Dermatology and Therapy最新文献

Introduction: Chronic nodular prurigo (CNPG), also known as prurigo nodularis, is an inflammatory neuroimmune skin disorder characterized by intense pruritus and nodular lesions resulting from scratching. CNPG affects patients' health-related quality of life (HRQoL); however, the magnitude of burden and clinical implications remain underrecognized in dermatologic practice.

Methods: This systematic review was conducted in accordance with PRISMA 2020 guidelines. Searches of PubMed and the Cochrane Library (April 2025) identified observational studies reporting HRQoL, symptom burden, or unmet needs in adults with CNPG. Two reviewers independently screened studies, extracted data, and assessed methodological quality using the STROBE checklist.

Results: Of 464 records identified, 23 studies met the inclusion criteria. CNPG was consistently associated with substantial impairment in HRQoL, primarily driven by uncontrolled pruritus. Mean Dermatology Life Quality Index scores ranged from 7 to 22, EQ-5D scores from 57.4 to 65.3, and Health Utilities Index Mark III scores were approximately 0.52, significantly lower than in control population (p < 0.001). Pruritus emerged as the dominant symptom and central determinant of HRQoL impairment, reflected by elevated Itchy Quality of Life, 5-D Itch, and 5-D Pruritus Life Quality scores. Sleep disturbances were reported by up to 100% of patients, while anxiety and depressive symptoms affected 26-46% and 16-57% of patients, respectively. CNPG was associated with impairment in daily activities (up to 100%), occupational functioning (up to 83%), and social or sexual relationships (27-95%). Treatment satisfaction was low (mean 57.4%), and higher pruritus intensity was associated with worse HRQoL and lower satisfaction. However, no mediation analyses were performed, and causal relationships between pruritus severity and HRQoL impairment cannot be established.

Conclusions: CNPG is associated with a substantial and multidimensional disease burden extending beyond cutaneous manifestations. Pruritus may emerge as the central driver of this burden, underscoring the importance of systematic assessment of HRQoL and itch severity.

Introduction: Real-world evidence on deucravacitinib in moderate-to-severe psoriasis remains limited, especially regarding difficult-to-treat areas such as scalp involvement. We conducted a multicenter retrospective study to assess the short-term effectiveness and safety of deucravacitinib in routine clinical practice, with a specific focus on scalp outcomes.

Methods: We enrolled 111 adult patients with moderate-to-severe psoriasis treated with deucravacitinib for at least 16 weeks across 19 different Italian dermatology units. Effectiveness was assessed in terms of PASI (Psoriasis Area and Severity Index) responses and scalp-specific Physician's Global Assessment (ss-PGA).

Results: At week 16, PASI 75, PASI 90, and PASI 100 were achieved by 49.6%, 29.7%, and 18.9% of patients, respectively, with response rates further improving to 84.9%, 60.6%, and 45.5% at week 32. Among patients with baseline scalp involvement (n = 49), 89.8% reached ss-PGA 0/1 at week 16 and 100% at week 32, showing rapid and sustained scalp clearance. Notably, baseline scalp involvement did not negatively affect overall skin response. Deucravacitinib demonstrated a favorable safety profile. Adverse events (AEs) were reported by 8.1% of patients and were all mild in severity. Treatment was discontinued in 2.7% of patients, and no severe AEs were observed.

Conclusion: Deucravacitinib demonstrated clinical effectiveness and a favorable safety profile in real-world practice, including excellent scalp clearance rates, confirming its therapeutic value even in patients with difficult-to-treat areas.

Introduction: Psoriasis may increase risk for comorbid diabetes and obesity. Tildrakizumab, an anti-interleukin-23 monoclonal antibody approved for the treatment of adults with moderate-to-severe plaque psoriasis, was evaluated in the pivotal phase 3 trials reSURFACE 1 and reSURFACE 2. This analysis evaluates the effects of comorbid diabetes with and without obesity on the efficacy and safety of tildrakizumab in patients with moderate-to-severe plaque psoriasis.

Methods: This is a post hoc, pooled subgroup analysis of patients in reSURFACE 1 and reSURFACE 2 grouped by diabetes and obesity status. Patients randomized to tildrakizumab 100 mg at week 0, week 4, and every 12 weeks thereafter, or placebo, were included. The original coprimary endpoints were the proportions of patients achieving a ≥ 75% improvement in Psoriasis Area and Severity Index score (PASI 75 response) and Physician Global Assessment score of 0/1 with ≥ 2-grade improvement (PGA 0/1 response) from baseline at week 12. Safety was assessed from treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

Results: Of 926 patients, 93 had diabetes mellitus. At week 12, regardless of diabetes status, significantly more patients receiving tildrakizumab vs placebo achieved a PASI 75 response (diabetes, 61.4% vs 5.6%; without diabetes, 62.6% vs 5.8%) and PGA 0/1 response (with diabetes, 54.4% vs 2.8%; without diabetes, 56.5% vs 6.2%; all P < 0.0001). Diabetes status did not significantly affect tildrakizumab efficacy at week 28. Patients with diabetes and comorbid obesity had generally similar responses. Although subgroup sizes were small, patients with diabetes and comorbid obesity had numerically higher frequencies of TEAEs and SAEs than those without diabetes.

Conclusions: Short-term efficacy of tildrakizumab was maintained in patients with and without diabetes mellitus. A higher frequency of AEs in patients with diabetes and obesity may be attributable to underlying disease and associated higher inflammation.

Trial registration: ClinicalTrials.gov identifier, NCT01722331 (reSURFACE 1), NCT01729754 (reSURFACE 2).

Introduction: This study aims to evaluate the real-life efficacy and safety of a biosimilar to reference product (RP) ustekinumab for the treatment of plaque psoriasis in different patient scenarios. The cohort included ustekinumab-switched patients, who switched from the RP to the biosimilar, and ustekinumab-naïve patients, never treated with ustekinumab. Ustekinumab-naïve patients were subdivided into bio-naïve (no prior biologic therapy) and bio-experienced (previous non-ustekinumab biologic therapy).

Methods: Adult patients with chronic plaque psoriasis treated with AVT04 were followed up to 28 weeks. Efficacy of the biosimilar was assessed by improvement of the Psoriasis Area Severity Index (PASI) 75, 90, and 100 responses from baseline to weeks 16 and 28. A cost-minimisation analysis over a 1-year time horizon was performed to estimate costs and potential savings with AVT04 versus RP across the Italian National Health Service (NHS).

Results: Throughout the observation period, a sustained improvement in PASI was observed in the overall cohort of 183 patients, encompassing both the ustekinumab-switched and ustekinumab-naïve groups. Within the ustekinumab-naïve group, a trend toward more favourable PASI 75/90/100 responses was observed in bio-naïve patients compared to bio-experienced patients. By 28 weeks of treatment, a higher proportion of bio-naïve patients compared to the bio-experienced group achieved PASI 75 (72.7% vs. 56.2%), PASI 90 (72.7% vs. 50.0%), and PASI 100 (54.5% vs. 37.5%), respectively (p > 0.05). No adverse events were reported during the study. Furthermore, the cost-minimisation analysis suggested that compared to the RP, AVT04 has the potential to generate approximately €5200 in annual savings per patient for the Italian NHS, representing around €20 million in nationwide savings.

Conclusion: AVT04 biosimilar shows consistent efficacy results in both ustekinumab-switching and ustekinumab-naïve patients, supporting its integration into real-world practice as an effective and cost-saving therapeutic option. Further studies are warranted to confirm and expand these preliminary findings across a broader bio-naïve cohort.

Introduction: Actinic keratosis (AK) is a prevalent, chronic skin condition and a precursor to cutaneous squamous cell carcinoma. Effective, patient-friendly therapies that target both visible and subclinical lesions are essential. Tirbanibulin, a topical microtubule inhibitor, is the latest treatment approved in the USA and European Union (EU) for treating non-hyperkeratotic, non-hypertrophic AK on the face and scalp. This study aimed to assess the overall value of tirbanibulin for treating AK on the face or scalp across Germany, Italy, and Spain and to identify key value drivers using a multi-stakeholder perspective.

Methods: This study used a multi-criteria decision analysis (MCDA) to assess the holistic value of tirbanibulin compared with 5-fluorouracil 4% (5FU-4%) across Germany, Italy, and Spain. The validated EVIDEM MCDA framework (tenth edition) included eleven criteria related to disease burden, treatment benefits, evidence quality, and comparative outcomes. A total of 18 participants-dermatologists, payers, and patients-evaluated the treatments in a two-phase process. Phase 1 involved weighing the criteria, and phase 2 involved scoring clinical, economic, and patient-reported evidence for both treatments. Results from both phases were used to calculate an estimated value. The approach supports transparent, stakeholder-informed decision-making for AK treatment.

Results: All criteria were rated as relevant, with the greatest importance assigned to "comparative safety/tolerability," "quality of evidence," and "comparative efficacy." Tirbanibulin received positive scores across all criteria, particularly for "expert consensus/guidelines," "quality of evidence," and "size of the affected population." The final estimated value of tirbanibulin was 0.622 on a -1 to +1 scale, indicating high perceived value. Value estimations were consistent across stakeholder types, with slight country-level variations.

Conclusions: Overall, participants recognized tirbanibulin as a valuable treatment for AK, on the basis of robust evidence, favorable safety/tolerability and patient-reported outcomes (PRO) profiles, and alignment with clinical guidelines, with similar efficacy compared with 5FU-4%.

Patients with chronic illnesses, especially those with autoimmune conditions such as rheumatoid arthritis, chronic urticaria, Crohn's disease, psoriasis, and diabetes, rely on injectable therapies for disease management. However, it is well established that patients with chronic illnesses often have poor adherence to therapy, with adherence rates reported to be approximately 50%. This leads to issues with gauging treatment efficacy, potentially leading to worsening of their disease, thus more appointments with healthcare professionals (HCPs), and consequently a higher cost burden placed on healthcare systems. Hence, there is an unmet need to educate HCPs on the topic of supporting patients to optimize the use of injectable therapies. In this podcast, Professor Jorge Sánchez of the University of Antioquia, Medellín, Colombia, brings awareness to some of the key causes of non-adherence to injectable therapy, explains how to identify patients who are at high risk for non-adherence, and discusses how issues with the use of injectables can be managed or improved to increase adherence. The podcast also highlights some patient-focused means of improving treatment adherence, such as providing patient counseling, education, and practice administration sessions to help with patient confidence and empowerment. In conclusion, there is a need for HCPs to identify and improve poor adherence to injectable therapies among patients with chronic illnesses. Podcast video (MP4 157107 KB).

Introduction: Hidradenitis suppurativa (HS) is a chronic, recurrent inflammatory skin disease. Emerging evidence suggests that the chronic systemic inflammation may predispose patients to an increased risk of malignancy. Despite this, information on cancer occurrence in patients with HS is scarce, and no meta-analysis has explored which types of cancer are more prevalent in patients with HS.

Methods: PubMed, Embase, and Web of Science were searched from inception until 7 March 2025 for studies investigating the risk of cancer in patients with HS compared with the general population. In addition, authors of unpublished studies (e.g., conference abstracts) were contacted for data retrieval. Studies had to report the number and/or risk of cancer overall or subtypes of cancer in patients with HS compared with the general population. Two independent authors conducted the screening and extracted data. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were followed. An inverse-variance-weighted random-effects meta-analysis was performed to calculate pooled odds ratio (ORs) and corresponding 95% confidence interval (CIs). The prespecified primary outcome was the risk of cancer overall and subtypes of cancer in patients with HS compared with the general population.

Results: A total of 11 studies encompassing 624,721 patients with HS and 393,691,636 controls were included. Compared with controls, patients with HS had a significantly elevated risk of cancer overall (OR: 1.82; 95% CI 1.13-2.93; p = 0.018) and of gastrointestinal (OR: 1.61; 95% CI 1.29-2.01; p = 0.0002), head and neck (OR: 2.41; 95% CI 1.92-3.02; p = 0.00005), hematological (OR: 1.71; 95% CI 1.38-2.12; p = 0.00005), respiratory cancers (OR: 1.81; 95% CI 1.03-3.17; p = 0.04), Hodgkin lymphoma (OR: 2.44; 95% CI 1.55-3.85; p = 0.0001), and non-Hodgkin lymphoma (OR: 1.15; 95% CI 1.03-1.29; p = 0.01). Few studies reported estimates adjusted for ethnicity and environmental risk factors.

Conclusions: Having HS was associated with an increased risk of cancer overall, including several specific subtypes. Studies adjusting for confounders are highly warranted to assess the long-term association between HS and cancer.

Introduction: Alopecia areata (AA) is an inflammatory hair loss disorder, which negatively impacts health-related quality of life (HRQoL). This study investigates treatment patterns and HRQoL by AA disease severity.

Methods: Data were drawn from the Adelphi Real World AA Disease Specific Programme™, a cross-sectional survey of dermatologists and patients in the USA from November 2023 to June 2024. Dermatologists reported patient demographics, clinical characteristics, treatment patterns, and mental health. Patients completed AA Symptom Impact Scale, Skindex-16 AA, and Work Productivity and Activity Impact questionnaires. Data were stratified by AA-Investigator Global Assessment (IGA) scores and physician-assessed disease severity.

Results: Overall, 65 physicians reported on 501 patients, of whom 81 self-reported data. In total, 211 patients had severe/very severe AA-IGA-scored AA, of whom 66% received oral Janus kinase and 31% received non-topical corticosteroids. Among 501 patients, 43% had concomitant conditions. Anxiety (74%) and depression (61%) were most prevalent in severe/very severe AA-IGA-scored AA. Patients with severe/very severe AA reported notably high mean (standard deviation) scores on the global AA Symptom Impact Scale (AA-IGA, 3.1 [2.5]; physician-assessed, 3.0 [2.4]), Skindex-16 Emotion subscale (AA-IGA, 59.5 [29.8]; physician-assessed, 59.8 [27.5]) and overall work impairment (AA-IGA, 16.2% [21.4]; physician-assessed, 17.5% [20.2]).

Conclusions: This study showed that AA severity may correlate with HRQoL, highlighting the need for validated severity measures.

Introduction: Laser resurfacing, with erbium-doped yttrium aluminum garnet (Erbium:YAG) lasers, is a leading treatment for photoaging owing to its relatively rapid healing profile. However, even with advanced technology, there remains a need for adjunctive topical treatments to enhance skin recovery, mitigate postprocedure pigmentation issues, and minimize postprocedure downtime.

Methods: This randomized, evaluator-blinded, controlled study evaluated a regenerative cream's performance following laser treatment. The study utilized a mini-zone model on the volar forearms of healthy participants to compare the cream's efficacy against laser treatment alone. Clinical and instrumental assessments were utilized to assess the efficacy of the regenerative cream in accelerating skin healing post laser.

Results: Within 7 days of treatment, the regenerative cream significantly improved skin hydration (76%, p < 0.05) and smoothness (10%, p < 0.05), reduced skin roughness, crusting/scaling (49%, p < 0.05), and visual skin uniformity (49%, p < 0.05), compared with laser treatment alone. In addition, the regenerative cream showed greater reduction in skin redness (-27%, p < 0.05) than laser alone at day 18 post laser. Moreover, the regenerative cream outperformed an anhydrous benchmark formula in hydration, skin smoothness, and roughness after just 7 days.

Conclusions: These findings highlight the potential of the regenerative cream as a valuable addition to laser resurfacing procedures, promoting faster healing with improved aesthetic outcomes.

Introduction: Generalized pustular psoriasis (GPP) is rare, chronic, and associated with life-threatening complications. We investigated the burden of GPP in France.

Methods: Using data from 2010 to 2021 in the Système National des Données de Santé database, healthcare resource utilization (HCRU), costs, comorbidities, mortality, and treatments were compared among GPP (N = 4351), plaque psoriasis (N = 12,945), and general population (N = 12,981) cohorts, matched for sex, age, Charlson Comorbidity Index (CCI) score, and region. GPP prevalence and incidence were also investigated.

Results: Annually, there were 0.5-0.8 new GPP cases per 100,000 people. Across the cohorts, 54.5-54.7% of people were male, with mean age 58.7-59.5 years and mean CCI score 1.98-2.06. The GPP cohort incurred significantly greater HCRU and costs versus the plaque psoriasis and general population cohorts, including greater proportions of patients receiving emergency care (78% vs 63% and 55%) and intensive care (28% vs 17% and 14%), longer hospitalizations (mean 38.5 vs 26.2 and 22.4 days per patient), and higher medication costs (€4360 vs €1991 and €1543 per patient-year), respectively. Despite similar CCI scores, GPP was associated with more cardiometabolic and psychological comorbidities versus the plaque psoriasis and general population cohorts, e.g., hypertension (37% vs 21% and 20%), obesity (21% vs 9% and 6%), depression (13% vs 4% and 4%), alcohol abuse (16% vs 3% and 3%), and sleep disorders (8% vs 4% and 3%), respectively. Treatments in the GPP cohort were those used for plaque psoriasis, including topical steroids (77%), systemic steroids (50%), and biologics (23%). Twelve-month survival was 86.9% (GPP), 97.5% (plaque psoriasis), and 90.0% (the general population).

Conclusion: HCRU, costs, and comorbidities with GPP were often double those for comparator cohorts, and mortality was higher. These findings highlight the need to use GPP-targeted treatments that improve patient outcomes and may reduce the burden on healthcare systems.