PMID- 37614958 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230825 IS - 2296-858X (Print) IS - 2296-858X (Electronic) IS - 2296-858X (Linking) VI - 10 DP - 2023 TI - Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study-IL PSO (Italian landscape psoriasis). PG - 1243843 LID - 10.3389/fmed.2023.1243843 [doi] LID - 1243843 AB - INTRODUCTION: Bimekizumab is a monoclonal antibody that targets Interleukin-17 A and F, approved for the treatment of moderate-to-severe plaque psoriasis. While bimekizumab has been evaluated in several phase-III clinical trials, real-world evidence is still very limited. METHOD: This multicenter retrospective study included patients affected by plaque psoriasis treated with bimekizumab from May 1, 2022 to April 30, 2023, at 19 Italian referral hospitals. Patients affected by moderate-to-severe plaque psoriasis eligible for systemic treatments were included. The effectiveness of bimekizumab was evaluated in terms of reduction in psoriasis area and severity index (PASI) compared with baseline at weeks 4 and 16. The main outcomes were the percentages of patients achieving an improvement of at least 75% (PASI75), 90% (PASI90) and 100% (PASI100) in PASI score. RESULTS: The study included 237 patients who received at least one injection of bimekizumab. One hundred and seventy-one patients and 114 reached four and 16 weeks of follow-up, respectively. Complete skin clearance was achieved by 43.3% and 75.4% of patients at weeks 4 and 16, respectively. At week 16, 86.8% of patients reported no impact on their quality of life. At week 16, there were no significant differences between bio-naive and bio-experienced patients in terms of PASI75, PASI90 and PASI100. The most commonly reported adverse events (AEs) were oral candidiasis (10.1%). No severe AEs or AEs leading to discontinuation were observed throughout the study. CONCLUSION: Our experience supports the effectiveness and tolerability of bimekizumab in a real-world setting with similar results compared with phase-III clinical trials. CI - Copyright (c) 2023 Gargiulo, Narcisi, Ibba, Balato, Bianchi, Brianti, Buononato, Burlando, Caldarola, Campanati, Campione, Carrera, Carugno, Cristaudo, Cusano, Dapavo, Dattola, De Simone, Gaiani, Gisondi, Giunta, Loconsole, Maione, Mortato, Marzano, Maurelli, Megna, Mercuri, Offidani, Orsini, Parodi, Pellacani, Potestio, Quaglino, Richetta, Romano, Sena, Venturini, Malagoli and Costanzo. FAU - Gargiulo, Luigi AU - Gargiulo L AD - Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy. AD - Department of Biomedical Sciences, Humanitas University, Milan, Italy. FAU - Narcisi, Alessandra AU - Narcisi A AD - Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy. FAU - Ibba, Luciano AU - Ibba L AD - Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy. AD - Department of Biomedical Sciences, Humanitas University, Milan, Italy. FAU - Balato, Anna AU - Balato A AD - Dermatology Unit, University of Campania L. Vanvitelli, Naples, Italy. FAU - Bianchi, Luca AU - Bianchi L AD - Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy. FAU - Brianti, Pina AU - Brianti P AD - Unit of Dermatology and Cosmetology, Vita-Salute San Raffaele University and Institute for Research and Care, Milan, Italy. FAU - Buononato, Dario AU - Buononato D AD - Dermatology Unit, University of Campania L. Vanvitelli, Naples, Italy. FAU - Burlando, Martina AU - Burlando M AD - Section of Dermatology, Department of Health Sciences (DISSAL), IRCCS San Martino University Hospital, Genoa, Italy. FAU - Caldarola, Giacomo AU - Caldarola G AD - Section of Dermatology, Department of Translational Medicine and Surgery, Catholic University of the Sacred Heart, Rome, Italy. AD - Dermatology Unit, Agostino Gemelli University Hospital, Rome, Italy. FAU - Campanati, Anna AU - Campanati A AD - Department of Clinical and Molecular Sciences-Dermatological Clinic, Universita Politecnica delle Marche, Ancona, Italy. FAU - Campione, Elena AU - Campione E AD - Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy. FAU - Carrera, Carlo G AU - Carrera CG AD - Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. FAU - Carugno, Andrea AU - Carugno A AD - Dermatology Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy. AD - PhD Program in Molecular and Translational Medicine (DIMET), University of Milan-Bicocca, Milan, Italy. FAU - Cristaudo, Antonio AU - Cristaudo A AD - Clinical Dermatology Unit, San Gallicano Dermatological Institute IRCCS, Rome, Italy. FAU - Cusano, Francesco AU - Cusano F AD - Department of Dermatology, Gaetano Rummo Hospital, Benevento, Italy. FAU - Dapavo, Paolo AU - Dapavo P AD - Department of Biomedical Science and Human Oncology, Second Dermatologic Clinic, University of Turin, Turin, Italy. FAU - Dattola, Annunziata AU - Dattola A AD - Dermatology Clinic, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy. FAU - De Simone, Clara AU - De Simone C AD - Section of Dermatology, Department of Translational Medicine and Surgery, Catholic University of the Sacred Heart, Rome, Italy. AD - Dermatology Unit, Agostino Gemelli University Hospital, Rome, Italy. FAU - Gaiani, Francesca M AU - Gaiani FM AD - Department of Dermatology, Dermatology Unit Azienda Ospedaliera San Donato Milanese, Milan, Italy. FAU - Gisondi, Paolo AU - Gisondi P AD - Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy. FAU - Giunta, Alessandro AU - Giunta A AD - Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy. FAU - Loconsole, Francesco AU - Loconsole F AD - Department of Dermatology, University of Bari, Bari, Italy. FAU - Maione, Vincenzo AU - Maione V AD - Department of Dermatology, ASST Spedali Civili Hospital, Brescia, Italy. FAU - Mortato, Edoardo AU - Mortato E AD - Department of Dermatology, University of Bari, Bari, Italy. FAU - Marzano, Angelo V AU - Marzano AV AD - Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. AD - Department of Pathophysiology and Transplantation, Universita degli Studi di Milano, Milan, Italy. FAU - Maurelli, Martina AU - Maurelli M AD - Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy. FAU - Megna, Matteo AU - Megna M AD - Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy. FAU - Mercuri, Santo R AU - Mercuri SR AD - Unit of Dermatology and Cosmetology, Vita-Salute San Raffaele University and Institute for Research and Care, Milan, Italy. FAU - Offidani, Annamaria AU - Offidani A AD - Department of Clinical and Molecular Sciences-Dermatological Clinic, Universita Politecnica delle Marche, Ancona, Italy. FAU - Orsini, Diego AU - Orsini D AD - Clinical Dermatology Unit, San Gallicano Dermatological Institute IRCCS, Rome, Italy. FAU - Parodi, Aurora AU - Parodi A AD - Section of Dermatology, Department of Health Sciences (DISSAL), IRCCS San Martino University Hospital, Genoa, Italy. FAU - Pellacani, Giovanni AU - Pellacani G AD - Dermatology Clinic, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy. FAU - Potestio, Luca AU - Potestio L AD - Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy. FAU - Quaglino, Pietro AU - Quaglino P AD - Department of Biomedical Science and Human Oncology, Second Dermatologic Clinic, University of Turin, Turin, Italy. FAU - Richetta, Antonio G AU - Richetta AG AD - Dermatology Clinic, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy. FAU - Romano, Francesca AU - Romano F AD - Department of Precision Medicine, Dermatology Unit, Universita degli Studi della Campania L. Vanvitelli, Naples, Italy. FAU - Sena, Paolo AU - Sena P AD - Dermatology Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy. FAU - Venturini, Marina AU - Venturini M AD - Department of Dermatology, ASST Spedali Civili Hospital, Brescia, Italy. FAU - Malagoli, Piergiorgio AU - Malagoli P AD - Department of Dermatology, Dermatology Unit Azienda Ospedaliera San Donato Milanese, Milan, Italy. FAU - Costanzo, Antonio AU - Costanzo A AD - Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy. AD - Department of Biomedical Sciences, Humanitas University, Milan, Italy. LA - eng PT - Journal Article DEP - 20230808 PL - Switzerland TA - Front Med (Lausanne) JT - Frontiers in medicine JID - 101648047 PMC - PMC10442506 OTO - NOTNLM OT - bimekizumab OT - biologics OT - psoriasis OT - psoriasis treatment OT - real-life COIS- LG has been a consultant for Almirall. PM has been a speaker for AbbVie, Lilly, Novartis, Janssen-Cilag, Celgene, Leopharma, and Almirall. AB has received honoraria for participation in advisory boards, meetings, or as speaker for AbbVie, Celgene, Janssen-Cilag, Eli Lilly, Novartis Pharma, Pfizer, Sanofi-Genzyme, and UCB Pharma. LB has received honoraria as a speaker or consultant for AbbVie, Janssen, Almirall Eli-Lilly, Leopharma, Novartis, Sanofi, Pfizer, and UCB Pharma. GC reports consulting fees or honorarium and payment for lectures from Lilly and Novartis. CD reports consulting fees or honorarium from Abbvie, Amgen, Novartis, Celgene, Sanofi, UCB Pharma, Janssen, and Lilly and payment for lectures from Abbvie, Lilly, Novartis, UCB Pharma, and Celgene. PG has been a consultant and/or speaker for Abbvie, Almirall, Amgen, Janssen, Leo-Pharma, Eli-Lilly, Novartis, Pierre Febre, Sandoz, Sanofi, and UCB. MB has acted as a speaker and consultant for AbbVie, Janssen, Amgen, Novartis, Eli Lilly, and UCB Pharma. CC has served as a board participant or speaker for Abbvie, Lilly, Janssen, Novartis, Celgene, Almirall, and Leopharma. PD has been a speaker for Novartis, Abbvie, Sanofi, UCB, Janssen, Lilly, and LeoPharma. FG acted as a speaker or consultant for Novartis, Abbvie, Eli Lilly, Celgene, LeoPharma, and Almirall. AG received grants or is an investigator for Biogen and Lilly; and is a consultant/advisory board/speaker for AbbVie, Almirall, Celgene, Janssen, Leo Pharma, Eli Lilly, Merck Sharpe Dohme, Novartis, Pfizer, Sandoz, and UCB. FL served on advisory boards and/or received honoraria for lectures from Abbvie, Janssen-Cilag, Novartis, Lilly, Sanofi. AM reports consultancy/advisory boards disease-relevant honoraria from AbbVie, Boehringer-Ingelheim, Novartis, Pfizer, Sanofi, and UCB. MMe acted as a speaker or consultant for Abbvie, Eli Lilly, Janssen, Leo-Pharma, UCB, and Novartis. AO acted as a speaker and consultant for Abbvie, Eli Lilly, Novartis, Celgene, Sanofi, Galderma, Leo Pharma, and Pierre Fabre. MV served as a speaker or advisory board member for Abbvie, Almirall, Amgen, Eli-Lilly, Galderma, Leo Pharma, Novartis, Pierre Fabre, and UCB Pharma. ACo has served as an advisory board member, consultant and has received fees and speaker's honoraria or has participated in clinical trials for Abbvie, Almirall, Biogen, LEO Pharma, Lilly, Janssen, Novartis, Pfizer, Sanofi Genzyme, and UCB-Pharma. AN has served on advisory boards, received honoraria for lectures and research grants from Almirall, Abbvie, Leo Pharma, Celgene, Eli Lilly, Janssen, Novartis, Sanofi-Genzyme, Amgen, and Boehringer Ingelheim. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2023/08/24 06:42 MHDA- 2023/08/24 06:43 PMCR- 2023/08/08 CRDT- 2023/08/24 04:12 PHST- 2023/06/21 00:00 [received] PHST- 2023/07/27 00:00 [accepted] PHST- 2023/08/24 06:43 [medline] PHST- 2023/08/24 06:42 [pubmed] PHST- 2023/08/24 04:12 [entrez] PHST- 2023/08/08 00:00 [pmc-release] AID - 10.3389/fmed.2023.1243843 [doi] PST - epublish SO - Front Med (Lausanne). 2023 Aug 8;10:1243843. doi: 10.3389/fmed.2023.1243843. eCollection 2023.