Long-Term Efficacy and Safety Data for HS Biologics

"Long-Term Efficacy and Safety Data for HS Biologics" takes up the clinical trial evidence behind adalimumab, secukinumab, and bimekizumab.

Chao reviews trial data for each approved biologic. Adalimumab's PIONEER 1 and 2 trials, with a three-year open-label extension, enrolled patients with an abscess and nodule count of three or more and early stage 2 or 3 disease; many had never used an anti-TNF agent, reflecting how little was known about the drug class at the time. He notes that documenting early stage 2 or 3, rather than stage 1, in a patient's chart is often necessary for insurance coverage. In the trial, 52.3% of patients maintained HiSCR through week 168 with continuous weekly dosing, and 57.1% of responders plus partial responders achieved HiSCR; the most common adverse events were headache and nasopharyngitis. Secukinumab's SUNSHINE and SUNRISE trials raised the bar to an abscess and nodule count of five or more, again in Hurley stage 2 or 3 patients. Results showed 42-46% achieving HiSCR at week 16, sustained to week 52; a week 104 extension showed numerically longer time to loss of response with continued dosing versus withdrawal, though not statistically significant. Headache was the most common adverse event. Bimekizumab's BE HEARD 1 and 2 trials, with a three-year extension, used the same five-lesion threshold and staging criteria. HiSCR50 reached 79.9% at week 48, maintained near 90.2% through week 148; common adverse events included worsening HS, COVID-19 infections, reflecting the pandemic-era trial timing, and oral candidiasis. Dr. Bush notes adalimumab's lower lesion threshold may partly explain its different response profile, and observes that IL-17 blockade appears to lead in efficacy, though TNF inhibitors still help some patients. On what matters most to patients, Dr. Bush says they care less about percentages than about feeling supported, quoting mentor Douglas DiRuggiero's line that clinicians are "providers of hope."

Up next, in "Safety Considerations and Biologic Treatment Selection in HS," the experts apply this safety and efficacy data directly to the case just introduced.