Jean-Philippe Lacour

Background: Dupilumab is reimbursed in France for adult patients with moderate‐to‐severe atopic dermatitis ( AD ), in cases of failure, intolerance or contraindication to cyclosporin A (CsA). The French National Authority for Health requested collection of data on dupilumab‐treated patients' characteristics and prior systemic treatments to examine conformity with the reimbursement scope. Objectives: This study aimed to describe characteristics of adult patients initiating dupilumab for AD and their prior lines of systemic treatments with a focus on CsA. Methods: Our dual approach combined information from two databases: the SNDS database allowing access to nationwide prescriptions for dupilumab (DUPIXAM study) and data collected by a sponsor‐initiated multicentre, cross‐sectional, observational study on patients initiating dupilumab for AD (MOVE study). Results: From December 2019 to May 2021, 594 eligible patients were included in the MOVE study. In parallel, from March 2019 to December 2020, 3216 adult patients with presumed indications of moderate‐to‐severe AD were extracted from SNDS. Patients' characteristics were quite similar: median age was > 34 years old and they were gender balanced. More than 69% of MOVE patients had severe AD and 82.8% had at least one atopic comorbidities. Previous systemic treatments were used by over 62.8% of patients, of whom over 75.0% had received CsA. Among the 25.0% without previous CsA, the indirect combinatory approach made it possible to estimate an unbiased proportion of CsA contraindications in 71.0% of patients. Conclusion: This joint analysis provided a detailed view of real‐world conditions of dupilumab use in France through the completeness of data, and constitutes a proof of concept that could be extended to address other health‐related questions.

Background: Limited data are available on long‐term efficacy and safety of biologics in patients with psoriasis and metabolic syndrome (MetS), a common comorbidity.Objectives: This analysis updates tildrakizumab efficacy and safety for up to 5 years in patients with and without MetS.Methods: This was a post hoc analysis of the double‐blind, randomized, placebo‐controlled, phase 3 reSURFACE 1 (NCT01722331) and reSURFACE 2 (NCT01729754) trials in adult patients with moderate to severe chronic plaque psoriasis. Analyses included data through Week 244 from patients who continuously received tildrakizumab 100 (TIL100) or 200 mg (TIL200) and entered the extension studies, stratified by baseline MetS status. Efficacy was assessed via Psoriasis Area and Severity Index (PASI) scores. Safety was evaluated from exposure‐adjusted incidence rates (EAIRs) of treatment‐emergent adverse events (TEAEs).Results: reSURFACE 1 and reSURFACE 2 analyses included 26 and 44 TIL100‐treated patients with MetS, 98 and 167 TIL100‐treated patients without MetS, 34 and 30 TIL200‐treated patients with MetS, and 111 and 130 TIL200‐treated patients without MetS, respectively. There were no clinically relevant differences in PASI 75/90/100 response rates at Week 244 between patients with vs without MetS. The proportion of patients with vs without MetS achieving absolute PASI score 83% vs >89% for TIL100 and >85% vs >90% for TIL200. Pooled EAIRs of TEAEs, serious TEAEs, and TEAEs of special interest were similar in patients with and without MetS.Conclusions: Tildrakizumab maintains efficacy and a favorable safety profile over 5 years in patients with psoriasis regardless of MetS status.

Background/Objectives We observed isolated cases of perialar intertrigo in children and teenagers that did not appear to correspond to any known clinical entity. The objective of this study was to describe the clinical features of this dermatosis and the clinical characteristics of the patients. Methods We conducted a prospective, multicenter cohort study in France from August 2017 to November 2019. All the patients under 18 years of age with chronic perinasal intertrigo were included. A standardized questionnaire detailing the clinical characteristics of the patients and the description of the intertrigo. If possible, a Wood's lamp examination of the intertrigo was done. Results Forty-one patients were included (25 boys and 16 girls, average age: 12.1 years). Intertrigo was bilateral in 38 patients (93%). The majority of patients had no symptoms (54%). Pruritus was present in 39% of cases. Orange red follicular fluorescence was present in the perialar region on Wood's light examination in 78% of cases with active fluorescence. The presumptive diagnoses suggested by the investigators were acne (24.4%), seborrheic dermatitis (19.5%), rosacea (9.8%), psoriasis (9.8%) and perioral dermatitis (7.3%). No diagnosis was proposed in 22% of the cases. Conclusions We describe a previously undescribed clinical sign which is characterized by a chronic bilateral erythematous intertrigo located in the perialar region. It can be isolated or associated with various facial dermatoses.

Background Tralokinumab, a fully human monoclonal antibody, specifically neutralizes interleukin‐13, a key cytokine driving peripheral inflammation in atopic dermatitis (AD). In phase II studies, tralokinumab combined with topical corticosteroids provided early and sustained improvements in AD signs and symptoms. Objectives To evaluate the efficacy and safety of tralokinumab monotherapy in adults with moderate‐to‐severe AD who had an inadequate response to topical treatments. Methods In two, 52‐week, randomized, double‐blind, placebo‐controlled, phase III trials, ECZTRA 1 and ECZTRA 2, adults with moderate‐to‐severe AD were randomized (3 : 1) to subcutaneous tralokinumab 300 mg every 2 weeks (Q2W), or placebo. Primary endpoints were IGA score of 0 or 1 at week 16 and EASI 75 at week 16. Patient achieving an IGA score of 0/1 and/or EASI 75 with tralokinumab at week 16 were rerandomized to tralokinumab Q2W or every 4 weeks or placebo, for 36 weeks. Results At week 16, more patients who received tralokinumab vs. placebo achieved an IGA score of 0/1: 15·8% vs. 7·1% in ECZTRA 1 [difference (95% CI) 8·6% (4·1–13·1); P = 0·002] and 22·2% vs. 10·9% in ECZTRA 2 [11·1% (5·8–16·4); P < 0·001] and EASI 75: 25·0% vs. 12·7% [12·1% (6·5–17·7); P < 0·001] and 33·2% vs. 11·4% [21·6% (15·8–27·3); P < 0·001]. Early improvements in pruritus, sleep interference, Dermatology Life Quality Index, SCORing Atopic Dermatitis and Patient‐Oriented Eczema Measure were observed from the first postbaseline measurements. The majority of week 16 tralokinumab‐responders maintained response at week 52 with continued tralokinumab treatment without any rescue medication (including topical corticosteroids). Adverse events were reported in 76·4% and 61·5% of patients receiving tralokinumab and in 77·0% and 66·0% of patients receiving placebo in the 16‐week initial period. Conclusions Tralokinumab monotherapy was superior to placebo at 16 weeks of treatment and was well tolerated up to 52 weeks of treatment.