PMID- 37726491
OWN - NLM
STAT- MEDLINE
DCOM- 20240311
LR  - 20240311
IS  - 0975-0711 (Electronic)
IS  - 0254-8860 (Linking)
VI  - 43
IP  - 1
DP  - 2024 Feb
TI  - Upfront tofacitinib in patients with biological-naive ulcerative colitis - An 
      Indian multicentric experience.
PG  - 237-243
LID - 10.1007/s12664-023-01434-9 [doi]
AB  - OBJECTIVES: Tofacitinib is a Janus Kinase inhibitor used for treating moderate to 
      severe ulcerative colitis (UC), mainly after the failure of biological therapy. 
      There is a paucity of data on the outcome of tofacitinib in biological-naive UC 
      patients. The present study was aimed at analyzing the safety and efficacy of 
      tofacitinib in biological-naive Indian patients with UC. METHODS: The present 
      study retrospectively evaluated consecutive patients with biological-naive 
      moderate-to-severe active UC from six tertiary care centers in India receiving 
      tofacitinib from September 2020 to September 2022. Clinical remission or response 
      assessment was based on partial Mayo score (PMS) calculated at baseline and weeks 
      eight, 16 and 24. RESULTS: Total 47 cases (57.4% male, median age: 32 years) were 
      included. After eight weeks of therapy, 33 (70.2%) achieved clinical remission 
      and eight (17.0%) had a primary failure. The baseline serum albumin at treatment 
      initiation was the only independent predictor of remission at eight weeks (Odds 
      ratio: 11.560, 95% CI: 1.478 - 90.404), but not at 16 weeks. By 24 weeks, 59.6% 
      (28/47) of the patients were in remission and 29.8% (14/47) had stopped 
      tofacitinib either due to failure (27.6%) or adverse events (AEs) (2.1%). Among 
      the 47 patients, 10 (21.2%) cases developed AEs during follow-up, including two 
      tuberculosis (4.2%), one cytomegalovirus (CMV) colitis (2.1%) and one herpes 
      zoster (2.1%). Four patients with infection required temporary drug 
      discontinuations. One required permanent discontinuation (mania). CONCLUSION: 
      Upfront tofacitinib is effective in biologic-naive Indian patients with 
      moderate-severe UC. Further randomized studies are required to validate the study 
      findings.
CI  - (c) 2023. Indian Society of Gastroenterology.
FAU - Giri, Suprabhat
AU  - Giri S
AD  - Department of Gastroenterology, Nizam's Institute of Medical Sciences, Hyderabad, 
      500 082, India.
FAU - Bhrugumalla, Sukanya
AU  - Bhrugumalla S
AD  - Department of Gastroenterology, Nizam's Institute of Medical Sciences, Hyderabad, 
      500 082, India.
FAU - Kamuni, Abhishek
AU  - Kamuni A
AD  - Department of Gastroenterology, Nizam's Institute of Medical Sciences, Hyderabad, 
      500 082, India.
FAU - Mishra, Debakanta
AU  - Mishra D
AD  - Department of Gastroenterology, Institute of Medical Sciences and SUM Hospital, 
      Bhubaneswar, 751 003, India.
FAU - Pati, Girish Kumar
AU  - Pati GK
AD  - Department of Gastroenterology, Institute of Medical Sciences and SUM Hospital, 
      Bhubaneswar, 751 003, India.
FAU - Agrawal, Dhiraj
AU  - Agrawal D
AD  - Department of Gastroenterology, PACE Hospital, Hyderabad, 500 081, India.
FAU - Verma, Govind
AU  - Verma G
AD  - Department of Gastroenterology, PACE Hospital, Hyderabad, 500 081, India.
FAU - Wagh, Rohit
AU  - Wagh R
AD  - Department of Gastroenterology, Lokmanya Tilak Municipal General Hospital and 
      Medical College, Mumbai, 400 022, India.
FAU - Chauhan, Shamshersingh
AU  - Chauhan S
AD  - Department of Gastroenterology, Lokmanya Tilak Municipal General Hospital and 
      Medical College, Mumbai, 400 022, India.
FAU - Ingle, Meghraj
AU  - Ingle M
AD  - Department of Gastroenterology, Lokmanya Tilak Municipal General Hospital and 
      Medical College, Mumbai, 400 022, India.
FAU - Chandnani, Sanjay
AU  - Chandnani S
AD  - Department of Gastroenterology, Topiwala National Medical College and BYL Nair 
      Hospital, Mumbai, 400 008, India.
FAU - Jain, Shubham
AU  - Jain S
AD  - Department of Gastroenterology, Topiwala National Medical College and BYL Nair 
      Hospital, Mumbai, 400 008, India.
FAU - Rathi, Pravin M
AU  - Rathi PM
AD  - Department of Gastroenterology, Topiwala National Medical College and BYL Nair 
      Hospital, Mumbai, 400 008, India.
FAU - Shukla, Akash
AU  - Shukla A
AD  - Department of Gastroenterology, Seth GS Medical College and KEM Hospital, 9th 
      Floor, New OPD Building, Parel, Mumbai, 400 012, India.
FAU - Kale, Aditya
AU  - Kale A
AUID- ORCID: 0000-0002-6925-0214
AD  - Department of Gastroenterology, Seth GS Medical College and KEM Hospital, 9th 
      Floor, New OPD Building, Parel, Mumbai, 400 012, India. adityapkale@yahoo.com.
LA  - eng
PT  - Journal Article
DEP - 20230920
PL  - India
TA  - Indian J Gastroenterol
JT  - Indian journal of gastroenterology : official journal of the Indian Society of 
      Gastroenterology
JID - 8409436
RN  - 87LA6FU830 (tofacitinib)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyrroles)
RN  - 0 (Piperidines)
RN  - 0 (Pyrimidines)
SB  - IM
MH  - Humans
MH  - Male
MH  - Adult
MH  - Female
MH  - *Colitis, Ulcerative/drug therapy
MH  - Protein Kinase Inhibitors/adverse effects
MH  - Retrospective Studies
MH  - Pyrroles/adverse effects
MH  - Treatment Outcome
MH  - *Piperidines
MH  - *Pyrimidines
OTO - NOTNLM
OT  - Drug reactions
OT  - Inflammatory bowel disease
OT  - Steroid-dependent disease
OT  - Tofacitinib
OT  - Ulcerative colitis
EDAT- 2023/09/20 00:43
MHDA- 2024/03/11 06:43
CRDT- 2023/09/19 23:32
PHST- 2023/05/05 00:00 [received]
PHST- 2023/07/18 00:00 [accepted]
PHST- 2024/03/11 06:43 [medline]
PHST- 2023/09/20 00:43 [pubmed]
PHST- 2023/09/19 23:32 [entrez]
AID - 10.1007/s12664-023-01434-9 [pii]
AID - 10.1007/s12664-023-01434-9 [doi]
PST - ppublish
SO  - Indian J Gastroenterol. 2024 Feb;43(1):237-243. doi: 10.1007/s12664-023-01434-9. 
      Epub 2023 Sep 20.