Dupilumab shows long-term effectiveness in a large cohort of treatment-refractory atopic dermatitis patients in daily practice: 52-Week results from the Dutch BioDay registry

Ariëns, Lieneke F.M.; Schaft, Jorien van der; Spekhorst, Lotte S; Bakker, Daphne; Romeijn, Geertruida L E; Kouwenhoven, T.; Kamsteeg, Marijke; Voorberg, Angelique N; Oosting, A. J.; Ridder, Ilona de; Sloeserwij, Annemieke; Haeck, Inge; Thijs, Judith L.; Schuttelaar, Marie L A; Bruin‐Weller, Marjolein S. de

doi:10.1016/j.jaad.2020.08.127

Cited by 63 publications

(97 citation statements)

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“…Our study found low discontinuation rates of dupilumab treatment (1.8%). This percentage of discontinuation is lower compared to the multicentre cohort of Ariëns et al (8.1%) and retrospective daily practice study of Jo et al (12%) [6,12].…”

Section: Commentarycontrasting

confidence: 53%

“…In our cohort, new-onset conjunctivitis was observed in 9.69% of patients, in accordance with the literature. The reported incidence in clinical trials and in real-life studies ranges from 5% to 28%, and from 6% to 62% of dupilumab-treated patients, respectively [3,4,6,11]. Regarding other AEs, we observed a lower incidence of red face and no case of arthralgia, reported by Kreeshan et al in 10 and 6 patients, respectively.…”

Section: Commentarysupporting

confidence: 48%

“…As matter of fact, we observed that at 52 weeks 68.48% of patients achieved EASI75 and 19.39% of patients EASI90, respectively. These percentages of efficacy at 52 weeks are higher than those reported in clinical trials [4] and in other reallife studies [6,9]. Indeed, Armario-Hita et al reported an EASI reduction of 79.3% in 70 patients at 24 weeks [10].…”

Section: Commentarymentioning

confidence: 68%

“…The efficacy and safety were demonstrated in clinical trials: the identically designed SOLO 1 and 2 studies reported results at 16 weeks of treatment with dupilumab in monotherapy [2]; while the CAFÉ and CHRONOS studies assessed the drug administered concomitantly with topical corticosteroids, at 16 and 52 weeks of treatment, respectively [3,4]. Currently, data regarding its daily practice setting, real-word effectiveness and tolerability up to 52 weeks are limited [5][6][7].…”

Section: Commentarymentioning

confidence: 99%

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Efficacy and Safety of Dupilumab in Clinical Practice: One Year of Experience on 165 Adult Patients from a Tertiary Referral Centre

Napolitano

Ferrillo

Patruno

et al. 2021

Dermatol Ther (Heidelb)

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We have read with great interest the article by Kreeshan et al., which reported data on effectiveness and laboratory safety of dupilumab. We performed a retrospective study including 165 adult patients affected by moderate-to-severe atopic dermatitis (AD) and treated with dupilumab for at least 52 weeks. A significant improvement in eczema area severity index (EASI) score after 16 and 52 weeks of treatment with dupilumab was observed. The mean EASI score at baseline was 28.84 ± 6.4 and significantly reduced to 10.05 ± 8.00 at 16 weeks (p \ 0.001), and to 3.04 ± 4.73 at 52 weeks (p \ 0.001), with a mean percentage reduction of 65.15% and 89.45%, respectively. Efficacy of dupilumab was demonstrated by a significant reduction of all the scores (P-NRS, S-NRS and DLQI). Furthermore, no patient discontinued the drug because of inefficacy. Fifty-seven out of 165 (34.54%) patients reported at least one adverse event (AE) during the 52-week treatment. Our study confirms that dupilumab can represent a long-term treatment for moderateto-severe adult AD, beyond 16 weeks. In our experience, dupilumab demonstrated a favourable safety profile at 52 weeks and only a few patients had to discontinue the treatment because of AEs.

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confidence: 53%

Section: Commentarysupporting

confidence: 48%

Section: Commentarymentioning

confidence: 68%

Section: Commentarymentioning

confidence: 99%

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Efficacy and Safety of Dupilumab in Clinical Practice: One Year of Experience on 165 Adult Patients from a Tertiary Referral Centre

Napolitano

Ferrillo

Patruno

et al. 2021

Dermatol Ther (Heidelb)

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“…18 years) who had been treated with dupilumab were eligible for the current study when they had been treated between 16 and 52 weeks at inclusion. This group was included because a steady state concentration of dupilumab from 16 weeks has been reported (7)(8)(9). On the 10th of April 2020, a digital questionnaire was sent to eligible patients, using Castor Electronic Data Capture (10).…”

Section: Study Design Population and Recruitmentmentioning

confidence: 99%

Eczema control and treatment satisfaction in atopic dermatitis patients treated with dupilumab – a cross-sectional study from the BioDay registry

Oosterhaven

Spekhorst

Zhang

et al. 2021

Journal of Dermatological Treatment

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Background: Eczema control is a new construct to be measured in atopic dermatitis (AD). Objectives: Measuring patient-perceived eczema control and treatment satisfaction in AD patients, treated with dupilumab between 16 and 52 weeks. Methods: Cross-sectional questionnaire study. Patients from the Dutch BioDay registry completed the Atopic Dermatitis Control Test (ADCT), Recap of Atopic Eczema (RECAP) and Treatment Satisfaction Questionnaire for Medication, Version II (TSQM v. II), along with other Patient Reported Outcome Measures (PROMs). Results: 104/157 patients responded (response rate 66.2%). Median ADCT score was 4 (interquartile range [IQR] 5); median RECAP score was 5 (IQR 6); median TSQM v.II global satisfaction score was 83.3 (IQR 25.0). According to the ADCT, 38.5-66.3% perceived their AD was 'in control', depending on the interpretability method used. Minimally clinically important difference (MCID) of !4 points for the DLQI and POEM was achieved respectively in N ¼ 66 (84.6%) and N ¼ 63 (78.8%) patients. Conclusion:When considering the favorable scores on other PROMs and the TSQM v. II, and comparing these to the relatively low percentage of patients perceiving control according to the ADCT, interpretability of eczema control still appears difficult. Treatment satisfaction in the studied cohort was high.

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Association of Serum Dupilumab Levels at 16 Weeks With Treatment Response and Adverse Effects in Patients With Atopic Dermatitis

et al. 2022

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ImportanceThe registered dose of dupilumab for adult patients with atopic dermatitis (AD) is 300 mg every other week. At present, it is unknown whether serum dupilumab levels are associated with treatment response or adverse effects.ObjectivesTo evaluate serum dupilumab levels at 16 weeks of treatment and to explore the association of serum dupilumab levels with treatment response and adverse effects in patients with AD.Design, Setting, and ParticipantsThis clinical, prospective, observational cohort study used data from the prospective BioDay Registry including adult patients with AD who started dupilumab treatment and for whom a serum sample was available at 16 weeks of treatment. All patients were treated according to the BioDay protocol in the University Medical Center Utrecht in the Netherlands. Patients received a loading dose of dupilumab 600 mg subcutaneously, followed by 300 mg every other week. Patients who had a dose adjustment or discontinued treatment before 16 weeks of treatment were excluded. Data analyses were performed from January to June 2022.Main Outcomes and MeasuresDisease severity of AD was assessed at baseline and at weeks 16 and 52 using the Eczema Area and Severity Index (EASI). Treatment response was defined as the percent reduction in EASI score vs the baseline score (eg, EASI 90 indicated a 90% reduction) and as an absolute EASI cutoff score of 7 or lower (controlled AD). Adverse effects were recorded during the first year. At 16 weeks, dupilumab serum levels and treatment responses were measured and analyzed. Multivariate logistic regression modeling was used to determine the prediction of response (EASI 90; EASI ≤7) and adverse effects at 52 weeks, with serum dupilumab levels at 16 weeks in the presence of the covariates age and sex.ResultsAmong the total of 295 patients with AD (mean [SD] age, 41.5 [15.9] years; 170 [57.6%] men), the median (IQR [range]) drug level was 86.6 μg/mL (64.6-110.0 μg/mL [10.1-382.0 μg/mL]) at 16 weeks of treatment. No significant differences were found in serum dupilumab levels between responder statuses (EASI, &lt;50, 50, 75, or 90) at week 16. Multivariate logistic regression analysis showed nonsignificant odds ratios (ORs) for serum dupilumab levels at 16 weeks regarding prediction of long-term response (EASI ≥90: OR, 0.96 [95% CI, 0.90-1.04; P = .34] and EASI ≤7: OR, 1.03 [95% CI, 0.93-1.14; P = .55]) and adverse effects (OR, 1.01 [95% CI, 0.95-1.07; P = .83]).Conclusion and RelevanceThis prospective clinical cohort study found a broad range of serum dupilumab levels at 16 weeks of treatment and no association with treatment response and adverse effects during first year of treatment. Response may be dependent on target availability of the interleukin-4 receptor subunit α, with an interpatient variability producing heterogeneity in response.

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Dupilumab shows long-term effectiveness in a large cohort of treatment-refractory atopic dermatitis patients in daily practice: 52-Week results from the Dutch BioDay registry

Abstract: M. S. (2021). Dupilumab shows long-term effectiveness in a large cohort of treatment-refractory atopic dermatitis patients in daily practice: 52-Week results from the Dutch BioDay registry, Journal of the American Academy of Dermatology, 84(4), e279-e280.

Cited by 63 publications

References 30 publications

Efficacy and Safety of Dupilumab in Clinical Practice: One Year of Experience on 165 Adult Patients from a Tertiary Referral Centre

Efficacy and Safety of Dupilumab in Clinical Practice: One Year of Experience on 165 Adult Patients from a Tertiary Referral Centre

Eczema control and treatment satisfaction in atopic dermatitis patients treated with dupilumab – a cross-sectional study from the BioDay registry

Association of Serum Dupilumab Levels at 16 Weeks With Treatment Response and Adverse Effects in Patients With Atopic Dermatitis

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