the first large-scale phase III clinical trials have shown the drug is also effective against hidradenitis suppurativa.
Dermatologist Professor Rodney Sinclair, from the University Melbourne, was lead investigator in Australia for the trials, which were published in The Lancet earlier this month.
“It’s probably the most devastating disease in dermatology,” he told Dermatology Republic. “It takes high-functioning, sociable teenagers and basically devastates their lives.”
He said the results had potential to change clinical practice in hidradenitis suppurativa, by offering patients a new effective, sustainable and safe treatment option.
“We know that hidradenitis suppurativa is a difficult to treat disease,” Professor Sinclair said.
“It is a chronic inflammatory skin disease that often begins in adolescence and is characterised by painful boil in the armpits and groin. The boils discharge foul smelling pus when they burst and eventually lead to scarring.
“Unfortunately, hidradenitis suppurativa is often under-recognised, resulting in delays in diagnosis and treatments. Pain can be debilitating, and patients often find it hard to walk or even sit.”
The trials demonstrated that secukinumab provided patients with pain relief, reduced boils and abscess count by more than 50% and, as a result, would likely reduce disfiguring and debilitating scarring.
According to the researchers, the trials were the largest study ever done in hidradenitis suppurativa and the first reporting efficacy and safety results up to 52 weeks of treatment.
“The trials were done in 40 countries and enrolled 1084 patients, representative of a real-world population of patients with moderate-to-severe hidradenitis suppurativa,” they wrote.
The trials showed that secukinumab 300mg every two weeks was consistently efficacious compared with placebo in improving clinical and patient outcomes following 16 weeks of treatment, with a favourable safety profile and responses sustained up to 52 weeks.
In both trials, those on a fortnightly dose met the primary endpoint of a clinical response to the drug.
In contrast, patients who received secukinumab every four weeks only met the primary endpoint in one trial. A further analysis found that patients who did not respond had more severe disease at baseline compared to those who did respond, which researchers said could explain the findings.
“Hidradenitis suppurativa clinical response values observed in both secukinumab groups at week 16 were sustained up to week 52,” the authors reported.
“There were no new or unexpected safety concerns detected across both trials for the duration of the study.”
Professor Sinclair said it was a myth that hidradenitis suppurativa was an infection related to poor hygiene.
“Hidradenitis suppurativa occurs when the body’s immune system produces an increased amount of IL-17A,” he said.
He said early diagnosis and treatment provided the best outcomes for patients, and that some patients with advanced disease especially those with pre-existing scarring would need to combine secukinumab with adjuvant treatments such as antibiotics to achieve full symptom control.