Long-term safety of Ixekizumab in adults with psoriasis, psoriatic arthritis, or axial spondyloarthritis: a post-hoc analysis of final safety data from 25 randomized clinical trials.

"Declarations Ethics approval and consent to participateThe protocols for all studies included in this analysis were approved by ethics committees or institutional review boards at participating sites. All studies were conducted in accordance with the ethical principles of the Declaration of Helsinki. Eligible patients provided written informed consent before initiating any study-related procedures. Consent for publicationNot applicable. Competing interestsCompeting interests: A.D. reports honorarium and participation in advisory boards at AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, UCB and research grants from AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer, UCB. A.B. has served as a speaker (received honoraria) for AbbVie, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, Regeneron, and Sanofi, served as a scientific adviser (received honoraria) for AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, Anaptysbio, Apogee, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Eli Lilly and Company, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo, Lipidio, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Paragon, Pfizer, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB Pharma, Union, Ventyx, Vibliome, and Xencor, and has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Concert, Dermavant, Eli Lilly and Company, Evelo, Evommune, Galderma, Incyte, Janssen, Leo, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB Pharma, and Ventyx. M.L. reports grants or contracts from Abbvie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara therapeutics, Dermavant Sciences, Eli Lilly, Incyte, Inozyme, Janssen Research & Development, LLC, Ortho Dermatologics, Pfizer, Sanofi-Regeneron, and UCB, Inc. A.B. additionally reports consulting fees from Aditum Bio, Almirall, AltruBio Inc., AnaptysBio, Apogee Therapeutics, Arcutis, Inc., Aristea Therapeutics, AstraZeneca, Atomwise, Avotres Therapeutics, Brickell Biotech, Boehringer-Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Celltrion, Corevitas, Dermavant Sciences, Dr. Reddy, EPI, Evommune, Inc., Facilitatation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Galderma, Genentech, Helsinn, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera, National Society for Cutaneous Medicine, Pfizer, Seanergy, Strata, Trevi, Verrica, and Vial Health Technologies. M.F. is an associate staff member at Mount Sinai Hospital; is a current employee and shareholder of Eli Lilly and Company; has received consulting, travel, or speaker fees from American Academy of Dermatology, Aerolase, Castle Biosciences, CeraVe-L’Ore´al, DREAM USA, Galderma Aesthetics, Glow Recipe, La Roche-Posay-L’Ore´al, Revian, Sonoma Pharmaceuticals, Sun Pharma, and Suneva Medical. A.K., N.E., D.Z., E.I., E.G. and T.H. are current employees and shareholders of Eli Lilly and Company. P.R. reports consulting fees and honorarium from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer and UCB. P.R. additionally reports support for attending meetings and/or travel from AbbVie, Janssen and UCB and a leadership or fiduciary role at the Canadian Academy of Health Science and Council of Canadian Academies. H.M.O. reports grants from Janssen, Novartis, Pfizer and UCB, consulting fees from Abbvie, Eli Lilly and Company, Hanssen, Moonlake, Novartis, Pfizer and UCB; support for attending meetings and/or travel from Janssen and Novartis; honorarium from Abbvie, Biogen, Eli Lilly and Company, Janssen, Novartis, Pfizer, Takeda and UCB; leadership or fiduciary role as Chair of the British Society for Spondyloarthritis. K.P. reports consultant, speakers bureau, clinical research grants, honoraria, steering committee membership and advisory board participation and participation as a scientific officer among the following; AbbVie, Acelyrin, Akros, Amgen, Anacor, Aralez Pharma, Arcutis, Avillion, Bausch Health, Boehring Ingelheim, Bristol-Myers Squibb, Can-Fite Biopharma, Celgene, Celltrion, Coherus, Dermavent, Dermira, Dice Pharma, Dow Pharma, Eli Lilly and Company, Evelo, Forbion, Galderma, Gilead, GSK, Incyte, Janssen, Kyowa Hakka Kirin, Leo, Meiji Seika Pharma, Merck, Mitsubishi Pharma, Novartis, Pfizer, Regeneron, Reistone, Roche, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda, UCB, vTv Therapeutics, Xencor. J.F.M. is a consultant and/or investigator for Amgen, Boehringer Inhelheim, Bristol-Myers Squibb, Abbvie, Dermavant, Eli Lilly, Incyte, Novartis, Janssen, UCB, Sanofi-Regeneron, Sun Pharma, Biogen, Pfizer and Leo Pharma. A.G. received honoraria as an advisory board member and consultant for Amgen, AnaptypsBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dice Therapeutics, Eli Lilly and Company, Janssen, Novartis, Sanofi, UCB, and Xbiotech and has received research/educational grants from AnaptypsBio, Moonlake Immunotherapeutics AG, Novartis, Bristol-Myers. Squibb, and UCB Pharma, (all paid to Mount Sinai School of Medicine). S.S. has served as a speaker and consultant with Abbvie, Janssen, Eli Lilly and Company and UCB; additionally, as a speaker with Pfizer and additionally as a consultant with Myriad, Novartis, Regeneron, Sanofi, Stelexis, Jubilant and Teijin and a board member of the National Psoriasis Foundation. Competing interests Competing interests: A.D. reports honorarium and participation in advisory boards at AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, UCB and research grants from AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer, UCB. A.B. has served as a speaker (received honoraria) for AbbVie, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, Regeneron, and Sanofi, served as a scientific adviser (received honoraria) for AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, Anaptysbio, Apogee, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Eli Lilly and Company, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo, Lipidio, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Paragon, Pfizer, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB Pharma, Union, Ventyx, Vibliome, and Xencor, and has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Concert, Dermavant, Eli Lilly and Company, Evelo, Evommune, Galderma, Incyte, Janssen, Leo, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB Pharma, and Ventyx. M.L. reports grants or contracts from Abbvie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara therapeutics, Dermavant Sciences, Eli Lilly, Incyte, Inozyme, Janssen Research & Development, LLC, Ortho Dermatologics, Pfizer, Sanofi-Regeneron, and UCB, Inc. A.B. additionally reports consulting fees from Aditum Bio, Almirall, AltruBio Inc., AnaptysBio, Apogee Therapeutics, Arcutis, Inc., Aristea Therapeutics, AstraZeneca, Atomwise, Avotres Therapeutics, Brickell Biotech, Boehringer-Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Celltrion, Corevitas, Dermavant Sciences, Dr. Reddy, EPI, Evommune, Inc., Facilitatation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Galderma, Genentech, Helsinn, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera, National Society for Cutaneous Medicine, Pfizer, Seanergy, Strata, Trevi, Verrica, and Vial Health Technologies. M.F. is an associate staff member at Mount Sinai Hospital; is a current employee and shareholder of Eli Lilly and Company; has received consulting, travel, or speaker fees from American Academy of Dermatology, Aerolase, Castle Biosciences, CeraVe-L’Ore´al, DREAM USA, Galderma Aesthetics, Glow Recipe, La Roche-Posay-L’Ore´al, Revian, Sonoma Pharmaceuticals, Sun Pharma, and Suneva Medical. A.K., N.E., D.Z., E.I., E.G. and T.H. are current employees and shareholders of Eli Lilly and Company. P.R. reports consulting fees and honorarium from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer and UCB. P.R. additionally reports support for attending meetings and/or travel from AbbVie, Janssen and UCB and a leadership or fiduciary role at the Canadian Academy of Health Science and Council of Canadian Academies. H.M.O. reports grants from Janssen, Novartis, Pfizer and UCB, consulting fees from Abbvie, Eli Lilly and Company, Hanssen, Moonlake, Novartis, Pfizer and UCB; support for attending meetings and/or travel from Janssen and Novartis; honorarium from Abbvie, Biogen, Eli Lilly and Company, Janssen, Novartis, Pfizer, Takeda and UCB; leadership or fiduciary role as Chair of the British Society for Spondyloarthritis. K.P. reports consultant, speakers bureau, clinical research grants, honoraria, steering committee membership and advisory board participation and participation as a scientific officer among the following; AbbVie, Acelyrin, Akros, Amgen, Anacor, Aralez Pharma, Arcutis, Avillion, Bausch Health, Boehring Ingelheim, Bristol-Myers Squibb, Can-Fite Biopharma, Celgene, Celltrion, Coherus, Dermavent, Dermira, Dice Pharma, Dow Pharma, Eli Lilly a"

"Funding These studies were funded by Eli Lilly and Company, which contributed to study design, data collection, data analysis, data interpretation, manuscript preparation and publication decisions."

"Trial registration NCT registration numbers for RCTs included in this integrated analysis can be found in Additional File 1."