Delphine Staumont-Sallé
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Research Subjects
Research Interests
Delphine Staumont-Sallé has a total of 502 co-authors. Here are the top co-authors by number of shared publications:
- Frédéric Dezoteux
Department of Dermatology, CHU Lille, Université Lille, U1286 Inserm INFINITE Institute for Translational Research in Inflammation, Lille, France
10 shared publications - David Dombrowicz
Univ. Lille, Inserm, CHU Lille, Institut Pasteur de Lille, U1011-EGID, Lille, France
8 shared publications E. Delaporte
Department of Dermatology, Lille University Medical Centre, Claude Huriez Hospital, Lille, France
6 shared publications- Eric Hachulla
Département de Médecine Interne et Immunologie Clinique, CHU Lille, Lille, France
6 shared publications - Sébastien Fleury
Univ. Lille, Inserm, CHU Lille, Institut Pasteur de Lille, U1011-EGID, Lille, France
6 shared publications - David Launay
CHU de Lille, Service de Médecine Interne et Immunologie Clinique, Centre de référence des Maladies Auto-Immunes et Auto-inflammatoires Systémiques rares de l'Adulte du Nord, Nord-Ouest, Méditerranée et Guadeloupe (CeRAINOM), 59000 Lille, France; U1286-INFINITE-Institute for Translational Research in Inflammation, Université de Lille, 59000 Lille, France; Inserm, 59000 Lille, France
5 shared publications
Latest Publications
- Open Access
- 16 September 2026
- Published by Oxford University Press (OUP) in Skin Health and Disease
Eosinophils and eosinophilic skin diseases: a narrative review
Eosinophils are multifunctional granulocytes central to type 2 inflammation, allergy and host defence. In dermatology, their presence is frequent, either as a secondary finding in well-defined inflammatory disorders or, more rarely, as the defining feature of primary eosinophilic dermatoses. The pathogenic role of eosinophils is linked to their ability to release toxic granule proteins, lipid mediators, cytokines and extracellular traps, which contribute to both host protection and tissue damage. Their activation is orchestrated by cytokines such as interleukin (IL)-3, IL-5 and granulocyte–macrophage colony-stimulating factor, and by chemokines including eotaxins, which ensure selective recruitment to inflamed tissues such as the skin. This review provides an updated overview of eosinophils in cutaneous disease. It delineates the spectrum of eosinophil-associated dermatoses, ranging from common disorders such as atopic dermatitis, chronic urticaria, bullous pemphigoid and drug hypersensitivity syndromes, to rare primary eosinophilic dermatoses including Wells syndrome, eosinophilic pustular folliculitis, and recurrent cutaneous eosinophilic vasculitis. These entities are clinically and histologically heterogeneous, may overlap with systemic hypereosinophilic syndromes, and often present diagnostic and therapeutic challenges. Beyond their direct cytotoxicity, eosinophils also contribute to fibrosis, immune regulation and potentially tumour surveillance. Recognizing their central role provides new perspectives for classification and management. Therapeutic strategies range from conventional corticosteroids to emerging targeted therapies, including monoclonal antibodies against IL-5 and IL-5R, and dupilumab targeting the type 2 pathway. By framing eosinophilic skin conditions within the broader concept of eosinophilic disorders, this review emphasizes the importance of early recognition, multidisciplinary evaluation and personalized therapeutic approaches to improve patient outcomes.
- 16 September 2026
- Published by Oxford University Press (OUP) in Skin Health and Disease
Open AccessEosinophils and eosinophilic skin diseases: a narrative review
Eosinophils are multifunctional granulocytes central to type 2 inflammation, allergy and host defence. In dermatology, their presence is frequent, either as a secondary finding in well-defined inflammatory disorders or, more rarely, as the defining feature of primary eosinophilic dermatoses. The pathogenic role of eosinophils is linked to their ability to release toxic granule proteins, lipid mediators, cytokines and extracellular traps, which contribute to both host protection and tissue damage. Their activation is orchestrated by cytokines such as interleukin (IL)-3, IL-5 and granulocyte–macrophage colony-stimulating factor, and by chemokines including eotaxins, which ensure selective recruitment to inflamed tissues such as the skin. This review provides an updated overview of eosinophils in cutaneous disease. It delineates the spectrum of eosinophil-associated dermatoses, ranging from common disorders such as atopic dermatitis, chronic urticaria, bullous pemphigoid and drug hypersensitivity syndromes, to rare primary eosinophilic dermatoses including Wells syndrome, eosinophilic pustular folliculitis, and recurrent cutaneous eosinophilic vasculitis. These entities are clinically and histologically heterogeneous, may overlap with systemic hypereosinophilic syndromes, and often present diagnostic and therapeutic challenges. Beyond their direct cytotoxicity, eosinophils also contribute to fibrosis, immune regulation and potentially tumour surveillance. Recognizing their central role provides new perspectives for classification and management. Therapeutic strategies range from conventional corticosteroids to emerging targeted therapies, including monoclonal antibodies against IL-5 and IL-5R, and dupilumab targeting the type 2 pathway. By framing eosinophilic skin conditions within the broader concept of eosinophilic disorders, this review emphasizes the importance of early recognition, multidisciplinary evaluation and personalized therapeutic approaches to improve patient outcomes.
- 17 June 2026
- Published by Oxford University Press (OUP) in Rheumatology
- Vol. 65 (7)
Gastrointestinal involvement in dermatomyositis: multicentric retrospective cohort study
Objectives: Gastrointestinal (GI) involvement in myositis is a severe extra muscular manifestation with potentially life-threatening outcomes. However, it remains poorly characterized. We aimed to evaluate the prevalence of GI involvement in dermatomyositis (DM) and to describe its characteristics in anti-NXP2 DM. Methods: The prevalence of GI involvement across DM subgroups was assessed in a retrospective monocentric DM cohort (n = 119). It was further investigated in a retrospective multicentric cohort of anti-NXP2 DM (n = 48). GI involvement (defined as any symptomatic GI lesion, excluding isolated dysphagia) was considered severe when requiring surgery and/or intensive care unit admission. Results: In the monocentric DM cohort, severe GI involvement was observed in 18% of anti-NXP2 patients and 6% of anti-MDA5 patients. Severe GI involvement was significantly more frequent in anti-NXP2 patients compared with other DM subgroups (hazard ratio 8.85 [95% CI 1.62–48.35]). In the multicentric anti-NXP2 cohort, severe GI involvement (including four digestive perforations and three digestive haemorrhages) occurred in 12.5% of patients. Anti-NXP2 patients with severe GI involvement were significantly younger (median age 24.5 vs 42.5 years; p< 0.01) and more frequently presented with facial oedema at diagnosis (83% vs 33%; p= 0.03). At the time of GI involvement, 78% of anti-NXP2 patients had concomitant skin and/or muscle disease activity. No deaths were reported. Conclusion: Severe GI involvement represents a life-threatening complication in DM and is mainly associated with anti-NXP2 antibody. In anti-NXP2 DM, young age and facial oedema are associated with severe GI involvement.
- 17 June 2026
- Published by Oxford University Press (OUP) in Rheumatology
- Vol. 65 (7)
Gastrointestinal involvement in dermatomyositis: multicentric retrospective cohort study
Objectives: Gastrointestinal (GI) involvement in myositis is a severe extra muscular manifestation with potentially life-threatening outcomes. However, it remains poorly characterized. We aimed to evaluate the prevalence of GI involvement in dermatomyositis (DM) and to describe its characteristics in anti-NXP2 DM. Methods: The prevalence of GI involvement across DM subgroups was assessed in a retrospective monocentric DM cohort (n = 119). It was further investigated in a retrospective multicentric cohort of anti-NXP2 DM (n = 48). GI involvement (defined as any symptomatic GI lesion, excluding isolated dysphagia) was considered severe when requiring surgery and/or intensive care unit admission. Results: In the monocentric DM cohort, severe GI involvement was observed in 18% of anti-NXP2 patients and 6% of anti-MDA5 patients. Severe GI involvement was significantly more frequent in anti-NXP2 patients compared with other DM subgroups (hazard ratio 8.85 [95% CI 1.62–48.35]). In the multicentric anti-NXP2 cohort, severe GI involvement (including four digestive perforations and three digestive haemorrhages) occurred in 12.5% of patients. Anti-NXP2 patients with severe GI involvement were significantly younger (median age 24.5 vs 42.5 years; p< 0.01) and more frequently presented with facial oedema at diagnosis (83% vs 33%; p= 0.03). At the time of GI involvement, 78% of anti-NXP2 patients had concomitant skin and/or muscle disease activity. No deaths were reported. Conclusion: Severe GI involvement represents a life-threatening complication in DM and is mainly associated with anti-NXP2 antibody. In anti-NXP2 DM, young age and facial oedema are associated with severe GI involvement.
- 16 June 2026
- Published by Wiley in Clinical & Experimental Allergy
- Vol. 56 (8) , 976-978
Safety and Outcomes of Direct Challenge in Adults With a History of Childhood Penicillin Allergy: A Multicenter Study
Summary: Direct penicillin challenge without skin testing was evaluated in adults with childhood reactions. Only a few patients had mild reactions, with no anaphylaxis or severe cutaneous adverse events.
- 16 June 2026
- Published by Wiley in Clinical & Experimental Allergy
- Vol. 56 (8) , 976-978
Safety and Outcomes of Direct Challenge in Adults With a History of Childhood Penicillin Allergy: A Multicenter Study
Summary: Direct penicillin challenge without skin testing was evaluated in adults with childhood reactions. Only a few patients had mild reactions, with no anaphylaxis or severe cutaneous adverse events.
- Open Access
- 1 January 2026
- Published by Wiley in Dermatologic Therapy
- Vol. 2026 (1)
Improved Quality of Life and Sleep in Psoriasis Patients Treated With Guselkumab: The CASSIOPEE Study
Background: Psoriasis has physical, psychological, and social consequences that extend beyond visible lesions. Quality of life (QoL) is frequently affected by fatigue, sleep disturbance, and impaired intimacy or social functioning. Although biologics can achieve durable skin clearance, their broader effects on daily well‐being in routine practice are less well documented. The CASSIOPEE study assessed these multidimensional outcomes in patients treated with guselkumab. Objectives: To evaluate the impact of guselkumab on QoL and objectively measured sleep in adults with moderate‐to‐severe psoriasis treated in routine clinical practice. Methods: CASSIOPEE was a prospective, noninterventional, multicentre French study. Adults with moderate‐to‐severe psoriasis initiating guselkumab were followed for 6 months. The primary endpoint was Dermatology Life Quality Index (DLQI) response at month 6 (M6). Secondary outcomes included patient‐reported measures of general health (EQ‐5D‐5L), fatigue (FACIT‐Fatigue), anhedonia (SHAPS), sexual QoL (RSS), cognitive function (PDQ‐5), alexithymia (TAS‐20), and monthly electronic ratings of pain and pruritus. Sleep and physical activity were continuously monitored using a wearable device. Results: Among the 207 enrolled patients, 88.9% achieved the DLQI minimal clinically important difference (MCID) by M6 and 60.1% had a DLQI score of 0/1. Sleep duration and quality improved, with 74.5% of patients gaining > 15 min/night and the proportion with high sleep quality increasing from 4.2% to 23.8%. Patient‐reported outcomes showed marked reductions in pruritus, skin pain, and fatigue, together with improvements in general health, sexual QoL, cognitive function, and anhedonia. Clinical effectiveness was reflected by 88.1% of patients achieving a Physician’s Global Assessment (PGA) score ≤ 1 and 55.1% reaching complete skin clearance at M6. Guselkumab was well tolerated; most adverse events were mild and 1.8% led to treatment discontinuation. Conclusions: In routine practice, guselkumab was associated with broad benefits across skin and QoL domains, including a marked improvement in wearable‐confirmed sleep outcomes that paraleled symptom relief.
- 1 January 2026
- Published by Wiley in Dermatologic Therapy
- Vol. 2026 (1)
Open AccessImproved Quality of Life and Sleep in Psoriasis Patients Treated With Guselkumab: The CASSIOPEE Study
Background: Psoriasis has physical, psychological, and social consequences that extend beyond visible lesions. Quality of life (QoL) is frequently affected by fatigue, sleep disturbance, and impaired intimacy or social functioning. Although biologics can achieve durable skin clearance, their broader effects on daily well‐being in routine practice are less well documented. The CASSIOPEE study assessed these multidimensional outcomes in patients treated with guselkumab. Objectives: To evaluate the impact of guselkumab on QoL and objectively measured sleep in adults with moderate‐to‐severe psoriasis treated in routine clinical practice. Methods: CASSIOPEE was a prospective, noninterventional, multicentre French study. Adults with moderate‐to‐severe psoriasis initiating guselkumab were followed for 6 months. The primary endpoint was Dermatology Life Quality Index (DLQI) response at month 6 (M6). Secondary outcomes included patient‐reported measures of general health (EQ‐5D‐5L), fatigue (FACIT‐Fatigue), anhedonia (SHAPS), sexual QoL (RSS), cognitive function (PDQ‐5), alexithymia (TAS‐20), and monthly electronic ratings of pain and pruritus. Sleep and physical activity were continuously monitored using a wearable device. Results: Among the 207 enrolled patients, 88.9% achieved the DLQI minimal clinically important difference (MCID) by M6 and 60.1% had a DLQI score of 0/1. Sleep duration and quality improved, with 74.5% of patients gaining > 15 min/night and the proportion with high sleep quality increasing from 4.2% to 23.8%. Patient‐reported outcomes showed marked reductions in pruritus, skin pain, and fatigue, together with improvements in general health, sexual QoL, cognitive function, and anhedonia. Clinical effectiveness was reflected by 88.1% of patients achieving a Physician’s Global Assessment (PGA) score ≤ 1 and 55.1% reaching complete skin clearance at M6. Guselkumab was well tolerated; most adverse events were mild and 1.8% led to treatment discontinuation. Conclusions: In routine practice, guselkumab was associated with broad benefits across skin and QoL domains, including a marked improvement in wearable‐confirmed sleep outcomes that paraleled symptom relief.
- Open Access
- 7 November 2025
- Published by Oxford University Press (OUP) in Clinical and Experimental Dermatology
- Vol. 51 (4) , 641-643
Addressing the unseen strain: mental load in atopic dermatitis – a nationwide French study
This nationwide French study investigates the mental load experienced by patients with atopic dermatitis, an often-overlooked aspect of the disease’s impact. Using validated tools, the study found that individuals with moderate to severe atopic dermatitis face significantly higher psychological strain, highlighting the need for more comprehensive patient support beyond physical symptom management.
- 7 November 2025
- Published by Oxford University Press (OUP) in Clinical and Experimental Dermatology
- Vol. 51 (4) , 641-643
Open AccessAddressing the unseen strain: mental load in atopic dermatitis – a nationwide French study
This nationwide French study investigates the mental load experienced by patients with atopic dermatitis, an often-overlooked aspect of the disease’s impact. Using validated tools, the study found that individuals with moderate to severe atopic dermatitis face significantly higher psychological strain, highlighting the need for more comprehensive patient support beyond physical symptom management.
- Open Access
- 23 September 2025
- Published by Springer Nature in Dermatology and Therapy
- Vol. 15 (11) , 3391-3407
Do Allergic Comorbidities Alter the Efficacy and Safety of Abrocitinib or Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis?
Introduction Allergic comorbidities are common in patients with atopic dermatitis (AD). Individual trials with abrocitinib or dupilumab demonstrated efficacy and safety in patients with moderate-to-severe AD and allergic comorbidities. This post hoc analysis of the phase 3 JADE COMPARE and DARE trials compared efficacy, safety, and quality of life following abrocitinib and dupilumab treatment in adults with moderate-to-severe AD, with or without comorbid asthma, allergic rhinitis, or food allergy. Methods Data were pooled from patients who received abrocitinib (200 mg/day) or dupilumab (300 mg/every 2 weeks) for 16 weeks with concomitant topical therapy. Assessments by self-reported asthma, allergic rhinitis, or food allergy included the proportion of patients achieving Investigator’s Global Assessment of clear or almost clear (IGA 0/1), ≥ 75% improvement in Eczema Area and Severity Index (EASI-75), ≥ 4-point improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4), least squares mean change from baseline in Dermatology Life Quality Index (DLQI) and SCORing Atopic Dermatitis (SCORAD), and safety. Results Of 1195 patients (abrocitinib, n = 588; dupilumab, n = 607), 377 (32%), 225 (19%), and 211 (18%) patients self-reported comorbid asthma, food allergy, or allergic rhinitis, respectively. Week 16 IGA 0/1 responses were comparable between patients with/without comorbidity with abrocitinib (52%/54% [with/without asthma], 50%/54% [with/without allergic rhinitis], and 53%/53% [with/without food allergy]) or dupilumab (42%/42%, 37%/43%, and 47%/41%). EASI-75 and PP-NRS4 responses and DLQI and SCORAD improvements were also comparable between patients with/without comorbidity in each treatment arm. Treatment-emergent adverse events were more common in patients with comorbidities in the abrocitinib (76%/67% [with/without asthma], 80%/67% [with/without allergic rhinitis], and 78%/67% [with/without food allergy]) and dupilumab (71%/53%, 71%/57%, and 62%/59%) arms. Conclusion Abrocitinib and dupilumab improved AD signs and symptoms with a manageable safety profile in patients with moderate-to-severe AD, regardless of asthma, allergic rhinitis, or food allergy. Graphical Abstract available for this article. Trial Registration ClinicalTrials.gov identifier, NCT03720470 (JADE COMPARE) and NCT04345367 (DARE). Graphical Abstract
- 23 September 2025
- Published by Springer Nature in Dermatology and Therapy
- Vol. 15 (11) , 3391-3407
Open AccessDo Allergic Comorbidities Alter the Efficacy and Safety of Abrocitinib or Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis?
Introduction Allergic comorbidities are common in patients with atopic dermatitis (AD). Individual trials with abrocitinib or dupilumab demonstrated efficacy and safety in patients with moderate-to-severe AD and allergic comorbidities. This post hoc analysis of the phase 3 JADE COMPARE and DARE trials compared efficacy, safety, and quality of life following abrocitinib and dupilumab treatment in adults with moderate-to-severe AD, with or without comorbid asthma, allergic rhinitis, or food allergy. Methods Data were pooled from patients who received abrocitinib (200 mg/day) or dupilumab (300 mg/every 2 weeks) for 16 weeks with concomitant topical therapy. Assessments by self-reported asthma, allergic rhinitis, or food allergy included the proportion of patients achieving Investigator’s Global Assessment of clear or almost clear (IGA 0/1), ≥ 75% improvement in Eczema Area and Severity Index (EASI-75), ≥ 4-point improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4), least squares mean change from baseline in Dermatology Life Quality Index (DLQI) and SCORing Atopic Dermatitis (SCORAD), and safety. Results Of 1195 patients (abrocitinib, n = 588; dupilumab, n = 607), 377 (32%), 225 (19%), and 211 (18%) patients self-reported comorbid asthma, food allergy, or allergic rhinitis, respectively. Week 16 IGA 0/1 responses were comparable between patients with/without comorbidity with abrocitinib (52%/54% [with/without asthma], 50%/54% [with/without allergic rhinitis], and 53%/53% [with/without food allergy]) or dupilumab (42%/42%, 37%/43%, and 47%/41%). EASI-75 and PP-NRS4 responses and DLQI and SCORAD improvements were also comparable between patients with/without comorbidity in each treatment arm. Treatment-emergent adverse events were more common in patients with comorbidities in the abrocitinib (76%/67% [with/without asthma], 80%/67% [with/without allergic rhinitis], and 78%/67% [with/without food allergy]) and dupilumab (71%/53%, 71%/57%, and 62%/59%) arms. Conclusion Abrocitinib and dupilumab improved AD signs and symptoms with a manageable safety profile in patients with moderate-to-severe AD, regardless of asthma, allergic rhinitis, or food allergy. Graphical Abstract available for this article. Trial Registration ClinicalTrials.gov identifier, NCT03720470 (JADE COMPARE) and NCT04345367 (DARE). Graphical Abstract
- Open Access
- 4 September 2025
- Published by Wiley in JEADV Clinical Practice
- Vol. 5 (1) , 124-131
Drug Hypersensitivity: A Correlation Study From Histopathology to Clinic
Background: Drug hypersensitivity (DH) can present with varied clinical and pathological manifestations that may mislead the referring physician. Available data regarding the concordance between pathological diagnosis and clinical findings in DH are scarce. Objectives: We aimed to describe the clinical spectrum of patients with an established histological diagnosis compatible with DH. Methods: We conducted a retrospective single‐centre study of adult patients using a coding system for pathological results for skin biopsy between 2011 and 2019. Clinical correlation was then analysed through the medical records. Results: A total of 408 biopsies were analysed. The differential diagnosis of DH was considered by the referring physician in 57% of cases ( n = 217), and the introduction of a new drug was reported in 63% of cases ( n = 237). In 19% of cases ( n = 70), DH was the only histological diagnosis provided by the reporting pathologist, whereas an alternative diagnosis was suggested in the remaining cases. After review of the pathological report, a final clinical diagnosis of DH was retained by the referring physician in 46% of cases ( n = 165/355), suggesting limited concordance between pathological findings and clinical review. When the diagnosis of DH was initially suggested by the referring physician, this diagnosis was confirmed in 67% of cases ( n = 145/217). The diagnosis of DH was made in 5 cases (1%) following the pathological examination when the referring physician did not initially propose a diagnosis of DH following clinical examination. In 25% of cases, the pathologist provided a final diagnosis of drug‐induced maculopapular exanthem (MPE), viral exanthem or eczema for the same biopsy, highlighting that the histological features of these three conditions can appear very similar and difficult to distinguish. Conclusions: Pathological to clinical correlation must be considered, particularly in the context of DH. Our study confirms a limited benefit from skin biopsying in cases of drug‐induced MPE.
- 4 September 2025
- Published by Wiley in JEADV Clinical Practice
- Vol. 5 (1) , 124-131
Open AccessDrug Hypersensitivity: A Correlation Study From Histopathology to Clinic
Background: Drug hypersensitivity (DH) can present with varied clinical and pathological manifestations that may mislead the referring physician. Available data regarding the concordance between pathological diagnosis and clinical findings in DH are scarce. Objectives: We aimed to describe the clinical spectrum of patients with an established histological diagnosis compatible with DH. Methods: We conducted a retrospective single‐centre study of adult patients using a coding system for pathological results for skin biopsy between 2011 and 2019. Clinical correlation was then analysed through the medical records. Results: A total of 408 biopsies were analysed. The differential diagnosis of DH was considered by the referring physician in 57% of cases ( n = 217), and the introduction of a new drug was reported in 63% of cases ( n = 237). In 19% of cases ( n = 70), DH was the only histological diagnosis provided by the reporting pathologist, whereas an alternative diagnosis was suggested in the remaining cases. After review of the pathological report, a final clinical diagnosis of DH was retained by the referring physician in 46% of cases ( n = 165/355), suggesting limited concordance between pathological findings and clinical review. When the diagnosis of DH was initially suggested by the referring physician, this diagnosis was confirmed in 67% of cases ( n = 145/217). The diagnosis of DH was made in 5 cases (1%) following the pathological examination when the referring physician did not initially propose a diagnosis of DH following clinical examination. In 25% of cases, the pathologist provided a final diagnosis of drug‐induced maculopapular exanthem (MPE), viral exanthem or eczema for the same biopsy, highlighting that the histological features of these three conditions can appear very similar and difficult to distinguish. Conclusions: Pathological to clinical correlation must be considered, particularly in the context of DH. Our study confirms a limited benefit from skin biopsying in cases of drug‐induced MPE.
- Open Access
- 29 August 2025
- Published by Oxford University Press (OUP) in British Journal of Dermatology
- Vol. 194 (2) , 225-235
Safety of tralokinumab in patients with moderate-to-severe atopic dermatitis followed for up to 4.5 years: an integrated analysis of eight clinical trials
Background: Patients with moderate-to-severe atopic dermatitis (AD) require long-term management. Understanding the long-term safety of new treatments is a top priority for patients and healthcare professionals. Objectives: To evaluate the safety of tralokinumab in adults and adolescents with moderate-to-severe AD by conducting an integrated safety analysis of seven placebo-controlled trials and the ongoing, open-label extension study ECZTEND (NCT03587805). Methods: An initial 16-week placebo-controlled (PBO-CTRL) safety set and an all-tralokinumab (ALL-TRALO) safety set combining the placebo-controlled trials and ECZTEND (data cutoff 30 April 2022) were analysed. All treatment-emergent adverse events were recorded. Adverse events of special interest (AESIs) were predefined. Safety areas of clinical interest for advanced systemic AD treatments were captured retrospectively. Proportions of patients with events and incidence rates (IRs) per 100 patient-years of exposure (PYE) were calculated. PYE was defined as the time until the first event or exposure end, whichever came first, and incidence was defined as the first event. Results: Safety results were similar between the PBO-CTRL safety set and ALL-TRALO safety set. In the latter, 2693 patients received tralokinumab for up to 238.5 weeks (approximately 4.5 years, PYE = 5320.2). Most adverse events (AEs) were nonserious, mild or moderate in severity, and occurred with similar frequencies between tralokinumab and placebo in the PBO-CTRL safety set. The most common AEs that occurred at higher rates for tralokinumab vs. placebo were nasopharyngitis [IR ratio (IRR) comparing tralokinumab vs. placebo 1.26], conjunctivitis (IRR 3.11) and injection site reaction (IRR 19.57). Dermatitis atopic and asthma occurred at lower rates with tralokinumab vs. placebo (IRR 0.51 and IRR 0.57, respectively). AESI eye disorders occurred at higher rates with tralokinumab vs. placebo (IRR 2.43) and 98% were mild to moderate. AESIs that were less frequent with tralokinumab vs. placebo included skin infections requiring systemic treatment (IRR 0.43) and eczema herpeticum (IRR 0.32). Rates of AEs of clinical interest (related to other approved systemic AD treatments) were low and similar between treatment groups. IRs of AEs did not increase with longer exposure in the ALL-TRALO safety set. Conclusions: Long-term use of tralokinumab in adults and adolescents with moderate-to-severe AD was well-tolerated and consistent with the initial placebo-controlled treatment period, with no new safety signals identified.
- 29 August 2025
- Published by Oxford University Press (OUP) in British Journal of Dermatology
- Vol. 194 (2) , 225-235
Open AccessSafety of tralokinumab in patients with moderate-to-severe atopic dermatitis followed for up to 4.5 years: an integrated analysis of eight clinical trials
Background: Patients with moderate-to-severe atopic dermatitis (AD) require long-term management. Understanding the long-term safety of new treatments is a top priority for patients and healthcare professionals. Objectives: To evaluate the safety of tralokinumab in adults and adolescents with moderate-to-severe AD by conducting an integrated safety analysis of seven placebo-controlled trials and the ongoing, open-label extension study ECZTEND (NCT03587805). Methods: An initial 16-week placebo-controlled (PBO-CTRL) safety set and an all-tralokinumab (ALL-TRALO) safety set combining the placebo-controlled trials and ECZTEND (data cutoff 30 April 2022) were analysed. All treatment-emergent adverse events were recorded. Adverse events of special interest (AESIs) were predefined. Safety areas of clinical interest for advanced systemic AD treatments were captured retrospectively. Proportions of patients with events and incidence rates (IRs) per 100 patient-years of exposure (PYE) were calculated. PYE was defined as the time until the first event or exposure end, whichever came first, and incidence was defined as the first event. Results: Safety results were similar between the PBO-CTRL safety set and ALL-TRALO safety set. In the latter, 2693 patients received tralokinumab for up to 238.5 weeks (approximately 4.5 years, PYE = 5320.2). Most adverse events (AEs) were nonserious, mild or moderate in severity, and occurred with similar frequencies between tralokinumab and placebo in the PBO-CTRL safety set. The most common AEs that occurred at higher rates for tralokinumab vs. placebo were nasopharyngitis [IR ratio (IRR) comparing tralokinumab vs. placebo 1.26], conjunctivitis (IRR 3.11) and injection site reaction (IRR 19.57). Dermatitis atopic and asthma occurred at lower rates with tralokinumab vs. placebo (IRR 0.51 and IRR 0.57, respectively). AESI eye disorders occurred at higher rates with tralokinumab vs. placebo (IRR 2.43) and 98% were mild to moderate. AESIs that were less frequent with tralokinumab vs. placebo included skin infections requiring systemic treatment (IRR 0.43) and eczema herpeticum (IRR 0.32). Rates of AEs of clinical interest (related to other approved systemic AD treatments) were low and similar between treatment groups. IRs of AEs did not increase with longer exposure in the ALL-TRALO safety set. Conclusions: Long-term use of tralokinumab in adults and adolescents with moderate-to-severe AD was well-tolerated and consistent with the initial placebo-controlled treatment period, with no new safety signals identified.
- Open Access
- 12 July 2025
- Published by Wiley in Clinical & Experimental Allergy
- Vol. 55 (12) , 1247-1250
Identification of the Cytokines, Growth Factors and Their Receptors Expressed by Human Blood Eosinophils: A Transcriptomics Approach
- 12 July 2025
- Published by Wiley in Clinical & Experimental Allergy
- Vol. 55 (12) , 1247-1250
Open AccessIdentification of the Cytokines, Growth Factors and Their Receptors Expressed by Human Blood Eosinophils: A Transcriptomics Approach
- Open Access
- 19 May 2025
- Published by Wiley in Journal of the European Academy of Dermatology and Venereology
- Vol. 40 (1) , e5-e7
SALT score distribution with ritlecitinib treatment up to 24 months in alopecia areata
- 19 May 2025
- Published by Wiley in Journal of the European Academy of Dermatology and Venereology
- Vol. 40 (1) , e5-e7
Open AccessSALT score distribution with ritlecitinib treatment up to 24 months in alopecia areata