Alavi, Afsáneh

AbstractBackgroundThe hidradenitis suppurativa (HS) clinical response (HiSCR) has come under scrutiny as several HS clinical trials failed to meet primary endpoints with high placebo responses. This may be due to limitations of the tool and raters' ability to accurately characterize and count lesions, rather than lack of efficacy of the studied drug. Due to HS lesion complexity and potential differences in rater training, it was hypothesized that there would be discrepancies in how providers characterize and count lesions for HS clinical trials.ObjectiveTo evaluate how HS providers and patients name and count HS lesions and to identify discrepancies among providers to initiate the development of consensus‐driven guidance for HS rater training.MethodsAn online survey was distributed to the members of HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC). Respondents were asked to classify lesion images composed of multiple and different morphology types and answer questions regarding inclusion of associated dermatological conditions.ResultsForty‐seven HISTORIC members responded (29 providers; 18 patients). There was variability in how respondents classified HS lesions. Of 12 questions containing images, four had ≥50% of respondents choosing the same answer. With an image of a lesion composed of different morphologies, 45% of providers counted it as a single lesion and 45% counted it as multiple distinct lesions. With an image of multiple interconnected draining tunnels, 7% of providers classified it as a single draining tunnel while 79% categorized it as multiple draining tunnels with the number estimated by visual inspection. There was also variability in deciding whether lesions occurring in associated conditions should be considered separately or included in HS lesion counts. Patient responses were also variable.ConclusionsThe result of the current study reaffirms the gap in how providers characterize and count HS lesions for clinical trials and the need to develop consensus‐driven rater training related to HS outcome measures.

Abstract Background Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease with a considerable disease burden. Existing treatment options are limited and often suboptimal; a high unmet need exists for effective targeted therapies. Objectives To explore the effects of spesolimab treatment in patients with HS. Methods This randomized double-blind placebo-controlled proof-of-clinical-concept (PoCC) study was conducted at 25 centres across 12 countries from 3 May 2021 to 21 April 2022. Patients had moderate-to-severe HS for ≥ 1 year before enrolment. Patients were randomized (2 : 1) to receive a loading dose of 3600-mg intravenous spesolimab (1200 mg at weeks 0, 1 and 2) or matching placebo, followed by maintenance with either 1200-mg subcutaneous spesolimab every 2 weeks from weeks 4 to 10 or matching placebo. The primary endpoint was the percentage change from baseline in total abscess and inflammatory nodule (AN) count at week 12. Secondary endpoints were the absolute change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4), percentage change from baseline in draining tunnel (dT) count, the proportion of patients achieving a dT count of 0, absolute change from baseline in the revised Hidradenitis Suppurativa Area and Severity Index (HASI-R), the proportion of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR50), the proportion of patients with ≥ 1 flare (all at week 12) and patient-reported outcomes. Results In this completed trial, randomized patients (n = 52) received spesolimab (n = 35) or placebo (n = 17). The difference vs. placebo in least squares mean is reported. At week 12, the percentage change in total AN count was similar between treatment arms: –4.1% [95% confidence interval (CI) –31.7 to 23.4]. There was greater numerical improvement in the spesolimab arm, as measured by IHS4 (13.9, 95% CI –25.6 to –2.3); percentage change from baseline in dT count (–96.6%, 95% CI –154.5 to –38.8); and the proportion of patients achieving a dT count of 0 (18.3%, 95% CI –7.9 to 37.5). Spesolimab treatment also improved HASI-R and HiSCR50 vs. placebo. Spesolimab demonstrated a favourable safety profile, similar to that observed in trials in other diseases. Conclusions This exploratory PoCC study supports the development of spesolimab as a new therapeutic option in HS.

AbstractWe report a case of a 41‐year‐old woman who developed pregnancy‐associated pyoderma gangrenosum (PG) at 4 weeks gestation. She was initially treated with prednisone, however, due to lack of improvement and risk of systemic corticosteroids in pregnancy, underwent a prednisone taper and was initiated on certolizumab pegol (CZP). The patient experienced complete wound re‐epithelialization 1 month after CZP initiation. She had no pregnancy complications except for prednisone‐associated gestational diabetes and gave birth to a healthy baby. CZP is a tumour necrosis factor‐inhibitor with negligible placental transfer and no known adverse effects in pregnancy. Its efficacy and safety for autoinflammatory dermatoses in pregnancy are very promising. This is the first case to report CZP treatment for PG in a pregnant patient.

AbstractBackgroundDermatology grand rounds are popular educational activities among dermatologists and trainees, contributing to improved knowledge and skills. Dermatology hospital conferences at Mayo Clinic Dermatology are separate from dermatology grand rounds in that they focus on inpatient consultations and dermatology admissions.ObjectivesThis study aimed to determine the types of cases presented during dermatology hospital grand rounds and evaluate the educational value of this continuing medical education (CME)‐accredited activity.MethodsThis retrospective study reviewed all inpatient dermatology cases presented during hospital grand rounds at Mayo Clinic Dermatology in Rochester, MN from 2019 to 2022; this study also reviewed the compiled surveys of faculty participants at our institution from 2019 to 2022.ResultsA total of 389 cases met the inclusion criteria for analysis. The most common diagnostic category was inflammatory/autoimmune diseases (157 cases, 40%), followed by infection or infestation (73 cases, 19%), drug‐induced eruptions (49 cases, 13%), neoplastic or metastatic diseases (41 cases, 11%), genetic/congenital disorders (21 cases, 5%), depositional/nutritional/metabolic conditions (15 cases, 4%) and wound/traumatic/iatrogenic dermatoses (12 cases, 3%), which were the least common. Most cases were presented for discussion of diagnosis and management (246 cases, 63%), but others focused on the arrival of diagnosis (119 cases, 31%) or management alone (24 cases, 6%). The compiled surveys of faculty participants (n = 50) indicated high satisfaction with dermatology hospital grand rounds, with the majority expressing that evidence‐based research was incorporated and positively impacted their practice. Most respondents indicated that hospital conference participation improved knowledge (97%), competence (64%), clinician performance (54%), patient outcomes (52%) and team performance (50%).ConclusionsThe cases presented during these conferences spanned from challenging inflammatory diseases to simple dermatoses, with over 800 literature references reviewed. Dermatology hospital grand rounds provide high value as a CME‐accredited activity for dermatology faculty, even for those without a specific interest in hospital/inpatient dermatology.

AbstractBackgroundNeutrophilic eccrine hidradenitis (NEH) is a benign neutrophilic dermatosis not well recognized beyond an association with malignancy. Although the disease is commonly reported in adults with malignancy, this association is uncommon in children. The diagnosis of NEH is predominantly based on histologic findings to exclude alternative diagnoses for adults, but biopsy is not usually required for children.MethodsA retrospective study was performed of adult and pediatric patients diagnosed with NEH at three Mayo Clinic sites from January 1, 1992, to January 1, 2022. The aim of this study was to elucidate risk factors for NEH and its clinical characteristics, treatment options, and natural course. Clinical information and pathologic results were collected from health records. Available pathologic slides were reviewed with a dermatopathologist.ResultsOf 47 patients identified, 33 had either histologic or clinical confirmation of the diagnosis; 21 were adults (64%), and 12 were children (36%). Most adults (16/21; 76%) had underlying malignancy and received chemotherapy. Five adults (24%) were classified as having idiopathic NEH, and they were younger and had higher NEH recurrence rates than the other adults. Only one pediatric patient (8%) had underlying malignancy. For 10 children (83%), NEH was preceded by strenuous activity. Initial findings of idiopathic NEH were palmoplantar eruptions for both adult and pediatric patients, whereas malignancy‐associated NEH commonly involved the face and axillae.ConclusionsAmong adults, NEH is commonly associated with malignancy and chemotherapy. Among children, idiopathic NEH occurs primarily after overexertion, and malignancy is highly unlikely to be the cause of NEH.

AbstractBackgroundHidradenitis suppurativa (HS) is a chronic inflammatory skin condition that causes substantial physical, emotional and psychological burdens. Guselkumab, a monoclonal antibody that binds to the p19 subunit of interleukin‐23, has demonstrated high levels of efficacy in the treatment of inflammatory diseases, including psoriasis and psoriatic arthritis.ObjectiveTo evaluate the effect of guselkumab on the treatment of HS, a phase 2, multicentre, randomized, placebo‐controlled, double‐blind, proof‐of‐concept study was conducted.MethodsPatients ≥18 years of age with moderate‐to‐severe HS for ≥1 year were randomized to (1) guselkumab 200 mg by subcutaneous (SC) injection every 4 weeks (q4w) through Week 36 (guselkumab SC); (2) guselkumab 1200 mg intravenously (IV) q4w for 12 weeks, then switched to guselkumab 200 mg SC q4w from Weeks 12 through 36 (guselkumab IV); or (3) placebo for 12 weeks, with re‐randomization to guselkumab 200 mg SC q4w at Weeks 16 through 36 (placebo → guselkumab 200 mg) or guselkumab 100 mg SC at Weeks 16, 20, 28 and 36 and placebo at Weeks 24 and 32 (placebo → guselkumab 100 mg). End points included HS clinical response (HiSCR) and patient‐reported outcomes.ResultsAlthough guselkumab SC or guselkumab IV resulted in numerically higher HiSCR versus placebo at Week 16 (50.8%, 45.0%, 38.7%, respectively), statistical significance was not achieved. Numerically greater improvements in patient‐reported outcomes were also observed for guselkumab SC and guselkumab IV versus placebo at Week 16. Through Week 40, no clear differences to suggest a dose response were observed for HiSCR and patient‐reported outcomes.ConclusionsDespite modest improvements, the primary end point was not met and the overall findings do not support the efficacy of guselkumab in the treatment of HS. Clinicaltrials.gov: NCT 03628924.

Current validated hidradenitis suppurativa (HS) severity assessment tools are time-consuming and impractical in fast-paced, ambulatory clinic settings. This study evaluated the construct validity of the most severe or ‘worst’ area local Hidradenitis suppurativa Activity and Severity Index-Revised (W-HASI-R) as a novel target area assessment tool for clinical setting use. W-HASI-R had strong association with the International Hidradenitis Suppurativa Severity Score System and abscess and nodule count, moderate association with Hurley stage and HS physician global assessment and weak, negative association with reverse-scored Dermatology Quality Life Index. The resulting data suggest that W-HASI-R may be an option as an efficient target area assessment tool for fast-paced, ambulatory settings.