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.

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Background At present, no real‐world studies are available on different dupilumab dosing regimens in controlled atopic dermatitis (AD). The aim of this study was to clinically evaluate a patient‐centered dupilumab dosing regimen in patients with controlled AD and to relate this to serum drug levels and serum biomarkers. Methods Ninety adult AD patients from the prospective BioDay registry were included based on their dupilumab administration interval according to a predefined patient‐centered dosing regimen. Group A (n = 30) did not fulfill the criteria for interval prolongation and continued using the standard dupilumab dosage (300 mg/2 weeks), group B (n = 30) prolonged dupilumab interval with 50% (300 mg/4 weeks), and group C (n = 30) prolonged dupilumab interval with 66%–75% (300 mg/6–8 weeks). AD severity score, patient‐reported outcomes, serum dupilumab levels, and serum biomarkers were analyzed over time. Results Disease severity scores did not significantly change over time during the tapering period in any of the groups. In groups B and C, the Numeric Rating Scale (NRS)‐pruritus temporarily significantly increased after interval prolongation but remained low (median NRS‐pruritus≤4). Median dupilumab levels remained stable in group A (standard dosage), but significantly decreased in groups B and C (24.1 mg/L (IQR = 17.1–45.6); 12.5 mg/L (IQR = 1.7–22.3)) compared with the levels during the standard dosage (88.2 mg/L [IQR = 67.1–123.0, p < .001]). Disease severity biomarker levels (CCL17/CCL18) remained low in all study groups during the whole observation period. Conclusions This study showed that dose reduction was successful in a subgroup of patients with controlled AD by using a patient‐centered dosing regimen. These patients showed stable low disease activity and low severity biomarkers over time.

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Clinical trials showed that upadacitinib, a selective Janus kinase-1 inhibitor, is effective for treatment of moderate-to-severe atopic dermatitis. However, daily practice studies are limited. This multicentre prospective study evaluated the effectiveness of 16 weeks of upadacitinib treatment for moderate-to-severe atopic dermatitis in adult patients, including those with previous inadequate response to dupilumab and/or baricitinib, in daily practice. A total of 47 patients from the Dutch BioDay registry treated with upadacitinib were included. Patients were evaluated at baseline, and after 4, 8 and 16 weeks of treatment. Effectiveness was assessed by clinician- and patient-reported outcome measurements. Safety was assessed by adverse events and laboratory assessments. Overall, the probabilities (95% confidence intervals) of achieving Eczema Area and Severity Index ≤ 7 and Numerical Rating Scale – pruritus ≤ 4 were 73.0% (53.7–86.3) and 69.4% (48.7–84.4), respectively. The effectiveness of upadacitinib was comparable in patients with inadequate response to dupilumab and/or baricitinib and in patients who were naïve for these treatments or who had stopped such treatments due to adverse events. Fourteen (29.8%) patients discontinued upadacitinib due to ineffectiveness, adverse events or both (8.5%, 14.9% and 6.4%, respectively). Most frequently reported adverse events were acneiform eruptions (n = 10, 21.3%), herpes simplex (n = 6, 12.8%), nausea and airway infections (both n = 4, 8.5%). In conclusion, upadacitinib is an effective treatment for patients with moderate-to-severe atopic dermatitis, including those with previous inadequate response to dupilumab and/or baricitinib treatment.

This study identified risk factors for the development of dupilumab-associated ocular surface disease in patients with moderate-to-severe atopic dermatitis in a large prospective daily practice cohort. Data from the Dutch BioDay Registry were used to assess the risk of developing dupilumab-associated ocular surface disease, by performing univariate and multivariate logistic regression analyses. A total of 469 patients were included, of which 152/469 (32.4%) developed dupilumab-associated ocular surface disease. Multivariate analysis showed a statistically significant association of the development of dupilumab-associated ocular surface disease with a history of any eye disease (history of self-reported episodic acute allergic conjunctivitis excluded) combined with the use of ophthalmic medication at the start of dupilumab (odds ratio 5.16, 95% confidence interval 2.30–11.56, p < 0.001). In conclusion, a history of any eye disease (history of self-reported episodic acute allergic conjunctivitis excluded) combined with the use of ophthalmic medication at baseline was associated with the development of dupilumab-associated ocular surface disease in patients with atopic dermatitis.

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Background Limited data is available regarding patient-centered dosing of dupilumab for atopic dermatitis (AD) in daily practice. Objectives To evaluate our patient-centered dupilumab dosing regimen in daily practice, to assess prognostic factors for successful tapering and to estimate medication-related cost savings. Methods This prospective multicenter study included adult AD patients, participating in the BioDay registry, treated with dupilumab for ≥1.3 years. Interval prolongation was considered in case of dupilumab standard dose for ≥1 year and persistent controlled AD (Eczema Area and Severity Index (EASI)≤7); ≥six months). Primary endpoints were the mean EASI and Numeric Rating Scale (NRS)-pruritus after start of tapering. Prognostic factors for successful tapering were analyzed with logistic regression and a cost saving analysis was performed. Results A total of 595 patients were included, of which 401 patients (mean EASI 2.5 (SD 2.3)); NRS-pruritus of 2.4 (SD 1.9) at start tapering) prolonged dupilumab interval. In 83.3% of these patients tapering was successful; most patients used dupilumab every 3 or 4 weeks (Q3W/Q4W). A significant small increase was observed for EASI (highest mean 3.5) and NRS-pruritus (highest mean 3.2) (p&lt;0.0001), however scores remained low. Predicting successful tapering showed non-significant odds ratios for all incorporated variables. The estimated cost saving was 3,977,033.98 EUR for 401 patients between January 2019-June 2022. Conclusions This study showed successful tapering of dupilumab in 83.3% of AD patients who attempted tapering while maintaining controlled disease and with the majority using Q3W/Q4W. Interval prolongation can be both beneficial for the patient and from a socio-economic perspective.