Treatment of moderate‐to‐severe atopic dermatitis with dupilumab in real clinical practice: a multicentre, retrospective case series

Armario‐Hita, J.C.; Pereyra‐Rodriguez, José Juan; Silvestre, J.F.; Ruíz‐Villaverde, Ricardo; Valero, Antonio; Izu-Belloso, Rosa; Jáuregui‐Presa, I.; Curto‐Barredo, Laia; Figueras‐Nart, Ignasi; Pinto, Pedro Herranz; Herraez‐Herrera, L.; Ortiz‐de‐Frutos, F.J.; Martínez-Pilar, Leandro; Sastre, Joaquı́n; Serra‐Baldrich, E.

doi:10.1111/bjd.18041

Cited by 44 publications

(64 citation statements)

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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%

“…18 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. 11,[33][34][35][36][37] Overall, patients in the current study had lower baseline EASI scores than patients in previous dupilumab studies and trials (Table S2; see Supporting Information). 11 In our study, patients were not asked to discontinue topical steroids or systemic immunosuppressants before the start of dupilumab treatment, resulting in lower baseline EASI scores than those from clinical trials that required a minimum washout period of 2 and 4 weeks, respectively.…”

Section: Discussionmentioning

confidence: 60%

“…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%

“…In our study, patients were not asked to discontinue topical steroids or systemic immunosuppressants before the start of dupilumab treatment, resulting in lower baseline EASI scores than those from clinical trials that required a minimum washout period of 2 and 4 weeks, respectively. Currently available daily practice studies with relatively high EASI scores did not report the presence of systemic treatment at baseline . From clinical experience, we know that discontinuation of systemic immunosuppressants in patients with AD often results in the exacerbation of their disease .…”

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: 60%

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%

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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Treatment Outcomes Associated With Dupilumab Use in Patients With Atopic Dermatitis

et al. 2022

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IMPORTANCE Clinical trial populations may not reflect clinical practice: knowledge generated in other settings can inform clinical decision-making.OBJECTIVE To evaluate self-reported disease control and quality of life after initiating dupilumab treatment in patients with atopic dermatitis (AD) in the the clinical setting.DESIGN, SETTING, AND PARTICIPANTS This cohort study using an online survey administered prior to (baseline) and at 1, 2, 3, 6, 9, and 12 months after dupilumab initiation included adults with moderate-to-severe AD who initiated treatment with dupilumab through the US patient support program and agreed to participate in the study. Data were collected between January 2018 and January 2020 and the analysis was completed in May 2020. INTERVENTIONS Clinically driven treatment with dupilumab.MAIN OUTCOMES AND MEASURES Disease control measured by the Atopic Dermatitis Control Tool (ADCT); concomitant AD therapies; satisfaction with therapy; skin symptoms (skin pain/soreness, hot/burning feeling, sensitivity to touch) assessed using numerical rating scales; flares; health-related quality of life assessed using the Dermatology Life Quality Index; sleep problems assessed using the ADCT item and a stand-alone question; and the AD-specific Work Productivity and Activity Impairment Questionnaire. RESULTSOf 699 patients who initiated dupilumab (431 [61.7%] female, 515 [73.7%] White), 632 and 483 completed the survey at months 1 and 12, respectively. As-observed results showed that most patients achieved adequate disease control (ADCT total score) at month 1 with further improvement at month 12 (385 of 632 patients [60.9%] and 374 of 483 [77.4%] for the 2 time points, respectively, vs 41 of 699 [5.3%] at baseline; both P < .001). Use of other AD therapies was reduced at each follow-up vs baseline, including topical and systemic corticosteroids, which were reduced at month 12 to 40.4% (195 of 483 patients) and 6.2% (30 of 483 patients), respectively, from 68.1% (476 of 699) and 34.9% (244 of 699), respectively, at baseline (both P < .001 vs baseline). Patient satisfaction with AD treatment was higher than baseline (120 of 699 [17.7%]) at each follow-up to 85.1% (411 of 483) at month 12 (P < .001). At each follow-up, patients reported reductions in flares, itch, skin symptoms, and improved sleep, health-related quality of life, and daily activities vs baseline. Results were consistent based on observed data and imputed data using pattern mixture models for missing data.CONCLUSIONS AND RELEVANCE Consistent with patient-reported outcomes in clinical trials, this cohort study found that dupilumab treatment was associated with rapid and sustained disease control for up to 12 months as demonstrated by statistically significant improvements relative to baseline on all patient-reported outcomes including treatment satisfaction.

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Efficacy and safety of dupilumab in pediatric patients with moderate to severe atopic dermatitis: a real-world study

Yang

et al. 2022

Arch Dermatol Res

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Treatment of moderate‐to‐severe atopic dermatitis with dupilumab in real clinical practice: a multicentre, retrospective case series

Cited by 44 publications

References 14 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

Treatment Outcomes Associated With Dupilumab Use in Patients With Atopic Dermatitis

Efficacy and safety of dupilumab in pediatric patients with moderate to severe atopic dermatitis: a real-world study

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