Selecting Biologics for Moderate-to-Severe Hidradenitis Suppurativa

By Amara Osei

Three biologics are approved for moderate-to-severe hidradenitis suppurativa, and their phase 3 trials reported clinical-response rates of 41.8% to 52%. These results do not establish a hierarchy because the studies enrolled different populations, assessed different time points and used different dosing schedules.

Hidradenitis suppurativa (HS) is an inflammatory disease in which tunnels and scarring can develop. The discussion noted that clinicians increasingly introduce biologic therapy early, aiming to intervene before those structural changes take hold.

On a recent Derm on Air episode, host Cynthia Trickett, MPAS, PA-C, of North Dallas Dermatology Associates, discussed phase 3 evidence with Buchi Neita, MCMSc, PA-C, of Epiphany Dermatology. Their conclusion emphasized trial populations, dosing flexibility and comorbidity profile over any single efficacy ranking.

What does adalimumab establish?

Adalimumab (Humira) is a tumor necrosis factor (TNF) inhibitor approved for HS in 2015 and now indicated for patients aged 12 years and older. Its PIONEER I and II phase 3 trials set the available benchmark using a 40-mg weekly dose.

• In PIONEER I, week-12 HS clinical response, measured by HiSCR50, reached 41.8% with adalimumab versus 26.0% with placebo (P = .003).
• In PIONEER II, week-12 HiSCR50 reached 58.9% with adalimumab versus 27.6% with placebo (P < .001).
• Serious adverse-event rates resembled placebo. Open-label extension data also showed that roughly 53% maintained HiSCR50 through week 168 while receiving continuous weekly dosing.

The week-168 finding supports sustained benefit in a substantial minority, but it comes from open-label extension data rather than a randomized comparison with another agent. The source does not provide a head-to-head estimate against secukinumab or bimekizumab.

What does secukinumab add?

Secukinumab (Cosentyx) is an interleukin-17A (IL-17A) inhibitor approved for HS in 2023. The 48-week SUNSHINE and SUNRISE studies were identical, multicenter, randomized, placebo-controlled, double-blind phase 3 trials, and both met their primary endpoint.

• At week 16, HiSCR50 ranged from 42% to 46% in treatment arms that reached statistical significance versus placebo.
• Responses persisted through week 52, and headache was the most common adverse event.
• Maintenance dosing every 4 weeks can be intensified to every 2 weeks for inadequate response.

That interval flexibility suits the variable course of HS, allowing clinicians to shorten the maintenance interval when the initial response proves insufficient. The cross-trial figures still cannot determine whether secukinumab performs better or worse than either adalimumab or bimekizumab.

What distinguishes bimekizumab?

Bimekizumab (Bimzelx), approved for HS in 2024, inhibits both IL-17A and IL-17F. The additional IL-17F target provides a mechanistic distinction because the source identifies IL-17F expression within HS tunnels, which it describes as inflammatory structures in their own right.

The BE HEARD I and II trials were two 48-week, randomized, double-blind, placebo-controlled, multicenter phase 3 studies. Both evaluated dosing every 2 weeks.

• In BE HEARD I, week-16 HiSCR50 reached 48% (138/289) with bimekizumab versus 29% (21/72) with placebo.
• In BE HEARD II, week-16 HiSCR50 reached 52% (151/291) versus 32% (24/74) with placebo.
• Responses were maintained or increased through week 48.
• Frequent treatment-emergent adverse events included HS flares, coronavirus infection and oral candidiasis.

The numerical results strengthen bimekizumab’s clinical evidence, but the dual mechanism does not itself prove superior performance. The differing populations and schedules, combined with the absence of a head-to-head trial, leave those comparative questions unresolved.

How do comorbidities guide selection?

Coexisting inflammatory bowel disease (IBD), which is more prevalent among patients with HS, generally favors TNF inhibition over IL-17 blockade. A history of recurrent candidiasis warrants caution with IL-17 agents.

These constraints make patient-specific evidence more relevant than an overall efficacy table. They also connect directly to observed safety data: oral candidiasis appeared among the frequently reported treatment-emergent events in the bimekizumab trials.

Trickett and Neita therefore framed biologic selection as a fit between the agent and the individual patient, rather than a contest for a universal winner. Dosing flexibility can further distinguish otherwise plausible choices, while early treatment aims to preserve tissue before tunnels and scarring develop.

Can the three agents be ranked directly?

No. Each drug was studied in a distinct population on a distinct dosing schedule, and no head-to-head trials have compared their efficacy or safety. Future comparative studies would be required before these separate datasets could define an efficacy hierarchy; until then, comorbidity profile, treatment response and dosing requirements remain the practical basis for selection.