Novel and Pipeline Therapies for Hidradenitis Suppurativa Management

Dr. Haley Naik presented information about new and emerging therapies for managing hidradenitis suppurativa (HS). The goal of HS management is to control inflammation and remove tissue that has been irreversibly damaged.

Haley Naik, MD, is a professor in the Department of Dermatology, UCSF School of Medicine.

First, Naik emphasized the importance of early intervention in halting disease progression. Medical therapies can control disease and prevent progression, but they work better the earlier they are started. The length of time that this “window of opportunity” for medical management lasts is variable, ranging from months to years. Some patients may never progress to tunnels and scarring. Dermatologists need to act as soon as a diagnosis is confirmed to prevent scarring that leads to more severe disease and requires surgical intervention in the future.

Second, Naik described the goals of medical management including: reducing pain, itch, and inflammation associated with present lesions; preventing the development of new lesions; and improving the pain and frequency associated with recurrent lesions. A complete response to medical therapy means the patient has no pain and no new lesions. These patients should continue on their current therapy. A partial response means that patients have reduced pain and reduced development of new lesions; these patients should either increase the dose of their current therapy or switch to a different therapy. Dermatologists can assess disease control by asking patients whether they are developing new lesions in new locations.

Third, Naik presented clinical trial data showing the safety and efficacy of targeted therapies for HS, including tumor necrosis factor (TNF) inhibitors (eg, adalimumab, infliximab) and interleukin (IL)-17 inhibitors (eg, secukinumab, bimekizumab, sonelokimab). The phase 3 PIONEER I and II trials of adalimumab for HS showed significantly greater improvement in patients who received adalimumab versus placebo. Anti-drug antibody development can be prevented in patients taking TNF inhibitors by treating them with methotrexate or azathioprine. High-dose, high-frequency infliximab is needed to treat HS. Infliximab carries an increased risk of infusion reactions that can be decreased with pre-medication. TNF inhibitors have an increased risk of upper respiratory and skin infections, especially in patients with diabetes and cardiovascular and pulmonary comorbidities. Older adults have an increased risk of malignancy on TNF inhibitors that requires diligent malignancy screening.

The phase 3 SUNSHINE and SUNRISE trials of secukinumab and the BE HEARD I and II trials of bimekizumab for HS showed similar efficacy to adalimumab. A phase 2 trial of sonelokimab also met its primary endpoint. IL-17 inhibitors increase the risk of fungal and candidal infections and the risk of developing inflammatory bowel disease. They act more slowly, with a sustained response noted at 4–6 months after treatment initiation. Dermatologists must diligently screen patients for gastrointestinal symptoms before starting treatment with an IL-17 inhibitor and should screen for fecal calprotectin for any new-onset gastrointestinal symptoms. IL-17 inhibitors are safe for older adults, even those with a history of malignancy or demyelinating disorders.

Fourth, Naik discussed emerging therapies for HS, including Janus kinase (JAK) inhibitors, IL-1 inhibitors, and Bruton tyrosine kinase (BTK) inhibitors. JAK inhibitors under investigation for HS include upadacitinib, povorcitinib, brepocitinib, and topical ruxolitinib. The dose-dependent risks of JAK inhibitors appear substantial according to current data and include congestive heart failure, myocardial infarction, and pulmonary embolism with povorcitinib and pneumonia and acute respiratory failure with upadacitinib. Early trials of the IL-1 inhibitor lutikizumab and the BTK inhibitor remibrutinib showed promising results.

To conclude, Naik emphasized that HS medical management requires layered therapy with a biologic agent in combination with other agents such as systemic antibiotics, hormonal therapy, JAK inhibitors, or another biologic.

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