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, A.; Bellon, N.; Mallet, S.; Puzenat, E.; Bursztejn, A.‐C.; Abasq, C.; Mazereeuw-Hautier, Juliette; Chiavérini, C.; Hubiche, T.; Raison‐Peyron, Nadia; Thanh, Aurélie Du; Barbarot, S.; Aubert, H.; Réguiai, Z.; Droitcourt, Catherine; Fievet, C.; Bellissen, A.; Bachelerie, M.; Nosbaum, Audrey; Armingaud, P; Regnault, M. Masson; Mahé, E.

doi:10.1111/jdv.18450

Cited by 17 publications

(15 citation statements)

References 24 publications

(56 reference statements)

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“…Te overall incidence of treatment-emergent adverse events was 7.7% in our pediatric cohorts during the 16-week dupilumab treatment period (Table 3), which was even lower than previous real-world studies in children aged 6-11 years (12.5%), adolescents (13.5%), and adults (17.5%) [14,15,18]. In fact, a larger regimen (Table 3) was partly administrated in our cohorts, which might further prove dupilumab a safe choice in pediatric patients, considering the low occurrence of adverse events.…”

Section: Discussioncontrasting

confidence: 62%

Dupilumab Improves Clinical Scores in Pediatric Patients Aged 2 to <18 Years with Uncontrolled Atopic Dermatitis: A Single‐Center, Real‐World Study

Wang

Shen

Liu

et al. 2023

Dermatologic Therapy

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Dupilumab is the first biologic agent approved for treatment of moderate to severe atopic dermatitis (AD). Phase 3 clinical trials have shown the efficacy and safety in AD children. However, real-world evidence is still scarce. Thirty-nine pediatric patients with uncontrolled AD who regularly received dupilumab were included in a single-center retrospective study. Eight patients (20.5%) were aged 2 to <6 years, fifteen (38.5%) were 6 to <12 years, and sixteen were 12 to <18 years. Changes in clinical AD scores (EASI, SCORAD, P-NRS, CDLQI, and POEM) at baseline, week 4 (W4), W10, and W16, as well as safety data were collected. At W16, the average EASI values dropped from 29.0 ± 16.2 to 5.1 ± 4.7, and 22 patients (73.3%) achieved 75% improvement in EASI. 16 patients (53.3%) achieved 75% improvement in SCORAD. Significant reduction was also observed in the changes of P-NRS, CDLQI, and POEM values. Notably, the change of clinical scores was similar among three age subgroups. At W16, the mean percent decreases in EASI for 2 to <6 years, 6 to <12 years, and 12 to <18 years, and subgroups were 67.3%, 78.5%, and 83.9%, respectively. A total of three cases of adverse effects were recorded, with conjunctivitis seen in two >6-year-old patients and the injection site reaction in one <6-year-old child. Dupilumab exhibited favorable efficacy and safety profile, including the 2 to <6 years old subgroup.

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Section: Discussioncontrasting

confidence: 62%

Dupilumab Improves Clinical Scores in Pediatric Patients Aged 2 to <18 Years with Uncontrolled Atopic Dermatitis: A Single‐Center, Real‐World Study

Wang

Shen

Liu

et al. 2023

Dermatologic Therapy

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“…Moreover, AEs led to treatment discontinuation in three (3.8%) patients. No serious AEs were collected [ 18 ].…”

Section: Discussionmentioning

confidence: 99%

Dupilumab Treatment in Children Aged 6–11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study

et al. 2022

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Background The management of paediatric atopic dermatitis (AD) is challenging, mostly relying on emollients and topical corticosteroids. Dupilumab, a fully human monoclonal antibody, has been recently approved for the treatment of children aged 6–11 years with moderate-to-severe AD not adequately controlled with topical therapies or when those therapies are not advisable. Objectives The aim of this study was to evaluate in real life the effectiveness and safety of dupilumab in the treatment of children aged from 6 to 11 years. Methods Demographic and clinical data of children aged 6–11 years, affected by moderate-to-severe AD and treated with dupilumab, were retrospectively collected from 24 dermatological and paediatric referral centres. Dupilumab was administered subcutaneously at an induction dose of 300 mg on day (D) 1, followed by 300 mg on D15 and 300 mg every 4 weeks. Disease severity was assessed at baseline and after week 2 (W2), W4 and W16 of dupilumab therapy using Eczema Area Severity Index (EASI), Pruritus Numerical Rating Scale (P-NRS) and Sleep NRS (S-NRS) and Children’s Dermatology Life Quality Index (c-DLQI) score. Results A total of 55 AD children (24 males [43.64%], 31 females [56.36%]; mean age 9.35 ± 1.75 years) were included. A significant improvement in EASI score, P-NRS, S-NRS and c-DLQI was observed from baseline to W16 of treatment with dupilumab. In particular, at W16 the proportion of patients achieving EASI75 was 74.54%. Moreover, at the same timepoint a significant mean percentage reduction for P-NRS, S-NRS and c-DLQI was also observed (68.39%, 70.22% and 79.03%, respectively). Conclusions Our real-life data seem to confirm the effectiveness of dupilumab in paediatric patients on all disease aspects, including extent and severity of signs, intensity of symptoms, sleep and QoL, with a good safety profile.

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“…Treatment groups received dupilumab monotherapy in two trials 12,13 , while the other two by Paller et al and Yang et al included patients applying concomitant TCs. 14,15 Measures used to assess disease severity in these studies included the Eczema Area Severity index (EASI), SCORing Atopic Dermatitis (SCORAD), and Investigator's Global Assessment (IGA). Three of the studies included patient reported outcomes such as the Dermatology Life Quality Index (DLQI) and the Pruritic Numeric Rating Scale for itch (P-NRS).…”

Section: Resultsmentioning

confidence: 99%

“…By reducing pruritic skin lesions, dupilumab resulted in improved quality of life for these children as measured through c-DLQI. 11,12,14,15 Of the studies included, no patients discontinued dupilumab due to severe treatment-emergent adverse events (TEAEs) related to dupilumab. Most prevalent side effects included conjunctivitis, nasopharyngitis, headaches, and injection-site reaction.…”

Section: Discussionmentioning

confidence: 99%

The Application of Dupilumab to Pediatric Patients Aged 6–11yrs with Moderate-to-Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled: The Clinical Data so Far

Balboul¹,

Kahn²,

Tracy³

et al. 2023

DDDT

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Background: While dupilumab has shown efficacy in improving atopic dermatitis, few studies have assessed the long-term clinical data of dupilumab use in pediatric patients. Objective: In the present study, we reviewed the current literature to assess reported efficacies, side effects, and risks of using dupilumab to treat atopic dermatitis in pediatric populations. Methods: Using PRISMA guidelines, the authors searched PubMed/MEDLINE and Embase for studies related to dupilumab treatment for atopic dermatitis in pediatric patients aged 6-11 years old. Results: A total of 512 pediatric patients (ages 6-11) were included. Outcome measures assessed by EASI, SCORAD, P-NRS, IGA and C-DLQI showed significant improvements in scores from those observed at baseline to the last treatment of dupilumab. Most reported adverse effects on dupilumab were conjunctivitis and infection site reactions. All studies reported that dupilumab was welltolerated. Limitations: Limitations include the low number of studies available and observation periods of up to 16 weeks, which may be too short to evaluate the drug's effectiveness and occurrence of adverse effects. This also limits our knowledge on whether there are sustained benefits and/or diminished efficacy as well as long-term side effects. Conclusion: Thus far, the data demonstrates dupilumab to be safe and effective in the management of moderate-to-severe atopic dermatitis in children aged 6-11 years. Future studies should evaluate long-term dupilumab use and sustained effects.

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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

Cited by 17 publications

References 24 publications

Dupilumab Improves Clinical Scores in Pediatric Patients Aged 2 to <18 Years with Uncontrolled Atopic Dermatitis: A Single‐Center, Real‐World Study

Dupilumab Improves Clinical Scores in Pediatric Patients Aged 2 to <18 Years with Uncontrolled Atopic Dermatitis: A Single‐Center, Real‐World Study

Dupilumab Treatment in Children Aged 6–11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study

The Application of Dupilumab to Pediatric Patients Aged 6–11yrs with Moderate-to-Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled: The Clinical Data so Far

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