PMID- 37843044
OWN - NLM
STAT- Publisher
LR  - 20231224
IS  - 1536-4844 (Electronic)
IS  - 1078-0998 (Linking)
DP  - 2023 Oct 16
TI  - Clinical and Endoscopic Outcomes Through 78 Weeks of Tofacitinib Therapy for 
      Ulcerative Colitis in a US Cohort.
LID - izad242 [pii]
LID - 10.1093/ibd/izad242 [doi]
AB  - BACKGROUND: Tofacitinib is an oral JAK inhibitor for the treatment of ulcerative 
      colitis (UC). We assessed outcomes through 78 weeks of tofacitinib therapy for UC 
      in a real-world setting. METHODS: This retrospective cohort study included adults 
      initiating tofacitinib for UC from May 1, 2018, to April 1, 2021, at a large 
      academic center in the United States. The primary outcome was steroid-free 
      clinical remission at 78 (+/-4) weeks (SFCR 78; simple clinical colitis activity 
      index </=2 with no corticosteroid use within 30 days). The secondary outcome was 
      tofacitinib discontinuation due to nonresponse (treatment persistence). 
      Additional outcomes were endoscopic response/remission and adverse events (AEs). 
      RESULTS: Seventy-three patients initiated tofacitinib, with a median follow-up of 
      88 weeks. Among patients with available data, 31 of 60 (51.7%) achieved SFCR 78, 
      21 of 47 (44.7%) achieved endoscopic remission during follow-up, and 25 of 73 
      (34.2%) discontinued tofacitinib during follow-up due to nonresponse (including 
      11 patients who required colectomy). Nineteen AEs were reported among 15 patients 
      during follow-up: shingles (n = 4, all without documented vaccinations), deep 
      venous thrombosis (n = 2), elevated liver enzymes (n = 2), skin abscess (n = 2), 
      pneumonia (n = 2), possible miscarriage (n = 2), norovirus (n = 1), COVID-19 
      (n = 1), lymphopenia (n = 1), Clostridioides difficile infection (n = 1), and 
      heart block (n = 1). One patient discontinued therapy due to an AE (elevated 
      liver enzymes), and no deaths occurred. CONCLUSION: Tofacitinib treatment was 
      effective in achieving SFCR for the majority of patients with UC through 78 
      weeks. Adverse events were consistent with the known safety profile of 
      tofacitinib, and AEs requiring discontinuation were rare. Due to limitations 
      regarding sample size, larger studies are needed to confirm these findings.
CI  - (c) 2023 Crohn's & Colitis Foundation. Published by Oxford University Press on 
      behalf of Crohn's & Colitis Foundation.
FAU - Dalal, Rahul S
AU  - Dalal RS
AUID- ORCID: 0000-0003-4622-8441
AD  - Division of Gastroenterology, Hepatology and Endoscopy, Department of Medicine, 
      Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
FAU - Sharma, Puza P
AU  - Sharma PP
AD  - Pfizer Inc, New York, NY, USA.
FAU - Bains, Kanwal
AU  - Bains K
AD  - Department of Nutrition, Brigham and Women's Hospital, Harvard Medical School, 
      Boston, MA, USA.
FAU - Pruce, Jordan C
AU  - Pruce JC
AD  - Division of Gastroenterology, Hepatology and Endoscopy, Department of Medicine, 
      Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
FAU - Allegretti, Jessica R
AU  - Allegretti JR
AUID- ORCID: 0000-0003-3585-2425
AD  - Division of Gastroenterology, Hepatology and Endoscopy, Department of Medicine, 
      Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
LA  - eng
GR  - Pfizer/
PT  - Journal Article
DEP - 20231016
PL  - England
TA  - Inflamm Bowel Dis
JT  - Inflammatory bowel diseases
JID - 9508162
SB  - IM
CIN - Inflamm Bowel Dis. 2024 Mar 1;30(3):516. PMID: 38142413
CIN - Inflamm Bowel Dis. 2024 Mar 1;30(3):515. PMID: 38142440
OAB - Tofacitinib treatment was effective in achieving steroid-free clinical remission 
      for the majority of patients with UC through 78 weeks. Adverse events, which 
      rarely required treatment discontinuation, were consistent with the known safety 
      profile of tofacitinib.
OABL- eng
OTO - NOTNLM
OT  - biologic
OT  - effectiveness
OT  - endoscopic
OT  - inflammatory bowel disease
OT  - safety
OT  - small molecule
EDAT- 2023/10/16 12:43
MHDA- 2023/10/16 12:43
CRDT- 2023/10/16 08:23
PHST- 2023/03/03 00:00 [received]
PHST- 2023/10/16 12:43 [medline]
PHST- 2023/10/16 12:43 [pubmed]
PHST- 2023/10/16 08:23 [entrez]
AID - 7318100 [pii]
AID - 10.1093/ibd/izad242 [doi]
PST - aheadofprint
SO  - Inflamm Bowel Dis. 2023 Oct 16:izad242. doi: 10.1093/ibd/izad242.