INTRODUCTION
Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease characterized by recurrent nodules, abscesses, and sinus tracts that primarily affect intertriginous regions.1 HS is a multifactorial disorder driven by follicular occlusion and rupture, resulting in a dysregulated immune response characterized by activation of Th1/ Th17 pathways, increased expression of proinflammatory cytokines, including interleukin (IL)-1, IL-17, and tumor necrosis factor (TNF)-α, and infiltration of neutrophils, monocytes, and mast cells.1 These processes may promote chronic inflammation, sinus tract formation, fibrosis, and scarring.1
HS demonstrates a bimodal age distribution, with incidence peaks in late adolescence and the mid-40s.1 Notably, nearly half of adults with HS report disease onset between 10 and 21 years of age.1 Although the prevalence of pediatric HS is likely underestimated, it is reported to affect approximately 0.03% of children and adolescents in the United States (US).1 Management of pediatric HS is typically multimodal, incorporating topical, systemic, and surgical therapies.2 Biologic therapies are increasingly used for moderate-to-severe disease; however, pediatric patients have historically been underrepresented in HS clinical trials and real-world studies, resulting in limited evidence to guide treatment in this population.2,3 Much of the current evidence supporting biologic use in children and adolescents is extrapolated from adult clinical trials, pediatric studies in other inflammatory diseases, and limited case series. Given the evolving therapeutic landscape and limited pediatric-specific evidence, this review provides an overview of important current and emerging biologic therapies for pediatric HS, integrating available pediatric data with adult clinical trial findings that may guide management in children and adolescents.
Adolescent FDA-Approved Treatments
Currently, adalimumab and secukinumab are the only biologic therapies approved by the US Food and Drug Administration (FDA) for the treatment of moderate-to-severe HS in pediatric patients.
Adalimumab
Adalimumab, a recombinant monoclonal antibody targeting TNF-α, was the first biologic to be FDA-approved for HS in adults in 2015, at a maintenance dose of 40 mg every week (EW) or 80 mg every other week (EOW).3,4 In 2018, approval was expanded to adolescents aged 12 years and older weighing greater than or equal to 30 kg, with recommended dosing of 40 mg EOW.5 This indication was based on pharmacokinetic and efficacy data from pediatric populations with psoriasis, Crohn’s disease, and juvenile idiopathic arthritis (JIA), as well as extrapolation from the phase III PIONEER I and II trials in adults with HS.5
A 2025 multicenter retrospective case series evaluated 65 pediatric patients (10-19 years old) with HS who initiated adalimumab and completed at least 6 months of therapy.3 At 6 months, 76.9% achieved Hidradenitis Suppurativa Clinical Response 50 (HiSCR50), defined as a reduction of at least 50% in total inflammatory nodule and abscess count and no observed increase in draining fistula or abscess count from baseline.3 Initial dosing was 80 mg EOW in 49.2% of patients, 40 mg EOW in 26.2%, and 40 mg weekly in 24.6%.3 Patients receiving the FDA-approved adolescent regimen (40 mg EOW) were significantly more likely to require dose escalation to maintain response than those initiated on adult dosing regimens (40 mg EW/80 mg EOW), independent of age at treatment initiation.3 These findings suggest that adult dosing may provide more durable disease control in select pediatric patients.3 Adverse events occurred in 7 patients (10.8%) and led to treatment discontinuation in 3 (4.6%).3 Respiratory tract infections were the most common adverse event (n=3), followed by isolated cases of paradoxical psoriasis, dizziness/nausea, injectionsite pain, and worsening atopic dermatitis.3 Most adverse events occurred in patients receiving 80 mg EOW.3
Secukinumab
Secukinumab, a monoclonal antibody targeting IL-17A, is the second biologic approved for the treatment of moderate-to-severe HS.6,7 It received FDA approval for adults in 2023, with approval expanded to adolescents aged greater than or equal to 12 years in 2026 at a maintenance dose of 150 mg every 4 weeks (greater than or equal to 30 kg and <90 kg) or 300 mg every 4 weeks (greater than or equal to 90 kg).6,7 Although no clinical trials have evaluated secukinumab specifically in pediatric patients with HS, its approval for adolescents is supported by efficacy and safety data from adult HS trials and pediatric studies in other approved indications, including plaque psoriasis and JIA.8 The phase III SUNSHINE and SUNRISE trials were multicenter, randomized, double-blind, placebo-controlled studies that enrolled 1,084 adults with moderate-to-severe HS from 219 sites across 40 countries.8 Participants received secukinumab 300 mg every 2 weeks, every 4 weeks, or placebo.8 In both trials, the every 2 week regimen achieved the primary endpoint, with significantly more patients attaining HiSCR50 at week 16 compared with placebo; responses were observed as early as weeks 2-4 and were sustained through week 52.8 The every 4 week regimen met the primary endpoint in SUNRISE but not SUNSHINE.8 Secukinumab also improved pain, lesion counts, and quality of life (QoL) measures, with a safety profile consistent with previous studies.8 The most commonly reported adverse events were headache, nasopharyngitis, and worsening HS, with no new safety signals identified through 52 weeks.8
HS demonstrates a bimodal age distribution, with incidence peaks in late adolescence and the mid-40s.1 Notably, nearly half of adults with HS report disease onset between 10 and 21 years of age.1 Although the prevalence of pediatric HS is likely underestimated, it is reported to affect approximately 0.03% of children and adolescents in the United States (US).1 Management of pediatric HS is typically multimodal, incorporating topical, systemic, and surgical therapies.2 Biologic therapies are increasingly used for moderate-to-severe disease; however, pediatric patients have historically been underrepresented in HS clinical trials and real-world studies, resulting in limited evidence to guide treatment in this population.2,3 Much of the current evidence supporting biologic use in children and adolescents is extrapolated from adult clinical trials, pediatric studies in other inflammatory diseases, and limited case series. Given the evolving therapeutic landscape and limited pediatric-specific evidence, this review provides an overview of important current and emerging biologic therapies for pediatric HS, integrating available pediatric data with adult clinical trial findings that may guide management in children and adolescents.
Adolescent FDA-Approved Treatments
Currently, adalimumab and secukinumab are the only biologic therapies approved by the US Food and Drug Administration (FDA) for the treatment of moderate-to-severe HS in pediatric patients.
Adalimumab
Adalimumab, a recombinant monoclonal antibody targeting TNF-α, was the first biologic to be FDA-approved for HS in adults in 2015, at a maintenance dose of 40 mg every week (EW) or 80 mg every other week (EOW).3,4 In 2018, approval was expanded to adolescents aged 12 years and older weighing greater than or equal to 30 kg, with recommended dosing of 40 mg EOW.5 This indication was based on pharmacokinetic and efficacy data from pediatric populations with psoriasis, Crohn’s disease, and juvenile idiopathic arthritis (JIA), as well as extrapolation from the phase III PIONEER I and II trials in adults with HS.5
A 2025 multicenter retrospective case series evaluated 65 pediatric patients (10-19 years old) with HS who initiated adalimumab and completed at least 6 months of therapy.3 At 6 months, 76.9% achieved Hidradenitis Suppurativa Clinical Response 50 (HiSCR50), defined as a reduction of at least 50% in total inflammatory nodule and abscess count and no observed increase in draining fistula or abscess count from baseline.3 Initial dosing was 80 mg EOW in 49.2% of patients, 40 mg EOW in 26.2%, and 40 mg weekly in 24.6%.3 Patients receiving the FDA-approved adolescent regimen (40 mg EOW) were significantly more likely to require dose escalation to maintain response than those initiated on adult dosing regimens (40 mg EW/80 mg EOW), independent of age at treatment initiation.3 These findings suggest that adult dosing may provide more durable disease control in select pediatric patients.3 Adverse events occurred in 7 patients (10.8%) and led to treatment discontinuation in 3 (4.6%).3 Respiratory tract infections were the most common adverse event (n=3), followed by isolated cases of paradoxical psoriasis, dizziness/nausea, injectionsite pain, and worsening atopic dermatitis.3 Most adverse events occurred in patients receiving 80 mg EOW.3
Secukinumab
Secukinumab, a monoclonal antibody targeting IL-17A, is the second biologic approved for the treatment of moderate-to-severe HS.6,7 It received FDA approval for adults in 2023, with approval expanded to adolescents aged greater than or equal to 12 years in 2026 at a maintenance dose of 150 mg every 4 weeks (greater than or equal to 30 kg and <90 kg) or 300 mg every 4 weeks (greater than or equal to 90 kg).6,7 Although no clinical trials have evaluated secukinumab specifically in pediatric patients with HS, its approval for adolescents is supported by efficacy and safety data from adult HS trials and pediatric studies in other approved indications, including plaque psoriasis and JIA.8 The phase III SUNSHINE and SUNRISE trials were multicenter, randomized, double-blind, placebo-controlled studies that enrolled 1,084 adults with moderate-to-severe HS from 219 sites across 40 countries.8 Participants received secukinumab 300 mg every 2 weeks, every 4 weeks, or placebo.8 In both trials, the every 2 week regimen achieved the primary endpoint, with significantly more patients attaining HiSCR50 at week 16 compared with placebo; responses were observed as early as weeks 2-4 and were sustained through week 52.8 The every 4 week regimen met the primary endpoint in SUNRISE but not SUNSHINE.8 Secukinumab also improved pain, lesion counts, and quality of life (QoL) measures, with a safety profile consistent with previous studies.8 The most commonly reported adverse events were headache, nasopharyngitis, and worsening HS, with no new safety signals identified through 52 weeks.8
