Alavi, A

ABSTRACT Background Hidradenitis suppurativa (HS) is an inflammatory condition associated with cysts of the folliculopilosebaceous unit primarily affecting intertriginous areas. HS has been correlated with smoke exposure in the adult population, but there is a knowledge gap in understanding its effect in pediatric and adolescent patients. This study assesses correlations between active and passive smoke exposure and the development of HS in the pediatric and adolescent population. Methods A retrospective case–control study was conducted at Mayo Clinic (2010–2023) of patients diagnosed with HS before the age of 18 years who were age‐, sex‐, and race‐matched to healthy controls in a 1:3 ratio, analyzed using Fisher exact for categorical variables and Kruskal–Wallis for continuous. Results One hundred and seventy‐four cases and 522 controls met inclusion criteria. The prevalence of active and passive smoke exposure was significantly higher in patients with HS compared to controls ( p = 0.001), with passive smoke accounting for 64.6% ( N = 31/48) of smoke exposure in patients with HS. Smoke exposure was associated with a significant increase in the odds of an HS diagnosis, with an odds ratio of 4.8 (95% CI: 3.06–7.61) for passive and/or active exposure, and 1.64 (95% CI: 1.01–2.61) for passive exposure alone. Smoke exposure was associated with a later age of diagnosis than those with no smoke exposure ( p < 0.001). Conclusion Prevalence of active and passive smoke exposure was higher in pediatric and adolescent patients with HS compared to age, sex, and race‐matched healthy controls. Smoke exposure increased the odds of having HS and was associated with a later age at diagnosis.

ABSTRACT The integration of Internet of Things devices in medicine has paved the way for novel diagnostic and therapeutic solutions that offer ‘smart’ capabilities, especially for at‐home wound monitoring. Such capabilities include increasing portability, diminished gaps in care through continuous analysis, and real‐time programmable manipulation of device parameters to intervene more rapidly. This scoping review explores the landscape of Internet of Things devices, including smart bandages, wearable and skin‐interfaced sensors, and mobile app‐connected devices, specifically designed for chronic wound monitoring in a remote, at‐home setting. We reviewed literature from PubMed, IEEE Xplore, Scopus, and Web of Science, using keywords related to Internet of Things and chronic wound care. The evaluation criteria focused on biomarkers analysed, Internet of Things connectivity technology, experimental models used for device validation, and unique device strengths or weaknesses. Our review identified 52 unique studies comprising 77 data entries across five biomarker categories: gas and oxygen saturation, pH, metabolic markers, biophysical parameters of the wound microenvironment, and molecular markers of inflammation or infection. These devices span a wide landscape of biomarkers analysed to predict and monitor wound recovery, with the potential to improve patient outcomes through personalised treatment and timely interventions. However, many devices were never validated clinically on humans and faced limitations in power delivery, accuracy, stability, and reliability that challenge their potential usability in humans for wound monitoring. This review provides a comprehensive understanding of the potential and limitations of Internet of Things devices in at‐home wound care, highlighting areas for future research and development.

ABSTRACT Background Pyoderma gangrenosum (PG) is a rare neutrophilic dermatosis highly associated with systemic comorbidities. Accurate diagnosis and treatment remain challenging due to its rarity and clinical mimickers. Objectives To evaluate demographic, clinical features and treatment outcomes in patients referred with suspected PG at a tertiary wound care centre. Methods A prospective observational study was conducted of patients referred for suspected PG between April 2021 and June 2023. Demographic, clinical and laboratory data, including biopsies and tissue cultures, were collected. Patients were categorised as having PG vs alternative diagnoses based on diagnostic criteria from Su, Maverakis and the PARACELSUS score. Results Of 60 patients (female, 51.7%; mean [SD] age 52.9 [14.0] years), 44 (73.3%) met at least one published diagnostic criterion for PG. The most common comorbidity was IBD (63.6%), followed by inflammatory arthritis (25.0%) and monoclonal gammopathy of undetermined significance (MGUS) (4.5%). Systemic corticosteroids were used by 40.9% of patients before referral, but steroid‐sparing agents and biologics were the primary treatments after consultation. Biologics and steroid‐sparing agents were associated with significant improvement in disease activity using the PGA score (average score decreased from 2.3 to 1.5, p < 0.005), with 40.9% achieving complete remission. Elevated serum inflammatory markers and faecal calprotectin were observed in PG patients but absent in non‐PG cases. Conclusions These prospective data support previously published rates of association between PG and systemic comorbidities. Steroid‐sparing anti‐neutrophilic and targeted therapies are effective steroid‐sparing strategies in managing PG. Small sample size and referral bias may limit generalisability.

Abstract Background The results of a previous phase IIa trial suggested efficacy of the anti-C5a compound vilobelimab in a small number of patients with severe hidradenitis suppurativa (HS) refractory to adalimumab treatment. Objectives To study the efficacy of vilobelimab in a larger-scale randomized phase IIb trial (SHINE) of patients with moderate-to-severe HS. Methods In total, 177 patients with moderate-to-severe HS were treated either with placebo or one of four doses of vilobelimab, a monoclonal antibody that targets the complement split product C5a. Hidradenitis Suppurativa Clinical Response (HiSCR) at 16 weeks was the primary endpoint. Those who achieved HiSCR switched to open-label low-dose vilobelimab; those who did not were switched to medium-dose vilobelimab. The trial was registered with the EU Clinical Trials Register (EudraCT number 2017-004501-40) and ClinicalTrials.gov (NCT03487276). Results The study did not meet the primary endpoint, perhaps due, in part, to an unexpectedly high HiSCR placebo response rate of 47.1%. HS flares decreased and post hoc analysis showed that high-dose vilobelimab significantly decreased the median draining tunnel counts and IHS4 score by 63%. Following the switch to medium-dose vilobelimab at week 16, 45.5% of those who did not respond to treatment achieved HiSCR at week 40. Conclusions Compared with placebo, vilobelimab treatment did not result in significant HiSCR improvements in patients with moderate-to-severe HS. Post hoc analysis revealed significant effects for the highest tested dose on draining tunnel reduction and IHS4 score, which captures reductions in draining tunnels. These findings warrant further investigation.

ABSTRACT Background Secukinumab, a fully human, monoclonal antibody targeting interleukin‐17A, is approved for moderate‐to‐severe HS in adults. This study evaluated pharmacokinetics (PK), high‐sensitivity C‐reactive protein (hsCRP) changes, and safety of secukinumab over 52 weeks in SUNSHINE and SUNRISE Phase 3 trials. Methods An exploratory analysis of pooled Phase‐3 trials evaluated serum PK and safety of secukinumab 300 mg every 2 (SECQ2W) or 4 weeks (SECQ4W). A population PK model assessed the effects of body weight, disease severity, and baseline hsCRP on secukinumab serum concentration. Exposure–response analysis assessed the relationship between predicted PK and HS clinical response [HiSCR]. No confirmatory statistical testing was performed. Results Mean serum trough concentration at Weeks 16, 24, and 52 was ~2‐fold higher with SECQ2W vs. SECQ4W. At Week 16, exposure overlap was high, with an estimated numerical increase in HiSCR of ~3% for SECQ2W over SECQ4W. At Week 52, HiSCR levels plateaued. At Week 16, hsCRP decreased from 18.6 ± 26.3 mg/L to 12.8 ± 18.0 mg/L (SECQ2W), 15.9 ± 27.6 mg/L to 11.5 ± 18.4 mg/L (SECQ4W), and remained unchanged with placebo (14.4 ± 22.5 mg/L to 14.7 ± 23.8 mg/L); reductions were sustained through Week 52. Higher body weight, disease severity, and baseline hsCRP were associated with lower secukinumab serum concentrations. Secukinumab immunogenicity was low (< 1%), with no new safety signals. Conclusion Secukinumab serum concentrations in patients with HS varied with body weight, disease severity, and baseline hsCRP. SECQ2W may benefit certain patients. Secukinumab reduced hsCRP through Week 52. The safety profile of secukinumab was consistent with other approved indications, with no apparent dose–response relationship observed. Trial Registration NCT03713619 (Novartis study code CAIN457M2301). NCT03713632 (Novartis study code CAIN457M2302)

Background: Hidradenitis suppurativa (HS) is a chronic inflammatory disease with fluctuating activity that requires long-term visual documentation to evaluate disease severity and treatment response. A standardized protocol for photographing HS is critically needed. Objectives: To establish a standardized protocol for using photography to clinically document HS. Methods: We brought together a panel of international experts and used a modified Delphi process to reach consensus on statements about standardized practices for using photography to document HS in clinical practice and research settings. A 75% agreement level was prespecified as the cutoff for consensus. Results: Consensus for photographically documenting HS was developed within 6 key areas: patient preparation, background, lighting, size and reference scale, camera considerations, and patient positioning. The revised and optimized protocol includes 34 standardized reference illustrations. However, the proposed recommendations are for ideal scenarios, and their implementation may not always be practical in a clinical setting. Variations in resources may not have been captured. Conclusions: The proposed consensus-based protocol provides a standard for consistent photographic documentation of HS. This protocol may help clinicians provide better disease surveillance and patient care, and it may aid in more precise and reliable research and clinical trials for HS.