PMID- 34887214
OWN - NLM
STAT- MEDLINE
DCOM- 20220211
LR  - 20220211
IS  - 1878-3562 (Electronic)
IS  - 1590-8658 (Linking)
VI  - 54
IP  - 2
DP  - 2022 Feb
TI  - Short-term effectiveness and safety of tofacitinib in ulcerative colitis - real 
      world data from tertiary medical centers in Israel.
PG  - 192-197
LID - S1590-8658(21)00849-5 [pii]
LID - 10.1016/j.dld.2021.11.009 [doi]
AB  - BACKGROUND: We sought to define the effectiveness and safety of tofacitinib in a 
      real-world (RW) cohort of Israeli patients with moderate to severe ulcerative 
      colitis (UC). METHODS: This was a multi-center retrospective observational cohort 
      study (2019-2020) to assess the effectiveness and safety of tofacitinib induction 
      and maintenance therapy up to 26 weeks. Clinical response and remission were 
      defined as a reduction in Simple Clinical Colitis Activity Index (SCCAI) or 
      partial Mayo score (PMS) of >/=3 points, and SCCAI </=2 or a PMS </=1, respectively. 
      RESULTS: We included 73 patients, 47% male; median age 26 years [IQR: 19.5-39.5], 
      disease duration 7 years [IQR: 2.5-14.5], follow-up 7.1 months [IQR: 3-12], 91% 
      biologics-experienced, and 74% >/= 2-biologics. Half of patients used concomitant 
      corticosteroids (CS). Overall, 56.1% discontinued therapy due to either lack of 
      response and/or adverse events (AEs), median time to discontinuation - 9.7 months 
      [IQR 3.4-16]. Overall, response, remission, and CS-free-remission were achieved 
      in 47.6%, 20.6%, and 17.5% of patients, respectively. At early maintenance (week 
      26), response, remission, and CS-free-remission were achieved in 65%, 22.5%, and 
      20% of patients, respectively. At week 26, tofacitinib 10 mg BID was still used 
      in 43%. Seventeen patients (23.2%) had an adverse event including herpes zoster- 
      2.7%, hospitalization- 12.3%, and colectomy- 2.7%. CONCLUSIONS: Tofacitinib was 
      effective in achieving CS-free-remission in about 1/5 of highly biologics 
      -experienced patients with UC. Despite a considerable proportion of patients 
      maintained on tofacitinib 10 mg bid, it was well tolerated and safe. Earlier 
      positioning of tofacitinib in the therapeutic algorithm may result in improved 
      outcomes.
CI  - Copyright (c) 2021. Published by Elsevier Ltd.
FAU - Avni-Biron, Irit
AU  - Avni-Biron I
AD  - IBD Center, Division of Gastroenterology, Rabin Medical Center, Petah Tikva, 
      Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 
      Electronic address: iritab@clalit.org.il.
FAU - Bar-Gil Shitrit, Ariella
AU  - Bar-Gil Shitrit A
AD  - Digestive Diseases Institute, Shaare Zedek Medical Center, Israel; Faculty of 
      Medicine, the Hebrew University of Jerusalem, Jerusalem, Israel.
FAU - Koslowsky, Benjamin
AU  - Koslowsky B
AD  - Digestive Diseases Institute, Shaare Zedek Medical Center, Israel; Faculty of 
      Medicine, the Hebrew University of Jerusalem, Jerusalem, Israel.
FAU - Levartovsky, Asaf
AU  - Levartovsky A
AD  - Department of Gastroenterology and Liver Diseases, Sheba Medical Center, Israel; 
      Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Kopylov, Uri
AU  - Kopylov U
AD  - Department of Gastroenterology and Liver Diseases, Sheba Medical Center, Israel; 
      Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Weisshof, Roni
AU  - Weisshof R
AD  - Gastroenterology Institute Rambam Health Care Campus, Israel; Rappaport Faculty 
      of Medicine, Technion, Haifa, Israel.
FAU - Aviv Cohen, Nathaniel
AU  - Aviv Cohen N
AD  - IBD Center, Department of Gastroenterology and Liver Diseases, Tel Aviv Medical 
      Center, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, 
      Israel.
FAU - Maharshak, Nitsan
AU  - Maharshak N
AD  - IBD Center, Department of Gastroenterology and Liver Diseases, Tel Aviv Medical 
      Center, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, 
      Israel.
FAU - Hovel, David
AU  - Hovel D
AD  - Department of Gastroenterology and Liver Diseases, Edith Wolfson Medical Center, 
      Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Israeli, Eran
AU  - Israeli E
AD  - Department of Gastroenterology and Liver Diseases, Edith Wolfson Medical Center, 
      Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Naftali, Timna
AU  - Naftali T
AD  - Department of Gastroenterology and Liver Diseases, Meir Medical Center, Israel; 
      Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Goren, Idan
AU  - Goren I
AD  - IBD Center, Division of Gastroenterology, Rabin Medical Center, Petah Tikva, 
      Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Snir, Yfat
AU  - Snir Y
AD  - IBD Center, Division of Gastroenterology, Rabin Medical Center, Petah Tikva, 
      Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Ollech, Jacob E
AU  - Ollech JE
AD  - IBD Center, Division of Gastroenterology, Rabin Medical Center, Petah Tikva, 
      Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Banai-Eran, Hagar
AU  - Banai-Eran H
AD  - IBD Center, Division of Gastroenterology, Rabin Medical Center, Petah Tikva, 
      Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Broitman, Yelena
AU  - Broitman Y
AD  - IBD Center, Division of Gastroenterology, Rabin Medical Center, Petah Tikva, 
      Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Sharar-Fischler, Tali
AU  - Sharar-Fischler T
AD  - IBD Center, Division of Gastroenterology, Rabin Medical Center, Petah Tikva, 
      Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Dotan, Iris
AU  - Dotan I
AD  - IBD Center, Division of Gastroenterology, Rabin Medical Center, Petah Tikva, 
      Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Yanai, Henit
AU  - Yanai H
AD  - IBD Center, Division of Gastroenterology, Rabin Medical Center, Petah Tikva, 
      Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 
      Electronic address: Henitya@clalit.org.il.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20211207
PL  - Netherlands
TA  - Dig Liver Dis
JT  - Digestive and liver disease : official journal of the Italian Society of 
      Gastroenterology and the Italian Association for the Study of the Liver
JID - 100958385
RN  - 0 (Adrenal Cortex Hormones)
RN  - 0 (Janus Kinase Inhibitors)
RN  - 0 (Piperidines)
RN  - 0 (Pyrimidines)
RN  - 87LA6FU830 (tofacitinib)
SB  - IM
CIN - Dig Liver Dis. 2022 Feb;54(2):151-153. PMID: 34953762
MH  - Adrenal Cortex Hormones/administration & dosage
MH  - Adult
MH  - Colectomy/statistics & numerical data
MH  - Colitis, Ulcerative/*drug therapy
MH  - Drug Therapy, Combination
MH  - Female
MH  - Follow-Up Studies
MH  - Hospitalization/statistics & numerical data
MH  - Humans
MH  - Induction Chemotherapy
MH  - Israel
MH  - Janus Kinase Inhibitors/*administration & dosage
MH  - Male
MH  - Piperidines/*administration & dosage
MH  - Pyrimidines/*administration & dosage
MH  - Retrospective Studies
MH  - Tertiary Care Centers
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Real-world data
OT  - Tofacitinib
OT  - Ulcerative colitis
COIS- Conflict of interest H. Yanai: reports institutional research grants from Pfizer; 
      consulting fees from Abbvie, Ferring, Janssen, Neopharm Ltd., Pfizer, Takeda; 
      honoraria for lectures from Abbvie, Janssen, Pfizer, Takeda; participation on a 
      Data Safety Monitoring Board or Advisory Board from Abbvie, Neopharm Ltd., 
      Pfizer, Takeda. I. Avni Biron: Consulting fees from Takeda; honoraria for 
      lectures from Abbvie, Janssen, Pfizer, Takeda, Neopharm Ltd; Clinical R&D team 
      employee, Medtronic. I.Dotan: Consultation: Arena, Athos therapeutics, Gilead, 
      Cambridge Healthcare, Wild bio, Food industries organization, Integra Holdings, 
      Iterative Scopes. Speakers Bureau/lectures: Janssen, Abbvie, Takeda, Pfizer, 
      Genentech/Roche, Arena, Neopharm, Celltrion, Rafa Laboratories, Ferring, Falk 
      Pharma, Nestle, Celgene/BMS, Abbott. DSMB/advisory boards: SPARE consortium 
      Janssen, Abbvie, Takeda, Pfizer, Genentech/Roche, Arena, Neopharm, Gilead, 
      Galapagos, Celltrion, Sublimity, Wild bio, Athos therapeutics, Food industries 
      organization, Celgene/BMS, Abbott, Sublimity, Sandoz. A. Bar-Gil Shitrit: 
      Research grants from Takeda and Janssen, Consulting and honoraria for lectures 
      from Takeda, Janssen' Abbvie, Pfizer and Neopharm. U. Kopylov: Research grants 
      from Janssen, Takeda Medtronic, Consulting and honoraria- Abbvie, BMS, Janssen, 
      MSD Medtronic, Takeda, Pfizer R. Weisshof: Consulting and honoraria for lectures 
      from Takeda, Janssen, Abbvie. Advisory board fees from Janssen and AMAG 
      Pharmaceuticals N. Maharshak: speaking and/ or consulting fees from Pfizer, 
      Takeda, Janssen, Ferring, BiomX, BMS, Nestle and grant support from Takeda, 
      Janssen, Abbott, Pfizer, BMS, Corundum Innovation Ltd E. Israeli: Research grants 
      from Abbvie; Consulting and honoraria for lectures from Takeda, Janssen, Abbvie, 
      Pfizer, Ferring Teva and BMS. I. Goren: Institutional research grant from Pfizer 
      JE Ollech: Institutional research grant from Pfizer B. Koslowsky, A. Levartovsky, 
      N. Aviv Cohen, D. Hovel, T. Naftali, Y. Snir, H. Banai-Eran, Y. Broitman, T. 
      Sharar-Fischler -None.
EDAT- 2021/12/11 06:00
MHDA- 2022/02/12 06:00
CRDT- 2021/12/10 05:53
PHST- 2021/09/20 00:00 [received]
PHST- 2021/11/08 00:00 [revised]
PHST- 2021/11/09 00:00 [accepted]
PHST- 2021/12/11 06:00 [pubmed]
PHST- 2022/02/12 06:00 [medline]
PHST- 2021/12/10 05:53 [entrez]
AID - S1590-8658(21)00849-5 [pii]
AID - 10.1016/j.dld.2021.11.009 [doi]
PST - ppublish
SO  - Dig Liver Dis. 2022 Feb;54(2):192-197. doi: 10.1016/j.dld.2021.11.009. Epub 2021 
      Dec 7.