Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study

Abstract

Background

Dupilumab is a monoclonal antibody against the IL-4/IL-13 receptor-subunit approved for the treatment of moderate-severe atopic dermatitis (AD). Some attempts to increase dose interval have been described in both trial and real-world settings.

Objective

This study aimed to identify predictive clinical and demographic factors affecting patient selection for dose spacing or treatment withdrawal due to satisfactory response.

Materials and methods

This retrospective study included adult patients with moderate-to-severe AD treated with dupilumab for at least 16 weeks. Descriptive statistics were performed to analyze demographic and clinical variables. Logistic regression models were used to identify predictor variables.

Results

A total of 818 adult patients with moderate-to-severe AD was included in the study and 12% (97/818) of them performed dose spacing to 3–4 weeks or treatment withdrawal (8%, 67/818). The presence of non-cutaneous atopic manifestations (OR = 1.59, 95%CI = 1.06–2.38, p = 0.024), prurigo nodularis phenotype (OR = 4.5, 95%CI = 1.87–10.9, p = 0.001) and the age at treatment initiation (OR = 1.82, 95%CI = 1.12–2.94, p = 0.015) were confirmed as the strongest predictors of dose spacing or treatment withdrawal while maintaining dupilumab effectiveness.

Conclusion

Our findings contribute to define the patient profile that could maintain the therapeutic response after dose spacing or treatment withdrawal.

Key message

• Predicting factors identified patients with dupilumab who could benefit of dose spacing or treatment withdrawal.

Keywords:

• Atopic dermatitis
• atopic eczema
• dose spacing
• dupilumab
• predictive factors

Author contributions

All authors made substantial contribution to this manuscript and provided revision and approval of the final draft for submission, in details: AC, GDB: Concept and design, analysis and interpretation of data, drafted the article. NG, GC, CDS, MM, DS: patient management, reviewed the article critically for important intellectual content. LDN: performed statistical analysis of data with graphical and tabular conceptualization. GDB, GC, NG: acquisition of data. KP, GG: reviewed the article critically for important intellectual content, gave final approval of the version to be published.

Ethics statement

We confirm that all the subjects gave their written informed consent and the study protocol was reviewed and approved by Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore, Prot N.: 0046558/20.

Disclosure statement

Ketty 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. Clara De Simone has acted as a speaker and consultant for Almirall, AbbVie, Janssen, Celgene, Leo Pharma, Novartis, Eli Lilly, and UCB Pharma. Andrea 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. Giacomo Caldarola has received honoraria as speaker and consultant for Abbvie, Almirall, Biogen, Eli Lilly, LEO Pharma, Novartis, Janssen, Sanofi, Pfizer, and UCB Pharma outside the submitted work. Giampiero Girolomoni served as consultant and/or speaker for AbbVie, Abiogen, Almirall, Amgen, Biogen, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli-Lilly, Leo Pharma, Merck Serono, Novartis, Pfizer, Samsung bioepis, Sanofi and UCB pharma. Niccolò Gori served as consultant and/or speaker for AbbVie, Leo Pharma, and Sanofi. Giacomo Dal Bello, Donatella Schena, Lucia Di Nardo and Martina Maurelli have no conflict of interests to disclose.

Data availability statement

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

Additional information

Funding

Nothing to declare.