Dayanand Medical College and Hospital Ludhiana, Punjab, India
Manjeet K. Goyal, MBBS, MD, Vandana Midha, MBBS, MD, Varun Mehta, MBBS, MD, DM, Shivam Kalra, MBBS, Dharmatama Singh, MSc, Ramandeep Kaur, PharmD, Arshdeep Singh, MBBS, MD, DM, Ajit Sood, MBBS, MD, DM Dayanand Medical College and Hospital, Ludhiana, Punjab, India
Introduction: Acute Severe Ulcerative Colitis (ASUC) is a medical emergency and a potentially life-threatening condition requiring hospitalization. Intravenous steroids are the mainstay of therapy, but 30–40% of patients will fail to respond to steroids and require progression to rescue therapy. The current study aimed to evaluate the role of tofacitinib in reducing steroid refractoriness when used as an adjunct to intravenous corticosteroids.
Methods: This is an open-label, parallel-group study performed at a tertiary care centre in India between January 2021 and April 2022. After taking informed consent, patients with ASUC, defined on the basis of Truelove Witts criteria, were enrolled and subjected to either intravenous hydrocortisone (100 mg 6 hourly) (group A) or intravenous hydrocortisone (100 mg 6 hourly) plus tofacitinib (10 mg thrice daily) (group B). Steroid responsiveness was defined using Oxford’s criteria on day 5. The rates of steroid refractoriness were compared between the two groups
Results: A total of 50 patients (mean age 38.92±14.32 Years, 46% males) were included during the study period. 22 patients (mean age 39±13.87 Years, 54.55% males) and 28 patients (mean age 38.85±14.92 Years, 39.29% males) were enrolled in groups A and B, respectively. Seven (31.81%) patients in group A and three (10.71%) patients in group B were steroid-refractory at day 5 (p=0.06; Figure 1). Mean C-reactive protein on day 5 was 15.83 ± 22.68 and 9.39 ± 8.5 in groups A and B, respectively (p=0.62).
Discussion: The use of tofacitinib as an adjunct to intravenous corticosteroids did not result in lower rates of steroid refractoriness in patients with ASUC. Larger randomized studies are however needed to establish the role of tofacitinib in patients with ASUC.
Figure: Figure 1: Comparison of Steroid responsiveness between two groups on the basis of Oxford Criteria
Disclosures:
Manjeet Goyal indicated no relevant financial relationships.
Vandana Midha indicated no relevant financial relationships.
Varun Mehta indicated no relevant financial relationships.
Shivam Kalra indicated no relevant financial relationships.
Dharmatama Singh indicated no relevant financial relationships.
Ramandeep Kaur indicated no relevant financial relationships.
Arshdeep Singh indicated no relevant financial relationships.
Ajit Sood indicated no relevant financial relationships.
Manjeet K. Goyal, MBBS, MD, Vandana Midha, MBBS, MD, Varun Mehta, MBBS, MD, DM, Shivam Kalra, MBBS, Dharmatama Singh, MSc, Ramandeep Kaur, PharmD, Arshdeep Singh, MBBS, MD, DM, Ajit Sood, MBBS, MD, DM. A0348 - Role of Tofacitinib as an Adjunct to Intravenous Corticosteroids in the Management of Acute Severe Ulcerative Colitis: An Interim Analysis, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.
