HS Research & Breakthroughs
A comprehensive guide to the 11 most important developments in Hidradenitis Suppurativa research right now - with citations, clinical trial links, and plain-language explanations of what each means for patients.
Last updated March 2026
Cosentyx Now Approved for Adolescents 12+ With HS
On March 13, 2026, the FDA approved secukinumab (Cosentyx, Novartis) for adolescents aged 12 and older with moderate-to-severe hidradenitis suppurativa. This marks the first IL-17A inhibitor approved for a pediatric HS population and doubles the number of FDA-approved biologics available to adolescent patients from one to two.
Why This Approval Matters for Young Patients
HS often begins after puberty, and the average delay from first symptoms to diagnosis is nearly a decade. Adolescents with HS face unique challenges including school absences, social isolation, and psychological impact during critical developmental years. Having a second approved biologic specifically for this age group gives dermatologists and families more treatment options at the age when the disease most commonly starts.
Approval Basis and Dosing
The approval was supported by adult SUNSHINE and SUNRISE Phase 3 trial data, pharmacokinetic modeling, and pediatric safety data from other secukinumab indications. Weight-based dosing was established to provide adolescent patients with similar drug exposure to adults. Secukinumab targets IL-17A, a key cytokine driving the neutrophil-mediated inflammation responsible for HS abscesses and tunnels.
Why it matters: Adalimumab (Humira) was previously the only biologic approved for adolescent HS. The addition of secukinumab as a second option is significant because some patients do not respond to TNF-alpha blockade. Having an IL-17A inhibitor available for adolescents means younger patients who fail adalimumab now have an evidence-based alternative rather than off-label use.
Bimekizumab: 3-Year Durability Confirmed
Three-year data from the BE HEARD I and II open-label extension trials, presented at the European Hidradenitis Suppurativa Foundation (EHSF) conference in Malta in February 2026, confirmed that bimekizumab (Bimzelx) produces deep and durable responses over the long term. This is now the longest-duration efficacy dataset for any IL-17A/F inhibitor in HS.
Key 3-Year Efficacy Numbers
At 3 years, 40.1% of assessed patients (147 of 367) achieved IHS4-100, meaning complete resolution of all inflammatory lesions including nodules, abscesses, and draining tunnels. A further 59.1% achieved IHS4-90 (near-complete response) and 77.4% achieved IHS4-75. These are among the highest long-term response rates ever reported for any HS biologic.
Disease Severity Transformation
At baseline, 87.4% of patients had severe HS by IHS4 criteria. By year 3, only 14.7% still had severe disease. The proportion of patients with mild or inactive HS (IHS4 score of 3 or less) rose from 0% at baseline to 59.4% at 3 years. Mean draining tunnel count fell from 3.8 at baseline to 0.9 at year 3. All patients transitioned to every-4-weeks dosing by the end of year 3.
Why it matters: Draining tunnels cause permanent structural damage and scarring. The fact that 40% of patients achieved complete lesion resolution at 3 years - and nearly 60% had mild or inactive disease - suggests bimekizumab can fundamentally alter the disease course for many patients, not just suppress symptoms temporarily.
Sonelokimab: Phase 3 Complete, BLA Filing Planned
Sonelokimab (MoonLake Immunotherapeutics) has completed its Phase 3 VELA program in adult HS, received FDA Fast Track Designation in February 2026, and the FDA has confirmed the pathway for a Biologic License Application (BLA) filing planned for the second half of 2026. If approved, sonelokimab would become the fourth biologic approved for HS and the first Nanobody therapy in dermatology.
VELA Phase 3 Trial Results
VELA-1 met all primary and key secondary endpoints with statistical significance (HiSCR75, delta to placebo of 17%, p less than 0.001). VELA-2 showed a clinically meaningful improvement (HiSCR75, delta to placebo of 9%) but the higher-than-expected placebo response in that trial prevented statistical significance at week 16. The combined VELA program showed clinically meaningful and statistically significant improvement across all primary and key secondary endpoints. 52-week data from both trials is expected in Q2 2026.
What Makes Sonelokimab Different
Sonelokimab is a Nanobody - a much smaller molecule (~40 kDa) than a full monoclonal antibody. It targets IL-17A/A, IL-17A/F, and IL-17F/F dimers simultaneously. A third domain binds human albumin, which concentrates the drug at sites of inflammatory edema. The VELA-TEEN Phase 3 trial is also underway - the first clinical study specifically designed for adolescent HS patients aged 12 to 17.
Why it matters: Sonelokimab's Nanobody structure may offer advantages in tissue penetration at inflamed sites. The adolescent-specific trial is particularly significant because HS often begins in the teenage years and there are currently no biologics specifically approved for adolescent HS.
Povorcitinib: 54-Week Data Presented at AAD 2026
Late-breaking 54-week data from the STOP-HS1 and STOP-HS2 Phase 3 trials of povorcitinib (Incyte) were presented at the 2026 American Academy of Dermatology Annual Meeting in Denver, Colorado in March 2026. This dataset represents the most comprehensive durability evidence yet for any oral therapy in hidradenitis suppurativa, and is expected to support Incyte's planned US regulatory submission in early 2026.
Phase 3 Results and 54-Week Durability
In both STOP-HS1 and STOP-HS2 (approximately 600 patients each), povorcitinib met the primary endpoint of HiSCR50 at week 12, with 40.2 to 42.3% of patients responding versus 28.6 to 29.7% on placebo. The 54-week dataset presented at AAD 2026 by Dr. Martina J. Porter, MD, FAAD confirms that responses are maintained and in many cases deepen over time. No MACE events or deaths were observed through week 24 of the trials.
What This Means for Patients
Povorcitinib would be the first oral JAK inhibitor specifically approved for HS if the NDA is accepted. Unlike biologics, which require injections every 2 to 4 weeks, povorcitinib is taken as a daily pill. This may make it more accessible for patients who have needle anxiety or difficulty with injection-based therapies. Incyte's planned US regulatory submission is expected in early 2026.
Why it matters: The 54-week data from AAD 2026 answers the critical question of long-term durability for the first oral HS therapy candidate. Sustained efficacy through more than a year is a key threshold for a chronic disease like HS, where patients need durable disease control rather than short-term improvement.
Lutikizumab: Positive Phase 3 Topline Results
AbbVie announced positive topline results from its Phase 3 pivotal study of lutikizumab in moderate-to-severe HS on October 29, 2025. Lutikizumab is a dual IL-1alpha and IL-1beta bispecific antibody representing a completely different mechanism of action from all currently approved HS biologics, which target TNF-alpha or IL-17. The Phase 2 data showed approximately 60% HiSCR response in patients who had already failed anti-TNF therapy.
Why IL-1 Is a New Target
IL-1alpha and IL-1beta are elevated in HS skin lesions and drive the neutrophil-mediated inflammation that causes abscesses and tunnels. Lutikizumab blocks both simultaneously with a single bispecific antibody. Crucially, the Phase 2 trial enrolled patients who had already failed adalimumab (Humira), making it potentially valuable for the significant proportion of patients who do not respond to TNF-alpha blockade.
AbbVie's Dual HS Strategy
AbbVie is pursuing two parallel HS programs: lutikizumab (IL-1 pathway) and upadacitinib (RINVOQ, a JAK1 inhibitor already approved for atopic dermatitis and other conditions). With positive Phase 3 topline results announced in October 2025, AbbVie is expected to proceed toward regulatory submission. The trial enrolled adults and adolescents aged 16 and older at sites worldwide.
Why it matters: Approximately 50% of HS patients do not achieve adequate response on currently approved biologics. A drug that works through a completely different pathway - and that showed efficacy specifically in anti-TNF failures - could help a large group of patients who currently have limited options.
Treat-to-Target: A New Standard of Care
A landmark consensus paper published in JEADV Clinical Practice in September 2025 introduced a formal treat-to-target (T2T) framework for HS, mirroring the approach long used in rheumatoid arthritis. Rather than accepting any improvement, the framework defines specific response milestones that should be achieved at defined time points, with treatment escalation if targets are not met.
The New Treatment Targets
The consensus recommends a minimum of HiSCR25 (25% improvement) by week 12 as an early signal of response, HiSCR50 (50% improvement) by weeks 24 to 48 as the medium-term target, and HiSCR75 (75% improvement) as the long-term goal for patients on biologics. If a patient does not meet the week 12 target, treatment should be re-evaluated rather than continued unchanged.
Why This Changes Clinical Practice
Previously, many clinicians would continue a biologic for 6 to 12 months before deciding it was not working. The T2T framework creates a structured decision tree: check at 12 weeks, escalate or switch if targets are not met, and aim for the highest achievable response rather than minimum acceptable improvement. This approach is already standard in rheumatology and has been shown to improve long-term outcomes.
Why it matters: Patients should ask their dermatologist about treat-to-target goals at their next appointment. If you have been on a biologic for more than 3 months without achieving at least a 25% reduction in abscesses and nodules, the new framework suggests it is time to discuss switching or escalating therapy rather than waiting longer.
IL-17 Biologics: Three Now Approved
Three biologics are now FDA-approved for moderate-to-severe HS in adults: adalimumab (Humira, 2015), secukinumab (Cosentyx, September 2023), and bimekizumab (Bimzelx, November 2024). For adolescents aged 12 and older, both adalimumab and secukinumab are now FDA-approved as of March 2026. Each targets a different part of the inflammatory cascade, giving clinicians and patients more options than ever before.
Secukinumab (Cosentyx) - FDA Approved September 2023
Secukinumab is an IL-17A inhibitor approved based on the SUNSHINE and SUNRISE trials. Approximately 45% of patients achieved HiSCR compared to 33% on placebo. It is administered as a subcutaneous injection every 2 weeks initially, then monthly.
Bimekizumab (Bimzelx) - FDA Approved November 2024
Bimekizumab targets both IL-17A and IL-17F simultaneously, which may explain its higher response rates. Phase 3 trials (BE HEARD I and II) showed HiSCR50 response rates of 48 to 52% at week 16. A 2025 network meta-analysis in JAMA Dermatology ranked bimekizumab as the most efficacious approved biologic for HS based on HiSCR50 and HiSCR75 outcomes.
Why it matters: Having three approved biologics with different mechanisms means that patients who do not respond to one drug now have evidence-based alternatives. The JAMA Dermatology 2025 network meta-analysis provides the first head-to-head comparison framework to guide treatment sequencing.
JAK Inhibitors (Oral Immune Drugs)
JAK inhibitors are oral pills that reduce immune signaling. Unlike biologics (which are injections), JAK inhibitors offer a convenient pill-based option for patients with moderate-to-severe HS. Povorcitinib is the furthest along in development, with Phase 3 data showing sustained efficacy through 24 weeks.
Povorcitinib (INCB054707)
Povorcitinib is a selective JAK1 inhibitor studied in Phase 3 trials (STOP-HS1 and STOP-HS2). Results showed statistically significant reductions in abscesses, nodules, and draining tunnels at 16 weeks, with sustained responses at 24 weeks. An NDA filing with the FDA is expected in 2026.
Other JAK Inhibitors in Development
Ritlecitinib (a JAK3/TEC inhibitor) and other JAK pathway drugs are in earlier-phase HS trials. The JAK inhibitor class is already approved for other inflammatory conditions including rheumatoid arthritis and atopic dermatitis.
Why it matters: Many patients prefer oral medication over injections. JAK inhibitors could become a first-line biologic-equivalent option that is easier to take and manage.
Precision Medicine and Immune Profiling
Researchers are beginning to map the specific immune pathways driving HS in individual patients. A February 2026 preprint from bioRxiv introduced a novel computational genomics approach to identifying precision therapeutics for HS based on each patient's genetic signature, representing a shift toward truly personalized HS care.
Cytokine Profiling and Treatment Prediction
Studies are identifying which cytokines (IL-17, IL-1, TNF-alpha, IL-36) are most elevated in individual patients. This profiling could predict which biologic a patient is most likely to respond to before they try it, ending the current trial-and-error approach to biologic selection.
Computational Drug Discovery for HS
A February 2026 preprint introduced a novel approach combining integrative genomics to identify precision therapeutics for HS based on disease-specific genetic signatures. This represents the first systematic application of computational drug discovery methods to HS and could accelerate identification of new treatment targets.
Why it matters: HS is likely multiple diseases under one umbrella. Precision medicine could end the current trial-and-error approach to biologic selection and dramatically improve outcomes by matching patients to the right drug based on their immune profile.
Earlier Biologic Treatment
Historically, biologics were reserved as a last resort after antibiotics, hormonal therapy, and other treatments failed. New evidence is challenging this approach, suggesting that earlier biologic intervention in moderate HS may slow or prevent disease progression.
The Case for Early Intervention
A 2024 retrospective study of 1,200 HS patients found that those who received biologics within 2 years of diagnosis had significantly lower rates of tunnel formation and scarring at 5-year follow-up compared to those who received biologics after 5 or more years of disease.
Changing Treatment Guidelines
The American Academy of Dermatology and European dermatology societies are both updating their treatment guidelines to reflect the growing evidence for earlier biologic use in moderate-to-severe HS. The 2026 Maui Derm consensus also emphasized early diagnosis and early escalation as core principles.
Combination Therapy: Medicine and Surgery
The 2026 Maui Derm consensus, led by Dr. Vivian Shi of the University of Washington HS Specialty Clinic, formalized the new treatment paradigm: HS care requires coordinated medical, surgical, and supportive strategies. Neither medication nor surgery alone achieves durable remission for most patients with established tunneling disease.
How the Combination Works
Biologics reduce systemic inflammation and suppress new lesion formation, while surgery physically removes established tunnels and scarred tissue. The biologic creates a better surgical environment and reduces post-surgical recurrence rates. The 2026 paradigm also introduced the concept of topical ruxolitinib cream (Opzelura) as an adjunct for superficial lesions.
Surgical Techniques
Wide local excision (removing all affected tissue) combined with biologic therapy shows the lowest recurrence rates. Deroofing (unroofing tunnels) is a less invasive option also being studied in combination with biologics. The 2026 framework also emphasized IV infliximab for severe Hurley Stage III patients who need rapid disease control before surgery.
Why it matters: HS requires multi-layered treatment strategies. The 2026 paradigm shift means patients should expect their care team to include both a dermatologist and a surgeon working together, rather than treating these as separate sequential steps.
Explosion of HS Research
HS research is expanding at an unprecedented rate. In 2025 alone, nearly 1,000 HS studies were published and dozens of clinical trials launched worldwide - a dramatic increase from fewer than 100 annual publications a decade ago. The pipeline now includes drugs targeting IL-17, IL-1, JAK, IL-36, and even the microbiome.
What Researchers Are Exploring
Active research areas include microbiome changes in HS patients, immune dysregulation mechanisms, hormonal influences (particularly androgens and the menstrual cycle), metabolic inflammation links (HS and metabolic syndrome), GLP-1 receptor agonists as anti-inflammatory agents, pain management, and quality-of-life interventions.
Patient Registries and Real-World Data
Large patient registries including the European HS Registry and NIH-funded observational studies are collecting real-world data from thousands of patients, enabling studies that clinical trials cannot - including long-term outcomes, comorbidities, and treatment patterns.
Why it matters: For decades HS was neglected by the research community. The current boom means patients diagnosed today will have far more treatment options within the next 5 years than those diagnosed a decade ago. The pipeline from Phase 1 to Phase 3 has never been fuller.
The Honest Reality
We are entering the first real wave of modern HS treatments. But challenges remain: many patients respond differently to biologics, tunnels and scarring are still difficult to treat, and HS is likely multiple diseases under one umbrella. Researchers are still figuring that out - and that work is finally happening at scale. The best advice for patients today is to stay informed, advocate for access to newer treatments, and consider enrolling in clinical trials when eligible.
Recent HS News
FDA Approves Cosentyx (Secukinumab) for Adolescents 12+ With Moderate-to-Severe HS
Healio / Novartis
Povorcitinib 54-Week STOP-HS Phase 3 Data Presented at AAD 2026 Annual Meeting in Denver
Incyte / HCPLive
Sonelokimab 52-Week VELA Data Expected Q2 2026; BLA Filing on Track for H2 2026
MoonLake Immunotherapeutics
Bimekizumab 3-Year BE HEARD EXT Data: 40% Achieve Complete Lesion Resolution
EHSF Conference, Malta / UCB Press Release
GLP-1 Medications (Ozempic/Wegovy) Associated with 54% Less Severe HS in 6-Month Study
JAMA Dermatology
FDA Confirms BLA Pathway for Sonelokimab in HS; Adolescent Trial (VELA-TEEN) Enrolling
MoonLake Immunotherapeutics / Dermatology Times
2026 HS Treatment Paradigm: Early Diagnosis, Combination Therapy, and Higher Response Targets
Maui Derm 2026 / AJMC
Povorcitinib Maintains Nearly 60% HiSCR50 Response Rate at 24 Weeks in STOP-HS Phase 3
EADV 2025 / Incyte
Treat-to-Target Framework for HS Published: HiSCR25 by Week 12, HiSCR50 by Week 24-48
JEADV Clinical Practice
Network Meta-Analysis Ranks Bimekizumab Highest for Efficacy Among All Approved HS Biologics
JAMA Dermatology
Finding Clinical Trials
Clinical trials offer access to cutting-edge treatments before they are widely available. Participating in a trial can benefit both you and the broader HS community. Here is how to find and evaluate them.
How to Find HS Trials
- Search ClinicalTrials.gov for 'Hidradenitis Suppurativa'
- Ask your dermatologist about trials at their institution
- Contact academic medical centers with HS specialty clinics
- Follow HS patient advocacy groups and dermatology society newsletters for trial announcements
- Join HS patient registries that connect patients with researchers
Questions to Ask About a Trial
- What phase is this trial, and what does that mean?
- What are the eligibility requirements?
- What are the potential risks and benefits?
- Is there a placebo arm, and what happens if I am in it?
- What is the time commitment and travel required?
- Will my current treatments be affected?
Latest from PubMed
New HS research articles fetched automatically every morning from the NCBI PubMed database.101 articles indexed.
Efficacy of Biologics for Hidradenitis Suppurativa: A Network Meta Analysis and Meta Regression for Baseline Disease Severity.
Pham J, Sholji T, Aghajani M, Maye E, Burrell K et al. (+2 more)
A geophysical model for understanding inflammatory lesion dynamics in hidradenitis suppurativa.
Garbayo-Salmons P
Defining Moderate Disease and Progression in Hidradenitis Suppurativa: An Expert Framework to Unlock the Window of Opportunity for Prompt Treatment.
Martorell A, Ingram JR, Sayed CJ, Bechara FG, Porter ML et al. (+8 more)
Ultrasound-guided Percutaneous Galvanic Current Compared to Ultrasound-guided Intralesional Corticosteroid Infiltration in Tunnels of Hidradenitis Suppurativa.
Soto-Moreno A, Cuenca-Barrales C, Sánchez-Díaz M, García-Vidal JA, Medina-Mirapeix F et al. (+1 more)
Genomic and proteomic insights into hidradenitis suppurativa.
Argyropoulou M, Stylianakis E, Ricaño-Ponce I, Keur N, Kanni T et al. (+4 more)
Diagnostic delay for hidradenitis suppurativa: No change in the 2015-2024 decade.
Samela T, Abeni D, Colonna L, Ciccone D, Di Guardo A et al. (+3 more)
Phenotype-genotype correlation and treatment outcomes in mevalonate kinase deficiency: A large Turkish cohort.
Kaplan MM, Ekici Tekin Z, Kılıç Könte E, Balık Z, Aydın T et al. (+37 more)
Secondary Amyloidosis in Hidradenitis Suppurativa: A Case Series and a Proposal for Practical Screening Recommendations.
Lara-Moya A, Ruiz-Villaverde R, Mas-Matas B, Molina-Leyva A, Garcia-Doval I et al. (+1 more)
Iron Deficiency in Immune-Mediated Inflammatory Skin Diseases: A Missing Link Between Systemic Inflammation, Immunometabolism, and Disease Burden.
Kucharczyk E, Andrzejczak K, Biliński K, Korgiel M, Ponikowska M
Ethics of Insurance-driven Barriers to Biologic Therapy in Hidradenitis Suppurativa.
Nwozo E, Onuoha C, Negbenebor NA
EPR26-161: Risk for Anal Cancers in Hidradenitis Suppurativa Patients With Anorectal Fistulas or Abscesses: A Retrospective Cohort Study.
Pillai M, Donato A
Bimekizumab for treatment of moderate to severe hidradenitis suppurativa: A real-world, single centre case series.
Pender EK, Carroll E, Visan MA, Hughes R, Kirby B
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