Dermatology and Therapy最新文献

Introduction: Amlitelimab (SAR445229, KY1005), a nondepleting anti-OX40 ligand monoclonal antibody, reduced lesions and pruritus in phase 2a and 2b trials in adults with moderate-to-severe atopic dermatitis (AD). Here, efficacy and durability of amlitelimab across body regions were evaluated, given that unmet needs remain for treatment of head and neck AD.

Methods: STREAM-AD phase 2b trial data were used in this post hoc analysis. Patients were randomized 1:1:1:1:1 to receive amlitelimab subcutaneously (250 mg with 500-mg loading dose, 250 mg, 125 mg, or 62.5 mg) or placebo every 4 weeks from weeks 0 to 24 (part 1). In part 2, clinical responders (patients achieving Investigator Global Assessment 0/1 and/or ≥ 75% reduction in Eczema Area and Severity Index [EASI-75] at week 24) were re-randomized 3:1 to withdraw from amlitelimab or continue their pre-week 24 amlitelimab dose through week 52. EASI subscores and signs were evaluated for head and neck, trunk, lower extremities, and upper extremities.

Results: Part 1 included 390 randomized patients; 190 continued to part 2. In part 1, all EASI body region subscores were reduced with all amlitelimab doses at week 24 (P ≤ 0.01). Additionally, the four EASI signs-erythema, edema, excoriation, and lichenification-were reduced with amlitelimab vs. placebo. Greater proportions of patients achieved EASI-75 per body region with all amlitelimab doses, compared to placebo (P ≤ 0.05). At week 52, clinical responders maintained improvements in each body region achieved in part 1, regardless of treatment continuation or withdrawal.

Conclusion: Improvements in AD signs and severity were observed with amlitelimab across all body regions. Notably, clinical responses were sustained following treatment withdrawal, supporting the potential for extended dosing intervals and durable off-treatment efficacy. Amlitelimab may be a treatment option for hard-to-treat head and neck AD that disproportionately impairs quality of life.

Trial registration: ClinicalTrials.gov Identifier NCT05131477.

Introduction: Systemic treatments including standard and targeted drugs for psoriasis could increase the risk of serious infections. In this study we assessed the serious infection risk associated with systemic treatments in patients with psoriasis.

Methods: A systematic review of randomised controlled trials (RCTs) and non-randomised studies of interventions (NRSIs) comparing systemic treatments with placebo or each other was performed. Studies included in Medline, Embase, Cochrane register, CINAHL and ClinicalTrials.gov until September 2024 were eligible if at least 50 adults or children with plaque psoriasis were studied. The primary outcome was serious infection defined as any infection resulting in hospitalization, administration of intravenous antibiotics, death or classified as serious by study authors. Two authors independently performed screening for study eligibility. A frequentist network meta-analysis (NMA) was performed using random effects model. RCT, NRSI and combined (RCT and NRSI) networks were created.

Results: From 119 eligible RCTs, 76 with at least one serious infection event (n = 39,044) and out of 33 eligible NRSIs, 6 without critical risk of bias (n = 306,762) were included in the NMA. Patients were predominantly male (up to 85%) with a mean age ranging from 13 to 52 years. The RCT network showed no increase in serious infection risk with any drug or drug class when compared with each other. The NRSI network showed higher risk with infliximab and adalimumab compared to several other drugs, especially infliximab vs methotrexate (IRR 2.85; 95% CI 1.48, 5.46), and adalimumab vs ustekinumab (IRR 1.51; 95% CI 1.25, 1.83). In the combined NMA, infliximab and adalimumab were additionally shown to have significantly higher risk than acitretin, bimekizumab, methotrexate, placebo, risankizumab, and secukinumab.

Conclusions: The tumour necrosis factor alpha (TNFα) inhibitors adalimumab and infliximab had higher risk of serious infections in the combined NMA. Our findings may inform clinicians and patients concerned about the risk of emergent serious infection on therapy.

Introduction: Hair loss is a multifactorial and complex condition influenced by hormonal changes, nutritional deficiencies, genetic predisposition, oxidative stress, aging, inflammation, and psychological stress. This 6-month study evaluated the hair growth-promoting efficacy and safety of a drinkable nutraceutical (Olistic^© Women) formulated with standardized ingredients to support hair health through multiple biological pathways.

Methods: A total of 106 premenopausal female subjects (18-40 years) clinically diagnosed with telogen effluvium were randomized in a double-blind manner into the active (n = 53) or placebo (n = 53) arm, taking 1 vial (25 mL) per day for 6 months. The primary endpoint was the increase in hair density from baseline versus placebo assessed by phototrichoscopy using TrichoScan^®; the secondary endpoints were the change in anagen-to-catagen/telogen (A:C/T) ratio assessed by phototrichogram using TrichoScan^®, as well as safety and tolerability. This study was reviewed and approved (approval number 20230918-EC48.23) by the Comité de Ética de la Investigación con medicamentos (CEIm) Regional de la Comunidad de Madrid in Madrid, Spain.

Results: Daily oral supplementation with the active product was well tolerated and resulted in a statistically significant increase in hair density versus placebo at day 90 (17.53 ± 2.46 vs 9.56 ± 2.43 hairs/cm²; P = 0.02) and day 180 (27.31 ± 2.61 vs 18.23 ± 2.98 hairs/cm²; P < 0.01). The A:C/T ratio showed a statistically significant increase from day 0 to day 180 in the active arm (from 8.20:1 to 14.19:1) versus placebo (from 7.43:1 to 8.76:1) (P < 0.001).

Conclusion: The tested nutraceutical showed a statistically significant increase in hair density and A:C/T ratio compared to placebo over 6 months in premenopausal women with telogen effluvium. These results not only support efficacy and safety of the tested nutraceutical but also that a multifactorial nutraceutical approach can effectively manage telogen effluvium in premenopausal women.

Trial registration: ClinicalTrials.gov identifier, NCT07111312 (retrospectively registered 07/2025).

Introduction: This study aimed to explore the relationship between atopic dermatitis (AD) disease severity and impact on patients and to describe AD treatment patterns and barriers to treatment in Brazil and Colombia.

Methods: Data were drawn from the Adelphi AD Disease Specific Programme™, a cross-sectional survey of physicians and their patients with AD, conducted in Brazil and Colombia between May 2022 and July 2023. Physicians provided data on demographics, clinical characteristics, treatments, and reasons for not prescribing targeted therapy (TT). Patients completed various patient-reported outcome (PRO) questionnaires: Patient-Oriented Eczema Measure, Dermatology Life Quality Index, EuroQol five-dimensional, and Work Productivity and Activity Impairment. Data were analysed descriptively. Comparisons between current severity were made using analysis of variance (ANOVA) or Kruskal-Wallis tests.

Results: Overall, 100 physicians provided data for 624 adult patients with AD from Brazil (n = 328) and Colombia (n = 296): 47% currently mild, 43% moderate, and 10% severe. For all the PRO measures analysed in Colombia and for the majority in Brazil, the impact on patients increased with increasing disease severity (p < 0.05). In total, 85% of patients with AD in Brazil and 73% in Colombia were treated with topical therapies, with 51% in Brazil and 77% in Colombia receiving systemic therapies, which included biologics (Brazil 12%; Colombia 33%) and oral Janus kinase inhibitors (Brazil 5% and Colombia 10%). The main barriers to TT in Brazil were patients being unable to pay for treatment and treatment not being covered by health insurance. In Colombia, the main barriers were formulary restrictions and patients being very recently diagnosed.

Conclusions: Increased AD disease severity was associated with a greater patient impact and reduced quality of life, with healthcare costs and formulary restrictions hindering optimal treatment across Brazil and Colombia.

Atopic dermatitis (AD) is a chronic inflammatory skin disease associated with impaired quality of life and a substantial burden of disease. Lebrikizumab is a monoclonal antibody that selectively binds with high affinity to interleukin-13, thereby inhibiting its cascade signaling and reducing inflammation. Lebrikizumab has demonstrated efficacy and safety in adults and adolescents ≥ 12 years with moderate-to-severe AD in randomized, placebo-controlled, phase 3 clinical trials. Here, we report a case series of four patients with moderate-to-severe AD who transitioned to lebrikizumab treatment in the Czech Republic. All four patients had failed previous targeted therapies (biologics or Janus kinase inhibitors) and/or cyclosporine treatments and presented with associated comorbidities. After 12 to 16 weeks of treatment with lebrikizumab, clinically significant improvements in signs and symptoms (assessed by Eczema Area and Severity Index [EASI], pruritus Numerical Rate Scale, quality of life assessed by the Dermatology Life Quality Index [DLQI], and/or Patient Oriented Eczema Measure [POEM]) were reported. The results of these four clinical cases support the effectiveness observed in randomized clinical trials and suggest that lebrikizumab may be an effective treatment for moderate-severe AD in real-world clinical practice, even in patients with comorbidities who have failed previous advanced treatments.

Introduction: Hair thinning is a prevalent concern influenced by multiple factors including stress, hormonal changes, diet, and lifestyle, with varying impacts across demographic groups. Oral supplements addressing these key root causes through a multi-targeting, patented, botanical-based Synergen Complex have been developed to combat hair thinning across different populations. This study sought to build on existing evidence from previous clinical studies evaluating hair growth and quality by evaluating the effectiveness of these nutraceuticals in enhancing hair fiber diameter, and thus hair strength and length, in adults with thinning hair.

Methods: This 6-month, prospective, open-label study included women, plant-based women, menopausal women, parous women, and men consuming commercially available hair growth nutraceuticals (HGNs) targeted to different demographics (Nutrafol^® Women, Vegan, Balance, Postpartum, and Men). All subjects had hair thinning, self-reported and confirmed by the study dermatologist. Assessments occurred at baseline, day 90, and day 180. Measurements included hair shaft diameter via light microscopy, hair breakage/shedding via a four-region hair pull test, investigator global assessment (IGA) of hair parameters, and subject self-perception questionnaire.

Results: A total of 252 participants enrolled, with 244 completing the study per protocol. Ingestion of the HGNs was associated with a significant increase in hair shaft diameter across all groups by day 180. Hair pull tests showed significant reductions in intact, broken, and total hair shedding overall. In-person IGA was correlated with significant improvements in hair attributes-strength, length, thickness, and overall hair health-across all groups. Self-perception data revealed strong agreement across groups with statements regarding hair improvements by day 180.

Conclusions: This study demonstrates that ingestion of these bio-specific HGNs are associated with significantly enhanced hair shaft diameter and decreased breakage, resulting in longer, stronger hair across their intended populations. These findings support the use of these HGNs for hair thinning, offering alternative options for various populations for improving hair growth and thickness.

Clinicaltrials: gov identifier, NCT06362941.

Introduction: Delays remain in patients receiving effective treatment strategies that have potential to clear their skin of psoriasis, improve their quality of life (QoL) and change the psoriatic disease course, which, if uncontrolled, can irreversibly alter an individual's life course (i.e. cumulative life course impairment [CLCI]). This study explored current international awareness and consideration of the potential impact of psoriasis over the life course within clinical assessments and decisions about its management.

Methods: Cross-sectional surveys collated insights from people with psoriasis and healthcare professionals (HCPs) treating psoriasis (dermatologists and primary care physicians [PCPs]) across 29 countries.

Results: Data were collected from 487 people with psoriasis, 574 dermatologists and 618 PCPs. Despite people with psoriasis highlighting a range of daily activities that are 'very frequently' or 'always' affected by their psoriasis, 37% were never or rarely asked by their HCPs how the disease affects their life. Fewer than half of people with psoriasis had a high understanding of the potential future impact of psoriasis (or CLCI-contributing factors), and 44% were unaware that clear/almost clear skin is now a realistic treatment target. Almost half of HCPs considered psoriasis to be of early onset when it presented at ≤ 15 years of age. Despite HCP awareness of the impact of psoriasis on QoL, many of the contributing factors to CLCI were not addressed routinely in clinical practice nor considered when deciding on treatment; 40% of dermatologists set treatment goals (such as clear skin/almost clear skin/target Dermatology Life Quality Index [DLQI]) sometimes, less frequently, or not at all.

Conclusions: Misalignment exists in the experience of people living with psoriasis versus its assessment in clinical practice. Support is needed for assessment and monitoring of elements that may contribute to CLCI in clinical practice worldwide, to guide early psoriasis treatment decision-making to mitigate the risk for CLCI. Infographic available for this article. INFOGRAPHIC.

Introduction: Lebrikizumab, a human monoclonal antibody that targets interleukin-13, is approved for treating moderate to severe atopic dermatitis in many regions. However, real-world data are lacking and are needed to inform its efficacy and safety in broader populations.

Methods: This retrospective study reviewed the Eczema Area and Severity Index (EASI) and Dermatology Life Quality Index (DLQI) at baseline and 16-20 weeks of 84 consecutive patients who received lebrikizumab subcutaneously at the label dose in a tertiary centre.

Results: EASI scores were available at 16-20 weeks for 72 patients. At this timepoint, 80.6% (58/72) achieved EASI 50, 56.9% (41/72) reached EASI 75, and 27.8% (20/72) attained EASI 90. DLQI was reduced by an average of - 1.5 points at 16-20 weeks. No serious adverse events were reported. Ocular adverse events occurred in 21.4% of the cohort (18/84). Eleven out of 14 patients that previously experienced conjunctivitis with dupilumab or tralokinumab had no recurrence with lebrikizumab.

Conclusion: In this real-world cohort of patients with atopic dermatitis, lebrikizumab demonstrated efficacy comparable to that observed in clinical trials. It may provide an alternative treatment option for individuals who have discontinued other biologics as a result of conjunctivitis.

Introduction: Generalized pustular psoriasis (GPP) is a chronic, systemic neutrophilic inflammatory disease, associated with acute flares and life-threatening complications. Plaque psoriasis, which is clinically and pathologically distinct from GPP, is also associated with mortality. While this has improved with the advent of effective biological therapies, progress in GPP is limited. The objective of this study was to compare all-cause mortality in GPP patients with that of plaque psoriasis patients and the general population.

Methods: Studies reporting mortality in GPP and ≥ 1 comparator group were selected for inclusion in meta-analyses through a systematic literature review and review of unpublished data. Two independent reviewers performed study screening and data extraction. Pooled hazard ratios (HRs) were calculated using random effects models.

Results: Primary meta-analyses included studies in Sweden and the USA, representing 3652, 8308 and 10,102 people with GPP, with plaque psoriasis and in the general population, respectively. All-cause mortality was 1.78 times higher (95% confidence interval [CI]: 1.52-2.09; P < 0.0001) for GPP than for plaque psoriasis and 2.92 times higher (95% CI: 1.12-7.60; P = 0.03) than for the general population. Sensitivity analyses, including studies in Germany and France, confirmed the primary results for GPP versus plaque psoriasis; pooled HRs were 1.79-2.31 (P < 0.01 for all analyses). Effect sizes across all four studies were considerably heterogeneous (I² = 93.58%; Q = 54.93; P < 0.0001). A study in Germany, with significant heterogeneity, possibly due to miscoding issues, was included in a sensitivity analysis for GPP patients versus the general population; the pooled HR reduced to 1.63 (95% CI: 0.45-5.97; P = 0.46), with considerable heterogeneity in effect sizes (I² = 98.35%; Q = 61.42; P < 0.0001).

Conclusion: GPP patients' all-cause mortality is 2-3 times higher than those for plaque psoriasis patients and the general population, highlighting the need for improved management of GPP. This analysis provides a reference point to evaluate changes in mortality following the introduction of targeted treatments.

Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by intense itch and recurrent lesions that impose clinical and economic burden. The individual and combined contributions of itch intensity and lesion severity to healthcare resource utilization (HCRU) and costs are not well defined. This study characterized real-world clinical phenotypes of moderate-to-severe AD based on itch and lesion severity and quantified their associations with HCRU and healthcare charges.

Methods: A retrospective cohort study was conducted using linked electronic health records and claims data from the OMNY Health Dermatology Platform (January 2022-June 2024). Patients aged ≥ 12 years with moderate-to-severe AD, defined by prescription treatment, were included. Patients were stratified into four clinical phenotypes based on their scores on the Itch Numerical Rating Scale (NRS) and Investigator Global Assessment (IGA): moderate itch and moderate lesions (MI-ML), severe itch and moderate lesions (SI-ML), moderate itch and severe lesions (MI-SL), and severe itch and severe lesions (SI-SL). Annualized all-cause HCRU and total healthcare charges were assessed using multinomial propensity score weighting. Logistic regression identified predictors of high total charges (≥ 90th percentile).

Results: Among 4433 patients with moderate-to-severe AD, phenotype distribution was MI-ML (33%), SI-ML (43%), MI-SL (4%), and SI-SL (21%). While HCRU event rates (hospitalizations, emergency visits) were similar across phenotypes, mean annual total charges differed notably. Compared with MI-ML ($23,697), charges increased with severe itch (SI-ML: + $2197), severe lesions (MI-SL: + $3705), and both severe itch and lesions (SI-SL: + $10,448), driven mainly by pharmacy and outpatient costs. Mean annual charges were highest in SI-SL ($34,145), followed by MI-SL ($27,402), SI-ML ($25,894), and MI-ML ($23,697). Severe itch alone was associated with elevated pharmacy expenditures, whereas severe lesions primarily increased outpatient costs. In multivariable models, biologic use, systemic therapy, and comorbidities were predictors of high total charges.

Conclusion: Both itch intensity and lesion severity independently and additively contributed to HCRU and economic burden of moderate-to-severe AD. Severe itch primarily increased pharmacy spending, while severe lesions drove outpatient costs. The combined phenotype of severe itch and lesions incurred the highest overall charges, underscoring the need for phenotype-informed, comprehensive AD management strategies.