Ulcerative Colitis Patients Continue to Improve Over the First Six Months of Vedolizumab Treatment: 12-Month Clinical and Mucosal Healing Effectiveness.
Crohn’s disease
mucosal healing
remission
steroid-free
ulcerative colitis
vedolizumab
Journal
Journal of the Canadian Association of Gastroenterology
ISSN: 2515-2092
Titre abrégé: J Can Assoc Gastroenterol
Pays: England
ID NLM: 101738684
Informations de publication
Date de publication:
Apr 2020
Apr 2020
Historique:
received:
02
07
2018
accepted:
01
11
2018
entrez:
25
4
2020
pubmed:
25
4
2020
medline:
25
4
2020
Statut:
ppublish
Résumé
Vedolizumab (VDZ) is a humanized monoclonal IgG1 antibody which inhibits leukocyte vascular adhesion and migration into the gastrointestinal tract through α4β7 integrin blockade. We retrospectively assessed the 12-month, real-world efficacy and safety of VDZ as induction and maintenance therapy in adult patients with ulcerative colitis (UC). The rates of clinical remission (CR, partial Mayo score < 2), steroid-free clinical remission (SFCR), and mucosal healing were assessed with nonresponder imputation analysis. Baseline independent predictors of clinical remission were investigated, and adverse events were recorded. We analyzed outcomes in 74 patients; 32% were anti-TNF naïve, 68% had pancolitis, and 46% were on systemic steroids at baseline. At week six, week 14, six months and one year, the CR rates were 26%, 34%, 39% and 39% respectively, and the SFCR rates were 24%, 31%, 38% and 39%, respectively. Among patients not in CR after induction, the probability of remission at six months was 20%. Sustained SFCR between weeks 14 and 52 and between weeks 22 and 52 was found in 69% and 86% of the patients, respectively. Steroid-free clinical remission at 12 months was significantly associated with remission after the induction phase (OR = 30.4; 95% CI, 6 to 150; Increasing remission rates were observed over the first six months of VDZ treatment. One-fifth of patients not in remission post-induction achieved remission by six months of continued therapy. Mucosal healing was associated with higher rates of one-year steroid-free remission and VDZ treatment continuation.
Sections du résumé
BACKGROUND
BACKGROUND
Vedolizumab (VDZ) is a humanized monoclonal IgG1 antibody which inhibits leukocyte vascular adhesion and migration into the gastrointestinal tract through α4β7 integrin blockade.
AIMS
OBJECTIVE
We retrospectively assessed the 12-month, real-world efficacy and safety of VDZ as induction and maintenance therapy in adult patients with ulcerative colitis (UC).
METHODS
METHODS
The rates of clinical remission (CR, partial Mayo score < 2), steroid-free clinical remission (SFCR), and mucosal healing were assessed with nonresponder imputation analysis. Baseline independent predictors of clinical remission were investigated, and adverse events were recorded.
RESULTS
RESULTS
We analyzed outcomes in 74 patients; 32% were anti-TNF naïve, 68% had pancolitis, and 46% were on systemic steroids at baseline. At week six, week 14, six months and one year, the CR rates were 26%, 34%, 39% and 39% respectively, and the SFCR rates were 24%, 31%, 38% and 39%, respectively. Among patients not in CR after induction, the probability of remission at six months was 20%. Sustained SFCR between weeks 14 and 52 and between weeks 22 and 52 was found in 69% and 86% of the patients, respectively. Steroid-free clinical remission at 12 months was significantly associated with remission after the induction phase (OR = 30.4; 95% CI, 6 to 150;
CONCLUSIONS
CONCLUSIONS
Increasing remission rates were observed over the first six months of VDZ treatment. One-fifth of patients not in remission post-induction achieved remission by six months of continued therapy. Mucosal healing was associated with higher rates of one-year steroid-free remission and VDZ treatment continuation.
Identifiants
pubmed: 32328546
doi: 10.1093/jcag/gwy065
pii: gwy065
pmc: PMC7165264
doi:
Types de publication
Journal Article
Langues
eng
Pagination
74-82Informations de copyright
© The Author(s) 2018. Published by Oxford University Press on behalf of the Canadian Association of Gastroenterology.
Références
J Crohns Colitis. 2015 Apr;9(4):356-66
pubmed: 25687206
J Crohns Colitis. 2017 Sep 1;11(9):1085-1089
pubmed: 28369329
Nat Clin Pract Gastroenterol Hepatol. 2006 Jul;3(7):390-407
pubmed: 16819502
Gastroenterology. 2015 May;148(5):1035-1058.e3
pubmed: 25747596
N Engl J Med. 2013 Aug 22;369(8):699-710
pubmed: 23964932
Clin Gastroenterol Hepatol. 2016 Nov;14(11):1593-1601.e2
pubmed: 26917043
Gastroenterology. 2014 Sep;147(3):618-627.e3
pubmed: 24859203
Aliment Pharmacol Ther. 2016 May;43(10):1090-102
pubmed: 27038247
J Crohns Colitis. 2018 Jan 24;12(2):245-257
pubmed: 29077833
Frontline Gastroenterol. 2017 Jul;8(3):196-202
pubmed: 28839909
Inflamm Bowel Dis. 2008 Dec;14(12):1660-6
pubmed: 18623174
Dig Dis Sci. 2017 Jun;62(6):1590-1596
pubmed: 28357697
Clin Gastroenterol Hepatol. 2017 Nov;15(11):1750-1757.e3
pubmed: 27890854
Aliment Pharmacol Ther. 2018 Mar;47(6):763-772
pubmed: 29359519
J Crohns Colitis. 2018 May 25;12(6):635-643
pubmed: 29370397
Am J Gastroenterol. 2015 Sep;110(9):1324-38
pubmed: 26303131
Aliment Pharmacol Ther. 2011 May;33(9):987-95
pubmed: 21366636
Scand J Gastroenterol. 2018 Feb;53(2):158-167
pubmed: 29258369
Inflamm Bowel Dis. 2015 May;21(5):1151-9
pubmed: 25844963
N Engl J Med. 2013 Aug 22;369(8):711-21
pubmed: 23964933
J Crohns Colitis. 2010 Oct;4(4):355-66
pubmed: 21122530
Aliment Pharmacol Ther. 2014 Mar;39(6):579-94
pubmed: 24479980
Gastroenterology. 2007 Feb;132(2):763-86
pubmed: 17258735
Aliment Pharmacol Ther. 2016 Dec;44(11-12):1199-1212
pubmed: 27714831
J Crohns Colitis. 2016 Apr;10(4):402-9
pubmed: 26681763
N Engl J Med. 2005 Dec 8;353(23):2462-76
pubmed: 16339095
Gastroenterology. 2008 Nov;135(5):1493-9
pubmed: 18848553
Inflamm Bowel Dis. 2015 Dec;21(12):2879-85
pubmed: 26288002
N Engl J Med. 1987 Dec 24;317(26):1625-9
pubmed: 3317057
Aliment Pharmacol Ther. 2017 Aug;46(3):310-321
pubmed: 28593685
Curr Treat Options Gastroenterol. 2016 Mar;14(1):83-90
pubmed: 26872815