Basel, Switzerland – A new way to treat a painful skin condition shows promise in a phase 2 trial, according to a late-breaking presentation at the American Academy of Dermatology (AAD) Association annual meeting. Novartis’ remibrutinib was well tolerated and showed high responder rates compared with placebo in patients with moderate-to-severe hidradenitis suppurativa.
Hidradenitis suppurativa is a condition that causes small, painful lumps to form under the skin. This rare condition affects about 1% of the populations and creates abscesses where the folds of the skin meet. It is a complex inflammatory disease but the exact cause it not well known. Women and Black or biracial people are more than likely to get hidradenitis suppurativa than men or Caucasian people.
FDA-approved treatments for moderate to severe hidradenitis suppurativa are biologics, including AbbVie’s Humira (adalimumab) and Novartis’ Cosentyx (secukinumab).
Developed by Novartis, remibrutinib is an oral therapy. It is an inhibitor of Bruton’s tyrosine kinase (BTK), a different therapeutic target with a very different mechanism of action that targets B cells. B cells and plasma cells are present hidradenitis suppurativa lesions. These cells are thought to activate BTK, which leads to the increased inflammatory response seen in chronic hidradenitis suppurativa.
In this phase 2b study, investigators — led by Alexa B. Kimball, M.D., MPH, professor of Dermatology, Beth Israel Deaconess Medical Center in Boston — enrolled 77 patients in Cohort D. Patients received either remibrutinib 25 mg twice day, 100 mg, twice day or placebo. The primary endpoint was the simplified hidradenitis suppurativa clinical response (sHiSCR), which assesses the reduction in the number of inflammatory lesions, at week 16. Additional endpoints include the number and severity of adverse events and skin pain response.
Overall, 80.2% of patients complete treatment, including 87.9% receiving remibrutinib 25 mg and 78.8% receiving remibrutinib 100 mg. Kimball and her colleagues found that the primary endpoint was met for both doses remibrutinib; patients treated with remibrutinib reported greater improvement in the simplified hidradenitis suppurativa clinical response assessment compared with placebo. Additionally, remibrutinib had a greater effect on number of inflammatory lesions, draining abscesses and pain response.
Adverse events were mild or moderate, with only one serious adverse event. Infections, primarily upper respiratory, were the most common adverse events in the treatment arms. Additionally an increase in liver enzymes was seen with patients treated with remibrutinib 25 mg and in the placebo arms but was not related to study treatment.
Novartis officials said it’s too early to discuss plans phase 3 trials for patients with hidradenitis suppurativa.
Remibrutinib is also being studied to treat patients with chronic spontaneous urticaria (CSU), which is characterized by the sudden appearance of itchy hives and swelling of the face, throat, hands or feet. CSU affects about 40 million worldwide.
In November 2023, Novartis released results from pivotal phase 3 trials (REMIX-1 and REMIX-2) of remibrutinib. Remibrutinib demonstrated in change from baseline compared with placebo in weekly urticaria activity, itch and hives at week 12. In these studies, remibrutinib well-tolerated with a favorable safety profile. The most commonly seen adverse events were respiratory tract infections (COVID-19 and nasopharyngitis, both comparable to placebo).
Novartis plans to submit regulatory applications for remibrutinib chronic spontaneous urticaria.
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