Dermatology and Therapy最新文献

Objectives: Allergic contact dermatitis occurs frequently in children. The proportion of children of color in the US is increasing, and racial and ethnic minority representation is important in pediatric allergic contact dermatitis research. The objectives of our study were to identify differences in age, sex, race and ethnicity among pediatric patch tests obtained from 2017 to 2022.

Methods: A total of 792 pediatric patients were evaluated, and patch test differences were analyzed among age, sex, race and ethnicity groups.

Results: Children in the age group 0-5 years had the highest number of positive reactions, and propolis was the most frequent allergen among females and in children in the age groups 6-11 years and 12-18 years. Carmine was the most frequent allergen among males and among children in the age group 1-5 years. Risk of sensitivity to multiple allergens varied with race and ethnicity.

Conclusions: The risk of patch test positivity to multiple allergens varied within the demographic groups evaluated. The etiology of these differences is likely multi-factorial and includes differences in exposure patterns and disparities in access.

Introduction: Patients with moderate-to-severe atopic dermatitis (AD), a body surface area (BSA) of ≤ 40%, and an itch numerical rating scale (NRS) score of ≥ 7 ("BARI itch dominant") have been characterized as an important group to consider for the oral janus kinase (JAK) 1/2 inhibitor baricitinib (BARI). Herein we aim to evaluate quality of life (QoL) and functioning outcomes in adult patients with BSA ≤ 40% and itch NRS ≥ 7 at baseline (BL) who received BARI 4 mg in the topical corticosteroid (TCS) combination trial BREEZE-AD7.

Materials: BREEZE-AD7 was a randomized, double-blind, placebo-controlled, parallel-group outpatient study involving adult patients with moderate-to-severe AD who received once-daily placebo or 2-mg or 4-mg BARI in combination with TCS for 16 weeks. Patients eligible for enrollment had to have BSA ≥ 10%. This post-hoc analysis focused on placebo and BARI 4 mg for patients with BSA ≤ 40% and itch NRS ≥ 7. QoL impairment was measured using a Dermatology Life Quality Index (DLQI) of ≤ 5, and functioning outcomes were assessed using the Work Productivity and Activity Impairment (WPAI) questionnaire. Data were reported descriptively. Last observation carried forward (LOCF) data were reported, excluding data collected after the first rescue therapy date or permanent study drug discontinuation. Non-responder imputation was used to account for missing data.

Results: At BL, patients with BSA ≤ 40% and itch NRS ≥ 7 had high QoL impairment. The mean DLQI score at BL for patients who received BARI 4 mg and placebo indicates a very large effect of AD on patients' QoL. Patients who received BARI and placebo experienced a significant itch burden and reported a similar itch NRS. At week 16, 61.5% of patients treated with BARI 4 mg indicated that it had no to only a small effect on their QoL (DLQI ≤ 5), versus 24.1% for patients receiving placebo (p < 0.01). A decrease in WPAI work impairment score of - 41.6 for BARI patients and - 7.0 for placebo patients was observed at week 16 (p < 0.01). Patients receiving BARI also observed a noticeable improvement in WPAI daily activity impairment of - 30.4 from baseline at week 16 compared to patients on placebo, who achieved - 12.2 (p < 0.01).

Conclusion: Despite having high QoL impairment at baseline, patients with itch-dominant AD treated with BARI 4 mg showed marked benefits in QoL, daily life activity, and work function compared to placebo after 16 weeks of treatment. Limitations include the small sample size analyzed.

Introduction: A novel antifungal formulation combining zinc oxide nanoparticles and Whitfield's spirit solution (ZnO-WFs) was developed to enhance the treatment of superficial fungal foot infections.

Methods: This 8-week, randomized, double-blinded controlled trial compared the efficacy, safety, and cost-effectiveness of ZnO-WFs with those of Whitfield's spirit solution (WFs) alone and a zinc oxide nanoparticle solution (ZnOs). Seventy of the 84 enrolled patients completed the trial.

Results: Patients treated with ZnO-WFs and WFs showed similar mycological cure rates, significantly outperforming ZnOs at the 4-week and 8-week evaluations (65.2% and 81.8% for ZnO-WFs and 66.7% and 83.3% for WFs, respectively, compared to 4.0% and 16.7% for ZnOs; P < 0.001). Particularly in nondermatophyte mold (NDM) infections, ZnO-WFs tended to have greater cure rates than WFs (90.0% vs 44.4% at 4 weeks, P = 0.057; 90.0% vs 55.6% at 8 weeks, P = 0.141). Patient satisfaction was equivalent across all groups. The cost-effectiveness analysis revealed that ZnO-WFs is a more economical option for managing NDM infections.

Conclusion: This study confirmed that both ZnO-WFs and WFs effectively treat superficial fungal foot infections. However, ZnO-WFs demonstrates a trend toward increased efficacy and lower cost per patient in managing NDM infections, suggesting a potential advantage over WFs in these specific cases.

Trial registration: ClinicalTrials.gov identifier, NCT05901961.

Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by pruritus and a relapsing course, affecting approximately 25% of children and 4-7% of adults. This study evaluated the efficacy, safety, and quality-of-life impact of tralokinumab, a humanized monoclonal antibody targeting interleukin-13 (IL-13), in treating moderate-to-severe AD in a real-world setting, with a focus on different AD phenotypes.

Methods: An observational cohort of 30 adults treated with tralokinumab for ≥ 16 weeks was analyzed. Clinical and demographic data were collected, and outcomes were assessed using the Eczema Area and Severity Index (EASI), Dermatology Life Quality Index (DLQI), and numeric rating scales (NRS) for pruritus and sleep disturbances.

Results: By week 16, 60% achieved a 75% improvement in EASI (EASI75) and 31% reached a 90% improvement in EASI (EASI90), reflecting substantial clinical improvements. A ≥ 4-point reduction in pruritus NRS was observed in 63% of patients by week 16, increasing to 70% by week 32. Similarly, 75% achieved significant improvements in sleep disturbance NRS by week 16, with sustained effects through week 32. Subgroup analysis revealed superior clinical responses in patients with early-onset AD and atopic comorbidities. Lower total immunoglobulin E (IgE) levels at week 16 correlated with better outcomes, suggesting total IgE as a potential biomarker. By week 32, 70% of patients had a DLQI ≤ 5, indicating minimal quality-of-life impact. Additionally, 88% reached at least one therapeutic target, and 81% met composite endpoints combining clinician-assessed and patient-reported outcomes. The safety profile was consistent with clinical trials, with mild conjunctivitis and injection site reactions as the most common adverse events.

Conclusion: These findings support tralokinumab as an effective and well-tolerated treatment, emphasizing the importance of phenotype-specific approaches in AD management.

Introduction: Patients with psoriasis (PsO) and permanent spinal cord injuries (SCI) resulting in paraplegia and tetraplegia may experience a higher rate of infections compared to patients with PsO without SCI. It can result in further challenges for therapeutic management with immunosuppressants (biological and non-biological treatments). Thus,  we aimed to evaluate the rate of infections in patients with PsO and SCI treated with systemic immunosuppressants.

Methods: This multicenter, retrospective observational study enrolled patients with PsO and traumatic SCI undergoing systemic immunosuppressive treatments for at least 5 years. All patients were evaluated by experienced, board-certified dermatologists and neurologists. Demographic and clinical data were collected.

Results: We enrolled 23 patients with SCI (16 with paraplegia and 7 with tetraplegia) treated with methotrexate (MTX) and different biologics (tumor necrosis factor (TNF) inhibitors (i) and interleukin (IL)-17i/IL-23i). Globally, patients with SCI treated with MTX displayed higher rates of infection compared to those treated with biologics. Patients with paraplegia had lower rates of infection compared to patients with tetraplegia during anti-psoriatic therapies (p < 0.05). Those treated with TNFi had greater rates of infection than those treated with IL-17i/IL-23i (p < 0.001). Patients with psoriatic arthritis (PsA) experienced a significant diagnostic delay and clinical monitoring of PsA severity was challenging.

Conclusion: In patients with moderate-to-severe PsO and concurrent traumatic SCI, dermatologists should consider using IL-17i/IL-23i as first-line therapy.

Introduction: Palmoplantar psoriasis (PPp) has a profound negative impact on patients' quality of life, and it represents a therapeutic challenge, as palms and soles are difficult to treat area. Although the efficacy profile of tildrakizumab has been well evaluated in the literature, data on its use for PPp are still limited. The objective of the study was to evaluate the efficacy and safety of tildrakizumab on moderate-to-severe plaque psoriasis with involvement of the palmoplantar area.

Methods: A multicenter, retrospective, real-life study was performed enrolling patients with moderate-to-severe plaque psoriasis involving the palmoplantar area undergoing treatment with tildrakizumab with a follow-up of at least 52 weeks. At baseline, demographic and clinical data were assessed. Psoriasis severity was evaluated by using Psoriasis Activity Severity Index (PASI), body surface area (BSA), Psoriasis Global Assessment (PGA), Pruritus-Numerical Rating Scale (P-NRS) and Dermatology Life Quality Index (DLQI). Palmoplantar PASI (ppPASI) was used to evaluate psoriasis severity in the palmoplantar region. Clinical improvement was evaluated at each follow-up visit [week (W) 4, 16, 52].

Results: A total of 99 patients were enrolled. A reduction in PASI, BSA, PGA, P-NRS and DLQI was observed at each time point. Mean ppPASI at baseline was 16.9 ± 13.2, which started to improve at W4 (8.9 ± 9.1) and continued to decrease at W16 (2.1 ± 3.1) and W52 (0.5 ± 1.0). Moreover, a sub-analysis showed that the probability of achieving ppPASI50 at W4 increased in case of nail psoriasis (p < 0.05) and decreased in bio-experienced patients (p < 0.001). Similarly, the probability of achieving ppPASI75 at W4 decreased in the case of prior biologic exposure (p < 0.05). Finally, patients with nail psoriasis showed a higher probability of reaching ppPASI75 at W16 (p < 0.05), whereas patients previously treated with systemic therapies for psoriasis reported a reduced probability of ppPASI75 achievement at this time point (p < 0.05).

Conclusion: Tildrakizumab was shown to be a fast and effective treatment for patients with PPp, being able to achieve significant results already after only 4 weeks of treatment. Moreover, the identification of potential clinical factors predictive of response may improve the selection of the best treatment in patients with PPp.

Introduction: Topical 5-fluorouracil (5-FU), 5% or 4% cream, is recommended among first-line treatments for actinic keratosis (AK). Local skin reactions (LSRs) are an expected and transient response to treatment with 5-FU but can lead to treatment discontinuation when severe. This analysis aimed to investigate whether the severity of LSRs during the treatment was associated with lesion clearance assessed 4 weeks after completing treatment.

Methods: This post hoc analysis pooled data from two randomised clinical trials (HD-FUP3B-048 and HD-FUP3B-049). Only patients treated with once-daily 5-FU 4% for 4 weeks were considered. Analyses included LSR severity at week 2 and 4 and clearance 4 weeks after completing treatment (week 8). Analysed LSRs were erythema, scaling, oedema, crusting, erosions, stinging and pruritus, which were each categorised as mild, moderate, severe or none. Response was categorised as complete clearance (CC; clearance of all lesions), partial clearance (PC; ≥ 75% clearance) or no clearance (NC; < 75% or for subgroup analyses NC < 100%).

Results: Data from 397 patients were included. The median number of AK was 11 (lower quartile Q1 = 7 and upper quartile Q3 = 18) and grades were mild to moderate (86.4% of patients) and severe. At week 8, 321 patients (80.9%) had CC/PC and 76 (19.1%) had NC. Patients who achieved CC/PC had, at baseline, more lesions, a more severe disease and lesions preferentially on the ears/face than patients with NC. In adjusted logistic regression analyses and across all LSR grades, CC/PC at week 8 was associated with occurrence of erythema, oedema, crusting and stinging at week 2 and all LSRs at week 4. Severe erythema observed at week 2 was significantly associated with lesion clearance compared with mild erythema. At week 4, both severe and moderate erythema, moderate scaling and moderate pruritus were significantly associated with lesion clearance at week 8 compared with mild LSRs. Results according to the LSR severity for patients who had 100% clearance are quite similar.

Conclusion: Our analysis showed that the severity of LSRs during 5-FU 4% treatment for AK was associated with a higher clearance rate. It appears that severe LSRs did not compromise treatment efficacy. Because LSRs can still be unpleasant, strategies must be developed to relieve patients to allow continued 5-FU 4% application.

Introduction: The impact of atopic dermatitis (AD) on daily life and different levels of quality of life (QOL) according to AD severity has not been fully elucidated. This study aimed to assess QOL in relation to the AD severity in Japan.

Methods: This observational study used anonymized data of health insurance association members and their families registered to a mobile health app. The QOL measures included the Dermatology Life Quality Index (DLQI), EuroQol five-dimensional five-level descriptive system (EQ-5D-5L), Work Productivity and Activity Impairment (WPAI), and sleep disturbance Numerical Rating Scale (NRS). The data were assessed according to AD severity: the Patient-Oriented Eczema Measure (POEM: 0-2, "clear/almost clear"; 3-7, "mild"; 8-16, "moderate"; 17-24, "severe"; 25-28, "very severe"); and itch NRS (0-10).

Results: Of 1507 adults with AD symptoms or undergoing treatments, 882 were identified with AD diagnosis records. Of those, 229 (26.0%), 242 (27.4%), 273 (31.0%), and 138 (15.6%) were included in the clear/almost clear, mild, moderate, and severe/very severe POEM groups, with mean ± standard deviation DLQI scores of 2.0 ± 2.7, 3.6 ± 3.3, 6.1 ± 4.4, and 10.4 ± 5.7, respectively. Higher DLQI scores were observed with increasing POEM severity and itch NRS (Spearman's rank correlation coefficient 0.629 and 0.615, respectively). EQ-5D-5L scores slightly lowered with increasing POEM severity, whereas WPAI percentage slightly increased. Sleep disturbance NRS increased with increasing AD severity in terms of POEM and itch NRS. Adults identified with AD diagnosis records (n = 882) yielded higher WPAI percentages than those without (n = 1204) in all four domains (Wilcoxon rank sum test, p < 0.001 for all).

Conclusion: This study, using real-world data in Japan, presented valuable data on the relationship between AD severity and various aspects of QOL. The data suggested greater QOL impairment with increasing AD severity; even at lower severity levels, QOL was impacted to some extent. The results highlight the need for careful consideration during clinical practice.