Effectiveness and safety of dupilumab for the treatment of atopic dermatitis in a real-life French multicenter adult cohort

Faiz, Sarah; Giovannelli, Jonathan; Podevin, Céline; Jachiet, Marie; Bouaziz, Jean‐David; Réguiai, Z.; Nosbaum, Audrey; Lasek, A.; Bouëdec, M.C. Ferrier Le; Du‐Thanh, Aurélie; Raison‐Peyron, Nadia; Tétart, F.; Duval-Modeste, Anne-Bénédicte; Miséry, Laurent; Aubin, F.; Dompmartin, Anne; Morice, C.; Droitcourt, Catherine; Soria, Angèle; Arnault, Jean‐Philippe; Delaunay, J.; Mahé, E.; Richard, M.‐A.; Schoeffler, A.; Lacour, Jean‐Philippe; Bégon, É.; Walter-Lepage, A.; Dillies, Anne-Sophie; Rappelle-Duruy, Sandrine; Barète, Stéphane; Bellon, N.; Bénéton, N.; Valois, A.; Barbarot, S.; Sénéchal, Julien; Staumont‐Sallé, D.

doi:10.1016/j.jaad.2019.02.053

Cited by 164 publications

(210 citation statements)

References 15 publications

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“…Although Dutch regulations do not require patients to have a minimum severity score to warrant dupilumab treatment, they do require patients to have failed treatment with at least one systemic immunosuppressant in a sufficient dose for at least 4 months with intensive guidance and instructions (Appendix S1; see Supporting Information). The majority of patients in our study (72%), and a similar proportion of patients in the daily practice studies available, had been treated with at least two different conventional systemic immunosuppressants, in contrast to a minority (26–28%) who used at least one systemic immunosuppressant in the SOLO trials . This suggests that patients in daily practice are at the end of the ‘severity spectrum’.…”

Section: Discussionmentioning

confidence: 58%

“…In our cohort, 62% (59 of 95) of the patients presented with eye symptoms suggestive for conjunctivitis, sicca and/or blepharitis, whereas conjunctivitis was observed in only 4–5% of the patients in the SOLO trials . However, the limited daily practice literature available also showed conjunctivitis incidence ranges up to 50% in patients treated with dupilumab . Literature on ocular comorbidities in AD shows that several ocular comorbidities are more prevalent among patients with AD than among the general population .…”

Section: Discussionmentioning

confidence: 62%

“…Although the methodology and follow‐up visits used in our study, clinical trials and the limited daily practice literature available were different, we tried to compare results …”

Section: Discussionmentioning

confidence: 99%

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Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data

et al. 2019

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Summary Background Dupilumab is the first biologic registered for the treatment of moderate‐to‐severe atopic dermatitis (AD), and efficacy was shown in phase III clinical trials (primary outcome at week 16 was reached in 38% of patients). Currently, there are limited daily practice data available for dupilumab, especially when it is combined with systemic immunosuppressants. Objectives To evaluate dupilumab treatment in daily practice in patients with AD. Methods In this observational cohort study, we prospectively included all adult patients with AD who had been treated with dupilumab in two university hospitals in the Netherlands. Concomitant systemic immunosuppressive treatment was monitored. Physician‐reported outcome measures and patient‐reported outcome measures (PROMs) after ≥ 12 weeks of follow‐up were analysed. We used a linear mixed‐effects model to determine changes in scores during follow‐up. Results Ninety‐five patients were included. Of these, 62 patients were using systemic immunosuppressants at baseline; the use of systemic immunosuppressants was continued during dupilumab treatment in 43 patients. From baseline to 16 weeks of treatment, the estimated mean Eczema Area and Severity Index score (0–72) decreased from 18·6 [95% confidence interval (CI) 16·0–21·4)] to 7·3 (95% CI 5·4–10·0), and the estimated mean PROMs showed a decrease of 41–66%. Investigator's Global Assessment 0 or 1 (clear/almost clear) was reached in 38% of the patients. Five patients discontinued dupilumab treatment due to side‐effects or ineffectiveness. Eye symptoms and orofacial (nonocular) herpes simplex virus (HSV) reactivation were reported in 62% and 8% of the patients, respectively. Conclusions Dupilumab treatment in daily practice shows a clinically relevant improvement of physician‐reported outcome measures and PROMs, which is in line with efficacy data from clinical trials. Besides frequently reported eye symptoms and orofacial (nonocular) HSV reactivation, there were no apparent safety concerns. What's already known about this topic? Dupilumab has been shown to be an efficacious treatment for atopic dermatitis in several clinical trials. However, it is known that there may be considerable differences in patient characteristics and treatment responses between clinical trials and daily practice. What does this study add? This study presents the first experience with dupilumab treatment in 95 patients with atopic dermatitis in daily practice in two Dutch university hospitals. Less stringent inclusion and exclusion criteria and follow‐up schedules, in contrast to those used in clinical trials, might better represent daily practice. Dupilumab treatment shows a clinically relevant improvement of physician‐ and patient‐reported outcome measures; besides patient‐reported eye symptoms (in 59 of 95 patients; 62%) and an apparent increase in orofacial (nonocular) herpes simplex virus reactivation (eight of 95 patients; 8%), there were no other safety concerns during follow‐up up to 16 weeks of dupilumab treatment.

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Section: Discussionmentioning

confidence: 58%

Section: Discussionmentioning

confidence: 62%

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Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data

et al. 2019

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“…As real world evidence publications with dupilumab are limited to date (Faiz et al, ; Ruiz‐Villaverde et al, ), so it is necessary to assess the performance of this treatment in real clinical practice, both in the short‐ and long‐term follow‐up.…”

Section: Baseline Characteristicsmentioning

confidence: 99%

“…We have extended our experience from previous publications up to 52 weeks, observing a maintenance of the response and no emerging or unpredicted AEs. Recently, another real clinical practice series of AD patients treated with dupilumab has been reported, showing significantly higher incidence of conjunctivitis (Faiz et al, ). As our experience appears to be different, further studies on the causes of conjunctivitis with dupilumab should bring us light on its possible, but ambiguous interconnection, as this AE was not reported in studies of dupilumab for other indications, including nasal polyposis and asthma, and may be unique to the AD population.…”

Section: Baseline Characteristicsmentioning

confidence: 99%

Fifty‐two week follow‐up safety and effectiveness results of dupilumab treatment of moderate‐to‐severe atopic dermatitis from a retrospective, multicentric series

Ruiz‐Villaverde

Domínguez-Cruz

Hita

et al. 2019

Dermatologic Therapy

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Atopic dermatitis (AD) is a chronic, systemic disease that has a multifactorial etiology, where immune system disorders and epidermal barrier dysfunction are added to the influence of genetic and environmental factors. Dupilumab has been approved by United States and the European Union regulatory agencies in 2017 for the treatment of moderate‐to‐severe AD in adult patients who are candidates for systemic treatment. In this short report, we present a retrospective, multicentric study, in which five hospitals in Andalusia, Spain, have taken part. Our objective is to evaluate the safety and effectiveness of dupilumab in patients with moderate‐to‐severe AD treated with dupilumab with at least 52 weeks of follow‐up.

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Efficacy and Safety of Lebrikizumab, a High-Affinity Interleukin 13 Inhibitor, in Adults With Moderate to Severe Atopic Dermatitis

et al. 2020

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IMPORTANCE Interleukin 13 (IL-13) is a central pathogenic mediator driving multiple features of atopic dermatitis (AD) pathophysiology.OBJECTIVE To evaluate the efficacy and safety of lebrikizumab, a novel, high-affinity, monoclonal antibody targeting IL-13 that selectively prevents formation of the IL-13Rα1/IL-4Rα heterodimer receptor signaling complex, in adults with moderate to severe AD. DESIGN, SETTING, AND PARTICIPANTSA phase 2b, double-blind, placebo-controlled, dose-ranging randomized clinical trial of lebrikizumab injections every 4 weeks or every 2 weeks was conducted from January 23, 2018, to May 23, 2019, at 57 US centers. Participants were adults 18 years or older with moderate to severe AD.INTERVENTIONS Patients were randomized 2:3:3:3 to placebo every 2 weeks or to subcutaneous injections of lebrikizumab at the following doses: 125 mg every 4 weeks (250-mg loading dose [LD]), 250 mg every 4 weeks (500-mg LD), or 250 mg every 2 weeks (500-mg LD at baseline and week 2). MAIN OUTCOMES AND MEASURESThe primary end point was percentage change in the Eczema Area and Severity Index (EASI) (baseline to week 16). Secondary end points for week 16 included proportion of patients achieving Investigator's Global Assessment score of 0 or 1 (IGA 0/1); EASI improvement of at least 50%, 75%, or 90% from baseline; percentage change in the pruritus numeric rating scale (NRS) score; and pruritus NRS score improvement of at least 4 points. Safety assessments included treatment-emergent adverse events.RESULTS A total of 280 patients (mean [SD] age, 39.3 [17.5] years; 166 [59.3%] female) were randomized to placebo (n = 52) or to lebrikizumab at doses of 125 mg every 4 weeks (n = 73), 250 mg every 4 weeks (n = 80), or 250 mg every 2 weeks (n = 75). Compared with placebo (EASI least squares mean [SD] percentage change, −41.1% [56.5%]), lebrikizumab groups showed dose-dependent, statistically significant improvement in the primary end point vs placebo at week 16: 125 mg every 4 weeks (−62.3% [37.3%], P = .02), 250 mg every 4 weeks (−69.2% [38.3%], P = .002), and 250 mg every 2 weeks (−72.1% [37.2%], P < .001). Differences vs placebo-treated patients (2 of 44 [4.5%]) in pruritus NRS improvement of at least 4 points were seen as early as day 2 in the high-dose lebrikizumab group (9 of 59 [15.3%]). Treatment-emergent adverse events were reported in 24 of 52 placebo patients (46.2%) and in lebrikizumab patients as follows: 42 of 73 (57.5%) for 125 mg every 4 weeks, 39 of 80 (48.8%) for 250 mg every 4 weeks, and 46 of 75 (61.3%) for 250 mg every 2 weeks; most were mild to moderate and did not lead to discontinuation. Low rates of injection-site reactions (1 of 52 [1.9%] in the placebo group vs 13 of 228 [5.7%] in all lebrikizumab groups), herpesvirus infections (2 [3.8%] vs 8 [3.5%]), and conjunctivitis (0% vs 6 [2.6%]) were reported.CONCLUSIONS AND RELEVANCE During 16 weeks of treatment, lebrikizumab provided rapid, dose-dependent efficacy across a broad range of clinical manifestations in adult patients with moderate to severe ...

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Effectiveness and safety of dupilumab for the treatment of atopic dermatitis in a real-life French multicenter adult cohort

Cited by 164 publications

References 15 publications

Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data

Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data

Fifty‐two week follow‐up safety and effectiveness results of dupilumab treatment of moderate‐to‐severe atopic dermatitis from a retrospective, multicentric series

Efficacy and Safety of Lebrikizumab, a High-Affinity Interleukin 13 Inhibitor, in Adults With Moderate to Severe Atopic Dermatitis

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