PMID- 37022762
OWN - NLM
STAT- MEDLINE
DCOM- 20230719
LR  - 20231120
IS  - 1365-2133 (Electronic)
IS  - 0007-0963 (Linking)
VI  - 189
IP  - 1
DP  - 2023 Jul 7
TI  - Safety of guselkumab treatment for up to 5 years in patients with 
      moderate-to-severe psoriasis: pooled analyses across seven clinical trials with 
      more than 8600 patient-years of exposure.
PG  - 42-52
LID - 10.1093/bjd/ljad115 [doi]
AB  - BACKGROUND: Guselkumab has demonstrated favourable safety and efficacy across 
      individual clinical studies in adults with moderate-to-severe plaque psoriasis. 
      OBJECTIVES: To evaluate the safety of guselkumab in patients with psoriasis using 
      pooled data from seven phase II/III studies (X-PLORE, VOYAGE 1, VOYAGE 2, 
      NAVIGATE, ORION, ECLIPSE, Japan registration). METHODS: All studies, except 
      NAVIGATE and ECLIPSE (active comparator-controlled only), included a 16-week 
      placebo-controlled period; X-PLORE, VOYAGE 1 and VOYAGE 2 included both placebo 
      and active controls. In most studies, guselkumab-treated patients received 100-mg 
      subcutaneous injections at week 0, week 4, and then every 8 weeks thereafter. 
      Safety data were summarized for the placebo-controlled period (weeks 0-16) and 
      through the end of the reporting period (up to 5 years). Incidence rates of key 
      safety events were integrated post hoc, adjusted for the duration of follow-up 
      and reported per 100 patient-years (PY). RESULTS: During the placebo-controlled 
      period, 544 patients received placebo (165 PY) and 1220 received guselkumab (378 
      PY). Through the end of the reporting period, 2891 guselkumab-treated patients 
      contributed 8662 PY of follow-up. During the placebo-controlled period, in the 
      guselkumab and placebo groups, respectively, rates of adverse events (AEs) were 
      346/100 PY and 341/100 PY, and infections were 95.9/100 PY and 83.6/100 PY. Rates 
      of serious AEs (6.3/100 PY vs. 6.7/100 PY), AEs leading to discontinuation 
      (5.0/100 PY vs. 9.7/100 PY), serious infections (1.1/100 PY vs. 1.2/100 PY), 
      malignancy (0.5 patients/100 PY vs. 0.0 patients/100 PY) and major adverse 
      cardiovascular events (MACE; 0.3/100 PY vs. 0.0/100 PY) were low and comparable 
      between guselkumab and placebo. Through the end of the reporting period, safety 
      event rates were lower than or comparable to the placebo-controlled period in 
      guselkumab-treated patients: AEs, 169/100 PY; infections, 65.9/100 PY; serious 
      AEs, 5.3/100 PY; AEs leading to discontinuation, 1.6/100 PY; serious infections, 
      0.9/100 PY; malignancy, 0.7/100 PY; and MACE, 0.3/100 PY. There were no cases of 
      Crohn disease, ulcerative colitis, opportunistic infection or active tuberculosis 
      related to guselkumab. CONCLUSIONS: In this comprehensive analysis of 2891 
      guselkumab-treated patients with psoriasis followed for up to 5 years (8662 PY), 
      guselkumab demonstrated favourable safety, consistent with previous reports. 
      Safety event rates in guselkumab-treated patients were similar to those observed 
      with placebo and were consistent throughout long-term treatment.
CI  - (c) The Author(s) 2023. Published by Oxford University Press on behalf of British 
      Association of Dermatologists.
FAU - Lebwohl, Mark G
AU  - Lebwohl MG
AD  - Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, 
      USA.
FAU - Merola, Joseph F
AU  - Merola JF
AD  - Department of Dermatology and Department of Medicine, Division of Rheumatology 
      and Immunology, Harvard Medical School, Brigham and Women's Hospital, Boston, MA, 
      USA.
FAU - Rowland, Katelyn
AU  - Rowland K
AD  - Janssen Scientific Affairs, LLC, Horsham, PA, USA.
FAU - Miller, Megan
AU  - Miller M
AD  - Janssen Research & Development, LLC, Spring House, PA, USA.
FAU - Yang, Ya-Wen
AU  - Yang YW
AD  - Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & 
      Johnson, Horsham, PA, USA.
FAU - Yu, Jenny
AU  - Yu J
AD  - Janssen Research & Development, LLC, Spring House, PA, USA.
FAU - You, Yin
AU  - You Y
AD  - Janssen Research & Development, LLC, Spring House, PA, USA.
FAU - Chan, Daphne
AU  - Chan D
AD  - Janssen Scientific Affairs, LLC, Horsham, PA, USA.
FAU - Thaci, Diamant
AU  - Thaci D
AUID- ORCID: 0000-0001-8513-550X
AD  - Institute and Comprehensive Center for Inflammatory Medicine, University of 
      Lubeck, Lubeck, Germany.
FAU - Langley, Richard G
AU  - Langley RG
AD  - Division of Clinical Dermatology & Cutaneous Science, Dalhousie University, 
      Halifax, NS, Canada.
LA  - eng
GR  - Janssen Research & Development LLC/
PT  - Clinical Trial
PT  - Journal Article
PL  - England
TA  - Br J Dermatol
JT  - The British journal of dermatology
JID - 0004041
RN  - FYS6T7F842 (Adalimumab)
RN  - 0 (Antibodies, Monoclonal)
RN  - 089658A12D (guselkumab)
SB  - IM
CIN - Br J Dermatol. 2023 May 13;:. PMID: 37177897
CIN - Br J Dermatol. 2023 Jul 7;189(1):e29. PMID: 37418651
MH  - Adult
MH  - Humans
MH  - Adalimumab/therapeutic use
MH  - *Antibodies, Monoclonal
MH  - Double-Blind Method
MH  - *Psoriasis/pathology
MH  - Severity of Illness Index
MH  - Treatment Outcome
COIS- Conflicts of interest M.G.L. is an employee of Mount Sinai and receives research 
      funds from AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara 
      Therapeutics, Dermavant Sciences, Eli Lilly, Incyte, Janssen Research & 
      Development, Ortho Dermatologics, Regeneron and UCB; and is a consultant for 
      Aditum Bio, Almirall, AltruBio, AnaptysBio, Arcutis, Aristea Therapeutics, 
      Avotres Therapeutics, Brickell Biotech, Boehringer Ingelheim, Bristol Myers 
      Squibb, Cara Therapeutics, Castle Biosciences, Celtrion, CorEvitas, Dermavant 
      Sciences, Dr. Reddy, EPI, Evommune, Facilitation of International Dermatology 
      Education, Forte Biosciences, Foundation for Research and Education in 
      Dermatology, Helsinn, Hexima, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera, 
      Pfizer, Seanergy, Strata, Trevi and Verrica. J.F.M. is a consultant and/or 
      investigator for AbbVie, Amgen, Biogen, Bristol Myers Squibb, Dermavant, Eli 
      Lilly, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun 
      Pharma and UCB. K.R. and D.C. are employees of Janssen Scientific Affairs; 
      employees own stock in Johnson & Johnson, of which Janssen is a subsidiary. M.M., 
      J.Y. and Y.Y. are employees of Janssen Research & Development; employees own 
      stock in Johnson & Johnson, of which Janssen is a subsidiary. Y.-W.Y. is an 
      employee of Immunology Global Medical Affairs, Janssen Pharmaceutical Companies 
      of Johnson & Johnson; employees own stock in Johnson & Johnson, of which Janssen 
      is a subsidiary. D.T. has received honoraria for participation on advisory 
      boards, as a speaker and for consultancy from AbbVie, Almirall, Amgen, Boehringer 
      Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Galderma, Janssen, Kyowa 
      Hakko Kirin, LEO Pharma, Merck Sharp & Dohme, Morphosys, Novartis, Pfizer, 
      Regeneron, Sandoz-Hexal, Sanofi, Sun Pharma and UCB; and has received research 
      grants from LEO Pharma and Novartis. R.G.L. has served and received compensation 
      in the form of grant funding and/or honoraria as principal investigator; and is 
      on the scientific advisory board or has served as a speaker for AbbVie, Amgen, 
      Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, LEO 
      Pharma, Merck, Novartis, Pfizer, Sun Pharma and UCB Pharma.
EDAT- 2023/04/07 06:00
MHDA- 2023/07/10 06:42
CRDT- 2023/04/06 11:53
PHST- 2023/01/19 00:00 [received]
PHST- 2023/03/14 00:00 [revised]
PHST- 2023/04/02 00:00 [accepted]
PHST- 2023/07/10 06:42 [medline]
PHST- 2023/04/07 06:00 [pubmed]
PHST- 2023/04/06 11:53 [entrez]
AID - 7109972 [pii]
AID - 10.1093/bjd/ljad115 [doi]
PST - ppublish
SO  - Br J Dermatol. 2023 Jul 7;189(1):42-52. doi: 10.1093/bjd/ljad115.