Hidradenitis suppurativa (HS), a chronic, inflammatory skin disease, causes significant morbidity. Until 2023, adalimumab was the only US-approved biologic for patients with moderate to severe HS. This study describes the clinical profile, treatment utilization, and residual disease burden in patients with HS initiating adalimumab in the USA. This observational cohort study used data from the Merative MarketScan® Commercial, Medicare, and Multi-State Medicaid claims databases. Adult patients who initiated adalimumab treatment between 2015 and 2018 were included (main cohort). Patients required continuous insurance enrolment during the year prior to adalimumab initiation (baseline period). Patients were followed until adalimumab discontinuation or study end (2022) to examine treatment patterns, discontinuation rates, predictors of discontinuation, and healthcare resource utilization (HCRU). Study objectives were repeated from the onset of the coronavirus 2019 (COVID-19) pandemic (COVID-19 cohort; 2020–2022). Statistical methods included Kaplan–Meier estimates and a multivariable proportional hazard regression model. The main cohort included 2367 adult patients (70.4
Atopic dermatitis (AD) presents a multidimensional burden, often beginning in infancy and accumulating over time. Beyond itch and pain, AD is associated with significant losses of health-related quality of life resulting from sleep disturbance, stigmatization, other atopic diseases and nonatopic comorbidities, among others. These associated conditions affect patients' physical and mental health, development, social interaction and productivity, resulting in what has been termed cumulative life course impairment (CLCI). To alter the trajectory of AD and improve patient outcomes, it is important to identify people at risk of CLCI, measure it in clinical practice and intervene with appropriate treatment. Although a digital, structured questionnaire for adults exists, a separate instrument to assess CLCI in children and adolescents would benefit our understanding of these issues in a patient population in need. This paper discusses the need for such a questionnaire, with the goal of increasing awareness of the lifelong impact of AD among healthcare professionals, caregivers and patients, potentially improving shared decision-making and facilitating conversations about treatment.
Background:Adalimumab (ADA) is an effective treatment for moderate to severe hidradenitis suppurativa (HS). However, nearly half of patients receiving the standard dose may lose response. Objective:To establish therapeutic thresholds for HS-specific ADA levels, leading to more personalized treatment. Methods:We conducted a single-center, prospective observational study of adults with HS treated with ADA (40 or 80mg/week, and 80mg/biweekly) at a specialized HS clinic (January 2023-May 2024). Serum samples were collected after ≥4 weeks of therapy to ensure steady state. Patients were stratified by physician-assessed response (low <50%, partial 50-75%, high >75% improvement). Associations of ADA concentration and clearance with response were tested using Spearman and Pearson correlations; discriminatory performance was evaluated with ROC analysis. Results:Among 46 enrolled patients, the majority was female (60.9%) and White (54.3%), with a median age of 38 years (IQR: 30-45). ADA serum concentrations positively correlated with clinical response (r = 0.43, p = 0.002). Low responders had significantly lower concentrations than partial (p = 0.029) and high responders (p = 0.007). Clearance was inversely correlated with ADA levels (r = -0.65, p < 0.001). Receiver operating characteristic analysis identified optimal thresholds of 10.7 μg/mL for ADA concentration and 0.5 L/day for clearance. Conclusion:Higher ADA concentrations and lower drug clearance are associated with better clinical outcomes in HS. ROC analysis identified 10.7 μg/mL (ADA concentration) and 0.5 L/day (clearance) as optimal cut-off values to differentiate low from partial/high responders. These findings suggest that therapeutic drug monitoring may help optimize ADA therapy in HS.
Career transitions are common in dermatology, making it important to understand the factors that shape faculty engagement in academia. To better understand these dynamics, we conducted a longitudinal cohort study of 685 full-time faculty from 120 U.S. dermatology departments in 2017, with follow-up in 2024. Retention was defined as continued full-time academic employment with an academic rank. Over the 7-year time period, 461 faculty (67.3
Importance:Hidradenitis suppurativa (HS) is a debilitating inflammatory skin disease with limited therapeutic options. Objective:To assess the efficacy and safety of lutikizumab, a dual-variable domain interleukin 1α/1β antagonist, for adult participants with moderate to severe HS who experienced anti-tumor necrosis factor (TNF) therapy failure. Design, Setting, and Participants:This phase 2, double-blind, placebo-controlled randomized clinical trial was conducted at 45 sites in 8 countries or territories (Australia, Canada, Germany, Greece, Japan, Puerto Rico, Spain, and the US) between December 28, 2021, and November 27, 2023, and included a 35-day screening period, a 16-week treatment period, and a 9-week safety follow-up. Data were analyzed in December 2023. Participants 18 years or older with a diagnosis of HS for 12 months or longer who experienced anti-TNF treatment failure were enrolled. Interventions:Eligible participants were randomized 1:1:1:1 to receive lutikizumab, 300 mg, every week; lutikizumab, 300 mg, every other week; lutikizumab, 100 mg, every other week; or placebo, every week. The trial drug was administered starting at baseline and through week 16. Main Outcomes and Measures:The primary end point was achieving a Hidradenitis Suppurativa Clinical Response (HiSCR 50) at week 16. The secondary efficacy objective was achieving at least a 30% reduction and at least 1-unit reduction from baseline in Patient's Global Assessment of skin pain (Numerical Rating Scale [NRS] 30) after 16 weeks of treatment among among patients with a baseline NRS 3 or greater. Additional end points included achieving HiSCR 75 and HiSCR 90, change and percentage change from baseline in draining tunnels, and change from baseline in Dermatology Life Quality Index total scores. Results:A total of 153 participants received at least 1 dose of the trial medication (94 female individuals [61.4%]; mean [range] age, 40.5 [19-75] years; 108 patients [70.6%] at Hurley stage III). At week 16, 19 (48.7%), 22 (59.5%), and 10 participants (27.0%) receiving lutikizumab, 300 mg, every week; lutikizumab, 300 mg, every other week; and lutikizumab, 100 mg, every other week, respectively, achieved HiSCR50 at week 16 compared with placebo (35.0%); posterior probabilities of positive treatment effect vs placebo were 89.3%, 98.5%, and 22.8%, respectively, using a bayesian analysis. Among participants with baseline NRS scores of 3 or greater, 10 (34.5%) who received lutikizumab, 300 mg, every other week and 8 (34.8%) who received lutikizumab, 300 mg, every week achieved an NRS30 response compared with 4 (12.9%) who received placebo. There were no deaths or treatment-emergent adverse events of neutropenia, serious hypersensitivity reactions, major adverse cardiovascular events, or opportunistic infections reported. Conclusions and Relevance:In this phase 2 randomized clinical trial, lutikizumab, 300 mg, every week and 300 mg every other week showed positive treatment effects vs placebo in a hard-to-treat moderate to severe HS population that experienced anti-TNF therapy failure. Trial Registration:ClinicalTrials.gov Identifier: NCT05139602.
This post hoc analysis of 2 randomized clinical trials examines whether C-reactive protein estimated response to adalimumab in patients with hidradenitis suppurativa.
Hidradenitis suppurativa (HS) adversely affects quality of life, education, work, relationships and mental health. The debilitating effects of HS can compound over a patient's lifetime and have lasting repercussions. The cumulative life course impairment (CLCI) model analyses the disease factors that could affect the life course trajectory of a patient, including effects on major life decisions and opportunities, such as relationships, career path, education and starting a family. As with other diseases, direct longitudinal data for CLCI would require large long cohort studies. Nonetheless, the evidence supports that common domains delineated in the CLCI document impact that are consistent with the negative impact of HS on life course.
Hidradenitis suppurativa (HS) is a chronic, painful skin disease associated with a high disease burden. Disease-related pain is frequently reported as the most troublesome symptom of HS. The SUNSHINE and SUNRISE phase 3 trials previously reported that secukinumab improved control of pain in patients with moderate to severe HS. The objective of this analysis was to evaluate the impact of secukinumab on multiple aspects of pain in patients with HS from SUNSHINE and SUNRISE. Patients were randomised to receive secukinumab 300 mg every 2 (SECQ2W) or 4 weeks (SECQ4W), or placebo until week 16. At week 16, the placebo group switched to receive SECQ2W (placebo-SECQ2W) or SECQ4W (placebo-SECQ4W), whereas the secukinumab groups continued their treatment, until week 52. Pain was assessed using the Patient’s Global Assessment of skin pain‒at worst on a continuous numeric rating scale (NRS) through week 52. Quartiles were used to categorise pain severity groups based on baseline NRS scores (NRS ≤ 3.3; NRS > 3.3 to ≤ 5.4; NRS > 5.4 to ≤ 7.2; NRS > 7.2). Additional assessments included quality of life (QoL) and pain medication use. At week 16, a greater mean (standard deviation) absolute change from baseline in skin pain was observed for patients treated with secukinumab [SECQ2W (− 1.35 (2.16)); SECQ4W (− 1.05 (2.02))] versus placebo [− 0.47 (2.07)]. In the SECQ2W and SECQ4W groups, in patients with NRS > 7.2 at baseline, 20.0
Hidradenitis suppurativa (HS) is a chronic, autoinflammatory skin disease associated with many comorbidities. One biologic (adalimumab) is approved for HS. This study assessed the sociodemographic characteristics, comorbidities, treatment patterns, healthcare resource utilization (HCRU) and associated costs of patients with HS following biologic approval. This non-interventional, retrospective cohort study involved adult (≥ 18 years) and adolescent (12–17 years) patients diagnosed with HS in the United States (US) using Optum’s de-identified Clinformatics® Data Mart Database during the period 1 January 2016 to 31 December 2018. Of 42,843 identified patients, 10,909 met the incident HS patient criteria (10,230 adults, 628 adolescents, 51 patients aged <12 years). Patients were mostly diagnosed by a general practitioner/pediatrician (adults: 41.6
BACKGROUND:Human CXC motif chemokine receptors 1 and 2 ligands are implicated in hidradenitis suppurativa (HS) pathogenesis. OBJECTIVE:To evaluate the efficacy and safety of eltrekibart, a monoclonal antibody targeting the CXC motif chemokine receptors 1 and 2 pathway, in HS. METHODS:In this phase 2 double-blind trial (NCT04493502), adults with moderate-to-severe HS were randomized 2:1 to receive eltrekibart 600 mg or placebo every 2 weeks. The primary endpoint was the proportion of participants achieving ≥50% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining fistula count relative to baseline (HS Clinical Response [HiSCR50]) at week 16. A prespecified Bayesian augmented control analysis was also implemented on the primary endpoint, which sourced historical placebo data from phase 3 HS trials. RESULTS:At week 16, 48.9% of 47 eltrekibart-treated participants and 31.8% of 20 placebo-treated participants achieved HiSCR50 (P = .19). For the augmented-control analysis, 65.6% of eltrekibart-treated participants and 32.3% of placebo-treated participants achieved HiSCR50 at week 16; posterior probability of eltrekibart superiority was 99.9%, with a 61.9% probability of ≥30% difference. Most treatment-emergent adverse events were mild or moderate. LIMITATIONS:Short timeline, limited geography, and small sample size. CONCLUSION:Neutralizing CXC motif chemokine receptors 1 and 2 ligands offer a promising HS treatment strategy.