Dermatology and Therapy最新文献

Introduction: Atopic dermatitis (AD) is a chronic, inflammatory skin disease with a hallmark symptom of pruritus. We developed Worst Pruritus Numeric Rating Scale (NRS)-a single-item, patient-reported outcome measure-to assess itch severity in clinical trial populations of adults with moderate-to-severe AD. The objective of this study was to evaluate the psychometric properties of Worst Pruritus NRS and determine its appropriateness for use in clinical trials assessing the efficacy of treatments among adults with moderate-to-severe AD.

Methods: We used data from a subset of 267 participants in a phase 2 clinical trial of rocatinlimab (NCT03703102; N = 274) to confirm reliability, validity, and ability to detect change in Worst Pruritus NRS. We estimated and confirmed a meaningful within-patient change (MWPC) threshold using anchor- and distribution-based methods.

Results: All intraclass correlation coefficients (ICCs) were ≥ 0.86, providing robust evidence for test-retest reliability. Evidence supported construct validity, including known-groups validity (all P < 0.0001). There were moderate, positive correlations between scores on Worst Pruritus NRS and supportive measures at week 16, including Dermatology Life Quality Index (DLQI) question 1 (itch item) (r = 0.78), DLQI (r = 0.66), Eczema Area and Severity Index (EASI) (r = 0.50), Investigator's Global Assessment (IGA) (r = 0.46), Body Surface Area of Involvement (BSA) (r = 0.40), and SCORing Atopic Dermatitis (SCORAD) itch item (r = 0.97). On average, patients with better DLQI question 1 scores, EASI, and IGA classifications achieved better (i.e., lower) scores on Worst Pruritus NRS at week 16 (P < 0.0001). Ability to detect change was supported with moderate-to-strong and positive correlations between Worst Pruritus NRS change scores and changes in supporting measures. MWPC estimates confirmed the commonly applied 4-point threshold value and a range of 3 to 4 points as indicative of meaningful within-patient change.

Conclusions: Worst Pruritus NRS is a reliable and valid patient-reported outcome measure to assess itch severity in clinical trial settings among adults with moderate-to-severe AD.

Atopic dermatitis (AD) is a chronic inflammatory skin condition characterized by intense itching, redness, and eczema. It significantly impacts the quality of life of affected individuals, often requiring long-term management strategies. Abrocitinib, an oral Janus kinase 1 (JAK1) inhibitor, is approved for the treatment of moderate-to-severe AD. Phase 2 and phase 3 abrocitinib randomized clinical trials in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) clinical development program have demonstrated the efficacy and safety of abrocitinib in both adults and adolescents with moderate-to-severe AD. This review article explores the benefit-risk profile of a flexible abrocitinib dosing approach, tailoring dose based on individualized treatment of patients and highlighting the available supportive data from the JADE randomized clinical trials for healthcare professionals as part of joint provider-patient decision making. Dosing flexibility and maintenance with the lowest effective dose is necessary to treat patients according to their individual disease course while minimizing safety risks. Safety data indicate that incidence of treatment-emergent adverse events is reflective of the current dosage, with no carry-over risk from a previous higher dosage. Overall, abrocitinib represents a valuable AD therapy that can be administered according to individual patient needs.Graphical abstract available for this article.

Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin condition requiring long-term management to maintain remission and prevent relapse. Appropriate use of topical anti-inflammatory medications is an important factor in improving symptoms in patients with AD. This study aimed to investigate the treatment methods for maintaining remission and application of anti-inflammatory topical therapy.

Methods: This observational study was conducted in October 2022, using medical claims data from DeSC Healthcare Inc., linked with survey data collected from users of kencom®, a health promotion application. Eligible patients were adults aged ≥ 19 years with a confirmed AD diagnosis and prescription history. The survey evaluated (1) the actual treatment situation during the remission maintenance phase; and (2) instructions, actual status and adherence for application of anti-inflammatory topical therapy.

Results: A total of 626 patients who answered the kencom® survey and met eligibility criteria were included. Of these, 42.3% were instructed to stop medication once eczema improved, while 34.2% were instructed to continue during remission. Regarding instructions for the amount applied, the most common response was "No specific instructions" (44.2%), followed by "Fingertip-unit (FTU)" (27.2%). In actual practice, "FTU" was the most common amount (42.2%). Regarding application area, the most frequent instruction and actual practice were "Apply only to areas with eczema with remaining inflammation" at 52.6% and 62.5%, respectively, followed by "Apply not only to the eczema or remaining inflamed areas but also the surrounding areas" at 24.0% and 37.2%. Regarding the application method, "Apply thinly" was the most common instruction and actual practice at 32.7% and 48.4%, respectively. Treatment adherence rates were generally high, at over 60%.

Conclusion: Guidance from healthcare professionals has a crucial role in the proper use of topical therapies for AD. It is essential to ensure that topical medications are used properly to help patients achieve their treatment goals.

Introduction: Despite the expanding range of approved systemic therapies for atopic dermatitis (AD) and psoriasis (PSO), data on patient preferences remain limited. It is largely unknown whether patients wish to initiate systemic treatment, which route of administration (oral versus subcutaneous) they prefer, or what factors drive their treatment preferences. This study evaluated the desire for systemic therapy among systemic treatment-naïve patients with AD or PSO, including disease-specific influencing factors and preferences for administration routes (subcutaneous injections vs. tablets).

Methods: Eligible patients with AD or PSO were recruited at two German university hospitals. Questionnaires collected demographic and clinical data, including disease severity, pruritus and pain intensity, quality of life (QoL) impairment, and desire for systemic therapy. Data analysis comprised Mann-Whitney U tests (between-group comparisons), and Spearman correlations (factors influencing therapy desire).

Results: From 253 recruited patients, systemic treatment-naïve patients with moderate-to-severe disease severity exclusively using topical therapies were selected (56 with AD, 63 with PSO); 77.8% of patients with PSO and 67.9% of patients with AD desired systemic therapy, mainly for superior efficacy, QoL improvement, and pruritus reduction. Administration preferences differed significantly (PSO 57.1% injections; AD 73.7% tablets; p < 0.005). The desire for systemic therapy moderately correlated with pain intensity (ρ = 0.422, p < 0.001) and QoL impairment (ρ = 0.379, p < 0.005) in AD and with male sex in PSO (ρ = 0.347, p < 0.005).

Conclusions: Most topically treated patients with moderate-to-severe AD or PSO desire systemic therapy, with distinct disease-specific administration preferences.

Historically, dermatology research and clinical practice in the United States (USA) have overlooked important considerations in the dermatological care of individuals with skin of color (SOC). With growing awareness of the disparities in health outcomes among racial and ethnic groups, it is critical to recognize the existing care gaps and implement initiatives that promote healthcare equity. To identify the unmet dermatological needs of these populations, a literature review was conducted from January 2020 to October 2023, which revealed 18 distinct dermatological care gaps categorized under four root causes: cultural diversity, income status, racial bias, and underrepresentation in medical and research settings. An initiative scan was performed using a similar search and prioritization strategy to assess ongoing activities led by medical societies, pharmaceutical companies, and patient organizations to address these care gaps. Sustaining these evidence-based interventions is essential to reducing racial and ethnic disparities in dermatology and driving meaningful change in the healthcare system within the USA. This review offers a snapshot of the current dermatological care landscape for patients with SOC and proposes a structured framework for evaluating outcomes and guiding future initiatives.

Background: Alopecia areata (AA), pressure-induced alopecia (PIA), and telogen effluvium (TE) are nonscarring forms of hair loss reported in patients undergoing surgical procedures under general anesthesia (GA). While AA is primarily autoimmune and stress-mediated, PIA arises from prolonged scalp pressure during surgery, and TE is typically triggered by metabolic or physiological stressors that induce a premature transition of anagen hairs into the telogen phase.

Objective: This review aims to explore the emerging evidence linking GA to the onset or exacerbation of these alopecic types.

Methods: Authors review currently available literature found in MEDLINE and Google Scholar databases and present it in a structured way.

Results: Currently available literature supports the existence of a link between GA and AA, PIA, and TE, and proposes several potential mechanisms including immune dysregulation, ischemia, hypoxia, and systemic stress responses on the basis of current findings.

Limitations: Despite existing evidence, significant gaps remain in understanding the associations between various forms of alopecia and GA, owing to a lack of high quality, structured research.

Conclusions: There is a possible link between GA and various forms of alopecia, although further research to clarify the relationships, identify at-risk individuals, and inform perioperative hair loss management strategies is needed.

Introduction: The German national psoriasis registry PsoBest collects long-term data on the effectiveness, safety, and tolerability of systemic treatments for psoriatic disease. Here, we describe patient characteristics and the safety and effectiveness of apremilast for the treatment of psoriatic disease in Germany based on data from PsoBest.

Methods: This was a descriptive analysis of observational data collected from PsoBest using cross-sectional (baseline characteristics) and longitudinal (outcomes, safety) designs. PsoBest recruits patients with moderate to severe plaque psoriasis or psoriatic arthritis who initiate a new systemic psoriasis treatment. Adverse events (AEs) and sociodemographic descriptors were reported for patients exposed to apremilast during the study period (safety cohort). Clinical and patient-reported outcomes were collected 3, 6, and 12 months after the initiation of apremilast monotherapy (outcomes cohort).

Results: From January 15, 2015 to June 30, 2020, 595 registry patients were exposed to apremilast; 417 were treated with apremilast monotherapy. Patients taking apremilast had a higher mean age and higher proportions of comorbidities such as cardiovascular or metabolic disease compared with those taking other nonbiologic systemic or biologic drugs. The most common nonserious AEs were drug ineffectiveness (14.1%), diarrhea (9.4%), nausea (7.1%), and headache (6.1%). The highest incidence rates of nonserious and serious AEs of special interest were for infections and infestations per system organ class (8.03/100 patient-years) and malignant or unspecified tumors (2.50/100 patient-years), respectively. Improvements in Dermatology Life Quality Index, patient-defined treatment benefits (Patient Benefit Index), body surface area, and Psoriasis Area and Severity Index were observed after 3, 6, and 12 months of apremilast treatment.

Conclusions: Patients in routine care treated with apremilast in the German PsoBest registry experienced treatment benefits and improved skin, psoriasis severity, and quality of life. Safety was consistent with the established safety profile. Apremilast is safe and effective for treating moderate to severe psoriatic disease.

Rosacea is a common, chronic, inflammatory disease of the skin, which predominantly (but not exclusively) affects the centrofacial region. Clinical features may include transient or persistent facial erythema, recurrent flushing, telangiectasia, papules, pustules, phymatous changes, and ocular disturbances. These can lead to significant physical and psychological burden and discomfort, which adversely affects a patient's quality of life (QoL). While current guidelines provide recommendations on treatment initiation and modification, there is a lack of information for long-term management and maintenance. The Rosacea-Expert Advice on Combined and Holistic approaches (REACH) group is an international group of experienced dermatologists, brought together to address these shortcomings. This paper summarizes discussions from three REACH Global Scientific Committee (GSC) meetings, with the objective to simplify the rosacea management pathway and ensure that healthcare professionals are aware of rosacea triggers, pathogenesis, risk factors, comorbidities, chronicity, patient satisfaction, monitoring, and treatment options. The REACH GSC developed a rosacea management pathway as a backbone for this publication-to advise on each step, including pitfalls to avoid, patient discussions to conduct, tools and guidelines to employ, and clinical factors to consider. Being able to discern all the clinical features of rosacea specific to each patient is imperative, from recognizing overriding signs and symptoms to understanding potential comorbidities and assessing impact on QoL. Clear and sensitive communication regarding these elements, and what outcomes are achievable, will help to optimize therapeutic management and foster a sense of patient empowerment and disease control. For patients, being able to engage in their own long-term care of symptoms, signs, and flares is critical. Deepening the understanding of the condition as a chronic, yet eminently manageable one, will help empower patients with rosacea and their dermatologists alike. The REACH GSC project was initiated and funded by Galderma.

Introduction: Patients with moderate-to-severe atopic dermatitis (AD) who discontinue dupilumab need additional therapeutic options. Lebrikizumab's distinct mechanism of action may provide that alternative treatment. We evaluated efficacy and safety of lebrikizumab in adults and adolescents with moderate-to-severe AD previously treated with dupilumab.

Methods: In the open-label ADapt trial, patients who discontinued dupilumab due to inadequate response, adverse events (AEs)/intolerance, or other reasons received lebrikizumab 250-mg every 2 weeks (Q2W) following 500-mg loading dose at baseline/week 2, through week 16, with optional topical therapy. From weeks 16-24, responders (≥ 75% improvement in Eczema Area and Severity Index [EASI 75] or Investigator's Global Assessment score 0/1 with ≥ 2-point improvement from baseline) received lebrikizumab every 4 weeks; inadequate responders continued lebrikizumab Q2W. The primary endpoint was EASI 75 at week 16 in the intent-to-treat population; EASI 75 was also analyzed by reason for dupilumab discontinuation. Secondary and exploratory efficacy endpoints were assessed throughout.

Results: Among the 86 patients enrolled, primary reasons for stopping dupilumab were inadequate response (n = 48, 55.8%), AEs/intolerance (n = 14, 16.3%), and other reasons (n = 24, 27.9%). Fifty-nine patients (68.6%) completed week 16; 52 patients (60.5%) completed week 24. At weeks 16 and 24, respectively, response rates were 57.4% (35/61) and 60.0% (33/55) for EASI 75; 53.2% (25/47) and 61.5% (24/39) for Pruritus Numeric Rating Scale ≥ 4-point improvement; and 83.0% (44/53) and 83.0% (39/47) for Dermatology Life Quality Index ≥ 4-point improvement. Most treatment-emergent AEs were mild/moderate. Serious AEs and discontinuations due to AEs were reported by 2 (2.3%) and 5 (5.8%) patients, respectively. Of the 10 patients who discontinued dupilumab due to eye-related events, facial dermatitis, or inflammatory arthritis, none reported similar events with lebrikizumab.

Conclusion: Results suggest that lebrikizumab provides meaningful improvements in skin clearance, itch, and quality of life in dupilumab-experienced patients with moderate-to-severe AD, with a safety profile consistent with other lebrikizumab phase 3 trials.

Trial registration: ClinicalTrials.gov identifier, NCT05369403.

Introduction: Psoriasis is a chronic inflammatory skin disease with a global prevalence of 1-5%, however its clinical and demographic profile in Kenya remains underexplored. This article describes the establishment of the Kenyan Psoriasis Registry at Moi Teaching and Referral Hospital in Eldoret, Kenya.

Methods: 214 subjects were enrolled between October 2024 and August 2025 at Moi Teaching and Referral Hospital. Both healthy controls and patients with psoriasis completed enrollment surveys and physical exams, and donated saliva samples.

Results: The initial cohort of 214 subjects (108 patients with psoriasis, 106 healthy controls) provides valuable insights into the demographics, clinical profiles, quality of life, and mental health characteristics of patients with psoriasis in Kenya. The mean age of psoriasis onset was 30.4 years, and mean age of diagnosis by a medical provider was 38.9 years old. 13.9% of patients with psoriasis reported a positive family history of psoriasis, and 9.3% of patients with psoriasis reported a diagnosis of psoriatic arthritis. The mean psoriasis area and severity index was 9.9 and mean Investigator Global assessment score was 3.0. Examination of treatment patterns revealed that moisturizers, prescription topical medications, and methotrexate were commonly tried while only 9.3% of individuals had ever received a biologic therapy. Patients with psoriasis reported significantly worse sleep disturbance, quality of life, and mental health compared to healthy controls.

Conclusion: This data highlights the unique characteristics of patients with psoriasis in Kenya. The Kenyan Psoriasis Registry continues to enroll patients and conduct yearly follow-ups, aiming to deepen the understanding of psoriasis in this population. These findings underscore the need for targeted research and advocacy to improve psoriasis care in Kenya.