Approved Hidradenitis Suppurativa Treatments and Pipeline Show Similar Efficacy, Safety Without Head-to-Head Trials

Both regulatory-approved and pipeline treatments for moderate to severe hidradenitis suppurativa demonstrate comparable efficacy and safety, offering hope for patients often dissatisfied with current treatment options. | Image Credit: syahrir - stock.adobe.com

Patients with moderate to severe hidradenitis suppurativa face significant unmet needs, with both regulatory-approved and pipeline treatments offering crucial insights into comparable efficacy and safety for patients who have historically reported dissatisfaction with available treatment options and faced long diagnostic delays, according to a study published in JAMA Dermatology.1

Patients with hidradenitis suppurativa experience unmet needs surrounding treatment options. The patient population has reported levels of treatment dissatisfaction, based on a study titled “The State of the Clinical Management Union: A Cross-Sectional Survey of Persons With Hidradenitis Suppurativa”.2 Previous research highlighted long diagnostic delays, limited treatment satisfaction, and a general lack of awareness regarding FDA approved therapies.

There are currently 3 medications that have received regulatory approval for hidradenitis suppurativa in the US and Europe.1 In 2015, the FDA approved adalimumab (Humira), but prior to the approval, patients with hidradenitis suppurativa relied on surgery to remove the skin affected by the disease combined with antibiotics.3

Almost 10 years after the FDA approved adalimumab, secukinumab (Cosentyx) was approved in 2023 to treat patients with hidradenitis suppurativa. About a year later, bimekizumab (Bimzelx; UCB Pharma) was approved for moderate to severe hidradenitis suppurativa in adult patients.4

Researchers conducted a living systemic review and network meta-analysis. They aimed to synthesize and compare efficacy and safety results to inform treatment guidelines and partnered decision-making on the medical management of moderate to severe hidradenitis suppurativa. Of 26 eligible trials, 25 provided available Hidradenitis Suppurativa Clinical Response (HiSCR)-50 data, encompassing 5767 total patients and 39 unique treatments.

The median of the mean ages across all treatment arms was 36.9 years. The median proportion of female individuals was 63%. Placebo was the most common treatment (n = 25 studies), followed by adalimumab (n = 7 studies), bimekizumab (n = 3 or n = 2 studies, depending on dose), and secukinumab (n = 2 studies).

Eleven of 26 studies qualified for HiSCR-75 analysis, representing 3384 total patients and 17 unique treatments and doses. The most common treatments included placebo (n = 11 studies), adalimumab (n = 4 studies), bimekizumab (n = 3 or n = 2 studies, depending on dose), and secukinumab (n = 2 studies).

Compared with placebo, the following treatments achieved significantly higher HiSCR-50 response rates:

• sonelokimab, 120 mg every 4 weeks
• lutikizumab, 300 mg every 2 weeks
• adalimumab, 40 mg once per week
• sonelokimab, 240 mg every 2 weeks
• bimekizumab, 320 mg every 2 weeks
• povorcitinib, 15 mg once per day
• bimekizumab, 320 mg every 4 weeks
• secukinumab, 300 mg every 4 weeks
• secukinumab, 300 mg every 2 weeks

Most differences between adalimumab 40 mg once per week and other targeted treatments did not show statistical significance.

The top 5 treatments for HiSCR-50 were:

• sonelokimab, 120 mg every 4 weeks
• adalimumab, 40 mg once per week
• sonelokimab, 240 mg every 4 weeks
• lutikizumab, 300 mg every 2 weeks
• bimekizumab, 320 mg every 2 weeks

Across 23 studies, patients experienced a serious adverse event (SAE) at rates ranging from 0% to 10% in placebo groups. In 6 adalimumab 40-mg once-weekly arms, SAE rates ranged from 0% to 8%. All other treatment arms saw SAE rates between 0% and 6%.

For patients discontinuing treatment due to adverse events, rates ranged from 0% to 10% in the placebo groups, 0% to 4% in the adalimumab (40 mg once-weekly) groups, and 0% to 15% (ropsacitinib) in the other active treatment groups.

The sparse connections limited the network, with only 4 of 26 studies directly comparing different medications. Researchers did not observe meaningful differences in the distribution of effect modifiers across trials, and nearly all trials used similar criteria to define moderate to severe hidradenitis suppurativa. Additionally, small sample sizes reduced the precision of estimates. Low confidence in many estimated effect sizes stemmed largely from imprecision and within-study bias. The results relate to efficacy at 12 or 16 weeks rather than long-term efficacy, which randomized control trials find difficult to assess. Lastly, researchers should view treatment rankings as tentative and interpret them in the context of OR point estimates and 95% CIs.

“Phase 2 results for several cytokine and small-molecule treatments are promising and require confirmation in larger phase 3 trials,” study authors concluded.

References

1. Garg A, Cohn E, Midgette B, Frasier K, Strunk A. Efficacy and safety of medical interventions for moderate to severe hidradenitis suppurativa a living systematic review and network meta-analysis. JAMA Dermatol. Published online July 2, 2025. doi:10.1001/jamadermatol.2025.1976
2. Andrus E. Patient survey highlights dissatisfaction and undertreatment in hidradenitis suppurativa care. Dermatology Times®. April 4, 2025. Accessed July 2, 2025. https://www.dermatologytimes.com/view/patient-survey-highlights-dissatisfaction-and-undertreatment-in-hidradenitis-suppurativa-care
3. Santoro C. Hidradenitis suppurativa: advancing treatment with biologics. AJMC®. January 12, 2025. Accessed July 2, 2025. https://www.ajmc.com/view/hidradenitis-suppurativa-advancing-treatment-with-biologics
4. Shaw ML. FDA approves bimekizumab in hidradenitis suppurativa. AJMC. November 20, 2024. Accessed July 2, 2025. https://www.ajmc.com/view/fda-approves-bimekizumab-in-hidradenitis-suppurativa