PMID- 37718932
OWN - NLM
STAT- MEDLINE
DCOM- 20231215
LR  - 20231215
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Linking)
VI  - 58
IP  - 9
DP  - 2023 Nov
TI  - Integrated safety analysis of filgotinib for ulcerative colitis: Results from 
      SELECTION and SELECTIONLTE.
PG  - 874-887
LID - 10.1111/apt.17674 [doi]
AB  - BACKGROUND: Filgotinib 200 mg (FIL200) is an approved treatment for adults with 
      moderately to severely active ulcerative colitis (UC). AIM: To report integrated 
      safety data from the phase 2b/3 SELECTION study (NCT02914522) and its ongoing 
      long-term extension study SELECTIONLTE (NCT02914535). METHODS: Safety outcomes 
      were analysed in adults with moderately to severely active UC who received 
      FIL200, filgotinib 100 mg (FIL100) or placebo once daily throughout the 11-week 
      SELECTION induction study, the 47-week SELECTION maintenance study (if 
      applicable) and SELECTIONLTE (if applicable). Exposure-adjusted incidence rates 
      (EAIRs) per 100 censored patient-years of exposure with 95% confidence intervals 
      were reported for treatment-emergent adverse events (AEs). Certain AE data were 
      presented in subgroups, including age and prior biologic exposure status. 
      RESULTS: This interim analysis included 1348 patients representing 3326.2 
      patient-years of exposure. Baseline characteristics of patients entering 
      SELECTION were similar across treatment groups. EAIRs for serious infection, 
      thromboembolic events and major adverse cardiovascular events (MACE) were 
      consistently low across treatment groups. Most patients with MACE had 
      cardiovascular risk factors. The EAIR for herpes zoster was numerically higher 
      for FIL200 than for placebo. Infection incidences were numerically higher in 
      biologic-experienced than biologic-naive patients. Higher incidences of certain 
      AEs in patients 65 years of age or older were as expected. Four deaths occurred, 
      including three cardiovascular deaths, none of which was considered related to 
      filgotinib. CONCLUSION: FIL200 and FIL100 were well tolerated with no unexpected 
      safety signals in patients with moderately to severely active UC, regardless of 
      previous biologic exposure or age. GOV IDENTIFIERS (NCT NUMBERS): NCT02914522, 
      NCT02914535.
CI  - (c) 2023 Galapagos NV. Alimentary Pharmacology & Therapeutics published by John 
      Wiley & Sons Ltd.
FAU - Schreiber, Stefan
AU  - Schreiber S
AUID- ORCID: 0000-0002-6807-9822
AD  - Department Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany.
FAU - Rogler, Gerhard
AU  - Rogler G
AD  - University Hospital of Zurich, University of Zurich, Zurich, Switzerland.
FAU - Watanabe, Mamoru
AU  - Watanabe M
AUID- ORCID: 0000-0002-5475-9544
AD  - Advanced Research Institute, Tokyo Medical and Dental University, Tokyo, Japan.
FAU - Vermeire, Severine
AU  - Vermeire S
AUID- ORCID: 0000-0001-9942-3019
AD  - Department of Gastroenterology and Hepatology, University Hospitals Leuven, 
      Leuven, Belgium.
FAU - Maaser, Christian
AU  - Maaser C
AUID- ORCID: 0000-0002-3889-405X
AD  - Outpatients Department of Gastroenterology, Department of Geriatrics, Hospital 
      Luneburg, Luneburg, Germany.
FAU - Danese, Silvio
AU  - Danese S
AUID- ORCID: 0000-0001-7341-1351
AD  - Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele, Milan, Italy.
AD  - Vita-Salute San Raffaele University, Milan, Italy.
FAU - Faes, Margaux
AU  - Faes M
AD  - Galapagos NV, Mechelen, Belgium.
FAU - Van Hoek, Paul
AU  - Van Hoek P
AD  - Galapagos NV, Mechelen, Belgium.
FAU - Hsieh, Jeremy
AU  - Hsieh J
AD  - Gilead Sciences, Inc., Foster City, California, USA.
FAU - Moerch, Ulrik
AU  - Moerch U
AD  - Gilead Sciences, Inc., Copenhagen, Denmark.
FAU - Zhou, Yan
AU  - Zhou Y
AD  - Gilead Sciences, Inc., Foster City, California, USA.
FAU - de Haas, Angela
AU  - de Haas A
AD  - Galapagos NV, Leiden, the Netherlands.
FAU - Rudolph, Christine
AU  - Rudolph C
AD  - Galapagos NV, Leiden, the Netherlands.
FAU - Oortwijn, Alessandra
AU  - Oortwijn A
AUID- ORCID: 0000-0002-8556-1004
AD  - Galapagos NV, Leiden, the Netherlands.
FAU - Loftus, Edward V Jr
AU  - Loftus EV Jr
AUID- ORCID: 0000-0001-7199-6851
AD  - Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and 
      Science, Rochester, Minnesota, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02914535
SI  - ClinicalTrials.gov/NCT02914522
SI  - ClinicalTrials.gov/NCT02914522
GR  - Galapagos/
GR  - Gilead Sciences/
PT  - Clinical Trial
PT  - Journal Article
DEP - 20230918
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Biological Products)
RN  - 0 (GLPG0634)
RN  - 0 (Pyridines)
RN  - 0 (Triazoles)
SB  - IM
EIN - Aliment Pharmacol Ther. 2023 Dec 3;:. PMID: 38044590
MH  - Adult
MH  - Humans
MH  - *Biological Products/therapeutic use
MH  - *Colitis, Ulcerative/drug therapy
MH  - Pyridines/therapeutic use
MH  - Triazoles/therapeutic use
EDAT- 2023/09/18 06:42
MHDA- 2023/12/05 12:43
CRDT- 2023/09/18 04:03
PHST- 2023/06/04 00:00 [revised]
PHST- 2023/04/13 00:00 [received]
PHST- 2023/07/16 00:00 [accepted]
PHST- 2023/12/05 12:43 [medline]
PHST- 2023/09/18 06:42 [pubmed]
PHST- 2023/09/18 04:03 [entrez]
AID - 10.1111/apt.17674 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2023 Nov;58(9):874-887. doi: 10.1111/apt.17674. Epub 2023 
      Sep 18.