BACKGROUND/OBJECTIVE LOW RISK OF SERIOUS INFECTIONS AND INFECTIONS OF INTEREST IN PSORIASIS PATIENTS TREATED WITH GUSELKUMAB FOR UP TO 5 YEARS IN VOYAGE 1&2 PHASE 3 TRIALS Richard G. Langley,1 Diamant Thaçi,2 Andrew Blauvelt,3 Tsen-Fang Tsai,4 Megan Miller,5 Jenny Yu,5 Yaung-Kaung Shen,5 Yin You,5 Ya-Wen Yang,6 Kim A. Papp,7 Luis Puig,8 Peter Foley9 1Dalhousie University, Halifax, NS, Canada, 2University of Luebeck, Luebeck, Germany; 3Oregon Medical Research Center, Portland, OR, USA; 4National Taiwan University Hospital, Taipei, Taiwan; 5Janssen Research & Development, LLC, Spring House/Horsham, PA, USA; 6 Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA; 7K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada; 8Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain; 9The University of Melbourne, St. Vincent’s Hospital Melbourne and Probity Medical Research, Skin Health Institute, Carlton, VIC, Australia • Treatment of psoriasis with immunomodulatory biologics may increase the risk for certain types of infections (eg, candidiasis, herpes zoster)1-3 • Guselkumab (GUS), a monoclonal antibody targeting the p19 subunit of interleukin-23, is approved for the treatment of moderate to severe psoriasis and active psoriatic arthritis • VOYAGE 1 and 2 were randomized, double-blinded, placebo (PBO)- and active-comparator-controlled Phase 3 studies that demonstrated the long-term efficacy and safety of GUS in patients (pts) with moderate to severe psoriasis4,5 ɤ Infection rates were low and comparable across groups during the PBO- and active-comparator periods of these studies4,5 • This analysis examines the risk of specific infection-related adverse events (AEs) in pts treated with GUS for up to 5 years using pooled data from VOYAGE 1 and 2 • In both studies: o Pts randomized to: – GUS 100 mg at Week (W)0, W4, then Q8W – PBO at W0, W4, and W12, followed by GUS 100 mg at W16 and W20, then Q8W – Adalimumab (ADA) 80 mg at W0, 40 mg at W1, then 40 mg Q2W through W47 (VOYAGE 1) or W23 (VOYAGE 2) o In VOYAGE 1, all pts entered an open-label GUS treatment period during W52-252 o In VOYAGE 2, all pts entered a randomized withdrawal and GUS retreatment period from W28-72; pts entered an open-label GUS treatment period during W76-252 o The last dose of GUS was administered at W252; safety was evaluated through W264 • Pooled safety data were analyzed in the GUS group (including W16 PBO crossover, N=1221), the ADA→GUS group (N=500), and the combined GUS group (GUS and ADA→GUS groups, N=1721) • Infection-related outcomes of interest included cumulative rates per 100 pt-years (PY) of overall, serious, and opportunistic infections (including active tuberculosis), along with treatment-emergent AEs (TEAEs) of Candida and herpes zoster infections • In 1721 pts with moderate to severe psoriasis who were treated with GUS for up to 5 years, observed infection‑related AE patterns were consistent with previously reported shorter‑term safety findings • Serious infections and infection‑related TEAEs of interest were infrequent • These results support GUS as a generally well tolerated therapy for the long‑term treatment of pts with moderate to severe plaque psoriasis METHODS CONCLUSIONS RESULTS Of 1721 pts treated with GUS, 78.4% (1349/1721) completed treatment with study drug through W252 • Total PY of follow-up: GUS (N=1221), 5254 PY; ADA→GUS (N=500), 1912 PY; Combined GUS (N=1721), 7166 PY Across groups, the overall rate of infections ranged from 56.8 to 62.0 per 100 PY of follow‑up. The most common (≥2.0 per 100 PY in any group) types of infections were nasopharyngitis, upper respiratory tract infection (URTI), bronchitis, and pharyngitis. • In the combined GUS group, there were a total of 8 reported cases of cellulitis, 8 cases of appendicitis, and 7 cases of pneumonia in 7166 PY of follow-up • No pt discontinued study drug due to an AE of Candida or herpes zoster infection • All events resolved (some without treatment, some with standard topical or oral therapy) • There were no reported opportunistic infections, including no cases of active tuberculosis, among GUS-treated pts from W0 to W264 • Rates (95% CI) of non-pathogen-specific fungal infections suspicious for Candida† were as follows: o GUS (N=1221): 0.11 (0.04, 0.25) o ADA→GUS (N=500): 0.16 (0.03, 0.46) o Combined GUS (N=1721): 0.13 (0.06, 0.24) Incidence rates were low for TEAEs of interest, including Candida and herpes zoster infections Across groups, the overall rate of serious infections was low and ranged from 0.52 to 0.97 per 100 PY of follow‑up. The most common (≥0.10 per 100 PY in any group) types of serious infections were cellulitis, appendicitis, and pneumonia. The most common Candida infections were vulvovaginal and skin infections Rate (95% CI) per 100 PY of TEAEs of interest* GUS (N=1221) ADA→GUS (N=500) Combined GUS (N=1721) Overall Candida infections 0.49 (0.32, 0.73) 0.52 (0.25, 0.96) 0.50 (0.35, 0.70) Vulvovaginal candidiasis 0.29 (0.16, 0.47) 0.05 (0.00, 0.29) 0.22 (0.13, 0.36) Skin candida 0.11 (0.04, 0.25) 0.37 (0.15, 0.75) 0.18 (0.10, 0.31) Oral candidiasis 0.04 (0.00, 0.14) 0.05 (0.00, 0.29) 0.04 (0.01, 0.12) Genital candidiasis 0.02 (0.00, 0.11) 0.05 (0.00, 0.29) 0.03 (0.00, 0.10) Balanitis candida 0.02 (0.00, 0.11) 0 (0.00, 0.16) 0.01 (0.00, 0.08) Candida infection 0.02 (0.00, 0.11) 0 (0.00, 0.16) 0.01 (0.00, 0.08) *Search criterion: MedDRA high-level term, Candida infections; preferred terms with rate >0 in any group are shown ADA, adalimumab; CI, confidence interval; GUS, guselkumab; PY, patient-years; TEAEs, treatment-emergent adverse events ReferencesDisclosures 1. Armstrong AW et al. Am J Clin Dermatol. 2016;17:329-36; 2. Shalom G et al. J Dermatolog Treat. 2019;30:534-9; 3. Kalb RE et al. JAMA Dermatol. 2015;151:961-9; 4. Blauvelt A et al. J Am Acad Dermatol. 2017;76:405-17; 5. Reich K et al. J Am Acad Dermatol. 2017;76:418-31. Richard G. Langley: Served and has received compensation in the form of grant funding and/or honoraria as principal investigator for and is on the scientific advisory board or has served as a speaker for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Sun Pharma, and UCB. Diamant Thaçi: Served as a consultant and/or advisor for AbbVie, Almirall, Beiersdorf, Inc., Boehringer Ingelheim, Celgene, Eli Lilly and Company, Hexal AG, Janssen-Cilag, Leo Pharma Inc, Novartis Pharmaceuticals Corp., Pfizer Inc., Sandoz Biopharmaceuticals, Sanofi, and UCB; as a speaker for AbbVie, Almirall, Celgene, Eli Lilly and Company, Hexal AG, Janssen-Cilag, Medac Pharma, Inc, Novartis Pharmaceuticals Corp., Pfizer Inc., Regeneron, Sandoz Biopharmaceuticals, Sanofi, Schering-Plough Corporation, and UCB; and as an investigator for AbbVie, Celgene, Eli Lilly and Company, GlaxoSmithKline, Janssen-Cilag, Leo Pharma Inc, Novartis Pharmaceuticals Corp., Parexel, Pfizer Inc., Regeneron, and UCB. Andrew Blauvelt: Served as a scientific adviser and/or clinical study investigator for AbbVie, Abcentra, Aligos, Almirall, Amgen, Arcutis, Arena, Aslan, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, EcoR1, Eli Lilly and Company, Evommune, Forte, Galderma, Incyte, Janssen, Landos, Leo, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, UCB, and Vibliome. Tsen‑Fang Tsai: Received honoraria from AbbVie, Eli Lilly, Janssen, Novartis, and Pfizer. Megan Miller, Jenny Yu, Yaung‑Kaung Shen, Yin You: Employees of Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), and own Johnson & Johnson stock and/or stock options. Ya‑Wen Yang: Employee of Janssen Pharmaceutical Companies of Johnson & Johnson; owns Johnson & Johnson stock/stock option. Kim A. Papp: received clinical research grants and/or honoraria as a consultant, and/or speaker, and/or investigator, and/or scientific officer, and/or advisory board member, and/or Steering Committee member for AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Avillion, Bausch Health, Valeant, Baxalta, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite Biopharma, Celgene, Coherus, Dermavant, Dermira, Dow Pharma, Eli Lilly, Evelo, Galapagos, Galderma, Genentech, Gilead, GSK, Incyte, Janssen, Kyowa Hakko Kirin, Leo, Medimmune, Meiji Seika Pharma, Merck (MSD), Merck- Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharma, Takeda and UCB. Luis Puig: Served as a speaker/consultant/advisory board member for and/or received research funding from AbbVie, Almirall, Amgen, Baxalta, Biogen, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Fresenius-Kabi, Gebro, Janssen, JS BIOCAD, Leo Pharma, Lilly, Merck-Serono, MSD, Mylan, Novartis, Pfizer, Regeneron, Roche, Sandoz, Samsung-Bioepis, Sanofi, and UCB. Peter Foley: Received grant support from AbbVie, Amgen, Celgene, Janssen, Leo Pharma, Lilly, Merck, Novartis, Pfizer, Sanofi, and Sun Pharma. He has served as an investigator for AbbVie, Akaal, Amgen, Arcutis, Argenx, Aslan, AstraZeneca, BMS, Boehringer Ingelheim, Botanix, Celgene, Celtaxsys, CSL, Cutanea, Dermira, Galderma, Genentech, GSK, Hexima, Janssen, Leo Pharma, Lilly, MedImmune, Melaseq/ Geneseq, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals Inc, Reistone, Roche, Sanofi, Sun Pharma, Teva, UCB Pharma, and Valeant, He has served on advisory boards for AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Galderma, GSK, Janssen, Leo Pharma, Lilly, Mayne Pharma, Merck, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Valeant. He has served as a consultant for BMS, Galderma, GenesisCare, Janssen, Leo Pharma, Lilly, Mayne Pharma, MedImmune, Novartis, Pfizer, Roche, UCB Pharma, and Wintermute. He has received travel grants from AbbVie, Galderma, Janssen, Leo Pharma, Lilly, Merck, Novartis, Pfizer, Roche, Sun Pharma, and Sanofi, and has served as a speaker for or received honoraria from AbbVie, Amgen, Celgene, Galderma, GSK, Janssen, Leo Pharma, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, Sun Pharma, and Valeant. ADA, adalimumab; GUS, guselkumab; PY, patient-years; URTI, upper respiratory tract infection ADA, adalimumab; GUS, guselkumab; PY, patient-years †As determined by diagnosis and location; search criteria included MedDRA preferred terms of fungal balanitis, genital infection fungal, vulvovaginal mycotic infection, oral fungal infection, tongue fungal infection, oropharyngitis fungal, and fungal esophagitis. Only preferred terms matching these search criteria were included in this analysis. *Search criterion: MedDRA high-level term, Candida infections ADA, adalimumab; GUS, guselkumab; PY, patient-years This poster was supported by Janssen Research & Development, LLC • Originally Presented at EADV’s 30th Congress, Virtual, September 29-October 2, 2021. Presented at The Winter Clinical Dermatology Conference - Hawaii® (WC22), 14th-19th JAN 2022.