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Arch Iran Med. 2021;24(5): 354-363.
doi: 10.34172/aim.2021.52
  Abstract View: 230
  PDF Download: 179

Original Article

Efficacy and Safety of Tofacitinib for Treatment of Moderate to Severe Active Ulcerative Colitis: First Report from Iran

Maryam Jameshorani 1, Homayoon Vahedi 2, Anahita Sadeghi 2, Ali Reza Sima 2, Amir Anushiravani 2, Helia Nateghi beige 2, Masoud M. Malekzadeh 2, Shokoofeh Naserinejad 2, Sudabeh Alatab 2*

1 Department of Internal Medicine, School of Medicine, Metabolic Disease Research Center, Zanjan University of Medical Sciences, Zanjan, Iran
2 Digestive Disease Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran
*Corresponding Author: Sudabeh Alatab MD, PhD; Digestive Disease Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Shariati Hospital, N. Kargar St., Tehran 14117, Iran. Tel: +98-21- 8241 5235, Fax: +98-21- 8241 5400, Email: sudabehalatab@yahoo.com; salatab@sina. tums.ac.ir

Abstract

Background: Tofacitinib, a selective inhibitor of JAK/STAT pathway, has recently become available in our region. Here, we examined the safety and efficacy of tofacitinib in active ulcerative colitis (UC).
Methods: In a prospective, non-randomized, placebo-free, 52-week clinical trial defined in two phases of induction and maintenance, adult patients with active UC and no response or loss of response to previous conventional treatments, or anti-TNF were recruited (IRCT20181217042020N2). Patients received 10 mg/BID of tofacitinib for 8 weeks. Clinically responding patients were entered into the maintenance phase and received tofacitinib 5 mg/BID for 44 weeks. Clinical evaluation, biochemical tests and endoscopy at time points of baseline, 8, 24 and 52 weeks were performed. The primary outcome was clinical remission at 8 and 52 weeks.
Results: Fifty out of 53 enrolled patients completed the induction phase. Clinical response and clinical remission at 8 weeks occurred in 84% and 9.5%, respectively. Forty-two patients who had clinical response entered the maintenance phase. Clinical remission based on the total Mayo score and the partial Mayo score occurred in 38.9% and 55.3% at 24 weeks and in 61.1% and 72.2% at 52 weeks, respectively. There was significant correlation between the total and partial Mayo score with regard to clinical remission in both 24 and 52 weeks. No serious adverse events, no case of herpes zoster, but two cases of deep vein thrombosis were seen.
Conclusions: Our study showed acceptable efficacy and safety for tofacitinib and suggested a correlation between the total Mayo score with partial Mayo score with regard to clinical remission.
Keywords: Inflammatory bowel disease, Therapy, Ulcerative colitis
Cite this article as: Jameshorani M, Vahedi H, Sadeghi A, Sima AR, Anushiravani A, Nateghi Beige H, et al. Efficacy and safety of tofacitinib for treatment of moderately to severely active ulcerative colitis: first report from Iran. Arch Iran Med. 2021;24(5):354- 363. doi: 10.34172/aim.2021.52
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Abstract View: 230

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Submitted: 28 Jul 2020
Accepted: 27 Feb 2021
ePublished: 01 May 2021
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