The State of the Clinical Management Union: A Cross-Sectional Survey of Persons With Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a chronic auto-inflammatory condition characterized by the presence of fluctuant, painful papules and nodules that can evolve into sinus tracts and deforming scarring.¹ HS often follows an unpredictable, relapsing, and remitting disease course and has a significant negative impact on quality of life.¹ HS is associated with social isolation, challenges with intimate relationships, and increased rates of anxiety and depression.^2-4 A variety of medications with variable efficacy are utilized for the treatment of HS, including topical and systemic antibiotics, anti-hormonal therapies, and immunosuppressants.¹ Many of these treatments are used off-label, and to date, only 2 US Food and Drug Administration (FDA)-approved biologic therapies are available--adalimumab and secukinumab.^1,5 Other management strategies include surgical interventions, such as wide excision and deroofing, which can be employed for the disfiguring sequelae but may involve extensive procedural aspects such as grafts and skin flaps.¹ Due to the impressive psychosocial and physical burden of HS, along with the predominately off-label therapeutic armamentarium, this study aimed to assess patients' experiences and satisfaction with managing their HS. The study also sought to understand patient knowledge and perceptions of emerging FDA-approved therapies.

An IRB-exempt (IRB#: NCR235179), 18-question survey was developed using the cloud-based survey tool SurveyMonkey and distributed via the HSconnect.org listserv for completion between November and December of 2023. Participation was optional; respondents were required to be 18 years of age or older and currently living with HS. Respondents not meeting eligibility criteria were excluded from participation. Demographic data collected included age, race and/or ethnicity, and gender. Responses were measured using free text, multiple-choice questions, and modified Likert scales. Survey responses were compiled for analysis using Fisher's exact tests and statistical significance was calculated using a standard 95% confidence interval, as well as ChatGPT to summarize free text responses.

Demographics In total 501 survey responses were collected with 423 (84.4%) completing the entire survey. The average age of participants was 37.35 years old (SEM = +/- 0.51) (n=501). Most respondents (91.82%, 460/501) identified as women, while a minority identified as men (4.99%, 25/501), non-binary individuals (2.2%, 11/501), or chose to self-describe (0.2%, 1/501). Participants were given the option to select more than 1 racial and ethnic category with most participants identifying as white/Caucasian (58.88%, 295/501). Other represented racial and ethnic groups included persons identifying as African American (25.35%, 127.501), Black (10.38%, 53/501), Latinx (9.18%, 46/501), Native American or Alaska Native (2.99%, 15/501), Asian (2.40%, 12/501), other (2.20%, 11/501), African Caribbean (2%, 10/501) and Middle Eastern or North African (0.8%, 4/501). Demographics of survey participants can be found in Table 1. Disease Characteristics The average age of HS onset was 20 years old (SEM = +/- 0.48) (n=483), while the average age of formal diagnosis with HS was 29 years old (SEM = +/- 0.57) (n=483). Most participants (93.17%, 450/483) were diagnosed with HS by a dermatologist or other healthcare provider and graded as either Hurley stage III (28.57%, 138/483), stage II (21.95%, 106.483) or stage I (6%, 29/483). Summarized disease characteristics are found in Table 1. Management Strategies Respondents utilized a variety of treatments for managing HS. The most utilized treatments including antimicrobial washes (ie, benzoyl peroxide, chlorhexidine) (69.03%, 292/423), antibiotics (ie, doxycycline, minocycline, trimethoprim-sulfamethoxazole) (54.85%, 232/423), and biologics (ie, adalimumab, infliximab) (28.84%, 122/423). Other treatments included anti-hormonal therapy (ie, birth control pills, spironolactone, finasteride) (24.82%, 105/423), corticosteroids (ie, triamcinolone) (18.91%, 80/423), diabetes medications (ie, metformin) (13.24%, 56/423), oral immunosuppressants (ie, methotrexate) (4.73%, 20/423), and other treatments not specified in the above categories (16.78%, 71/423). The mean number of treatments utilized per respondent was 2.36 (SEM = +/- 0.065) (n=423). Of those participants who utilized more than 1 treatment for disease

management, the most frequent combination was antibiotics and antimicrobial washes (28.37%, 120/423). Disease Management Satisfaction, FDA-Treatment Knowledge, and Related Challenges In evaluating respondent satisfaction with their disease management strategy, only 17.97% of participants were satisfied or very satisfied (17.97%, 76/423). Additionally, most participants indicated that they were unaware of FDA-approved therapies (73.52%, 311/423) and had not discussed these options with their dermatologist or other healthcare provider (55.79%, 236/423). When asked to quantify how many of the treatments they currently utilized for the management of HS were FDAapproved, many respondents were unsure (48.94%, 207/423). A sub-analysis of respondents grouped according to their Hurley stages (Hurley I-III only) found that patients with more severe disease were more likely to have discussed FDA-approved therapies with their dermatologist or healthcare provider (P=0.00391). However, neither knowledge nor current utilization of FDA-approved therapies was significantly different across Hurley stages (P=0.5756 and P=0.1588, respectively). The greatest respondent-reported challenge in finding FDA-approved treatments to manage HS was a lack of awareness about options (48.46%, 205/423). Other challenges included an insufficient number of treatments (43.26%, 183/423), difficulty finding treatment for HS subtype (38.30%, 162/423), high cost (30.97%, 131/423), and lack of regular access to a dermatologist or other healthcare provider (21.75%, 92/423). Perceptions and Impact of Secukinumab Approval Despite many respondents reporting a lack of knowledge about FDA-approved options, most responses indicated it was important or extremely important to have FDA-approved options (60.04%, 254/423). Along with these findings, most respondents (71.37%, 304/423) expressed confidence to high confidence in the development of additional HS treatments given the recent approval of secukinumab. Greater disease severity (Hurley stage III) was statistically correlated with more respondents reporting either "moderate-to-high" or "little-to-none" confidence in the development of more FDA-approved therapies following the approval of secukinumab (P=0.0289) compared to Hurley stages I or II. In evaluating the impact of more FDA-approved options for HS management, patients anticipated improved physical health (85.58%, 362/423), mental health (77.78%, 329/423), and personal relationships (59.81%, 253/423). Participants were also given 2 free-text response options to elaborate on the personal impact of FDA-approved options, as well as an opportunity to provide feedback related to secukinumab approval. Responses were condensed as artificial intelligence (AI)-generated summaries and coded based on frequency of variables as assigned in the Dermatology Quality Life Index (DLQI).⁶ The most frequent DLQI variables in response to the personal impact of FDA-approved options were disease activity (119/296), self-confidence (78/296), and treatment effort and access (71/296). These data are represented in Figures 1-3.

This national survey of individuals with HS provides insight into the current demographic landscape of HS and the treatment experience of those living with HS. Firstly, the results herein were consistent with the literature at the time of disease onset and diagnosis. Estimated disease onset according to published studies is after puberty with an associated 7- to 12-year delay in diagnosis.¹ Both of these observations were supported by responses with an average onset at approximately 20 years and diagnosis at approximately 29 years old. However, there were inconsistencies in the perceived prevalence of HS across different racial and ethnic groups. While current studies suggest that HS is more prevalent in Black and/or African American and Latinx women, most survey participants were white/Caucasian women which could attributed to the makeup of the listserv.^1-3 Notably, this study highlighted that a small minority of respondents are satisfied with current treatments available for HS, and many are unaware of FDA-approved options, with over half of respondents reporting that their dermatologist or other healthcare provider had not discussed FDA-approved options with them. Yet, most respondents indicated that it was important to have FDA-approved treatments for HS and believed that their use would lead to improved overall quality of life. Specifically, both the summaries of free text responses and DLQI frequency graph demonstrated that additional FDA therapies would have a pronounced impact on quality-of-life measures such as selfconfidence and overall health. These findings emphasize the overwhelming potential to ease the tremendous psychosocial burden of HS on patients with the addition of more approved treatments. Additionally, our findings underscore the amount of work left to address gaps in patient education and employ adequate advertising strategies to enhance patient awareness of available treatments for their condition. Survey findings provided insight that respondents are likely being undertreated with available systemic therapies. According to the North American clinical management guidelines for HS published in 2019, biologics (ie, adalimumab) are firstline treatments for managing moderate (Hurley stage II) to severe (Hurley stage III) HS.⁷ However, of these respondents, less than 1 quarter (23.58%, 25/106) of those in Hurley stage II and slightly over half (51.45%, 71/138) of those classified into Hurley stage III reported using biologics. This undertreatment is likely correlated with the high rates of dissatisfaction with management strategies, as supported by a recent qualitative study of HS treatment selection. In this study, Salame et al performed an investigation to explore factors affecting treatment decisions and demonstrated that respondents with HS who experienced increased pain and debilitation were more willing to incorporate a biologic medication compared to their counterparts.⁸ It was shown that patients perceived biologics as a last resort option for management of disease, influenced by a combination of misunderstanding adverse risks, quality of information available on the internet, conversations with their dermatologist, advertisements, and the experiences of friends and family.⁸ Investigators called attention to the gaps in knowledge that dermatologists must help their patients fill to assist patients in making educated decisions focused on prevention of disease progression. Another recent study by Tolson et al could also explain undertreatment and dissatisfaction of HS management in the context of dermatology versus non-dermatology clinicians. In this investigation, antibiotic prescribing patterns of dermatologists versus non-dermatologists were compared, and showed that 72% of HS visits were conducted by nondermatology clinicians with antibiotics prescribed in 51.9% of these encounters. While there was no difference found between these groups in their likelihood to prescribe antibiotic therapies, dermatology clinicians most commonly prescribed tetracyclines, a first-line recommendation for systemic antibiotics in treatment of HS per guidelines, whereas nondermatology clinicians most commonly prescribed penicillin/ cephalosporins.⁹ While the respondents were not specifically questioned about whether or not a dermatologist manages their HS, treatment dissatisfaction rates expressed by respondents may be impacted by the care received from a non-dermatology provider who may be less familiar with HS-specific therapeutic options, treatment guidelines, and have varied levels of exposure and formal education in this area compared to their dermatologist counterparts. Nearly 75% of respondents endorsed that the recent approval of secukinumab instills confidence in the development of future, more effective treatments for HS which are sorely lacking to date. While respondent-reported thoughts related to approval of secukinumab were of varied opinion, most concerns were related to insurance coverage and side effects. This suggests that the remaining hesitancy regarding confidence in the development of these treatments is primarily centered on issues of access and cost. Further supporting this, other responses indicated that respondents were cautiously optimistic about the general efficacy of secukinumab, noting that its recent approval is an encouraging step toward expanding treatment options in the near future. Interestingly, self-identified Hurley stage III respondents had polarized opinions, as they were statistically more likely to have either greater or lesser confidence compared to respondents with milder disease manifestations. This could in part be due to the notion that increased disease severity is associated with more ‘failed’ experiences with available therapeutic options, and as a result, linked with a greater degree of skepticism. For example, a respondent who has been on adalimumab and found it to be ineffective for their HS may be more apprehensive about the development of additional FDA therapies, especially if those treatments are in the same

medication category, such as in the case of adalimumab and secukinumab which are both biologics. Limitations Limitations of this study include its cross-sectional design and potential for sampling and response bias which limits generalizability. Additionally, accuracy of responses is limited by potential misinterpretation of question stems by respondents. Finally, in assessing free responses related to the approval of secukinumab, many respondents indicated little to no knowledge about its approval, potentially signaling a premature distribution of the survey and a missed opportunity to educate respondents.

These survey results provide invaluable insight into the high rates of respondent dissatisfaction with current HS treatment options, likely attributed to undertreatment with available therapies and gaps in respondent knowledge. Respondents were overwhelmingly unaware of FDA-approved options and reported that their dermatologist or other healthcare provider had not recommended these therapies for them, despite biologics being first-line therapies for moderate-to-severe HS. Apart from these sentiments, respondents expressed a strong desire for increased development and approval of FDA-approved therapies, which were strongly associated with a perceived positive impact on quality of life. Future research and advocacy efforts should focus on increasing the number of FDA-approved therapies, while simultaneously addressing potential treatment inadequacies in patient care and knowledge. Future studies should further evaluate other underlying reasons such as barriers to care, advertising approaches, and utilize enhanced patient-provider communication strategies to address gaps in care, empower patients, and dispel misinformation.

The authors have no conflicts of interest. Ethics statement: This study was declared IRB-exempt by the research ethics committee of The George Washington School of Medicine and Health Sciences IRB-Board (IRB#: NCR235179).

Adam J. Friedman MD FAAD ajfriedman@mfa.gwu.edu