Evaluation of long-term efficacy, safety, and reasons for discontinuation of dupilumab for moderate to severe atopic dermatitis in clinical practice: A retrospective cohort study

Jo, Christine E.; Georgakopoulos, Jorge R.; Ladda, Matthew; Ighani, Arvin; Mufti, Asfandyar; Drucker, Aaron M.; Piguet, Vincent; Yeung, Jensen

doi:10.1016/j.jaad.2020.02.029

Cited by 24 publications

(35 citation statements)

References 4 publications

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“…These data are in line with results from controlled study where about one third of patients who interrupted dupilumab experienced persistent ≥75% of EASI improvement 15 . In 7 (4.7%) patients there was a minimal or absent improvement of AD, which meant not having reached EASI‐50 after 16 weeks (primary inefficacy); this data was in line with the literature 16 . Cutaneous side effects, severe enough to induce drug discontinuation, were observed in four patients (2.6%).…”

Section: Discussionsupporting

confidence: 90%

Drug survival of dupilumab compared to cyclosporin in moderate‐to‐severe atopic dermatitis patients

Bello

Maurelli

Schena

et al. 2020

Dermatologic Therapy

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Dupilumab and cyclosporin are recommended treatments for moderate-to-severe atopic dermatitis (AD). The objective of this study was to investigate drug survival of dupilumab in comparison with CsA, reasons of drug discontinuation, and predictive parameters of drug survival in daily practice. Retrospective study including patients with moderate-to-severe AD treated with dupilumab or cyclosporin (CsA) from January 1, 2019 to April 30, 2020. Drug survival analysis was performed using the Kaplan-Meier method and predictive factors were analyzed using multivariate Cox regression analyses. Adult patients with AD (n = 251) treated with dupilumab (n = 149) or CsA (n = 102) were included. Sixteen months from baseline, 82% of patients receiving dupilumab were still on treatment vs 11% of those treated with CsA. Reason for withdrawing dupilumab were primary inefficacy in 4.7% of patients, persistent clinical remission in 7.4%, and cutaneous adverse effects in 2.0%. Older age at diagnosis and shorter AD duration predicted shorter dupilumab survival. Reasons for CsA withdrawal included adverse effects in 23.5% of patients, persistent clinical remission in 15.6%, and a minimal or absent improvement in 11.7%. Dupilumab has a longer drug survival compared to CsA. Only a limited number of dupilumab patients discontinued treatment due to adverse effects and/or ineffectiveness.

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Section: Discussionsupporting

confidence: 90%

Drug survival of dupilumab compared to cyclosporin in moderate‐to‐severe atopic dermatitis patients

Bello

Maurelli

Schena

et al. 2020

Dermatologic Therapy

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“…Dupilumab has been demonstrated to be an effective treatment for patients with moderateto-severe AD in clinical trials [9][10][11] and in real-life studies [2,[19][20][21][22][23][24][25][26][27][28][29][30][31][32][33]. To date, there have been some reports on real-world experience with dupilumab, including six multicenter studies [14,19,[22][23][24]26].…”

Section: Discussionmentioning

confidence: 99%

“…As regards the safety of dupilumab, new onset conjunctivitis was observed in 66 patients (12.2%). The reported incidence in clinical trials [9][10][11]and in real-life studies [2,[19][20][21][22][23][24][25][26][27][28][29][30][31][32][33]39]ranges from 5% to 28%, and from 6% to 62% of dupilumab-treated patients, respectively. During the clinical development of dupilumab in AD [40], the incidence of conjunctivitis was around 10% and infrequent in patients with asthma or nasal polyposis, suggesting that some characteristics of patients with AD may contribute to cause this, as eye involvement can be a comorbidity in AD [41].…”

Section: Discussionmentioning

confidence: 99%

Use of Dupilumab in 543 Adult Patients With Moderate-to-Severe Atopic Dermatitis: A Multicenter, Retrospective Study

Nettis¹,

Ferrucci²,

Ortoncelli³

et al. 2022

J Investig Allergol Clin

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Background: Dupilumab has been demonstrated to be an effective treatment for patients with moderate-to-severe atopic dermatitis (AD) in clinical trials. However, evidence of real-world experience with dupilumab in a broader population is limited to date. Methods: Adult patients with moderate-to-severe AD, defined as an Eczema Area Severity Index (EASI) score of 24 or higher, treated with dupilumab at ten Italian academic centers, were included in the study. Physician-reported outcome measures (EASI), patient-reported outcome measures (pruritus and sleep score, Dermatology Life Quality Index, DLQI) and serological markers [immunoglobulin (Ig) E and eosinophil count] after 16 weeks were analyzed. Results: We enrolled 543 patients with moderate-to-severe AD. Two patients (0.4%) discontinued treatment. The median ± interquartile percentage change from baseline to 16 weeks of treatment in the EASI score was-87.5±22.0 (p<0.001). EASI-50, EASI-75 and EASI-90 response rates were 98.1%, 81.5%, and 50.8% after 16 weeks. At 16 weeks, 93.0% of the patients had achieved a 4point or higher improvement in DLQI from baseline. During dupilumab treatment, 12.2% of the patients developed conjunctivitis, and total IgE significantly decreased (p<0.001). Interestingly, in the multivariate logistic regression model, the risk of developing dupilumab-related conjunctivitis was associated with early AD onset [OR, 2.25; 95%CI, 1.07-4.70; p=0.03] and presence of eosinophilia [OR, 1.91; 95%CI, 1.05-3.39; p=0.03]. Conclusion: To date, this is the broadest real-life study in AD patients treated with dupilumab. We observed significant improvements induced by dupilumab in adult patients with moderate-to-severe AD, to a greater extent than those reported in clinical trials.

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“…Furthermore, emerging post-marketing surveillance data of patients on dupilumab confirms an approximately 10% incidence of conjunctivitis. In one recent real-world review of 54 patients, 2 patients had to discontinue due to, or for reasons related to, conjunctivitis symptoms [66]. Since this drug-specific side effect had already been recognised during pre-marketing phase II-III studies and continues to be non-reported in any anti-IL-13 treated cohort, it is highly likely that conjunctivitis will not be associated with long-term IL-13 elimination.…”

Section: Safety Of Anti-il-13 Vaccinationmentioning

confidence: 99%

Virus-Like Particle-Mediated Vaccination against Interleukin-13 May Harbour General Anti-Allergic Potential beyond Atopic Dermatitis

Foerster

Molęda

2020

Viruses

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Virus-like particle (VLP)-based anti-infective prophylactic vaccination has been established in clinical use. Although validated in proof-of-concept clinical trials in humans, no VLP-based therapeutic vaccination against self-proteins to modulate chronic disease has yet been licensed. The present review summarises recent scientific advances, identifying interleukin-13 as an excellent candidate to validate the concept of anti-cytokine vaccination. Based on numerous clinical studies, long-term elimination of IL-13 is not expected to trigger target-related serious adverse effects and is likely to be safer than combined targeting of IL-4/IL-13. Furthermore, recently published results from large-scale trials confirm that elimination of IL-13 is highly effective in atopic dermatitis, an exceedingly common condition, as well as eosinophilic esophagitis. The distinctly different mode of action of a polyclonal vaccine response is discussed in detail, suggesting that anti-IL-13 vaccination has the potential of outperforming monoclonal antibody-based approaches. Finally, recent data have identified a subset of follicular T helper cells dependent on IL-13 which selectively trigger massive IgE accumulation in response to anaphylactoid allergens. Thus, prophylactic IL-13 vaccination may have broad application in a number of allergic conditions.

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Evaluation of long-term efficacy, safety, and reasons for discontinuation of dupilumab for moderate to severe atopic dermatitis in clinical practice: A retrospective cohort study

Cited by 24 publications

References 4 publications

Drug survival of dupilumab compared to cyclosporin in moderate‐to‐severe atopic dermatitis patients

Drug survival of dupilumab compared to cyclosporin in moderate‐to‐severe atopic dermatitis patients

Use of Dupilumab in 543 Adult Patients With Moderate-to-Severe Atopic Dermatitis: A Multicenter, Retrospective Study

Virus-Like Particle-Mediated Vaccination against Interleukin-13 May Harbour General Anti-Allergic Potential beyond Atopic Dermatitis

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