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Multicenter Study
. 2023 Apr;43(4):299-306.
doi: 10.1007/s40261-023-01258-7. Epub 2023 Apr 3.

Real-Life Experience of Tralokinumab for the Treatment of Adult Patients with Severe Atopic Dermatitis: A Multicentric Prospective Study

Axel De Greef  1 , Pierre-Dominique Ghislain  2 , Audrey Bulinckx  3 , Alison Coster  4 , Céline de Halleux  5 , Thomas Damsin  6 , Marie-Claude Jacobs  7 , Erwin Suys  8 , Samer Zoghaib  9 , Marie Baeck  2
Affiliations
Multicenter Study

Real-Life Experience of Tralokinumab for the Treatment of Adult Patients with Severe Atopic Dermatitis: A Multicentric Prospective Study

Axel De Greef et al. Clin Drug Investig. 2023 Apr.

Abstract

Background: Tralokinumab, the first fully human monoclonal antibody that binds specifically to interleukin-13, was safe and effective for treating atopic dermatitis (AD) in clinical trials, but real-life experience is still limited.

Objectives: The objective of this study was to evaluate the effectiveness and safety of tralokinumab in severe AD in a real-life multicenter prospective cohort.

Methods: Adult patients with severe AD were enrolled between January 2022 and July 2022 and received tralokinumab subcutaneously for 16 weeks. Objective and subjective scores were collected at baseline, weeks 6 and 16. Adverse events were reported throughout the study.

Results: Twenty-one patients were included. An improvement of at least 75% on the Eczema Area and Severity Index (EASI 75) was achieved in 66.7% of patients at week 16. The median objective and subjective scores at week 16 were significantly (p < 0.001) lower than those at baseline. Combination with cyclosporine was sometimes necessary at the beginning of treatment, and addition of upadacitinib was required for some patients with very severe disease during the treatment. The most frequent adverse events were flares of eczema (23.8%) and reactions at injection site (19.0%). No cases of conjunctivitis were reported. Four patients (19.0%) discontinued treatment.

Conclusions: Tralokinumab is an effective first-line biotherapy for severe AD. However, therapeutic response may be progressive. Safety data were reassuring. Atopic dermatitis flares or reactions at the injection site may lead to discontinuation of treatment. A history of conjunctivitis on dupilumab is not a contraindication to the initiation of tralokinumab.

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Conflict of interest statement

Axel De Greef, Pierre-Dominique Ghislain and Marie Baeck disclose their past participation on the tralokinumab advisory board organized by LEO Pharma but declare that the current study was conducted in an independent manner. Pierre-Dominique Ghislain received consultancy fees for expert work in clinical trials with other drugs from LEO Pharma. Audrey Bulinckx, Alison Coster, Céline de Halleux, Thomas Damsin, Marie-Claude Jacobs, Erwin Suys and Samer Zoghaib disclose no conflict of interest.

Figures

Fig. 1
Fig. 1
Differences between baseline and week 16 for EASI (A), SCORAD (B), DLQI (C), PP-NRS (D), RECAP (E) for each patient (each colored dot), illustrated in boxplots. Each boxplot graphically represents the distribution of each quantitative variable (scores) by displaying minimum, maximum, first/third quartiles and median (bold line). The width of the box is proportional to the number of patients with the same score value. Statistical significance (P) is evaluated using pairwise Wilcoxon signed-rank test (V = statistical value of the test). CI confidence interval of rank biserial correlation, DLQI Dermatology Life Quality Index, EASI Eczema Area and Severity Index, PP-NRS peak pruritus numeric rating scale, RECAP RECap for AtoPic eczema, SCORAD SCORing Atopic Dermatitis
Fig. 2
Fig. 2
Example of clinical improvement from baseline to week 16 in a patient receiving tralokinumab, topical corticosteroids and cyclosporine during the first weeks of treatment (complete cyclosporine withdrawal was achieved by week 10). DLQI Dermatology Life Quality Index, EASI Eczema Area and Severity Index, PP-NRS peak pruritus numeric rating scale, RECAP RECap for AtoPic eczema, SCORAD SCORing Atopic Dermatitis
See this image and copyright information in PMC

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