Dermatology: Practical and Conceptual


Research Letter | Dermatol Pract Concept. 2023;13(3):e2023143 1

Real-Life Safety and Effectiveness of Dupilumab 
in Patients with Concomitant Malignancies: a Case 

Series
Luigi Gargiulo1,2, Carlo Alberto Vignoli1,2, Andrea Cortese1,2, Luciano Ibba1,2,  

Antonio Costanzo1,2, Alessandra Narcisi1,2

1 Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy

2 Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy

Citation: Gargiulo L, Vignoli CA, Cortese A, Ibba L, Costanzo A Narcisi A. Real-Life Safety and Effectiveness of Dupilumab in Patients 
With Concomitant Malignancies: A Case Series. Dermatol Pract Concept. 2023;13(3):e2023143. DOI: https://doi.org/10.5826/
dpc.1303a143

Accepted: December 12, 2022; Published: July 2023

Copyright: ©2023 Gargiulo et al. This is an open-access article distributed under the terms of the Creative Commons Attribution-
NonCommercial License (BY-NC-4.0), https://creativecommons.org/licenses/by-nc/4.0/, which permits unrestricted noncommercial use, 
distribution, and reproduction in any medium, provided the original authors and source are credited.

Funding: None.

Competing Interests: Antonio Costanzo has been a consultant and/or speaker for Abb-Vie, Almirall, Amgen, Janssen, Leo Pharma, Eli Lilly, 
Galderma, Boehringer, Novartis, Pfizer, Sandoz, and UCB. Alessandra Narcisi has been a consultant and/or speaker for Abb-Vie, Almirall, 
Amgen, Janssen, Leo Pharma, Eli Lilly, Boehringer, Novartis, Pfizer and UCB. Luigi Gargiulo, Carlo Alberto Vignoli, Andrea Cortese and 
Luciano Ibba have nothing to disclose.

Authorship: All authors have contributed significantly to this publication.

Corresponding Author: Carlo Alberto Vignoli, Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4,  
Pieve Emanuele (MI), 20090, Italy. E-mail: c.alberto.vignoli@gmail.com

Ethics / Patient Consent Statement: All included patients had provided written consent for retrospective study of data collected during 
routine clinical practice.

Introduction

Dupilumab is a human monoclonal antibody which targets 

the alpha subunit of the interleukin (IL)-4-Receptor, blocking 

the signaling of both IL-13 and IL-4 and it is the first biologic 

drug approved for moderate-to-severe atopic dermatitis [1]. 

According to a systematic review from Braddock et al [2], 

data on the role of IL-13 and IL-4 in carcinogenesis are con-

flicting and there is paucity of evidences regarding the use 

of dupilumab in patients with concomitant malignancies [3].

We report our experience with 10 patients with previ-

ous history of cancer and 4 patients who developed a malig-

nancy during treatment with dupilumab, from January 2019 

to June 2022.

Case Presentation

Ten patients started dupilumab after receiving a diagnosis of 

cancer (Table 1):

• Three patients had previously undergone partial thyroid-

ectomy for papillary thyroid carcinoma (4, 6 and 29 years 

before receiving dupilumab, respectively).

• Two women had a history of ductal breast cancer: one 

received chemotherapy 12 years before the start of dup-

ilumab, while the second patient underwent surgery 

6 years before.

• Two patients had a diagnosis of prostatic cancer: one 

started dupilumab 4.5 years after the prostatectomy, while 



2 Research Letter | Dermatol Pract Concept. 2023;13(3):e2023143

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Research Letter | Dermatol Pract Concept. 2023;13(3):e2023143 3

the other received dupilumab one year after radiotherapy 

and hormonal therapy.

• One woman had history of ovarian cancer, treated with 

chemotherapy 11 years before starting dupilumab.

• One patient underwent pulmonary lobectomy for a lung 

adenocarcinoma 4 years before dupilumab.

• One patient was diagnosed with multiple squamous cell 

carcinomas (SCCs).

All patients are currently undergoing a specific onco-

logic follow-up, according to guidelines from the Italian As-

sociation of Medical Oncology. Overall, 4 patients started 

dupilumab less than 5 years after the cancer diagnosis. One 

patient received dupilumab one year after completing ra-

diotherapy. Six patients have already completed one year of 

treatment with dupilumab, without any cancer progressions 

or recurrences.

Among our patients treated with dupilumab, 4 devel-

oped malignancies during therapy (Table 1). After 7 months 

of therapy, two patients were diagnosed with a melanoma 

in situ and a pT1a melanoma respectively, both completely 

excised. Another patient was diagnosed with a SCC. Another 

patient was diagnosed with prostatic carcinoma two months 

after starting dupilumab; he is currently receiving hormonal 

therapy after prostatectomy. All of these patients never inter-

rupted dupilumab and they are still on treatment, complet-

ing one year of follow-up.

Conclusions

The role of IL-4 and IL-13 in carcinogenesis is still unclear. A 

systematic review did not show a higher risk of malignancy 

when specifically targeting the IL-13 and IL-4 pathway [2]. 

In literature, several case series on patients with concomitant 

malignancies have been described, showing no elevated risk 

of cancer recurrences or relapses [4-5]. In our experience, 

three of the four cancers diagnosed during treatment with 

dupilumab were cutaneous malignancies. The fourth patient 

was diagnosed with a prostatic adenocarcinoma two months 

after the start of dupilumab: considering his age (61 years 

old) and the short timespan between the diagnosis and the 

start of the treatment, no causal effect could be observed. 

Finally, none of our patients experienced cancer progressions 

or relapses during treatment.

We have described a case series of patients with con-

comitant malignancies treated with dupilumab. Larger pro-

spective studies with longer follow-up are needed to further 

assess this topic. Larger prospective studies with longer 

follow-up are needed to further assess this topic.

References

1. Costanzo A, Amerio P, Asero R, et al. Long-term management of 

moderate-to-severe adult atopic dermatitis: a consensus by the 

Italian Society of Dermatology and Venereology (SIDeMaST), 

the Association of Italian Territorial and Hospital Allergists 

and Immunologists (AAIITO), the Italian Association of Hos-

pital Dermatologists (ADOI), the Italian Society of Allergolog-

ical, Environmental and Occupational Dermatology (SIDAPA), 

and the Italian Society of Allergy, Asthma and Clinical Immu-

nology (SIAAIC). Ital J Dermatol Venerol. 2022;157(1):1-12. 

DOI:10.23736/S2784-8671.21.07129-2. PMID: 34929995.

2. Braddock M, Hanania NA, Sharafkhaneh A, Colice G, Carlsson M.  

Potential Risks Related to Modulating Interleukin-13 and  

Interleukin-4 Signalling: A Systematic Review.  Drug Saf. 2018; 

41(5):489-509. DOI:10.1007/s40264-017-0636-9. PMID: 2941 

1337. PMCID: PMC5938313.

3. Shirley M. Dupilumab: First Global Approval.  Drugs. 2017; 

77(10):1115-1121. DOI:10.1007/s40265-017-0768-3. PMID: 

28547386.

4. Siliquini N, Giura MT, Viola R, et al. Atopic dermatitis, dupi-

lumab and cancers: a case series.  J Eur Acad Dermatol Vene-

reol. 2021;35(10):e651-e652. DOI:10.1111/jdv.17264. PMID: 

33797094.

5. Fowler E, Rosen J, Lev-Tov H, Yosipovitch G. Two Cancer  

Patients Receiving Dupilumab for Treatment of Atopic Derma-

titis.  Acta Derm Venereol. 2019;99(10):899-900. DOI:10.2340 

/00015555-3201. PMID: 31037315.