PMID- 36998249
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230401
IS  - 2631-827X (Electronic)
IS  - 2631-827X (Linking)
VI  - 5
IP  - 2
DP  - 2023 Apr
TI  - Efficacy and Safety of Advanced Therapies for Moderately to Severely Active 
      Ulcerative Colitis at Induction and Maintenance: An Indirect Treatment Comparison 
      Using Bayesian Network Meta-analysis.
PG  - otad009
LID - 10.1093/crocol/otad009 [doi]
LID - otad009
AB  - BACKGROUND: Given rapid innovation in advanced therapies for moderately to 
      severely active ulcerative colitis (UC), we investigated their comparative 
      efficacy and safety during induction and maintenance through network 
      meta-analysis. METHODS: Using Bayesian methods, endpoints of clinical remission 
      and clinical response per Full Mayo score, and endoscopic improvement were 
      assessed in bio-naive and -exposed populations. Safety was assessed in overall 
      populations by all adverse events (AEs), serious AEs, discontinuation due to AEs, 
      and serious infections. Phase 3 randomized controlled trials were identified via 
      systematic literature review, including the following advanced therapies: 
      infliximab, adalimumab, vedolizumab, golimumab, tofacitinib, ustekinumab, 
      filgotinib, ozanimod, and upadacitinib. Random effects models were used to 
      address between-study heterogeneity. Intent-to-treat (ITT) efficacy rates were 
      calculated by adjusting maintenance outcomes by likelihood of induction response. 
      RESULTS: Out of 48 trials identified, 23 were included. Across all outcomes and 
      regardless of prior biologic exposure, ITT efficacy rates were highest for 
      upadacitinib, owing to its highest ranking for all efficacy outcomes in induction 
      and for all but clinical remission during maintenance among bio-naive induction 
      responders. For all advanced therapies versus placebo, there were no significant 
      differences in serious AEs or serious infections across therapies. For all AEs, 
      golimumab had higher odds versus placebo during maintenance; for discontinuation 
      due to AEs, upadacitinib had lower odds versus placebo during induction, while 
      ustekinumab and vedolizumab had lower odds versus placebo during maintenance. 
      CONCLUSIONS: Upadacitinib may be the most efficacious therapy for moderately to 
      severely active UC based on ITT analyses, with similar safety across advanced 
      therapies.
CI  - (c) The Author(s) 2023. Published by Oxford University Press on behalf of Crohn's & 
      Colitis Foundation.
FAU - Panaccione, Remo
AU  - Panaccione R
AUID- ORCID: 0000-0002-5247-940X
AD  - Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, 
      University of Calgary, Calgary, Alberta, Canada.
FAU - Collins, Eric B
AU  - Collins EB
AUID- ORCID: 0000-0002-9329-847X
AD  - Medicus Economics LLC, Milton, Massachusetts, USA.
FAU - Melmed, Gil Y
AU  - Melmed GY
AUID- ORCID: 0000-0002-2591-5165
AD  - Cedars-Sinai Medical Center, Los Angeles, California, USA.
FAU - Vermeire, Severine
AU  - Vermeire S
AUID- ORCID: 0000-0001-9942-3019
AD  - Department of Gastroenterology & Hepatology, University Hospital Leuven, KU 
      Leuven, Leuven, Belgium.
FAU - Danese, Silvio
AU  - Danese S
AUID- ORCID: 0000-0001-7341-1351
AD  - Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele, Department of 
      Gastroenterology, University Vita-Salute San Raffaele, Milan, Italy.
FAU - Higgins, Peter D R
AU  - Higgins PDR
AD  - Department of Medicine, Division of Gastroenterology, University of Michigan, Ann 
      Arbor, Michigan, USA.
FAU - Kwon, Christina S
AU  - Kwon CS
AD  - Cytel, Inc., Waltham, Massachusetts, USA.
FAU - Zhou, Wen
AU  - Zhou W
AD  - AbbVie Inc., North Chicago, Illinois, USA.
FAU - Ilo, Dapo
AU  - Ilo D
AD  - AbbVie Inc., North Chicago, Illinois, USA.
FAU - Sharma, Dolly
AU  - Sharma D
AD  - AbbVie Inc., North Chicago, Illinois, USA.
FAU - Sanchez Gonzalez, Yuri
AU  - Sanchez Gonzalez Y
AUID- ORCID: 0000-0001-7261-1933
AD  - AbbVie Inc., North Chicago, Illinois, USA.
FAU - Wang, Si-Tien
AU  - Wang ST
AUID- ORCID: 0000-0003-1537-7110
AD  - Medicus Economics LLC, Milton, Massachusetts, USA.
LA  - eng
PT  - Journal Article
DEP - 20230301
PL  - England
TA  - Crohns Colitis 360
JT  - Crohn's & colitis 360
JID - 101752188
CIN - doi: 10.1093/crocol/otad011
PMC - PMC10045885
OTO - NOTNLM
OT  - advanced therapies
OT  - clinical trials
OT  - network meta-analysis
OT  - ulcerative colitis
COIS- R.P. has received consulting fees, speaker fees, and research support from 
      AbbVie, Abbott, Alimentiv (formerly Robarts), Amgen, Arena Pharmaceuticals, 
      AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim Celgene, Celltrion, 
      Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Galapagos, Genentech, 
      Gilead Sciences, Glaxo-Smith Kline, Janssen, Merck, Mylan, Oppilan Pandion, 
      Pharma, Pandion Pharma, Pfizer, Progenity, Protagonist Therapeutics, Roche, 
      Satisfai Health, Sandoz, Schering-Plough, Shire, Sublimity Therapeutics, 
      Theravance Biopharma, UCB, and Takeda Pharmaceuticals. G.Y.M. has consulted for 
      AbbVie, Arena, Boehringer-Ingelheim, Bristol-Meyers Squibb/Celgene, Entasis, 
      Ferring, Janssen, Medtronic, Pfizer, Shionogi, Takeda, Techlab, and has received 
      research grants from Pfizer. S.V. has received research grants from AbbVie, J&J, 
      Pfizer, Galapagos, Takeda and has received consulting and/or speaking fees from 
      AbbVie, AbolerIS Pharma, AgomAb, Alimentiv, Arena Pharmaceuticals, AstraZeneca, 
      Avaxia, BMS, Boehringer Ingelheim, Celgene, CVasThera, Dr Falk Pharma, Ferring, 
      Galapagos, Genentech-Roche, Gilead, GSK, Hospira, Imidomics, Janssen, J&J, Lilly, 
      Materia Prima, MiroBio, Morphic, MrMHealth, Mundipharma, MSD, Pfizer, Prodigest, 
      Progenity, Prometheus, Robarts Clinical Trials, Second Genome, Shire, Surrozen, 
      Takeda, Theravance, Tillots Pharma AG, and Zealand Pharma. S.D. has served as a 
      speaker, consultant, and advisory board member for Schering-Plough, AbbVie, 
      Actelion, Alphawasserman, AstraZeneca, Cellerix, Cosmo Pharmaceuticals, Ferring, 
      Genentech, Grunenthal, Johnson and Johnson, Millenium Takeda, MSD, Nikkiso Europe 
      GmbH, Novo Nordisk, Nycomed, Pfizer, Pharmacosmos, UCB Pharma, and Vifor. 
      P.D.R.H. has received consultancy support from AbbVie, Pfizer, and Eli Lilly; and 
      research grants from AbbVie, Pfizer, and Eli Lilly. Y.S.G., D.I., D.S., and W.Z. 
      are AbbVie employees and may own AbbVie stock and/or options. E.B.C., C.S.K., and 
      S.-T.W. have received consulting fees and research support from AbbVie.
EDAT- 2023/04/01 06:00
MHDA- 2023/04/01 06:01
PMCR- 2023/03/01
CRDT- 2023/03/31 02:03
PHST- 2022/09/21 00:00 [received]
PHST- 2023/04/01 06:01 [medline]
PHST- 2023/03/31 02:03 [entrez]
PHST- 2023/04/01 06:00 [pubmed]
PHST- 2023/03/01 00:00 [pmc-release]
AID - otad009 [pii]
AID - 10.1093/crocol/otad009 [doi]
PST - epublish
SO  - Crohns Colitis 360. 2023 Mar 1;5(2):otad009. doi: 10.1093/crocol/otad009. 
      eCollection 2023 Apr.