Evaluation of Children with Psoriasis from the BiPe Cohort: Are Patients Using Biotherapies in Real Life Eligible for Phase III Clinical Studies?

Phan, C.; Beauchet, Alain; Burztejn, Anne-Claire; Sévérino-Freire, Maëlla; Mazereeuw‐Hautier, J.; Barbarot, S.; Girard, C.; Lasek, A.; Réguiai, Z.; Abasq, C.; Sassolas, B.; Droitcourt, Catherine; Perrussel, M.; Hadj‐Rabia, S.; Mallet, S.; Phan, Alice; Lacour, Jean‐Philippe; Bourrat, E.; Aubin, F.; Mahé, E.; Pédiatrique, Groupe de Recherche de Recherche de la Société Française de Dermatologie de

doi:10.1007/s40272-019-00335-9

Cited by 11 publications

(15 citation statements)

References 16 publications

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“…For example, in a recent real‐life cohort of children with psoriasis, it was shown that more than 50% of children included in the cohort were ineligible for randomized controlled trial. Thus, efficacy and safety results from phase 3 clinical trials in selected populations may not sufficiently reflect what is observed in real life, hence the need for results from real‐life cohort studies 22 . Our study investigated whether children treated for atopic dermatitis with dupilumab in real‐life practice would differ from children in the original phase 3 trial from Paller 12 .…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and safety of dupilumab in the treatment of atopic dermatitis in children (6–11 years): data from a French multicentre retrospective cohort in daily practice

Lasek

Bellon

Mallet

et al. 2022

Acad Dermatol Venereol

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Background Dupilumab is the first biotherapy available for the treatment of moderate-to-severe childhood atopic dermatitis (AD).Objective The aim of this study was to evaluate the effectiveness and safety of dupilumab in daily practice.Methods Patients aged 6-11, who had received a first dose of dupilumab, were included in this multicentre retrospective cohort study. The primary endpoint was change in SCORAD after 3 months of treatment. Secondary endpoints were change in IGA score at 3 months, proportion of patients with SCORAD50 and SCORAD75, description of adverse events and proportion of children in our cohort who would be excluded from pivotal phase 3 clinical trial.Results Eighty patients were included. After 3 months of treatment, there was a significant decrease in SCORAD (mean: 21.8 AE 13.8 vs 53.9 AE 18.5; P < 0.0001) and IGA (1.3 AE 0.8 vs 3.5 AE 0.7; P < 0.0001). Conjunctivitis was observed in 11.3% (n = 9/80); three patients experienced dupilumab facial redness (DFR); 17.5% (n = 14/80) reported injection site reactions; 6.3% (n = 5/80) discontinued treatment. 61.2% (n = 49/80) children were ineligible in the phase 3 trial. Limitations There is no control group. Because it was a real life study based on information from patient medical records in a French multicentre cohort, we cannot rule out the presence of reporting bias generated by the use of patient reported characteristics and missing information.

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Section: Discussionmentioning

confidence: 99%

Effectiveness and safety of dupilumab in the treatment of atopic dermatitis in children (6–11 years): data from a French multicentre retrospective cohort in daily practice

Lasek

Bellon

Mallet

et al. 2022

Acad Dermatol Venereol

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“…Although the percentages of overall drug survival were not stated, calculated 1-year (42.9%) and 3-year (11.4%) drug survival rates in another study of biologics in pediatric psoriasis were lower than our results. 29…”

Section: Discussionmentioning

confidence: 99%

A Comparison of Psoriasis Severity in Pediatric Patients Treated With Methotrexate vs Biologic Agents

et al. 2020

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and the European Working Group on Pediatric Psoriasis IMPORTANCE Few studies have compared the use of methotrexate and biologics, the most commonly used systemic medications for treatment of moderate to severe psoriasis in children.OBJECTIVE To assess the real-world, 6-month reduction in psoriasis severity and long-term drug survival (rate and duration of adherence to a specific drug) of methotrexate vs biologics in plaque psoriasis in children. DESIGN, SETTING, AND PARTICIPANTSA retrospective medical records review was conducted at 20 European and North American centers. Treatment response was based on site-reported Psoriasis Area and Severity Index (PASI) and/or Physician Global Assessment (PGA) scores at baseline and within the first 6 months of treatment. Participants included all 234 consecutively seen children with moderate to severe psoriasis who

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“…[6][7][8] In 2018, we conducted a retrospective nationwide study of biological treatments for pediatric psoriasis (BiPe) evaluating the drug survival of biologic agents in children with psoriasis in a real-life setting. 9,10 It is well-established that not all patients will respond to the first biologic agent they receive. In the BiPe cohort, loss of efficacy (19.2%) and primary inefficacy (8.9%) were the most common causes of biologic discontinuation.…”

Section: Introductionmentioning

confidence: 99%

Switching biologics in children with psoriasis: Results from the BiPe cohort

Phan

Beauchet

Réguiai

et al. 2021

Pediatric Dermatology

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Background: There is currently little information on switching biologics in pediatric psoriasis.Objective: To evaluate the real-world clinical practice and safety of switching biologics in the "Biological Treatments for Pediatric Psoriasis" (BiPe) cohort. Methods: Data for all 134 patients included in the BiPe cohort were analyzed. A further evaluation of the subpopulation of patients who switched from a first-line Pediatric Dermatology PHAN et Al.

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Evaluation of Children with Psoriasis from the BiPe Cohort: Are Patients Using Biotherapies in Real Life Eligible for Phase III Clinical Studies?

Cited by 11 publications

References 16 publications

Effectiveness and safety of dupilumab in the treatment of atopic dermatitis in children (6–11 years): data from a French multicentre retrospective cohort in daily practice

Effectiveness and safety of dupilumab in the treatment of atopic dermatitis in children (6–11 years): data from a French multicentre retrospective cohort in daily practice

A Comparison of Psoriasis Severity in Pediatric Patients Treated With Methotrexate vs Biologic Agents

Switching biologics in children with psoriasis: Results from the BiPe cohort

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