BACKGROUND:The novel cream formulation of calcipotriol and betamethasone dipropionate based on polyaphron dispersion technology (CAL/BDP PAD-cream), has shown promising results on psoriasis in phase 3 clinical trials. However, real-world data on scalp are limited. OBJECTIVES:To assess clinician-reported outcomes (ClinROs) and patient-reported outcomes (PROs) of CAL/BDP PAD-cream in adults with mild-to-moderate scalp psoriasis under real-world conditions in Europe. METHODS:PRO-SCALP is a prospective, non-interventional, multicentre, cohort study conducted between June 2023 and October 2024 in Germany, Spain and the United Kingdom. Data were collected at baseline and Week 8 (end of study, EOS). PROs included Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9), Scalpdex questionnaire, Worst Itch-Numerical Rating Scale (WI-NRS), sleep disturbances, Psychosocial Effects of Scalp Psoriasis Questionnaire and adherence. ClinROs included treatment satisfaction and physician global assessment of scalp (scalp-PGA) and scalp-modified Psoriasis Area and Severity Index (S-mPASI). RESULTS:253 patients (mean age: 47.9 years; 65.2% females) had evaluable data. 59.9% of them reported high adherence (visual analogue scale score 80-100). At EOS, mean (standard deviation) global satisfaction (TSQM-9) was 76.0 (21.6) and 77.6% of patients achieved a scalp-PGA score of 0/1 (clear/almost clear). Moreover, 68.4% achieved scalp-PGA success (scores of 0/1 and ≥2-point improvement). WI-NRS, S-mPASI and Scalpdex scores improved significantly (p<0.0001) from baseline to EOS. Sleep patterns and psychosocial outcomes also improved. CONCLUSIONS:CAL/BDP PAD-cream is associated with high treatment satisfaction and improved clinical outcomes and quality of life in the real-world management of scalp psoriasis.

Chronisch-entzündliche Darmerkrankungen, Spondyloarthritiden und insbesondere Psorasisarthritis sind keine isolierten Organerkrankungen, sondern Manifestationen einer gemeinsamen Darm-Gelenk-Achse. Bei einem relevanten Anteil der Patient:innen mit Morbus Crohn oder Colitis ulcerosa treten im Verlauf muskuloskelettale Manifestationen bis hin zur Spondyloarthritis auf. Umgekehrt finden sich bei rheumatologischen Erkrankungen häufig subklinische intestinale Entzündungszeichen. Pathophysiologisch verbinden Barrierestörungen, Dysbiose und die IL(Interleukin)-23/IL-17-Achse Mukosa und Enthesis zu einem inflammatorischen Netzwerk. Die Transition verläuft stufenweise über prodromale Phasen mit subklinischer Enthesitis und Arthralgien. Für die Gastroenterologie ergibt sich daraus eine zentrale Rolle in der Früherkennung systemischer Entzündung und in der interdisziplinären Steuerung der Erkrankung.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease associated with significant diagnostic delays and impact on quality of life. Current guidelines prioritize antibiotics as first-line therapy, but experts increasingly recognize the need for earlier targeted therapy intervention to prevent irreversible scarring and tunnel formation. To establish consensus on clinical scenarios during the 14th European Hidradenitis Suppurativa Foundation Conference in February 2025, 54 HS experts participated in a Delphi consensus, using a Likert scale (−5 to +5) to vote on 16 statements concerning first-line therapy criteria with biologics and/or small molecules for eligible patients. Seventy-eight HS experts were invited, and 54 participated via hybrid onsite and electronic voting. Experts rated 16 pre-defined statements regarding first-line use of biologics and/or small molecules for HS using a Likert scale (−5 to +5). Agreement metrics were stratified as majority agreement (≥70%, median 3.0–3.5), consensus (≥75%, median 3.5–4.5), and strong consensus (≥90%, median ≥4.5). Statements were subsequently ranked for clinical relevance. Strong consensus was reached for patients contraindicated for antibiotics, rapid disease progressors and those with severe disease. Consensus also supported upgrading patients with moderate disease (IHS4 ≥ 4), frequent flares (≥3 in 12 weeks), multiple affected areas and specific phenotypes including anogenital involvement. Strong consensus emerged for syndromic HS and for patients with inflammatory comorbidities such as inflammatory bowel disease and arthritis. Paediatric patients with a positive family history and moderate disease were also considered candidates for first-line biologics or small molecules. This consensus provides evidence-based criteria for upgrading HS patients to first-line biologic therapy, reflecting expert practices across Europe aimed at preventing irreversible disease progression. The results support a ‘hit hard and early’ approach to minimize scarring and tunnel formation, although prospective studies are still needed to validate these expert-driven recommendations.

Introduction: In the assessment of a psoriasis treatment, traditional endpoints evaluated independently may not fully capture the multidimensional nature of treatment response. Best response to calcipotriol/betamethasone dipropionate (CAL/BDP) cream based on polyaphron dispersion (PAD) technology has recently been defined as a restrictive composite endpoint comprising two efficacy outcomes (Physician’s Global Assessment [PGA] 0–1 and modified Psoriasis Area and Severity Index [mPASI] <2) and one quality of life outcome (Dermatology Life Quality Index [DLQI] 0–1). Case Presentation(s): This retrospective case series aims to provide further insights into the demographics and outcomes of patients achieving best response to CAL/BDP PAD-cream based on this newly defined composite endpoint. From the 213 patients with mild-to-moderate psoriasis who received CAL/BDP PAD-cream in the European MC2-01-C7 phase 3 clinical trial (NCT03802344), seven patients who achieved best response at Week 4 and/or Week 8 and had available clinical photographs were evaluated. The mean patient age was 55.0 years (range: 34–68), with a mean psoriasis duration of 19.9 years (range: 6.9–29.1). Results support the efficacy of CAL/BDP PAD-cream in improving both clinical signs and quality of life. Conclusion: Despite existing variability in key baseline characteristics and long disease duration, all included patients met the novel restrictive composite endpoint after 8 weeks, which reflects complete/almost complete clearance of psoriasis and no impact on patient quality of life.

Atopic dermatitis is commonly associated with depressive symptoms and fatigue, which significantly impact quality of life. While clinical trials suggest beneficial effects of dupilumab on mental health, real-world evidence remains limited. This longitudinal cohort study analysed data from adult patients treated with dupilumab in the TREATgermany registry. Subgroups were defined by baseline Center for Epidemiologic Studies Depression Scale (CES D) scores ≥16 (clinically significant depressive symptoms) and Fatigue Severity Scale (FSS) scores >4 (significant fatigue). Clinical severity (Eczema Area and Severity Index [EASI], objective Scoring Atopic Dermatitis [oSCORAD]), quality of life (DLQI), psychological symptoms, treatment needs and benefits (PNQ, PBI) and drug survival were assessed over 12 months. Among 633 patients, those with elevated baseline CES-D (n=309) or FSS (n=281) scores reported greater disease burden measured by DLQI, while EASI and oSCORAD did not differ between subgroups. Both CES-D and FSS scores decreased markedly within the first 3 months. Sleep and social functioning needs were more frequently reported in high-burden subgroups and more often fulfilled after 12 months. Drug survival was comparable across subgroups. Dupilumab treatment was associated with significant improvements in depressive symptoms, fatigue and skin severity. Patients with higher baseline mental health burden showed comparable improvements in patient relevant domains, supporting the broad relevance of dupilumab in real-world atopic dermatitis care.

BACKGROUND:Bimekizumab (BKZ), an IL-17A and IL-17F inhibitor, has demonstrated a rapid and high level of complete skin clearance in patients with psoriasis and complete normalization of the transcriptional signature of lesional skin after 8 weeks. OBJECTIVE:We sought to assess the durability of initial clinical response to BKZ for up to 4 years and investigate molecular mechanisms leading to the observed response. METHODS:Clinical data were pooled from 3 1-year phase 3 feeder studies (BE VIVID, BE READY, and BE SURE) and their 3-year open-label extension (BE BRIGHT). Transcriptomic analyses were conducted on 3 independent single-cell RNA-sequencing data sets from lesional psoriasis biopsies and bulk RNA-sequencing data from a phase 2a study. RESULTS:Among patients who achieved complete skin clearance after 16 weeks, continued to receive double-blind BKZ treatment, and entered BE BRIGHT, 73.0% achieved this response at the end of year 4 (N = 503; modified nonresponder imputation). Single-cell transcriptomic analyses revealed a group of tissue-resident memory T (TRM) cells in lesional skin expressing IL17A and/or IL17F that are minimally present in healthy skin, postulated to constitute a pathogenic TRM-cell subset. Prosurvival factors expressed in TRM cells in lesional skin were identified, with IL7R shown to be more highly expressed in IL17F+ than in IL17A+ TRM cells. Reversal of expression of these prosurvival factors, alongside a general TRM gene signature, was demonstrated in bulk transcriptomic analyses after 8 weeks of treatment (2 BKZ doses). CONCLUSIONS:The strong durability and high response level observed with BKZ may be associated with normalization of pathogenic TRM cells.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease associated with significant diagnostic delays and impact on quality of life. Current guidelines prioritize antibiotics as first-line therapy, but experts increasingly recognize the need for earlier targeted therapy intervention to prevent irreversible scarring and tunnel formation. To establish consensus on clinical scenarios during the 14th European Hidradenitis Suppurativa Foundation Conference in February 2025, 54 HS experts participated in a Delphi consensus, using a Likert scale (-5 to +5) to vote on 16 statements concerning first-line therapy criteria with biologics and/or small molecules for eligible patients. Seventy-eight HS experts were invited, and 54 participated via hybrid onsite and electronic voting. Experts rated 16 pre-defined statements regarding first-line use of biologics and/or small molecules for HS using a Likert scale (-5 to +5). Agreement metrics were stratified as majority agreement (≥70%, median 3.0-3.5), consensus (≥75%, median 3.5-4.5), and strong consensus (≥90%, median ≥4.5). Statements were subsequently ranked for clinical relevance. Strong consensus was reached for patients contraindicated for antibiotics, rapid disease progressors and those with severe disease. Consensus also supported upgrading patients with moderate disease (IHS4 ≥ 4), frequent flares (≥3 in 12 weeks), multiple affected areas and specific phenotypes including anogenital involvement. Strong consensus emerged for syndromic HS and for patients with inflammatory comorbidities such as inflammatory bowel disease and arthritis. Paediatric patients with a positive family history and moderate disease were also considered candidates for first-line biologics or small molecules. This consensus provides evidence-based criteria for upgrading HS patients to first-line biologic therapy, reflecting expert practices across Europe aimed at preventing irreversible disease progression. The results support a 'hit hard and early' approach to minimize scarring and tunnel formation, although prospective studies are still needed to validate these expert-driven recommendations.

Hidradenitis suppurativa (HS) ist eine chronisch rezidivierende, immunvermittelte Entzündungserkrankung der terminalen Haarfollikeleinheit mit Knoten, Abszessen, Drainagetunneln, Narbenbildung, Schmerzen und erheblicher Einschränkung der Lebensqualität. Der aktuelle leitlinienbasierte Therapieansatz ist multimodal und kombiniert Allgemeinmaßnahmen, Schmerztherapie, antiseptische bzw. antibiotische Strategien, systemische antiinflammatorische Therapie und – bei geeigneten Läsionen – chirurgische Verfahren. Für die systemische Therapie moderater bis schwerer Formen der HS sind nach europäischem Therapiestandard neben Antibiotika insbesondere Adalimumab sowie die IL-17-gerichteten Biologika Secukinumab und Bimekizumab als zugelassene Optionen relevant. Diese narrative Übersicht fasst Wirkstoffe zusammen, die sich aktuell in klinischer Prüfung bei HS befinden. Grundlage sind primär ClinicalTrials.gov und ergänzend publizierte Studien. Die Pipeline ist breit und umfasst IL-17-, IL-36- und IL-1-gerichtete Biologika, intrazelluläre Kinaseinhibitoren, duale immunmodulatorische Antikörper, Chemokin‑, Komplement- und Neutrophilen-orientierte Strategien, topische Präparate, PDE-4-Hemmung sowie metabolische Ansätze. Die Vielzahl neuer Ansätze unterstreicht den weiterhin hohen therapeutischen Bedarf. Dabei werden unterschiedliche Bereiche des adaptiven und angeborenen Immunsystems abgedeckt. Diese breiten und teils multimodalen Ansätze sind aufgrund der immunlogischen Heterogenität der Erkrankung auch sinnvoll. GLP-1-RA sind neben den rein immunologisch wirkenden Therapien eine interessante Ergänzung und könnten zusammen mit den immunsupressiven Therapien eine noch bessere Wirkung zeigen.

Tildrakizumab is approved for moderate-to-severe plaque psoriasis in 2 doses, 100 mg and 200 mg, with comparable safety profiles. This study aimed to establish pan-European consensus on optimal tildrakizumab dosing and titration using a modified Delphi methodology. A steering group of 8 European dermatologists developed 48 consensus statements addressing tildrakizumab prescribing, dose selection and titration. The statements were incorporated into an online Likert survey and distributed across 9 European countries to experienced dermatologists. Consensus was predefined as ≥75% agreement. Seventy-two dermatologists completed the survey. Consensus was achieved for 35/48 statements (73%). Based on the results, initiation with the 100 mg dose may be considered in patients weighing <90 kg with a body mass index <25, moderate disease severity or who are biologic-naïve. Initiation with the 200 mg dose may be considered in patients weighing ≥90 kg and/or with a body mass index ≥25, severe disease, high-impact area involvement in the context of severe disease, prior interleukin-23p19 inhibitor failure or failure of ≥2 biologics. Up-titration to 200 mg may be considered for suboptimal response, while down-titration to 100 mg may be considered after ≥1 year of sustained remission. Adoption of this guidance may facilitate more consistent, individualized dosing and improved patient outcomes.

Minimal disease activity (MDA) has recently been introduced as comprehensive treatment target in atopic dermatitis (AD), integrating both clinician- and patient-reported outcomes. Evidence on the real-world feasibility and impact of achieving MDA on quality of life (QoL) remains limited. This analysis evaluated the association between MDA achievement and QoL outcomes in patients with moderate-to-severe AD receiving upadacitinib (UPA) in real-world clinical practice. This interim analysis used data from the ongoing, prospective, multicenter, non-interventional UP-TAINED study (NCT05139836) in Germany. Analyses included all patients without treatment interruptions during the first 12 months (n = 259). Disease control was classified as optimal, moderate, or none. Optimal control (MDA) was defined as Eczema Area and Severity Index (EASI) ≤ 3 and Worst Pruritus Numeric Rating Scale (WP-NRS) ≤ 0/1; moderate control as EASI ≤ 3 with WP-NRS 2–3 or EASI > 3–7 with WP-NRS ≤ 3; and no control as EASI > 7 or WP-NRS > 3. QoL outcomes were assessed using validated patient-reported measures. MDA was achieved by 38.2

Background Atopic dermatitis (AD) is a chronic inflammatory disease with a high clinical burden and risk of persistence in pediatric patients. Objective To assess safety and efficacy of treatment with dupilumab for up to 2 years in infants and young children with AD. Methods Patients aged 6 months to 5 years who had previously participated in parent studies LIBERTY AD PRESCHOOL Part A or B (NCT03346434), with moderate-to-severe AD at parent study baseline, were enrolled in the ongoing LIBERTY AD PED open-label extension (OLE) study (NCT02612454). Patients initially received weight-based dupilumab (3 or 6 mg/kg once a week); following protocol amendment, patients were switched to a weight-tiered dose every 4 weeks (200 mg for patients weighing 5 to < 15kg; 300 mg for patients weighing 15 to < 30kg). The use of concomitant medications (topical corticosteroids, antihistamines, and topical calcineurin inhibitors) was permitted without restriction, but patients were not permitted to use systemic medication for AD except as rescue treatment. Analyses were descriptive, with no formal statistical hypothesis. Results This analysis included 180 patients, of whom 106 completed the week 104 visit. A total of 87.8% patients experienced treatment-emergent adverse events (TEAEs; 24.4% mild, 52.2% moderate, 11.1% severe). One serious, drug-related TEAE (pinworm infection) did not lead to treatment discontinuation and resolved over time. One drug-related event of severe urticaria led to permanent treatment discontinuation but was not considered serious and resolved over time. By week 104, 92.1% patients achieved a 75% reduction in Eczema Area and Severity Index from parent study baseline, and the mean reduction in body surface area affected by AD was 49.0% from parent study baseline. Conclusions In this OLE study, treatment with dupilumab for up to 2 years in infants and young children with AD demonstrated sustained efficacy with a safety profile consistent with prior studies, supporting its long-term continuous use in pediatric patients. Clinical Trial Registration ClinicalTrials.gov Identifier: NCT02612454

BACKGROUND:Hidradenitis suppurativa (HS) is a chronic, relapsing, immune-mediated inflammatory disease of the terminal hair follicle unit, characterized by inflamed nodules, abscesses, draining tunnels, scarring, pain, and substantial impairment of quality of life. Current guideline-based management is multimodal and combines general measures, pain management, antiseptic and antibiotic strategies, systemic anti-inflammatory therapy, and, where appropriate for selected lesions, surgical procedures. According to European treatment standards, systemic treatment options for moderate-to-severe HS include antibiotics as well as approved biologic therapies, particularly adalimumab and the IL-17-targeted agents secukinumab and bimekizumab. OBJECTIVE:This narrative review summarizes therapeutic agents currently under clinical investigation for HS. The analysis is primarily based on ClinicalTrials.gov, supplemented by published clinical studies. RESULTS:The therapeutic pipeline is broad and includes the following: IL-17-, IL-36-, and IL-1-targeted biologics; intracellular kinase inhibitors; dual immunomodulatory antibodies; chemokine-, complement-, and neutrophil-directed strategies; topical agents; PDE4 inhibition; and metabolic approaches. CONCLUSION:The diversity of emerging therapeutic strategies highlights the persistently high unmet need in HS. These approaches target distinct components of both the adaptive and innate immune systems. Given the immunological heterogeneity of HS, such broad and partly multimodal strategies appear biologically plausible and clinically meaningful. Beyond purely immunologically acting therapies, GLP‑1 receptor agonists represent an interesting complementary approach and may, in combination with immunosuppressive therapies, provide added benefit and generate promising clinical data.

Scalp psoriasis is often associated with poor adherence to topical therapy. A novel formulation of calcipotriol and betamethasone dipropionate based on polyaphron dispersion (CAL/BDP PAD-cream) showed improved outcomes and satisfaction in the PRO-SCALP study, particularly in patients with high adherence. We evaluated how adherence to CAL/BDP PAD-cream influences patients- and clinicians-reported outcomes and treatment preferences in mild-to-moderate scalp psoriasis under real-life conditions in Europe. PRO-SCALP patients reported their adherence level using a visual analogue scale (VAS). Outcomes were compared between low- and high-adherence subgroups. Among 252 patients, 59.9

Purpose To characterize how office-based gynecological practices in the Rhine-Main region of Germany recognize, assess, treat, and refer patients with hidradenitis suppurativa (HS). Methods This cross-sectional postal survey was conducted from November 2023 to July 2024. A study-specific 16-item questionnaire assessed familiarity with HS, diagnostic confidence, use of severity classifications, treatment approaches, assessment of comorbidities, and interdisciplinary care. All 240 practices in the predefined sampling frame were invited. Analyses were descriptive and used item-specific denominators. Results Completed questionnaires were returned by 142 practices (response rate, 59.2%). Familiarity with HS was reported by 122 practices (85.9%), and 101 (71.1%) were confident or very confident in making the diagnosis. Only 3 practices (2.1%) used the Hurley classification, whereas 123 (86.6%) reported using no recognized severity score. Local treatment alone was initiated by 61 practices (43.0%). In separate questionnaire items, combined local and systemic treatment was reported by 3 practices (2.1%) and systemic treatment by 38 (26.8%). Evaluation of associated conditions was reported by 50 practices (35.2%). Dermatology was involved by 134 practices (94.4%), either alone or with additional specialties. Further HS education was desired by 123 practices (86.6%). Conclusion Although self-reported recognition of HS was high, selected guideline-recommended elements of structured assessment and comprehensive management were used inconsistently. Targeted education and clearly defined interdisciplinary pathways may strengthen the role of gynecologists in early recognition and coordinated care.

BACKGROUND:Atopic dermatitis (AD) substantially affects quality of life, yet standardized severity measures may not capture patient-centred priorities, making systematic needs assessment essential for personalized care. OBJECTIVES:This study aimed to systematically assess and rank treatment needs in adults with moderate to severe AD, identify patient subgroups with distinct need profiles and evaluate how well these needs were met after 2 years of specialized dermatological care. METHODS:In this prospective observational study from the TREATgermany registry, 697 adults with moderate to severe AD completed the validated Patient Benefit Index (PBI) at baseline (T1) and at 2-year follow-up (T2), capturing treatment goal importance and achievement. Subgroup analyses were performed based on age, sex, educational status and age at AD onset. Associations between clinical measures and perceived benefit were analysed. RESULTS:The most frequently prioritized treatment goals were being free of itching (97.8% high agreement), regaining control of the disease (95.3%) and relief from skin burning (92.0%). The importance of itch reduction was not correlated with baseline pruritus intensity, and perceived benefit was more closely linked to relative clinical improvement than to absolute disease severity. Beyond these shared priorities, treatment needs varied across subgroups: older patients valued treatment safety and reduced dependence on medical care, women emphasized psychosocial and appearance-related goals, individuals with lower educational status highlighted financial concerns and patients with adult-onset AD prioritized diagnostic certainty and disease control. After 2 years, 96.6% of patients reported meaningful treatment benefit. Patient-reported outcomes (POEM) were more strongly associated with perceived benefit than physician-assessed measures (oSCORAD, EASI). CONCLUSION:Patient treatment needs in AD vary by demographic and clinical factors, with pruritus consistently rated as the highest priority. Patient-reported outcomes align more closely with perceived benefit than physician assessments, underscoring the value of systematic needs assessments to guide individualized treatment decisions and shared decision-making.