Gender Influence on Bimekizumab Response in Patients with Psoriasis: Results of a Real-World Multicenter Retrospective Study-IL PSO (Italian Landscape PSOriasis)

Helena Gioacchini^#¹, Agnese Rossi^#¹, Maria Esposito², Emanuele Vagnozzi², Maria Concetta Fargnoli³, Paolo Gisondi⁴, Francesco Bellinato⁴, Chiara Assorgi⁵, Pina Brianti⁶, Santo Raffaele Mercuri⁶, Martina Burlando⁷, Emanuele Cozzani⁷, Giovanna Brunasso⁸, Stefano Caccavale⁹, Anna Balato⁹, Giacomo Caldarola^{10

11}, Clara De Simone^{10

11}, Elena Campione¹², Alessandro Giunta¹², Francesco Tonon¹³, Marina Venturini¹³, Carlo Giovanni Carrera¹⁴, Angelo Valerio Marzano¹⁴, Andrea Carugno¹⁵, Paolo Sena¹⁶, Antonio Costanzo^{17

18}, Alessandra Narcisi^{17

18}, Francesco Cusano¹⁹, Paolo Dapavo²⁰, Pietro Quaglino²⁰, Annunziata Dattola²¹, Antonio Giovanni Richetta²¹, Francesca Gaiani²², Piergiorgio Malagoli²², Matteo Megna²³, Luca Potestio²³, Edoardo Mortato²⁴, Francesco Loconsole²⁴, Francesca Romano²⁵, Andrea Faragalli²⁶, Rosaria Gesuita^{26

27}, Tommaso Bianchelli²⁸, Federico Diotallevi^#²⁹, Diego Orsini^#⁵, Anna Campanati^#³⁰

Affiliations

¹ Dermatology Clinic, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Italy.
² Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
³ Scientific Direction, San Gallicano Dermatological Institute (IRCCS), Rome, Italy.
⁴ Department of Medicine, Section of Dermatology and Venereology, University of Verona, Piazzale A. Stefani 1, 37126, Verona, Italy.
⁵ Clinical Dermatology Unit, San Gallicano Dermatological Institute (IRCCS), Rome, Italy.
⁶ Dermatology and Cosmetology Unit, Vita-Salute San Raffaele University and Research and Treatment Institute, Milan, Italy.
⁷ Section of Dermatology, Department of Health Sciences (DISSAL), IRCCS San Martino University Hospital, Genoa, Italy.
⁸ Department of Internal Medicine 2, Dermatology, Villa Scassi Hospital, ASL3, Genoa, Italy.
⁹ Dermatology Unit, Department of Mental and Physical Health and Preventive Medicine, University of Campania Luigi Vanvitelli, Naples, Italy.
¹⁰ Dermatologia, Dipartimento Di Medicina E Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy.
¹¹ Dipartimento Di Scienze Mediche E Chirurgiche, UOC Di Dermatologia, Fondazione Policlinico Universitario A Gemelli - IRCCS, Rome, Italy.
¹² Dermatology Unit, Department of Systems Medicine, Fondazione Policlinico Tor Vergata, University of Rome Tor Vergata, Rome, Italy.
¹³ Dermatology Clinic, ASST Spedali Civili Di Brescia and University of Brescia, Brescia, Italy.
¹⁴ Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore, Milan, Italy.
¹⁵ Department of Medicine and Surgery, University of Insubria, Varese, Italy.
¹⁶ Dermatology Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy.
¹⁷ Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
¹⁸ Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
¹⁹ Complex Operative Unit of Dermatology, Azienda Ospedaliera San Pio, Benevento, Italy.
²⁰ Dermatology Clinic, Department of Medical Sciences, University of Turin, Turin, Italy.
²¹ Dermatology Clinic, Department of Internal, Anaesthesiological and Cardiovascular Clinical Sciences, Sapienza University, Rome, Italy.
²² Department of Dermatology, Dermatology Unit San Donato Milanese Hospital, Milan, Italy.
²³ Section of Dermatology, Department of Clinical Medicine and Surgery, University Federico II of Naples, 80131, Naples, Italy.
²⁴ Dermatology Clinic Azienda Ospedaliero Universitaria Policlinico Consorziale, Bari, Italy.
²⁵ UOSD Dermatology, Azienda Ospedaliera Di Rilievo Nazionale 'A.Cardarelli', Naples, Italy.
²⁶ Interdepartmental Centre of Epidemiology, Biostatistics and Medical Information, Technology Polytechnic University of Marche, Ancona, Italy.
²⁷ IRCSS, INRCA, Ancona, Italy.
²⁸ Dermatology Unit, Istituto Nazionale Di Riposo E Cura Per Anziani, INRCA-IRCCS Hospital, Ancona, Italy.
²⁹ UOC Dermatology, Hospital Carlo Urbani, Jesi, Ancona, Italy. federico.diotallevi@hotmail.it.
³⁰ Dermatology Clinic, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Italy. anna.campanati@gmail.com.

^# Contributed equally.

PMID: 40358828
PMCID: PMC12126367
DOI: 10.1007/s13555-025-01435-w

Gender Influence on Bimekizumab Response in Patients with Psoriasis: Results of a Real-World Multicenter Retrospective Study-IL PSO (Italian Landscape PSOriasis)

Helena Gioacchini et al. Dermatol Ther (Heidelb). 2025 Jul.

. 2025 Jul;15(7):1797-1811.

doi: 10.1007/s13555-025-01435-w. Epub 2025 May 13.

Authors

Affiliations

¹ Dermatology Clinic, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Italy.
² Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
³ Scientific Direction, San Gallicano Dermatological Institute (IRCCS), Rome, Italy.
⁴ Department of Medicine, Section of Dermatology and Venereology, University of Verona, Piazzale A. Stefani 1, 37126, Verona, Italy.
⁵ Clinical Dermatology Unit, San Gallicano Dermatological Institute (IRCCS), Rome, Italy.
⁶ Dermatology and Cosmetology Unit, Vita-Salute San Raffaele University and Research and Treatment Institute, Milan, Italy.
⁷ Section of Dermatology, Department of Health Sciences (DISSAL), IRCCS San Martino University Hospital, Genoa, Italy.
⁸ Department of Internal Medicine 2, Dermatology, Villa Scassi Hospital, ASL3, Genoa, Italy.
⁹ Dermatology Unit, Department of Mental and Physical Health and Preventive Medicine, University of Campania Luigi Vanvitelli, Naples, Italy.
¹⁰ Dermatologia, Dipartimento Di Medicina E Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy.
¹¹ Dipartimento Di Scienze Mediche E Chirurgiche, UOC Di Dermatologia, Fondazione Policlinico Universitario A Gemelli - IRCCS, Rome, Italy.
¹² Dermatology Unit, Department of Systems Medicine, Fondazione Policlinico Tor Vergata, University of Rome Tor Vergata, Rome, Italy.
¹³ Dermatology Clinic, ASST Spedali Civili Di Brescia and University of Brescia, Brescia, Italy.
¹⁴ Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore, Milan, Italy.
¹⁵ Department of Medicine and Surgery, University of Insubria, Varese, Italy.
¹⁶ Dermatology Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy.
¹⁷ Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
¹⁸ Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
¹⁹ Complex Operative Unit of Dermatology, Azienda Ospedaliera San Pio, Benevento, Italy.
²⁰ Dermatology Clinic, Department of Medical Sciences, University of Turin, Turin, Italy.
²¹ Dermatology Clinic, Department of Internal, Anaesthesiological and Cardiovascular Clinical Sciences, Sapienza University, Rome, Italy.
²² Department of Dermatology, Dermatology Unit San Donato Milanese Hospital, Milan, Italy.
²³ Section of Dermatology, Department of Clinical Medicine and Surgery, University Federico II of Naples, 80131, Naples, Italy.
²⁴ Dermatology Clinic Azienda Ospedaliero Universitaria Policlinico Consorziale, Bari, Italy.
²⁵ UOSD Dermatology, Azienda Ospedaliera Di Rilievo Nazionale 'A.Cardarelli', Naples, Italy.
²⁶ Interdepartmental Centre of Epidemiology, Biostatistics and Medical Information, Technology Polytechnic University of Marche, Ancona, Italy.
²⁷ IRCSS, INRCA, Ancona, Italy.
²⁸ Dermatology Unit, Istituto Nazionale Di Riposo E Cura Per Anziani, INRCA-IRCCS Hospital, Ancona, Italy.
²⁹ UOC Dermatology, Hospital Carlo Urbani, Jesi, Ancona, Italy. federico.diotallevi@hotmail.it.
³⁰ Dermatology Clinic, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Italy. anna.campanati@gmail.com.

^# Contributed equally.

PMID: 40358828
PMCID: PMC12126367
DOI: 10.1007/s13555-025-01435-w

Abstract

Introduction: Several studies have demonstrated that psoriasis severity is generally greater in male patients, but it is unclear whether this gender difference may affect short-term therapeutic response. Notably, no studies have specifically investigated bimekizumab, a humanized, full-length IgG1 monoclonal antibody that acts as a dual inhibitor of interleukin (IL)-17A and IL-17F.

Methods: This was a cross-sectional, observational, retrospective, multicenter analysis. A cohort of 318 patients with moderate to severe psoriasis, 229 male patients (median [IQR] age 35 [23-67] years) and 89 female patients (median [IQR] age 33 [20-68] years), were retrospectively evaluated for short-term response (16 weeks) to bimekizumab according to standard dosage (320 mg at weeks 0, 4, 8, 12, and 16, and every 8 weeks thereafter). Patients were assessed to evaluate whether gender differences in demographic and clinical characteristics can affect treatment response to standard dose of bimekizumab, during the first 16 weeks of treatment. Therapeutic outcomes were evaluated by analyzing Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores recorded in each patient at three consecutive time points: baseline (T0), after 4 weeks (T4), and after 16 weeks of treatment (T16).

Results: Male patients showed more severe disease at baseline, compared to female patients (p = 0.01). A significant reduction in disease severity was observed in both male and female patients after 16 weeks of treatment, but male patients showed a faster decrease in PASI score between baseline and week 4 of treatment compared to female patients (p < 0.001). Nevertheless, by week 16, difference in PASI response and DLQI reduction between genders became less pronounced.

Conclusion: Although male patients exhibit greater disease severity at baseline compared to female patients, this does not result in a differential response to bimekizumab over the short term. Both male and female patients had equal probability of achieving complete or near-complete disease remission within the first 4 weeks of treatment, and both maintain this response status through week 16. The therapeutic benefit of bimekizumab may be due to the rapid dual inhibition of IL-17A and IL-17F, which may lead to consistent and robust clinical response across genders, regardless of baseline disease severity. Our results suggest a "gender severity-invariant effect" of bimekizumab, highlighting the treatment as rapidly effective in both genders, despite initial differences in disease severity.

Keywords: Bimekizumab; Gender; Psoriasis; Real world evidence; Treatment.

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Conflict of interest statement

Declarations. Conflict of Interest: Maria Esposito: Has served as a speaker/consultant for Abbvie, Amgen, Almirall, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Sanofi, uCB. Maria Concetta Fargnoli: Has served as a consultant/advisor, received speaker honoraria and/or grants, and/or participated as an investigator for Amgen, Almirall, Abbvie, Boehringer Ingelheim, BMS, Galderma, Kyowa Kyrin, Incyte, Leo Pharma, Pierre Fabre, uCB, Lilly, Pfizer, Janssen, MSD, Novartis, Sanofi, Regeneron, Sun Pharma, Takeda. Matteo Megna: Has acted as a speaker or consultant for Abbvie, Amgen, Almirall, Eli Lilly, Novartis, Janssen, uCB, Leo Pharma. Anna Balato: Has acted as a speaker and/or consultant for Abbvie, Almirall, Amgen, Boehringer Ingelheim, Bristol-Meyer-Squibb, Janssen, Eli Lilly, Leo Pharma, Novartis, Sanofi, uCB. Martina Burlando: Has acted as a speaker or consultant for Abbvie, Eli Lilly, Janssen, Leo Pharma, uCB, Novartis, Bristol-Meyer-Squibb, and Boehringer Ingelheim. Emanuele Cozzani: Has acted as a speaker or consultant for Abbvie, Almirall, Eli Lilly, Leo Pharma, Novartis. Paolo Gisondi: Has acted as a speaker or consultant for Abbvie, Amgen, Almirall, Eli Lilly, Janssen, Leo Pharma, uCB, Novartis, Sanofi, Pierre Fabre. Paolo Gisondi is Editorial Board members of Dermatology and Therapy. Paolo Gisondi were not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Anna Campanati: Has served as a speaker, consultant, or advisory board member for Abbvie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galderma, Incyte, Leo Pharma, Merck Sharp & Dohme, Janssen-Cilag, Novartis, Pfizer, Regeneron, Sanofi-Aventis, and UCB Pharma. Anna Campanati is Editorial Board members of Dermatology and Therapy. Anna Campanati is not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Diego Orsini: Has acted as a speaker and/or consultant for Abbvie, Leo Pharma, UCB, Bristol-Meyer-Squibb, and Boehringer Ingelheim. Annunziata Dattola: Has acted as a speaker, consultant, or advisory board member for Abbvie, Almirall, Amgen, Eli Lilly, Leo Pharma, Janssen, Novartis, Boehringer Ingelheim, and uCB Pharma. Giacomo Caldarola: Has received honoraria as a speaker and consultant for Abbvie, Almirall, Biogen, Eli Lilly, Leo Pharma, Novartis, Janssen, Sanofi, Pfizer, and UCB Pharma. Clara De Simone: Has received honoraria as a speaker or advisory board member or participated in clinical trials for AbbVie, Almirall, Amgen, Leo Pharma, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi Genzyme, and uCB Pharma. Elena Campione: Has served as an advisory board member, received speaker fees, and/or research grants from Almirall, Amgen, Abbvie, Bristol Myers Squibb, Incyte, Leo Pharma, and uCB. Antonio Costanzo: Has acted as a consultant and/or speaker for AbbVie, Almirall, Amgen, Janssen, Leo Pharma, Eli Lilly, Galderma, Boehringer, Novartis, Pfizer, Sandoz, and uCB. Alessandra Narcisi: Has served on advisory boards, received speaker honoraria, and research grants from Almirall, AbbVie, BMS, Leo Pharma, Celgene, Eli Lilly, Janssen, Novartis, Sanofi-Genzyme, Amgen, and Boehringer Ingelheim. Piergiorgio Malagoli: Has acted as a speaker for AbbVie, Lilly, Novartis, Janssen-Cilag, Celgene, Leo Pharma, and Almirall. Paolo Dapavo: Has acted as a speaker for Novartis, AbbVie, Sanofi, uCB, Janssen, Lilly, and Leo Pharma. Francesco Loconsole: Has served on advisory boards and/or received honoraria for lectures from AbbVie, Janssen-Cilag, Novartis, Lilly, and Sanofi. Marina Venturini: Has served as an advisory board member and/or consultant, received speaker fees, and/or participated in clinical trials for AbbVie, Almirall, Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, Leo Pharma, Novartis, and uCB Pharma. Andrea Carugno: Has acted as a speaker and/or consultant for Almirall, Amgen, Abbvie, Boehringer Ingelheim, Eli Lilly, Leo Pharma, Janssen-Cilag, Novartis, and uCB Pharma. All other authors have no conflicts of interest to declare. Ethical Approval: This study was performed in accordance with the Helsinki Declaration of 1964 and its later amendments. The ethics committee of UNIVPM approved the study protocol and all enrolled participants provided written informed consent. The patients in this manuscript have given written informed consent to publication of their case details. The study was approved by local ethical committees of each center (see supplementary material).

Figures

**Fig. 1**
PASI (Psoriasis Area and Severity Index) and DLQI (Dermatology Life Quality Index) reduction in whole group of patients, according to time endpoints (week 4 and week 16)

**Fig. 2**
PASI (Psoriasis Area and Severity Index) and DLQI (Dermatology Life Quality Index) reduction in 16 weeks treated patients with bimekizumab according to gender

**Fig. 3**
62-year-old male (M) patient and 60-year-old female patient (F) at baseline (a, c) and after 4 weeks of bimekizumab (b, d). The patients provided written informed consent for the publication of these images

See this image and copyright information in PMC

References

1. Armstrong AW, Read C. Pathophysiology, clinical presentation, and treatment of psoriasis: a review. JAMA. 2020;323(19):1945–60. 10.1001/jama.2020.4006. - PubMed
1. Parisi R, Symmons DP, Griffiths CE, Ashcroft DM, Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) Project Team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol 2013;133:377–85. 10.1038/jid.2012.339. - PubMed
1. Augustin M, Reich K, Blome C, Schäfer I, Laass A, Radtke MA. Nail psoriasis in Germany: epidemiology and burden of disease. Br J Dermatol. 2010;163:580–5. 10.1111/j.1365-2133.2010.09831.x. - PubMed
1. Benzian-Olsson N, Dand N, Chaloner C, et al. Association of clinical and demographic factors with the severity of palmoplantar pustulosis. JAMA Dermatol 2020. 10.1001/jamadermatol.2020.3275. - PMC - PubMed
1. Colombo D, Cassano N, Bellia G, Vena G. Gender medicine and psoriasis. World J Dermatol. 2014;3:36–44. 10.5314/wjd.v3.i3.36.

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Gender Influence on Bimekizumab Response in Patients with Psoriasis: Results of a Real-World Multicenter Retrospective Study-IL PSO (Italian Landscape PSOriasis)

Affiliations

Gender Influence on Bimekizumab Response in Patients with Psoriasis: Results of a Real-World Multicenter Retrospective Study-IL PSO (Italian Landscape PSOriasis)

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

LinkOut - more resources

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