PracticalDermatology

According to several experts in the field of hidradenitis suppurativa (HS), a revolutionary shift unfolding in research and treatments is underway. Among recent advances in this area, a newly approved treatment option is now available for patients with HS, and the use of ultrasound imaging in the assessment of HS is gaining traction in dermatology practices.

“The most notable change in HS treatment was the recent FDA approval in October 2023 of the biologic secukinumab, sold under the brand name Cosentyx, for adults with moderate-to-severe HS,” Vivian Shi, MD, FAAD, associate professor in the department of dermatology at the University of Arkansas for Medical Sciences in Little Rock, told Practical Dermatology^®.¹ “This drug is an IL-17A inhibitor that was previously only approved for psoriasis and some types of arthritis.”

Secukinumab was approved based on results of the phase 3 SUNSHINE (ClinicalTrials.gov Identifier: NCT03713619) and SUNRISE (ClinicalTrials.gov Identifier: NCT03713632) trials, which demonstrated a clinical response (defined as a 50% or greater increase in the number of abscesses and inflammatory nodules and no increase in abscesses and draining tunnels) in patients receiving secukinumab 300 mg every two weeks compared to placebo. At 16 weeks, a greater number of patients in both trials showed a clinical response with secukinumab vs. placebo: 44.5% vs. 29.4% (P <.05) in the SUNSHINE trial and 38.3% vs. 26.1% (P <.05) in the SUNRISE trial.^1,2

Similar results were observed in patients receiving secukinumab every four weeks, and the response improved over time to week 52 (to roughly 56% in both trials) for patients on both dose regimens.¹ At 16 weeks, secukinumab demonstrated a favorable safety profile, and no study-related deaths were reported.¹

“The approval of secukinumab is an important improvement in the availability of treatments for HS, as the only other previously approved biologic was adalimumab,” Dr. Shi said.

Treatment of HS Across Stages

Treatment strategies for HS include topical, systemic, and surgical approaches tailored to each patient depending on disease severity and presenting symptoms.^3,4

“For localized disease with solitary papulonodules and abscesses, treatment can range from topical antimicrobials and washes to intralesional corticosteroids, oral antibiotics, spironolactone, metformin, and laser,” explained Alexis Lyons, MD, FAAD, dermatologist at Forefront Dermatology in both Ann Arbor and Novi, MI, in a conversation with Practical Dermatology.

Studies suggest that any form of laser hair removal can be helpful in early disease, including Nd:YAG, alexandrite, diode, and intense pulsed light, according to Steve Daveluy, MD, FAAD, associate professor and program director of dermatology at Wayne State University School of Medicine in Detroit, MI.^5,6 Dr. Daveluy noted in an interview with Practical Dermatology^® that using interstitial injections with higher doses of triamcinolone has changed his practice and can lead to permanent resolution of abscesses, nodules, and even tunnels.⁷ He said that he uses the 40 mg/cc concentration even if for the first flare for that lesion, and advised that clinicians inject it directly into nodules and around the cavity in tunnels and abscesses so it doesn’t flow out of the cavity and stays in the surrounding skin.

Hadar Lev-Tov, MD, MAS, associate professor in the Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery at the University of Miami Miller School of Medicine, added that he and his colleagues recently reported “the potential effect of clascoterone cream, which is approved for treatment of acne, as an off-label use in the treatment of mild or nodular HS.” Among 12 patients who used the cream (mostly females; median age, 28 years), with twice-daily application to all active and inactive HS lesions, 83% reported improvement in a median follow-up time of 12 weeks.⁸

“For more severe, widespread, or treatment refractory disease with scarring and tunneling, treatment is primarily systemic and includes oral antibiotics, intravenous antibiotics, systemic immune modulators such as adalimumab and secukinumab, and surgical procedures,” Dr. Lyons said.

WINDOW OF OPPORTUNITY

In our interview with Dr. Daveluy, he discussed the importance of early recognition and treatment in HS.

“Research is demonstrating that we need to treat the disease in its early stages to prevent progression – we call this the ‘window of opportunity,’ and early recognition is key,” he explained. “If you see any patient with pimples, folliculitis, boils, abscesses, nodules, or tunnels in the axillae, groin, buttocks, or inframammary region, one simple question can help screen for HS: Have you had more than one outbreak of boils in armpits, groin, buttocks, or under the breast in the past 6 months? If the answer is yes, the positive predictive value for a diagnosis of HS is 96%.”⁹

Biologics are the “quarterback” of the treatment team for disease control in severe HS, according to Dr. Shi. However, Dr. Daveluy cited findings showing that only 1.8% of patients with moderate-to-severe HS were receiving biologic treatment, suggesting vast underutilization of biologics in this patient population.¹⁰

He also pointed out that recent evidence shows the use of biologics is associated with better responses to surgery and should not be paused, contradicting the belief that biologics may increase the risk of infection or delayed would healing after surgery among patients with HS.¹¹

Dr. Daveluy also emphasized the importance of offering options for flare treatments across all stages of HS, including giving patients access to the office when flaring. In addition to intralesional triamcinolone injections, which provide relief to the injected lesion within 24 to 48 hours, he suggested deroofing as another option to relieve flares of abscesses or tunnels.

“We’re seeing more providers performing the simple and effective deroofing procedure, from dermatologists to emergency medicine physicians to primary care providers,” Dr. Daveluy said. Deroofing is superior to incision and drainage, with a much lower recurrence rate (4%-19% vs. 100%).¹²

Most patients with moderate-to-severe disease require multiple treatment strategies.

“If a treatment gives partial relief, we continue to add to the regimen until we get things under control,” Dr. Daveluy explained. “It’s also really important to note that many patients require a combination of medical and surgical therapy – medical therapies work better with surgery, and surgery works better combined with medical treatment.”

Additionally, “In the area of wound care, we recently published a consensus paper that provides some initial guidelines for clinicians on how to handle disease-related wounds as well as surgical wounds, Dr. Lev-Tov said.¹⁵

Along with addressing the physical symptoms of HS, Dr. Lyons emphasized the critical need to evaluate patients for psychological comorbidities.

“HS can be extremely distressing and has high rates of comorbid anxiety and depression,” she noted.¹⁶ “Support groups, including Hope for HS, have been established to provide a community to connect and support those with HS, advocate for change, raise awareness, and disseminate knowledge.”

Dr. Lyons added that various professional groups have published HS treatment guidelines, including the North American guidelines for HS Management by the United States and Canadian Hidradenitis Suppurativa Foundations.¹⁷

Emerging Developments in HS Research

Despite the myriad developments in HS research, numerous questions and other needs remain, including further work to identify the etiology of HS.

“It is critical for the advancement of the field and for the benefit of our patients that we know more about what is causing this cruel, relentless disease,” Dr. Lev-Tov said. “I am excited to see more NIH funding directed toward HS-specific research. This is nothing short of a revolution for the agency, which has traditionally sponsored zero HS studies and is now a major sponsor.”

He also pointed to advanced clinical trials investigating a group of Janus kinase (JAK) inhibitors that are showing promise as oral agents compared to biologic injections.¹⁸ In October 2023, results of a double-blind, dose-ranging, placebo-controlled phase 2 trial (ClinicalTrials.gov Identifier: NCT04476043) investigating povorcitinib, an oral JAK1 inhibitor developed by Incyte.¹⁹

HS patients were randomized to receive 15, 45, or 75 mg of povorcitinib or placebo. At 16 weeks, 48.1% (P=0.0445), 44.2% (P=0.0998), and 45.3% (P=0.0829) of each group achieved clinical response, compared to 28.8% of the placebo group.¹⁹

Treatment-emergent adverse events (TEAEs) were observed in 60.0% of the povorcitinib-treated patients vs 65.5% with placebo. The most common TEAEs were fatigue, headache, nausea, upper respiratory tract infection, and diarrhea.¹⁹

At the 8th Annual Symposium on Hidradenitis Suppurativa Advances (SHSA) held in Phoenix, AZ, in October 2023, Incyte presented additional phase 2 data regarding the quality of life impact associated with povorcitinib as well as baseline patient characteristics associated with achieving clinical response with the drug. Phase 3 trials of povorcitinib are currently underway.²⁰

“All in all, there’s a lot of enthusiasm about medical management for HS, and multiple clinical trials are ongoing,” Dr Lov-Tov said. However, “We do not have many studies looking at earlier disease, i.e., Hurley stage 1 or isolated, nodular disease.” This area represents a gap that warrants further attention in research.

THE ROLE OF ULTRASOUND IN HS MANAGEMENT

The use of ultrasound imaging for HS assessment and surgical planning is increasing in both research and clinical practice.^13,14 We asked each expert interviewed for this article to weigh in on the pros and cons of this approach.

Dr. Shi: Ultrasound can be a useful tool in the measurement of HS disease severity to detect the number of pseudocysts, sinus tracts, hair follicle widening, and fluid collections. Many of these findings are hard to discern from physical exam alone because the disease changes occur under the skin surface in the hair follicle. Ultrasound can be beneficial prior to surgical excision to determine the extent of involvement and the location for removal.

The limitation of this approach is that the use of ultrasound may not ultimately impact the treatment regimen in some cases, as it is a multifactorial patient-driven decision. We need further research regarding the impact of ultrasound on clinical decisions, and the development of criteria to streamline its use is warranted.

Dr. Lyons: I have found that ultrasound prior to surgical procedures for HS has been particularly helpful. This approach allows physicians to map out the affected areas, including subcutaneous nodules that may not be clinically apparent when looking at the area with the naked eye, and to establish boundaries for sinus tracts and tunnels beneath the skin prior to surgery. This facilitates removal of the entire affected areas to reduce the risk for recurrence in the treatment area.

Limitations of utilizing ultrasound to assess the extent of HS involvement and tunneling include the length of time required to perform an adequate ultrasonographic exam and the additional specialized training that is required to obtain satisfactory images and to understand and interpret the ultrasound images.

Dr. Lev-Tov: The field of HS has created such demand that innovation is virtually unavoidable. In that sense, the use of ultrasound in HS is really leading the way for the rest of our field. Traditionally, ultrasound was inefficient in the hands of the dermatologist because the machines are expensive and bulky and require specialized training. However, the advent of portable ultrasound – and especially portable ultrasound with high-frequency resolution – may hold potential for a renaissance of skin imaging with ultrasound.

In HS specifically, ultrasound can improve the accuracy of disease staging, which has been shown to lead to significant changes in management in up to 4 out of every five patients.¹⁴ Ultrasound can be used for planning surgery as well as guiding lesional injections. I am very excited to see how the introduction of ultrasound into the hands of dermatologists will transform our specialty.

Dr. Daveluy: Ultrasound assessment can be very useful in the assessment of HS. It has been proven to more accurately detect tunnels than clinical examination, which is useful when planning a surgery, since it’s always important to try to remove all the tunnels.

The main limitations of ultrasound are availability and expertise: Not many clinics have incorporated ultrasound examination in the management of HS yet, so it’s actually rare right now to find someone who will use it, but its use is expanding. Some training is also required to develop the skills to successfully use ultrasound, but it can be learned and mastered quickly, so that’s not a major burden.

Ultrasound is now being included in some clinical trials as a means to assess HS. This may lead to more accurate assessment of disease response, which is a major challenge in studying HS treatments.

“There are many ongoing clinical trials for new biologics with various mechanisms,” according to Dr. Shi,¹⁸ and Dr. Lyons noted that 49 active or recruiting HS studies are currently listed on ClinicalTrials.gov, many of them looking at new treatment modalities, comparing efficacy of different treatments, investigating comorbidities, exploring genetics, and studying the pathophysiology behind the disease.

Other therapies being investigated for HS include bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F. Bimekizumab was developed by UCB and was recently approved by the FDA for the treatment of adults with moderate to severe plaque psoriasis.²¹

According to analyses of pooled data from 2 phase 3 trials (NCT04242446 and NCT04242498), clinical response rates were higher at 16 weeks in patients with moderate-to-severe HS who were treated with bimekizumab (roughly 56%-58% across 3 dosing regimens) compared to those receiving placebo (33.4%). By week 48, more than 8 in 10 patients had maintained clinical response bimekizumab.²²

The most common TEAEs with bimekizumab were hidradenitis (18.7%), oral candidiasis (11.2%), and coronavirus infection (10.8%). Serious TEAEs were reported in 4.5%-7.0% of patients.²²

Dr. Daveluy told Practical Dermatology he anticipates that numerous medications in the pipeline will continue to transform the landscape of HS treatment, and that selecting the optimal therapies for each patient represents an upcoming challenge in personalized medicine for individuals with HS.

In other studies, “Research into the microbiome of the skin and gut in HS is helping us understand the complicated role that bacterial colonization plays in the systemic immune response seen in HS,” he added.¹⁸ “It’s not an infection, which is a myth we are working hard to combat, but bacteria do play a role in stimulating an immune reaction.”

He added that he’s pleased to see a greater focus on pain management strategies in HS research, given that pain is the most bothersome symptom in this patient population and has a substantial impact on patient quality of life.¹⁸

Advocacy and Support for HS

All of the expert contributors emphasized their support for the HS Foundation, which provides grants to support research, and to create educational opportunities for physicians, patients, resident physicians, and advanced practice providers. Dr. Lev-Tov serves president-elect of the foundation, while Dr. Daveluy serves on the board of directors and Dr. Shi is a member of the executive board.

Dr. Lev-Tov expressed excitement about the HS Foundation’s portfolio of recent support, from small hypotheses-generating studies to career development, awards, and collaboration with the Dermatology Foundation. The HS Foundation also provides a range of resources for providers, including prior authorization templates for various treatments.

Additionally, the HS Coalition is a newly formed collaborative group of patient advocates and health professionals initiated by UCB, Inc.²³

“We hope to provide support and resources to physicians, patients, and caregivers to help improve laws and policies that affect HS, such as insurance coverage, access to healthcare, disease awareness, and more,” Dr. Daveluy explained. “It’s a really exciting time for this field, and the future is bright for everyone affected by HS.”

The authors report no relevant disclsoures.

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8. Hargis A, Yaghi M, Maskan Bermudez N, Lev-Tov H. Clascoterone in the treatment of mild hidradenitis suppurativa. J Am Acad Dermatol. Published online September 2, 2023. doi:10.1016/j.jaad.2023.08.064

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11. Shanmugam VK, Mulani S, McNish S, Harris S, Buescher T, Amdur R. Longitudinal observational study of hidradenitis suppurativa: impact of surgical intervention with adjunctive biologic therapy. Int J Dermatol. 2018;57(1):62-69. doi:10.1111/ijd.13798

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14. Mendes-Bastos P, Martorell A, Bettoli V, Matos AP, Muscianisi E, Wortsman X. The use of ultrasound and magnetic resonance imaging in the management of hidradenitis suppurativa: a narrative review. Br J Dermatol. 2023;188(5):591-600. doi:10.1093/bjd/ljad028

15. Chopra D, Anand N, Brito S, et al. Wound care for patients with hidradenitis suppurativa: Recommendations of an international panel of experts. J Am Acad Dermatol. 2023;89(6):1289-1292. doi:10.1016/j.jaad.2023.07.1037

16. Caccavale S, Tancredi V, Boccellino MP, Babino G, Fulgione E, Argenziano G. Hidradenitis suppurativa burdens on mental health: A literature review of associated psychiatric disorders and their pathogenesis. Life (Basel). 2023;13(1):189. doi:10.3390/life13010189

17. Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations: Part I: Diagnosis, evaluation, and the use of complementary and procedural management. J Am Acad Dermatol. 2019;81(1):76-90. doi:10.1016/j.jaad.2019.02.067

18. Hunt A, Qian V, Olds H, Daveluy S. The current clinical trial landscape for hidradenitis suppurativa: A narrative review. Dermatol Ther (Heidelb). 2023;13(7):1391-1407. doi:10.1007/s13555-023-00935-x

19. Kirby JS, Okun MM, Alavi A, et al. Efficacy and safety of the oral Janus kinase 1 inhibitor povorcitinib (INCB054707) in patients with hidradenitis suppurativa in a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study. J Am Acad Dermatol. 2023;S0190-9622(23)03037-2. doi:10.1016/j.jaad.2023.10.034

20. Incyte. Data from Incyte’s povorcitinib clinical program to be featured at the 8th Annual Symposium on Hidradenitis Suppurativa Advances (SHSA). Published online October 13, 2023. Accessed December 14, 2023.

21. UCB. BIMZELX[®] approved by the U.S. FDA for the treatment of adults with moderate to severe plaque psoriasis. Published online October 18, 2023. Accessed December 14, 2023.

22. Phase 3 Data analysis presented at EADV 2023 showed bimekizumab achieved high thresholds of clinical response in hidradenitis suppurativa. Published online October 12, 2023. Accessed December 14, 2023.

23. UCB. Going beyond the medicine: How UCB Is addressing the needs of people living with hidradenitis suppurativa. Published October 13, 2023. Accessed November 29, 2023.