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Hidradenitis suppurativa (HS) Learning Zone
Declaration of sponsorship Novartis Pharma AG

HS Treatment

Declaration of sponsorship Novartis Pharma AG
Read time: 75 mins
Last updated:25th Oct 2022
Published:16th Sep 2021

Discover how timely and efficacious treatment of hidradenitis suppurativa (HS) is needed to minimise the immense burden of the disease. Also learn about: 

  • The unmet needs for patients with hidradenitis suppurativa in our interview with Dr Joslyn Kirby
  • Treatment goals and treatment options available for hidradenitis suppurativa patients
  • The future of hidradenitis suppurativa treatment in our overview of clinical trials

Unmet needs in HS


Join Dr Joslyn Kirby to gain an overview of the unmet needs for patients with hidradenitis suppurativa.

The significant diagnostic delay of hidradenitis suppurativa, in addition to the unpredictability of the disease and response to treatment, has led to a number of unmet needs for patients1.

An understanding of these unmet needs is essential for creating multidisciplinary approaches to care, developing new treatments, guiding researching, and supporting patients1.

What are unmet needs in the life impact and comorbidities of hidradenitis suppurativa?

To determine the unmet needs of patients with hidradenitis suppurativa, the Global Survey Of Impact and Healthcare Needs (Global VOICE) project (N = 1,299) carried out the largest and most comprehensive multinational study of patient perspectives1.

In the study, a large proportion of hidradenitis suppurativa patients reported a moderate to extreme and domain-specific impact on their life caused by the disease1. Moreover, 10% of patients reported being unable to find employment and 15% considered themselves disabled and unable to work1.

A smaller, but more recent study on unmet needs in people with hidradenitis suppurativa reported that 47% of patients found the referral process ‘very difficult’ and although biologics improved symptoms in 63% of patients, time to receiving treatment was >2 years2.

Hidradenitis suppurativa can have a large impact on life, such as reduced enjoyment of activities, independence, self-esteem and body image as well as increased stigmatisation and isolation3–5

The need to appropriately assess the psychological burden and impact on quality of life of hidradenitis suppurativa is currently a notable unmet need that may be addressed through the development of a disease-specific quality of life instrument for measuring life impact (Table 1)1,2

Table 1: Unmet needs of patients with hidradenitis suppurativa and potential mechanisms to address them (Adapted1). POC, point-of-care; QoL, quality of life.

Domain Unmet need Potential mechanisms to address unmet needs
Life impact and comorbid conditions Life impact assessment • Disease-specific QoL instrument to measure life impact
Mental wellness • Address psychosocial impact of the disease through interdisciplinary care with mental health professionals
Diagnosis and disease awareness Disease awareness • Promote advocacy and interdisciplinary education with patient support groups and medical organisations
• Research and peer-reviewed publication
Delay in diagnosis • Develop POC diagnostics to help distinguish abscess and inflamed epidermal cysts by non-dermatologists
• Promote the role of the dermatologist in diagnosis and management
Quality and cost of care • Improve dermatology access to manage disease flares
Associated diseases • Identify associated conditions, their related mechanisms, and their modification with treatment
• Develop guidelines with recommendations for prevention and screening of associated conditions
• Establish interdisciplinary care teams to provide comprehensive care
Treatment and management Safe and effective treatment • Develop reliable and feasible tools to measure disease
• Develop relevant outcome measures to assess treatment efficacy
• Advance research to identify disease mechanism and potential therapeutic targets
• Develop medical treatments with improved efficacy and safety profiles
• Evaluate outcomes for procedural treatments
• Develop guidelines for pain management
Control of symptoms • Develop appropriate and effective strategies to address pain, drainage, odour, fatigue, and flare

Mental wellness

There is also an important unmet need to address the considerable psychosocial concerns associated with hidradenitis suppurativa1.

Mood disorders are likely due to the physical and psychosocial impact of the disease, resulting in a reduction in quality of life1

More than 30% of patients in the Global VOICE project reported depression or anxiety, with mood disorders in general representing the most common comorbidity. Notably, around 9% of patients reported suicidal ideation or a suicide attempt. In light of the known association between hidradenitis suppurativa and completed suicide, this high frequency represents a significant issue1.

These concerns may be addressed through coping and resilience strategies as well as interdisciplinary care with mental health professionals (Table 1)1.

What are the unmet needs in diagnosing hidradenitis suppurativa and screening for comorbidities?

Addressing the unmet need of diagnostic delay for patients with hidradenitis suppurativa is essential (Table 1)1. In the Global VOICE project, patients experienced an average 10-year delay to diagnosis despite approximately half of patients reporting disease flares daily or weekly, and over 80% experiencing flares at least monthly1.

This is in addition to approximately 25% visiting an emergency department and 16% needing hospitalisation a minimum of four to five times for acute symptoms1.

Underdiagnosis may be in part due to a general lack of disease awareness in hidradenitis suppurativa in addition to its comorbidities1

A social media monitoring study in the US and Europe has provided insights into the real-world journey of people with HS, suggesting a need for greater awareness of HS among healthcare professionals2. Results of this study, presented at the 31st European Academy of Dermatology and Venereology (EADV) Congress (EADV 2022), indicated people with HS consider lack of healthcare professional awareness of HS as a key factor contributing to delayed and missed diagnoses2.

In the Global VOICE study, over 80% of patients reported having a comorbid condition. In previous studies, this burden was found to be greater in patients with hidradenitis suppurativa than patients without hidradenitis suppurativa as well as patients with psoriasis3.

What are the unmet needs in treating and managing hidradenitis suppurativa?

A further fundamental unmet need for patients with hidradenitis suppurativa is the development of appropriate and effective pain management strategies that support the needs of patients1.

In the study, 90% of Global VOICE patients had experienced recent pain and 60% described the pain as moderate to worst possible1. Chronicity of pain can also have a significant impact. In the Global VOICE project, approximately 4% of Global VOICE patients were associated with substance misuse. However, strategies for addressing pain are not well established and can be highly variable1.

Treatment dissatisfaction is also a major unmet need. The most common reasoning identified by patients of the Global VOICE study was poor efficacy and undesirable adverse effects1

Approximately 30% of patients were also dissatisfied with procedural treatments in the Global VOICE study and nearly 50% of patients expressed low optimism for controlling their symptoms in the future1.

A real-world study of people with HS in the US and Europe has also revealed substantial ongoing unmet needs in those with moderate-to-severe disease who only achieve a partial or lack of response to biologic therapy4. Partial/non-responders had more significant burden of disease, poorer disease control, more symptoms and greater impact on health-related quality of life, compared to responders4. The results of this study highlight the need for novel treatments with better response rates to reduce disease burden in moderate-to-severe HS4.

Newer treatments are however in clinical trials and research is continually unravelling the complex pathophysiology that gives rise to hidradenitis suppurativa1. Additionally, there is an international initiative to develop a core set of measures for trials in hidradenitis suppurativa. The goal of this initiative is to improve the measurement of disease activity and treatment response in addition to comparing therapeutic effectiveness1.

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HS treatment goals


Explore the treatment goals of hidradenitis suppurativa with Dr Joslyn Kirby, including the reduction of symptoms and long-term control.

Currently, the treatment of hidradenitis suppurativa consists of several types of medication and surgical management based on the individual subjective impact and objective severity of the disease. The aim of treatment is to improve quality of life by limiting the incidence and duration of flares, reducing inflammation and suppuration, relieving pain, and preventing infection (Figure 1)5–7.

Reducing the symptoms of hidradenitis suppurativa

The aim of treatment is to prevent new lesions and reduce the extent and progression of the disease. Current guidelines recommend the use of medications, procedures, lifestyle changes, and complementary and alternative medicine8.

A wide range of medications can be used to reduce flares, manage pain, and improve quality of life, including6:

  • antibiotics (to prevent infections)
  • biologics (to target the pathophysiology and reduce inflammation)
  • corticosteroids (to reduce inflammation)
  • hormones (to reduce androgen effects on symptoms)
  • retinoids (to reduce inflammation and heal lesions)
  • topical and intralesional therapies (to aid healing and soften / shed scaly skin)

Lifestyles changes, such as reducing smoking and losing weight, can also help to reduce the symptoms of hidradenitis suppurativa8.

Typically, surgical interventions cure hidradenitis suppurativa lesions locally, through the removal of irreversibly damaged skin. However, remaining dermal sinus tracts or tunnels may lead to recurrence. Alternatively, systemic treatment with anti-inflammatory antibiotics may result in less surgery by9,10:

  • lowering disease activity (such as inflammation and pain)
  • reducing the size of the affected area

It is therefore recommended that, at Hurley stage II and above, anti-inflammatory treatment should be considered an induction therapy before surgery9,10.

T2 HS_Fig1.png

Figure 1. Treatment goals for hidradenitis suppurativa5,6,11,12

Relieving pain in hidradenitis suppurativa

Pain is a significant factor of hidradenitis suppurativa that reduces the quality of life of patients13. Guidelines recommend an individualised treatment plan provided by a variety of healthcare professionals, such as5,6:

  • dermatologists
  • pain specialists
  • psychologists

Treatments can include topical painkillers and oral nonsteroidal anti-inflammatory drugs, such as aspirin and ibuprofen, for acute pain as well as opioids and anticonvulsants for chronic pain5,6.

Preventing infection in hidradenitis suppurativa

Some of the destructive processes involved in the chronic, relapsing lesions of severe hidradenitis suppurativa are likely caused by the infiltration of bacteria through open wounds. In addition to malodourous lesions, severe scars, and decreased mobility, in rare cases secondary infections can lead to14:

  • repeated cellulitis
  • septicaemia
  • lumbosacral epidural abscess
  • sacral bacterial osteomyelitis

To heal wounds and prevent bacterial infection, a mixture of local wound care and oral antibiotics is recommended5,6. This can include antiseptic washes, negative-pressure wound therapy, and antibiotics applied to the skin or wounds5,6.

Is there a recommended treatment algorithm for hidradenitis suppurativa?

The ideal treatment of hidradenitis suppurativa should minimise recurrence rate and impact on quality of life. Recommendations include medical management in the early states and the use of surgery as early as possible following the formation of abscesses, fistulas, scars, and sinus tracts15.

Three notable algorithms for the treatment of hidradenitis suppurativa have been proposed that use variations of Hurley staging:

  • The European S1 guideline (2015) by Zouboulis et al.5
  • Evidenced-based approach to treatment (2016) by Gulliver et al.16
  • Hurley staging refined (2017) by Horváth et al. - The Dutch expert group17

The algorithms suggested by the European S1 guidelines and by Gulliver et al. both utilise the original Hurley staging system combined with evidence-based treatment options5,17. In modern practice, the decision to use anti-inflammatory treatment is predicated on the occurrence of inflammation and suppuration. However, Hurley staging was originally created for surgical purposes and lacks information on the number of affected areas or the degree of inflammation.

A later proposed algorithm is the treatment ladder by Horváth et al., which utilises a refined Hurley staging system that takes into account both the presence and amount of inflammation as a factor for making treatment decisions17.

Following assessment with the Hurley staging system, various options for lifestyle changes, medication, and surgical management can be considered depending on the impact and severity of the disease5,6.

How can long-term control be achieved in hidradenitis suppurativa?

Personalised medicine, through the use of patient characteristics such as demographics, disease phenotype, and pharmacogenetics, may be a future strategy for predicting the patient response to treatment in hidradenitis suppurativa18.

Long-term control of hidradenitis suppurativa requires newer outcome measures to be developed that are simple, quick, and validated, in order to define treatment response18

Several physician-reported outcome measures exist for hidradenitis suppurativa; however, each has a number of drawbacks18. Ingram et al. carried out a systematic review of all clinical outcome measure instruments used for hidradenitis suppurativa trials19.

The study assessed 30 outcome measure instruments: sixteen physician-reported, eleven patient-reported, and three composite. Of the instruments, 27 were found to lack validation and only one instrument was found to be supported by validated evidence; the Hidradenitis Suppurativa Clinical Response (HiSCR)19.

However, despite the good-quality validation data to support HiSCR, the validity of this score fell below the acceptable range (Spearman’s rho > 0.6) compared to Hurley stage and the Modified Sartorius Score19,20.

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Treatment options for HS


Find out the treatment options that are currently available to reduce symptoms, relieve pain, and prevent infection with Dr Joslyn Kirby.

Hidradenitis suppurativa is lifelong, recurring, and difficult to manage. Early recognition and treatment are essential for preventing progression of the disease. Treatment should be tailored to the patient, with medications in early stages followed by surgery in more severe cases6,7.

Currently, data is limited for novel treatments of hidradenitis suppurativa. However, as the understanding of HS increases, exciting new research is driving the development of the future treatment landscape. Here we provide an overview of some of the data for current and novel HS treatments.

What lifestyle changes can help to manage hidradenitis suppurativa?

Outside of medication and surgery, a variety of lifestyle changes have been shown to positively impact the disease activity or severity of hidradenitis suppurativa21–24.

Smoking cessation

It is widely known that active smokers have a poorer long-term prognosis than non-smokers or former smokers21,22. In a previous study, it was shown that 49% of former smokers and non-smokers reported remission compared with 29% of active smokers, after a median follow-up of 22 years22.

Weight loss

In patients with hidradenitis suppurativa, a positive correlation has been seen between body mass index and disease severity23. A retrospective study (N = 383) showed that two years after receiving bariatric surgery, 49% of patients reported no symptoms, 20% reported less activity, 20% reported no change, and 11% experienced an increase in disease activity24.

Are there topical treatments for hidradenitis suppurativa?

Two topical treatments are available for mild inflammatory hidradenitis suppurativa, resorcinol cream and clindamycin lotion25.

Topical clindamycin is often the first-line therapy for mild to moderate HS with evidence from multiple clinical trials supporting its safety and efficacy. A small double-blind randomised control trial (N = 30) of patients with Hurley stage I and II hidradenitis suppurativa showed a reduction in nodules, abscesses, and pustules following three months of daily topical clindamycin26. Further studies have also shown that clindamycin can reduce pain after 16 weeks27.

However, there is growing evidence that these antibiotic-based treatments are contributing to antibiotic resistance 28,29. In a cross-sectional analysis of 239 patients using topical clindamycin, a large proportion developed antibiotic resistant strains of Staphylococcus aureus when compared to patients using no antibiotics, prompting the authors to recommend that a more targeted approach for long-term HS treatment was necessary, such as resorcinol cream28.

Resorcinol cream is utilised for its keratolytic effect and mild antiseptic properties25. In an open study (N = 32) of patients with Hurley stage I and II disease applying resorcinol (15%) twice daily for 30 days, 19% achieved clinical resolution of a treated boil after 7 days, and 84% after 30 days30. In a larger study investigating patient satisfaction with 15% resorcinol treatment, 84.8% of patients were highly satisfied with treatment based on effectiveness and side-effects31.

A 2022 study comparing 15% resorcinol with 1% clindamycin at 12 weeks of treatment reported that patients receiving resorcinol saw significant improvements in all endpoint analyses when compared to clindamycin32. Topical resorcinol is therefore a strong contender for improved HS treatment, and an alternative to clindamycin to prevent antibiotic resistance.

What systemic treatments are there for hidradenitis suppurativa?

In patients with inflammation and suppuration, treatment primarily consists of oral anti-inflammatory antibiotics25.

Due to the limited efficacy data for specific antibiotics, treatment choice is primarily based on personal preference25

Patients with mild-to-moderate hidradenitis suppurativa can be treated with antibiotics from the tetracycline family25. These include doxycycline and minocycline, which are known to inhibit neutrophilic migration, chemotaxis and angiogenesis, and upregulate IL-10, in addition to their antibiotic properties33.

Moderate-to-severe hidradenitis suppurativa can be treated with clindamycin and rifampicin. These antibiotics both eliminate superinfection and have a notable impact on the immune system34–41.

Recent data presented at the 2022 American Academy of Dermatology (AAD) congress provided an updated reference for empiric use of antibiotic therapy in HS based on region and bacterial strain42. A retrospective analysis of 485 patients with HS were included in the study, which reported that anatomically distinct regions are often infected with different bacterial strains and therefore require specific antibiotic therapy. The results of this analysis conclude that trimethoprim-sulfamethoxazole (TMP/SMX) or tetracyclines should be used as empiric therapy for lesions in the axilla, buttocks and groin. Ampicillin should only be used as first line therapy for patients with inframammary lesions. TMP/SMX should be used for patients with multiple sites of HS lesions if the inframammary area is involved, otherwise a tetracycline may be used as a general first line empiric therapy42.

T2 HS Fig2 May 2022.png

Figure 2. Antibiotic recommendations for hidradenitis suppurativa lesions according to anatomical location (Adapted42).

Other systemic treatments that are commonly prescribed or have been associated with a beneficial effect on hidradenitis suppurativa can be seen in Table 2, subdivided by disease severity43.

Table 2: Recommendations for hidradenitis suppurativa treatment based on disease severity guided by the Hurley clinical staging system (Adapted44).

Hurley clinical staging system Non-Medical Pharmacological Surgical
Stage I (Mild) Steps that should be considered regardless of severity:

Provide education, counselling, and support

Avoid skin trauma

Encourage lifestyle modifications, including weight loss and smoking cessation
First-line: topical clindamycin, oral tetracycline
Second-line: topical resorcinol, hormonal therapy, intralesional corticosteroid injection
Incision and drainage (not encouraged)
Stage II (Moderate) First-line: topical clindamycin, oral tetracycline
Second-line: topical resorcinol, hormonal therapy, intralesional corticosteroid injection
Third-line: Refer to a dermatologist
If multiple medical therapies have failed, refer to a plastic surgeon for excisions
Stage III (Severe) Refer to a dermatologist for oral retinoids, immunosuppressive agents and biologic agents If multiple medical therapies have failed, refer to a plastic surgeon for excisions

Are any biologics approved for hidradenitis suppurativa?

For patients with moderate-to-severe hidradenitis suppurativa who fail antibiotic treatment, biologics are an alternative treatment option that can be used for prolonged periods of time25.

Limited data is available for various investigational biologics, currently adalimumab is the only biologic approved for the treatment of hidradenitis suppurativa25,45,46

Adalimumab is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of hidradenitis suppurativa in patients 12 years and older45,46. For the European indication, this is specifically for patients with an inadequate response to conventional systemic therapy46.

Adalimumab

In 2012, a phase II parallel randomised controlled trial (Table 3), showed that clinical efficacy after 12 weeks was achieved by a significantly greater (P=0.025) number of patients receiving 40 mg adalimumab (17.6%) than 40 mg every other week (EOW) group (9.6%) or placebo (3.9%)47.

The efficacy of the adalimumab 40 mg weekly dose led to two substantial phase III trials, PIONEER I and PIONEER II47,48

Following these results, the PIONEER I and PIONEER II trials were carried out. In these trials it was found that the clinical response rate, defined by hidradenitis suppurativa clinical response (HiSCR), was significantly higher in the adalimumab weekly groups at week 12 in PIONEER 1 (41.8% vs. 26.0%, P=0.003) and PIONEER II (58.9% vs. 27.6%, P<0.001) compared to placebo48.

In both studies, incision and drainage, or injection of intralesional triamcinolone acetonide suspension, were allowed. However, in PIONEER I oral antibiotics were restricted, while in PIONEER II a stable dose of antibiotics was allowed48.

Although adalimumab has been approved for a 40 mg weekly dose, many patients continue to suffer due to the severity of their disease, and don’t respond to this conventional dosing. A recent study investigating the safety and efficacy of 80 mg of adalimumab was therefore conducted, and the results presented at the 2022 AAD congress49. The study was small, enrolling only 6 patients with severe HS non-responsive to 40 mg of adalimumab. Despite its small sample size, the patient’s response to 80 mg was positive, with a significant decrease in severity and number of HS lesions, and no reported serious adverse events. Although this dosing has not been well documented in the literature, further studies could pave the way for improved treatment guidelines using adalimumab.

Table 3. Randomised controlled trials for adalimumab in hidradenitis suppurativa (Adapted50). ADA, adalimumab; EOW, every other week; HiSCR, hidradenitis suppurativa clinical response; HS-PGA, hidradenitis suppurativa Physician Global Assessment; SC, subcutaneous; SS, sartorius score; wk, week.

Trial Patients and therapy Efficacy
Kimball et al. 2012
Phase II
ADA 40 mg/wk SC (N = 51)
ADA 40 mg EOW SC (N = 52)
Placebo SC (N = 51)
17.6% HS-PGA after 12 wk
9.6% HS-PGA after 12 wk
3.9% HS-PGA after 12 wk
P=0.025 (40 mg/wk vs placebo)
P=0.25 (40 mg EOW vs placebo)
PIONEER I
Phase III
ADA 40 mg/wk SC (N = 153)
Placebo SC (N = 154)
41.8% HiSCR after 12 wk
26.0% HiSCR after 12 wk
P=0.003
PIONEER II
Phase III
ADA 40 mg/wk SC (N = 163)
Placebo SC (N = 163)
58.9% HiSCR after 12 wk
27.6% HiSCR after 12 wk
P<0.001

What non-pharmacological treatments are there for hidradenitis suppurativa?

Various laser and light-based treatments have been investigated for the treatment of hidradenitis suppurativa, including25:

  • CO2 laser
  • Neodymium-doped yttrium aluminium garnet
  • Photodynamic therapy

Although at every stage of hidradenitis suppurativa, surgical treatment is currently an essential intervention, with surgical options ranging from incision and drainage to wide excisions25.

A prospective study investigating the efficacy of surgical deroofing for HS management reported that deroofing results in lower recurrence rate and improvements in pain and quality of life51.However, there is disagreement in the literature, with another study citing that recurrence frequently occurs post-deroofing52. Partial or complete deroofing may therefore be an option to avoid recurrence in mild to moderate hidradenitis suppurativa53.

Research into hidradenitis suppurativa has increased considerably in recent years, leading to further insights into the pathogenesis of the disease. As these new insights produce a clearer picture, they are opening up the possibility of novel treatment targets and the long-term control of this chronic inflammatory disease.

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Future treatments for moderate-to-severe HS

Get to know the novel treatments currently being investigated that leverage the evolving understanding of hidradenitis suppurativa pathophysiology with Dr Joslyn Kirby.

Unravelling the pathogenic pathways involved in the development of hidradenitis suppurativa is paving the way for novel therapeutic targets. Currently, there are various small-molecule drugs and biologics under investigation with the aim of targeting new therapeutic targets in moderate-to-severe hidradenitis suppurativa54.

What treatments are currently being investigated for hidradenitis suppurativa?

A variety of novel treatment targets are currently being investigated for hidradenitis suppurativa (Figure 1) that may give rise to a better control of the disease. These targets include tumour necrosis factor (TNF)-α, various interleukins, leukotriene B4, and the Janus kinase (JAK) pathway54,55.

T2 HS_Fig2.png

Figure 3. Proposed key cells and mediators in the evolution of hidradenitis suppurativa and associated pathogenesis-based target therapies under investigation (Adapted54). IL, interleukin; JAK, janus kinase; LTB4, leukotriene B4; TNF-α, tumour necrosis factor-α. * Adalimumab is FDA and EMA approved for moderate-to-severe hidradenitis suppurativa in adults and adolescents from 12 years of age; with an active disease and prior failure to systemic treatment stipulation for the EMA label45,46.

An overview of investigational treatments in hidradenitis suppurativa is provided in Table 4.

Table 4: Investigational treatments for hidradenitis suppurativa (Adapted56,57). *Trial status as per clinicaltrials.gov; however, trial results were reported at EADV 2022 Congress58. Note: Information current as of 12 October 2022. This is intended as a brief summary of investigational treatments for HS, not an exhaustive list. C5a, complement component 5a; G-CSF, granulocyte colony-stimulating factor IL, interleukin; IRAK4, IL-1 receptor associated kinase 4; JAK1, Janus kinase 1; PDE-4, phosphodiesterase-4; TYK2, Tyrosine kinase 2.

Study Investigative Drug Therapeutic Target Phase Status
NCT03972280 CSL324 G-CSF I Completed
NCT03827798 Iscalimab CD40 II Recruiting
NCT03827798 LYS006 Unknown II Recruiting
NCT02643654 Bermekimab IL-1A II Completed
NCT03512275 Bermekimab IL-1A II Completed
NCT04988308 Bermekimab IL-1A II Recruiting
NCT04019041 Bermekimab IL-1A II Completed
NCT05139602 Lutikizumab (ABT-981) IL-1A/B II Recruiting
NCT03910803 Brodalumab IL-17A II Not yet recruiting
NCT03713632 Secukinumab IL-17A III Completed
NCT03713619 Secukinumab IL-17A III Active, not recruiting
NCT03248531 Bimekizumab IL-17A and IL-17F II Completed
NCT04242446 Bimekizumab IL-17A and IL-17F III Active, not recruiting
NCT04242498 Bimekizumab IL-17A and IL-17F III Active, not recruiting
NCT04901195 Bimekizumab IL-17A and IL-17F III Enrolling by invitation
NCT05322473 Sonelokimab (M1095) IL-17A and IL-17F II Recruiting
NCT03926169 Risankizumab IL-23 p19 II Completed
NCT04084665 Guselkumab IL-23 I Withdrawn (COVID-19 Pandemic)
NCT04061395 Guselkumab IL-23 II Unknown*
NCT03628924 Guselkumab IL-23 II Completed
NCT04762277 Spesolimab IL-36 II Completed
NCT03852472 C5aR antagonist C5a receptor II Completed
NCT03487276 IFX-1 – anticomplement C5a antibody C5a receptor II Completed
NCT03275870 Hydroxychloroquine Inflammation, protozoa I-II Completed
NCT04092452 PF-06650833
Brepocitinib (PF-06700841)
Ropsacitinib (PF 06826647)
IRAK4
TYK2/JAK1
TYK2
II Completed
NCT03569371 Povorcitinib (INCB054707) JAK1 II Completed
NCT03607487 Povorcitinib (INCB054707) JAK1 II Completed

Are any other TNFα inhibitors being investigated for hidradenitis suppurativa?

Infliximab

One prospective, randomised, double blind, placebo-controlled, crossover study of infliximab has been published. In this study, significantly more patients from the infliximab group reached a 25–50% decrease in the hidradenitis suppurativa severity index (HSSI) than in the placebo group (P<0.001)59.

However, patients on the induction schedule of 5 mg/kg for eight weeks followed by a maintenance regimen every eight weeks have been seen to develop “wearing off” effects approximately four weeks following infusion. A 4-week interval may therefore be more effective60.

Etanercept

A small, placebo-controlled, randomised control trial (N = 20) compared etanercept 50 mg subcutaneously twice weekly to placebo for 12 weeks. However, despite double dosing, no difference was found in the Physician’s Global Assessment, Patient’s Global Assessment or Dermatology Life Quality Index (DLQI)61.

What interleukin inhibitors are being investigated for hidradenitis suppurativa?

A number of phase II and phase III clinical trials for interleukin inhibitors are currently ongoing. These include trials of biologics that target IL-17A such as secukinumab, bimekizumab and brodalumab, as well as biologics that target IL-23, such as risankizumab and guselkumab (Table 4)55,56.

Some key interleukin inhibitors in clinical development for HS are summarised below.

Anakinra

The efficacy of a biologic targeting IL-1a in hidradenitis suppurativa is under investigation as IL-1 is significantly upregulated in hidradenitis suppurativa lesional skin62–64.

A small, placebo-controlled, randomised control trial examined the efficacy of 100 mg daily anakinra, a recombinant human IL-1 receptor antagonist, after 12 weeks of treatment and after a 12-week follow-up (Table 4). At week 12, 78% of patients receiving anakinra achieved the target HiSCR, compared with 30% receiving placebo. However, this decreased after 12 weeks of follow-up to 33% in the anakinra group and 10% in the placebo group65.

Bermekimab

Another anti-IL-1 therapy, bermekimab is under evaluation in phase II trials for HS55. In a prospective randomised phase II trial (N = 20), 60% of people treated with 7.5 mg/kg bermekimab intravenously every 2 weeks achieved HiSCR compared to 10% in the placebo group by the end of week 1266. In an open-label phase II study of 42 people, weekly administration of 400 mg bermekimab was effective in achieving HiSCR at week 12, in those who were naïve to or had previously failed anti-TNF therapy67. A further phase II trial is currently ongoing55.

Secukinumab

Secukinumab has attracted attention due to the recent evidence of the activation and upregulation of the IL-17 pathway involved in hidradenitis suppurativa inflammation64.

The efficacy, safety and tolerability of secukinumab has been evaluated in two identical double-blind phase III trials of people with moderate-to-severe HS, labelled SUNSHINE and SUNRISE (N = 543 and 541, respectively)68–71. Participants were given 300 mg of secukinumab (after standard weekly loading doses) every 2 or 4 weeks for 16 weeks, or placebo68,69. Results of the primary endpoint analysis were presented at the 31st European Academy of Dermatology and Venereology (EADV) Congress in September 202269.

For those that received secukinumab every two weeks, a significantly higher proportion of patients achieved a HiSCR compared to placebo, across both the SUNSHINE and SUNRISE trials, (45.0% vs 33.7% [P=0.0070] and 42.3% vs 31.2% [P=0.0149], respectively)68,69

For those who received secukinumab every 4 weeks, the response for achieving HiSCR was superior to placebo in the SUNRISE study (46.1% vs 31.2% [P=0.0022])68,69, but not in the SUNSHINE study (41.8% vs 33.7% [P=0.0418])68. Treatment with secukinumab was well-tolerated, consistent with the safety profile of secukinumab in existing indications, and no new safety signals were observed68,69. While full results of these studies are not yet published, these phase III data have been submitted to regulatory authorities in Europe, with a submission to the US FDA anticipated during 202268. The SUNRISE and SUNSHINE clinical trials have both reached their 52-week extension study1,3,4, with results expected in 202368.

In addition, a small open-label 24-week trial (N = 9) of patients with moderate-to-severe hidradenitis suppurativa, with a previous antibiotic treatment failure, received 300 mg of subcutaneous secukinumab per week for 5 weeks, which was then extended to every 4 weeks for up to 24 weeks. At week 24, 67% of patients demonstrated HiSCR, with only common adverse events reported72.

Delve into the future in our expert interview with Dr Joslyn Kirby to learn how research is helping to find the most effective medicines for patients with HS.

Brodalumab

Brodalumab is another biologic targeting IL-17A, and has been investigated in a number of clinical studies73,74,75. In one impressive study, 100% of patients achieved HiSCR and 80% achieved an International HS Severity Score System (IHS4) category change at week 12. Clear improvements were also demonstrated in pain, itch, quality of life and depression. No significant adverse events associated with the treatment were reported75.

Bimekizumab

Bimekizumab has similarly attracted attention as a humanised anti-IL17A and IL-17F monoclonal antibody64.

A phase II study of bimekizumab (N = 79) assessed the percentage of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 compared to placebo. The uniquely designed study also used adalimumab as an active comparator and used the Hidradenitis Suppurativa Severity Score System (IHS4) as a secondary outcome measure76.

The results showed that bimekizumab had a higher HiSCR rate compared to placebo at Week 12 (57.3% vs 26.1%; posterior probability of superiority equalled 0.998, calculated using Bayesian analysis).

At week 12, a higher percentage of bimekizumab-treated participants achieved HiSCR75 (46%) compared to placebo (10%) and adalimumab-treated participants (35%). Moreover, a higher percentage of bimekizumab-treated participants achieved HiSCR90 (32%) compared to placebo (0%) and adalimumab-treated participants (15%)77.

In terms of severity, mean IHS4 at Week 12 for bimekizumab was 16.0 (SD, 18.0) compared with IHS4 of 40.2 (SD, 32.6) with placebo. Serious adverse events were reported in 4% of the bimekizumab group, 10% of the placebo-group, and 5% of the adalimumab group77.

As bimekizumab demonstrated clinically meaningful improvements across all outcome measures, three phase III trials of bimekizumab (BE HEARD 1, 2 and EXT) for moderate-to-severe hidradenitis suppurativa are also currently underway55,56.

Ustekinumab

Inhibition of cytokines IL-12 and IL- 23 with ustekinumab (45–90 mg) has also been investigated in a small, prospective, open-label trial. Of the 12 patients that completed the study, 35% achieved a reduction in MSS of ≥50% at week 40 and 47% achieved a reduction of 25–50%. Five patients dropped out of the trial due to lack of efficacy, side-effects, or psychological problems78.

Guselkumab

Results of a small phase II open-label study of guselkumab in moderate-to-severe HS were reported at EADV 202258. Of the 20 people who received 16 weeks of treatment with 200 mg guselkumab, 13 (65%) achieved HiSCR, with a significant decrease in the median IHS4-score (from 8.5–5.0, P=0.002) and median abscess and nodule (AN) count reduction (from 6.5–4.0, P=0.002)58. Treatment was well-tolerated, and one serious adverse event was considered unrelated to guselkumab58.

A multicentre retrospective Spanish study of 69 people with HS was also presented at EADV 202279. In this population, most had severe disease and prior experience with adalimumab treatment. Overall, 58% and 57% achieved HiSCR after 16 and 24 weeks of guselkumab treatment, respectively, at a dose of 100–200 mg, every 2–8 weeks79. One-third of patients stopped guselkumab (23%), mostly due to inefficacy or lost efficacy (69%), and no serious adverse events were reported79.

What other novel treatments are currently being investigated?

Various other phase I and II trials are also currently ongoing, or have recently been completed. These include the investigation of weekly administration of an anticomplement C5a antibody (IFX-1) in an open-label phase II study of 12 patients as well as hydroxychloroquine 200 mg twice daily for the treatment of patients with hidradenitis suppurativa (Table 4)80,81.

Apremilast (PDE-4 inhibitor)

Apremilast (30 mg twice daily), a phosphodiesterase 4 (PDE-4), has also been investigated in a randomised control trial of twenty patients with mild-to-moderate HS (Table 4). Randomised 3:1 to apremilast and placebo, respectively, 53.3% of the apremilast group achieved HiSCR after 16 weeks compared to 0% of the placebo group (P=0.055). Moreover, a significantly different mean difference in AN count was observed between the two groups (−2.6, P=0.011)82.

Complement 5a (C5a)

The role of complement in inflammation and its relationships to HS has been well investigated over the last decade83. Specifically, C5a, which links bacterial response pathways to inflammation through upregulation of inflammatory cytokines. For this reason, antibodies targeting C5a are being developed and tested in numerous inflammatory conditions. For example, avacopan, an oral C5a inhibitor, showed preliminary success in improving HiSCR responses compared with placebo (42.6%; 22.4%) when administered at 30 mg twice daily over 16 weeks84. With an excellent safety profile, further studies involving larger sampling are required to understand the full potential of C5a antagonism in hidradenitis suppurativa.

Inhibitors of the Janus Kinase (JAK) family

The JAK-STAT pathway can be activated through signalling from various interleukin receptors and type I interferons, inducing inflammation58, and several JAK inhibitors are under evaluation for efficacy in HS58.

The JAK1 inhibitor INCB054707 is being evaluated in three phase II trials in patients with moderate to severe HS55,85–87. The 16-week results of a phase II study (N = 209) were presented at EADV 202285–87, with a greater proportion of patients achieving HiSCR with INCB054707 compared to placebo, and no evidence for increased risk of serious toxicity87. Improvements were also reported for HS- and dermatology-specific QoL and reduced fatigue86, with dose-dependent improvements in patient-reported skin pain, analgesic use, and itch85, for INCB054707, compared with placebo.

A placebo-controlled, parallel-group phase 2a umbrella trial of patients with moderate-to-severe HS has also evaluated the tyrosine Kinase 2 (TYK2) inhibitor ropsacitinib (PF-06826647), the IL-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor PF-06650833 and the dual TYK2/JAK1 inhibitor brepocitinib (PF-06700841)55,88. The 16-week results, also presented at EADV 2022, demonstrated consistent and robust efficacy for brepocitinib, but not for PF‑06650833 or PF‑0682664788. The authors concluded that broader inhibition of both the TYK2 and JAK1 pathway with brepocitinib may be necessary to demonstrate efficacy in people with moderate-to-severe HS88.

A further IRAK4 inhibitor KT-474 is also in phase I development58.

To find out more about hidradenitis suppurativa, click here to get expert opinions from Dr Joslyn Kirby

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