Updated HS Guidelines Bring Biologics and Early Intervention

Two additional biologics—secukinumab (Cosentyx) and bimekizumab (Bimzelx)—have received FDA approval for hidradenitis suppurativa (HS) since the previous guidelines in 2019, and the updated recommendations include both.

The update, jointly supported by the HS Foundation and the American Academy of Dermatology (AAD), adds targeted options for moderate to severe disease, evidence for several off-label treatments, and stronger emphasis on individualized care and early intervention before permanent tissue damage develops.

The US and Canadian HS foundations jointly developed the previous guidelines; broader organizational backing now supports the updated recommendations. The organizations also intend the document to inform treatment selection and disease monitoring and to help patients obtain access to necessary care.

Haley Naik, MD, a dermatologist at the University of California, San Francisco, and president of the HS Foundation, told Dermatology Times: “I think what I would share is that HS is a progressive disease. Once tunnels and scarring have formed, that damage is irreversible.”

Evidence for systemic therapy

The update evaluates evidence supporting adalimumab, secukinumab, bimekizumab, and infliximab. Phase 3 trials of adalimumab, secukinumab, and bimekizumab evaluated efficacy with the Hidradenitis Suppurativa Clinical Response (HiSCR) 50 and HiSCR75 endpoints.

Infliximab recommendations draw on a different evidence base that includes historical clinical trials, more recent studies, and clinical experience supporting high-dose, high-frequency administration for HS management.

The guidelines distinguish strong from conditional recommendations and require clinicians to balance clinical benefits, potential risks, treatment burden, and individual circumstances when selecting treatment.

• A conditional recommendation signals that the preferred approach may depend on disease characteristics, patient preferences, potential benefit, risk, and treatment burden.
• Conditional recommendations against guselkumab, risankizumab, etanercept, and vilobelimab indicate that these agents generally are not recommended for most patients, although clinicians may consider them in select circumstances.

Naik also highlighted additional evidence supporting several off-label therapies, giving clinicians more flexibility when developing individualized treatment plans.

Topical options and tobacco

Placebo-controlled trial evidence involving topical clindamycin, resorcinol, and ruxolitinib cream supports their potential use in HS management. The findings remain preliminary: larger clinical trials need to strengthen the evidence and guide future recommendations. Additional phase 3 data on topical ruxolitinib cream are anticipated in the coming year and may clarify its role in HS treatment.

The guidelines conditionally recommend tobacco cessation as a strategy that may improve patients’ responses to disease-directed therapies. Naik cautioned that this does not mean cessation alone treats HS; it reflects findings associating tobacco use with reduced response to certain treatments. Additional research needs to clarify relationships among tobacco exposure, disease activity, and treatment outcomes.

Why timing matters

HS is a progressive inflammatory condition that can cause draining tunnels, extensive scarring, and substantial physical and psychosocial burden. Medical treatment alone cannot fully reverse structural damage once it forms.

Naik advised clinicians to routinely assess pain, provide adequate symptom management, and escalate treatment promptly when patients lack sufficient disease control. She also warned against prolonged periods of ineffective treatment before appropriate escalation, particularly now that the updated guidance strongly recommends additional biologic therapies.

What changes in the clinic now?

The practical change is earlier, more deliberate movement from recognition to effective control, not simply a longer medication list. Clinicians should assess HS early, select from a broader evidence-based range, monitor response, manage symptoms, and escalate promptly rather than allow prolonged ineffective treatment.

Recommendation strength matters because a conditional recommendation leaves room for disease characteristics, patient preferences, potential benefit, risk, and treatment burden. Clinicians should not treat every listed agent as interchangeable; the evidence supporting each option now comes with a clearer clinical hierarchy.

The HS Foundation has created HowTreatHS.com as a centralized educational resource for interpreting the recommendations and applying emerging evidence in individualized care. The site supports both clinical decision-making and implementation of the updated guidance.

Further phase 3 ruxolitinib data may refine future recommendations, while research on tobacco exposure, disease activity, and outcomes may clarify the cessation pathway. The goal is better long-term outcomes, but the update’s most immediate direction is clear: establish control early and escalate before irreversible tunnels and scarring set in.