PMID- 37330926 OWN - NLM STAT- MEDLINE DCOM- 20230711 LR - 20230822 IS - 1865-8652 (Electronic) IS - 0741-238X (Print) IS - 0741-238X (Linking) VI - 40 IP - 8 DP - 2023 Aug TI - Safety of IL-23 p19 Inhibitors for the Treatment of Patients With Moderate-to-Severe Plaque Psoriasis: A Narrative Review. PG - 3410-3433 LID - 10.1007/s12325-023-02568-0 [doi] AB - The approved biologics targeting interleukin (IL)-23 p19 for the treatment of moderate-to-severe plaque psoriasis, including guselkumab, tildrakizumab, and risankizumab, have generally favorable safety profiles. The aim of the current review is to describe in detail the safety of these selective inhibitors. A literature search was performed using PubMed from inception to 1 November 2022, to identify clinical trials and real-world evidence publications using the keywords "guselkumab," "tildrakizumab," and "risankizumab." Overall, the most common adverse events (AEs) associated with IL-23 p19 inhibitors in clinical trials were nasopharyngitis, headache, and upper respiratory tract infections. Rates of serious AEs and AEs of interest, including serious infections, nonmelanoma skin cancer (NMSC), malignancies excluding NMSC, major adverse cardiovascular events, and serious hypersensitivity reactions, were not increased with long-term use in clinical trials. Selectively targeting IL-23 p19 was also not associated with elevated risk of opportunistic infections, tuberculosis reactivation, oral candidiasis, or inflammatory bowel disease. Results from real-world studies were similar, supporting the safe long-term use of these biologics in a wider population of patients with psoriasis, including older patients, patients for whom multiple biologics failed, and those with comorbidities such as obesity, metabolic syndrome, cardiovascular disease, dyslipidemia, diabetes, hypertension, and psoriatic arthritis. This review is limited by the lack of direct comparisons among therapeutic agents due to differences among study designs and safety data reporting methods. In conclusion, the favorable safety profiles of IL-23 p19 inhibitors support their long-term use in the management of patients with moderate-to-severe psoriasis. CI - (c) 2023. The Author(s). FAU - Blauvelt, Andrew AU - Blauvelt A AD - Oregon Medical Research Center, 9495 SW Locust Street, Suite G, Portland, OR, 97223, USA. ablauvelt@oregonmedicalresearch.com. FAU - Chiricozzi, Andrea AU - Chiricozzi A AD - Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli - IRCCS, Rome, Italy. AD - Dermatologia, Dipartimento di Medicina e Chirurgia Traslazionale, Universita Cattolica del Sacro Cuore, Rome, Italy. FAU - Ehst, Benjamin D AU - Ehst BD AD - Oregon Medical Research Center, 9495 SW Locust Street, Suite G, Portland, OR, 97223, USA. FAU - Lebwohl, Mark G AU - Lebwohl MG AD - Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. LA - eng PT - Journal Article PT - Review DEP - 20230618 PL - United States TA - Adv Ther JT - Advances in therapy JID - 8611864 RN - 0 (Interleukin-23) RN - 0 (Interleukin-23 Subunit p19) RN - 0 (Biological Products) MH - Humans MH - Interleukin-23/therapeutic use MH - Interleukin-23 Subunit p19 MH - *Psoriasis/drug therapy MH - Comorbidity MH - *Biological Products/therapeutic use MH - Treatment Outcome MH - Severity of Illness Index PMC - PMC10329957 OTO - NOTNLM OT - Biologics OT - Guselkumab OT - IL-23 p19 inhibitors OT - Psoriasis OT - Risankizumab OT - Safety OT - Tildrakizumab COIS- Andrew Blauvelt has served as a scientific adviser and/or clinical study investigator for AbbVie, Aclaris, Akros, Allergan, Almirall, Amgen, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermavant Sciences, Dermira Inc., FLX Bio, Galderma, Genentech/Roche, GlaxoSmithKline, Janssen, LEO Pharma, Lilly, Meiji, Merck Sharp & Dohme, Novartis, Pfizer, Purdue Pharma, Regeneron, Revance, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, UCB, Valeant, and Vidac; and as a paid speaker for AbbVie, Regeneron, and Sanofi Genzyme. Andrea Chiricozzi has been an advisory board member and consultant and has received fees and speaker's honoraria or has participated in clinical trials for AbbVie, Almirall, LEO Pharma, Lilly, Janssen, Novartis, and Sanofi Genzyme. Benjamin D. Ehst has served as a consultant and/or clinical study investigator for AbbVie, Aclaris, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant Sciences, Dermira Inc., Lilly, Evelo Biosciences, Janssen, LEO Pharma, Novartis, Ortho, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB; and as a paid speaker for Dermavant, Incyte, LEO Pharma, Lilly, Novartis, Ortho Dermatologics, Regeneron, and Sanofi Genzyme. Mark G. Lebwohl is an employee of Mount Sinai and receives research funds from AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Dermavant Sciences, Incyte, Janssen Research & Development LLC, Lilly, Ortho Dermatologics, Regeneron, and UCB; and is a consultant for Aditum Bio, Almirall, AltruBio Inc. AnaptysBio, Arcutis, Aristea Therapeutics, Arrive Technologies, Avotres Therapeutics, BiomX, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Dr. Reddy's Laboratories, Evelo Biosciences, Evommune Inc., Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Helsinn Therapeutics, Hexima Ltd., LEO Pharma, Meiji Seika Pharma, Mindera, Pfizer, Seanergy, and Verrica. EDAT- 2023/06/18 19:17 MHDA- 2023/07/11 06:42 PMCR- 2023/06/18 CRDT- 2023/06/18 14:47 PHST- 2023/04/07 00:00 [received] PHST- 2023/05/25 00:00 [accepted] PHST- 2023/07/11 06:42 [medline] PHST- 2023/06/18 19:17 [pubmed] PHST- 2023/06/18 14:47 [entrez] PHST- 2023/06/18 00:00 [pmc-release] AID - 10.1007/s12325-023-02568-0 [pii] AID - 2568 [pii] AID - 10.1007/s12325-023-02568-0 [doi] PST - ppublish SO - Adv Ther. 2023 Aug;40(8):3410-3433. doi: 10.1007/s12325-023-02568-0. Epub 2023 Jun 18.