Current treatment goals are achieved by the majority of patients with atopic dermatitis treated with tralokinumab: results from a multicentric, multinational, retrospective, cohort study

ABSTRACT

Background

Tralokinumab is a human monoclonal antibody targeting interleukin-13 that is approved for the treatment of moderate-severe atopic dermatitis. Studies analyzing the efficacy and safety of tralokinumab in a real-world setting are scarce.

Research design and methods

A European, multicentric, real-world, retrospective cohort study was defined to assess the effectiveness and safeness profile of tralokinumab, investigating the achievement of pre-specified treatment goals; and to detect potential differences in terms of effectiveness and safeness across some selected patient subcohorts.

Results

A total of 194 adult patients were included in this study. A significant improvement in physician-assessed disease severity was detected at each follow-up visit as compared with baseline and similar trend was observed for patient-reported outcomes and quality of life. No meaningful difference in effectiveness was found when considering patient age (<65 versus ≥65 years), neither dissecting patient cohort in dupilumab-naive vs dupilumab-treated subjects. Among tralokinumab-treated patients, 88% achieved at least one currently identified real-world therapeutic goal at week 16.

Conclusions

This retrospective multicenter study confirmed the effectiveness and safeness of tralokinumab throughout 32 weeks of observation, showing the achievement of therapeutic goals identified in both trial and real-world settings in a large proportion of tralokinumab-treated patients.

KEYWORDS:

• Atopic dermatitis
• eczema
• tralokinumab
• IL-13 inhibitor
• Treatment goals

Declaration of interest

L Bianchi declares to have acted as a speaker and consultant for AbbVie, Novartis, Janssen‐Cilag, Pfizer, UCB, and LeoPharma, outside the submitted work. A Chiricozzi has served as advisory board member and consultant and has received fees and speaker’s honoraria or has participated in clinical trials for AbbVie, Almirall, Bristol Myers Squibb, Leo Pharma, Lilly, Janssen, Novartis, Pfizer, and Sanofi Genzyme, outside the submitted work. C Conrad has been scientific adviser and/or clinical study investigator for AbbVie, Actelion, Almirall, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli-Lilly, Incyte, Janssen, LEO Pharma, MSD, Novartis, Pfizer, Samsung, Sanofi, and UCB. Silvia Ferrucci has been principal investigator in clinical trials for ABBVIE, Almirall, Galderma, Leo Pharma, Sanofi, Amgen, Novartis, Bayer and received honoraria for lectures for Novartis and Menarini. M Galluzzo declares to have acted as speakers and/or consultants for AbbVie, Almirall, Eli‐Lilly, Janssen‐Cilag, LeoPharma, Novartis and Sanofi, outside the submitted work. G Girolomoni has received personal fees from AbbVie, Abiogen, Almirall, Amgen, Biogen, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli-Lilly, Leo Pharma, Merck Serono, Novartis, Pfizer, Samsung, and Sanofi. N Gori served as advisory board member and received honoraria for lectures for AbbVie, Sanofi, and Leo-Pharma. AV Marzano reports consultancy/advisory boards disease-relevant honoraria from AbbVie, Boehringer-Ingelheim, Novartis, Pfizer, Sanofi, Janssen, and UCB. Michela Ortoncelli has received research grant/travel for AbbVie, Almirall, Amgen, Leo Pharma, Lilly, Janssen, Novartis, Pfizer, Sanofi Genzyme UCB Pharma, Pierre Fabre, and Sun Pharma. K Peris has served on advisory board, received honoraria for lectures and/or research grants for Abbvie, Almirall, Lilly, Galderma, Leo Pharma, Pierre Fabre, Novartis, Sanofi, Sun Pharma, Janssen. S Ribero has received research grant/travel for AbbVie, Almirall, Amgen, Leo Pharma, Lilly, Janssen, Novartis, Pfizer, Sanofi Genzyme UCB Pharma, Pierre Fabre, and Sun Pharma. T Torres has received consultancy and/or speaker’s honoraria from and/or participated in clinical trials sponsored by AbbVie, Amgen, Almirall, Arena Pharmaceuticals, Biocad, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Fresenius-Kabi, Janssen, LEO Pharma, Eli Lilly, MSD, Mylan, Novartis, Pfizer, Samsung-Bioepis, Sanofi-Genzyme, Sandoz, and UCB. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14712598.2023.2292627

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics statement

Approval of this study was obtained by the Local Ethics Committee – Comitato Etico Territoriale Lazio Area 3, Prot ID: 5909. Permission was obtained from each center involved to use their patient records for the purposes of this study. Patient records were anonymized. Written informed consent was obtained from patients, whereby they also gave consent for their anonymized data to be used for research and publication purposes.

Author contributions

All authors contributed significantly to this work, in details: Chiricozzi A. for study conception and design, and article writing; Ferrucci SM, Balato A, Ortoncelli M, Maurelli M, Galluzzo M, Munera Campos M, Seremet T, Caldarola G, De Simone C, for Ippoliti E for patient management and data collection; Di Nardo L for statistical analysis and data interpretation; Torres T, Gkalpakiotis S, and Gori N for article drafting and data interpretation; Conrad C, Carrascosa JM, Bianchi L, Argenziano G, Ribero S, Girolomoni G, Marzano AV, Peris K for critical revision of the draft and supervision;

The submitted manuscript has been read, reviewed, and approved by all the authors. All have agreed on the journal to which the article will be submitted. All authors reviewed and agreed on all versions of the article before submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage.

All authors agreed to take responsibility and be accountable for the contents of the article and to share responsibility to resolve any questions raised about the accuracy or integrity of the published work.

Data availability statement

Enquiries related to the data generated or analyzed during this study can be directed to the corresponding author.

Additional information

Funding

This paper was not funded.