Tofacitinib for patients with anti-TNF refractory ulcerative proctitis: a multicenter cohort study from the GETAID.
Ulcerative proctitis
refractory proctitis
tofacitinib
Journal
Journal of Crohn's & colitis
ISSN: 1876-4479
Titre abrégé: J Crohns Colitis
Pays: England
ID NLM: 101318676
Informations de publication
Date de publication:
05 Oct 2023
05 Oct 2023
Historique:
received:
16
06
2023
medline:
5
10
2023
pubmed:
5
10
2023
entrez:
5
10
2023
Statut:
aheadofprint
Résumé
While ulcerative proctitis (UP) can dramatically impair quality-of-life, treatments efficacy has been poorly investigated in UP as it was historically excluded from phase 2/3 randomized controlled trials in ulcerative colitis. To assess the effectiveness and safety of tofacitinib for the treatment of UP. We conducted a retrospective multicenter study in seventeen GETAID centers including consecutive patients with UP treated with tofacitinib. The primary endpoint was steroid-free remission between week 8 and week 14, defined as a partial Mayo score of 2 (and no individual subscore above 1). Secondary outcomes included clinical response and steroid-free remission after induction and at one year. All the 35 enrolled patients previously received anti-TNF therapy and 88.6% were exposed to at least two lines of biologics. At baseline, the median partial Mayo score was 7 (IQR[5.5-7]). After induction (W8-W14), 42.9% and 60.0% of patients achieved steroid-free remission and clinical response, respectively. At one year, the steroid-free clinical remission and clinical response rates were 39.4% and 45.5%, respectively, while 51.2% (17/33) were still receiving tofacitinib treatment. Survival without tofacitinib withdrawal was estimated at 50.4% (95%CI[35.5-71.6]) at one year. Only a lower partial Mayo at baseline was independently associated with remission at induction (Odds ratio (OR) = 0.56 for an increase of 1, 95% confidence interval (95%CI) [0.33-0.95], p = 0.03). Five (14.3%) adverse events were reported with one leading to treatment withdrawal (septic shock secondary to cholecystitis). Tofacitinib may offer a therapeutic option for patients with refractory UP.
Sections du résumé
BACKGROUND
BACKGROUND
While ulcerative proctitis (UP) can dramatically impair quality-of-life, treatments efficacy has been poorly investigated in UP as it was historically excluded from phase 2/3 randomized controlled trials in ulcerative colitis.
AIM
OBJECTIVE
To assess the effectiveness and safety of tofacitinib for the treatment of UP.
METHODS
METHODS
We conducted a retrospective multicenter study in seventeen GETAID centers including consecutive patients with UP treated with tofacitinib. The primary endpoint was steroid-free remission between week 8 and week 14, defined as a partial Mayo score of 2 (and no individual subscore above 1). Secondary outcomes included clinical response and steroid-free remission after induction and at one year.
RESULTS
RESULTS
All the 35 enrolled patients previously received anti-TNF therapy and 88.6% were exposed to at least two lines of biologics. At baseline, the median partial Mayo score was 7 (IQR[5.5-7]). After induction (W8-W14), 42.9% and 60.0% of patients achieved steroid-free remission and clinical response, respectively. At one year, the steroid-free clinical remission and clinical response rates were 39.4% and 45.5%, respectively, while 51.2% (17/33) were still receiving tofacitinib treatment. Survival without tofacitinib withdrawal was estimated at 50.4% (95%CI[35.5-71.6]) at one year. Only a lower partial Mayo at baseline was independently associated with remission at induction (Odds ratio (OR) = 0.56 for an increase of 1, 95% confidence interval (95%CI) [0.33-0.95], p = 0.03). Five (14.3%) adverse events were reported with one leading to treatment withdrawal (septic shock secondary to cholecystitis).
CONCLUSION
CONCLUSIONS
Tofacitinib may offer a therapeutic option for patients with refractory UP.
Identifiants
pubmed: 37796025
pii: 7289562
doi: 10.1093/ecco-jcc/jjad169
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© The Author(s) 2023. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.