PMID- 35734858
OWN - NLM
STAT- MEDLINE
DCOM- 20221005
LR  - 20221231
IS  - 1440-1746 (Electronic)
IS  - 0815-9319 (Print)
IS  - 0815-9319 (Linking)
VI  - 37
IP  - 10
DP  - 2022 Oct
TI  - Safety and efficacy of long-term tofacitinib treatment in East Asian patients 
      with ulcerative colitis in OCTAVE Open.
PG  - 1884-1892
LID - 10.1111/jgh.15923 [doi]
AB  - BACKGROUND AND AIM: Tofacitinib is an oral small molecule Janus kinase inhibitor 
      for the treatment of ulcerative colitis (UC). We present safety and efficacy data 
      from patients from East Asia (Japan, Korea, and Taiwan) in OCTAVE Open, an 
      open-label, long-term extension study. METHODS: Patients in remission at OCTAVE 
      Open baseline received tofacitinib 5 mg twice daily (BID); all others received 
      tofacitinib 10 mg BID. Proportions and IRs (unique patients with events/100 
      patient-years) were calculated for adverse events (AEs) of special interest. 
      Efficacy endpoints were evaluated up to 36 months. RESULTS: In OCTAVE Open, 
      105/944 patients were from East Asia (tofacitinib 5 mg BID, n = 22; tofacitinib 
      10 mg BID, n = 83). Overall, 87.6% and 24.8% of patients had AEs and serious AEs, 
      respectively; IRs (95% CI) for AEs of special interest were herpes zoster (HZ; 
      non-serious and serious), 6.07 (3.40-10.02); serious infections, 1.47 
      (0.40-3.76); opportunistic infections, 1.91 (0.62-4.45); major cardiovascular 
      adverse events, 0.37 (0.01-2.04); malignancies (excluding non-melanoma skin 
      cancer [NMSC]), 0.37 (0.01-2.04); and NMSC, 0.00 (0.00-1.35). No deaths, venous 
      thromboembolic events, or gastrointestinal perforations occurred. At month 36, 
      68.2% and 54.2% of patients had a clinical response, 68.2% and 53.0% had 
      endoscopic improvement, and 63.6% and 49.4% were in remission with tofacitinib 5 
      and 10 mg BID, respectively. CONCLUSIONS: The HZ IR in East Asian patients was 
      numerically higher versus the global study population; excluding HZ, tofacitinib 
      safety and efficacy were consistent with the global study population.
CI  - (c) 2022 Pfizer Inc. Journal of Gastroenterology and Hepatology published by 
      Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons 
      Australia, Ltd.
FAU - Matsuoka, Katsuyoshi
AU  - Matsuoka K
AUID- ORCID: 0000-0002-2950-7660
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Toho University Sakura Medical Center, Chiba, Japan.
FAU - Hisamatsu, Tadakazu
AU  - Hisamatsu T
AUID- ORCID: 0000-0002-1178-3536
AD  - Department of Gastroenterology and Hepatology, Kyorin University School of 
      Medicine, Tokyo, Japan.
FAU - Kim, Hyo Jong
AU  - Kim HJ
AUID- ORCID: 0000-0002-9675-4557
AD  - Center for Crohn's and Colitis, Kyung Hee University College of Medicine, Seoul, 
      Korea.
FAU - Ye, Byong Duk
AU  - Ye BD
AUID- ORCID: 0000-0001-6647-6325
AD  - Department of Gastroenterology and Inflammatory Bowel Disease Center, Asan 
      Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
FAU - Arai, Shoko
AU  - Arai S
AUID- ORCID: 0000-0003-4609-1609
AD  - Pfizer Japan Inc, Tokyo, Japan.
FAU - Hoshi, Masato
AU  - Hoshi M
AUID- ORCID: 0000-0003-2874-1807
AD  - Pfizer Japan Inc, Tokyo, Japan.
FAU - Yuasa, Hirotoshi
AU  - Yuasa H
AD  - Pfizer R&D, Japan, Tokyo, Japan.
FAU - Tabira, Junichi
AU  - Tabira J
AD  - Pfizer R&D, Japan, Tokyo, Japan.
FAU - Toyoizumi, Shigeyuki
AU  - Toyoizumi S
AUID- ORCID: 0000-0002-7011-5263
AD  - Pfizer R&D, Japan, Tokyo, Japan.
FAU - Shi, Nanzhi
AU  - Shi N
AUID- ORCID: 0000-0002-8050-9311
AD  - Pfizer R&D, Japan, Tokyo, Japan.
FAU - Woo, Joon-Suk
AU  - Woo JS
AD  - Pfizer Korea Inc, Seoul, Korea.
FAU - Hibi, Toshifumi
AU  - Hibi T
AUID- ORCID: 0000-0002-6256-1204
AD  - Center for Advanced IBD Research and Treatment, Kitasato University Kitasato 
      Institute Hospital, Tokyo, Japan.
LA  - eng
GR  - Pfizer/
PT  - Journal Article
DEP - 20220721
PL  - Australia
TA  - J Gastroenterol Hepatol
JT  - Journal of gastroenterology and hepatology
JID - 8607909
RN  - 0 (Janus Kinase Inhibitors)
RN  - 0 (Piperidines)
RN  - 0 (Pyrimidines)
RN  - 0 (Pyrroles)
RN  - 87LA6FU830 (tofacitinib)
SB  - IM
MH  - *Colitis, Ulcerative
MH  - Humans
MH  - *Janus Kinase Inhibitors/adverse effects/therapeutic use
MH  - Piperidines
MH  - Pyrimidines
MH  - Pyrroles
MH  - Treatment Outcome
PMC - PMC9796539
OTO - NOTNLM
OT  - Janus kinase inhibitors
OT  - herpes zoster
OT  - ulcerative colitis
EDAT- 2022/06/24 06:00
MHDA- 2022/10/06 06:00
PMCR- 2022/12/28
CRDT- 2022/06/23 03:13
PHST- 2022/05/31 00:00 [revised]
PHST- 2021/12/16 00:00 [received]
PHST- 2022/06/18 00:00 [accepted]
PHST- 2022/06/24 06:00 [pubmed]
PHST- 2022/10/06 06:00 [medline]
PHST- 2022/06/23 03:13 [entrez]
PHST- 2022/12/28 00:00 [pmc-release]
AID - JGH15923 [pii]
AID - 10.1111/jgh.15923 [doi]
PST - ppublish
SO  - J Gastroenterol Hepatol. 2022 Oct;37(10):1884-1892. doi: 10.1111/jgh.15923. Epub 
      2022 Jul 21.