World Congress of Gastroenterology

WCOG 2019


 
Induction therapy with Tofacitinib in patients with moderate –to -severe ulcerative colitis
SUDABEH ALATAB 1 ZHALEH DINARI 2 HOMAYOON VAHEDI 1 ANAHITA SADEGHI 1 ALIREZA SIMA 1

1- DIGESTIVE DISEASE RESEARCH CENTER, DIGESTIVE DISEASE RESEARCH INSTITUTE, SHARIATI HOSPITAL, TEHRAN UNIVERSITY OF MEDICAL SCIENCES, TEHRAN, IRAN
2- DEPARTMENT OF INTERNAL MEDICINE, KERMANSHAH UNIVERSITY OF MEDICAL SCIENCES
 
Background/Aims:

Inflammatory bowel disease (IBD), has two main forms of Ulcerative Colitis (UC) and Crohn’s Disease (CD) and characterized with chronic- relapsing inflammation of the gastrointestinal tract. The JAK-STAT signaling pathway is implicated in the pathogenesis of IBD. We evaluated the efficacy of Tofacitinib, an oral, small-molecule Janus kinase inhibitor, for induction of clinical response in active UC.

 

Materials and Methods:

This study was a prospective, open-label, clinical trial (IRCT20181217042020N1). Adult patients (n=54) with moderate-to-severe UC (mayo score >7) who had inadequate response or intolerance to conventional or TNF antagonists therapy were enrolled. Patients received 10 mg Tofacitinib twice daily for 8 weeks. The primary end point was achieving clinical response (30% reduction from baseline in mayo score with at least 3 points and no rectal bleeding subscore >1). Adverse events (AEs) and laboratory parameters were recorded

 

Results:

50 patients completed the study. The mean age of subjects was 37.6 years with mean UC duration of 8.02 years. No significant changes occurred in lipid profile, hematological index and liver function tests. The levels of ESR (26.8 vs 15.8 mm/h, p= 0.001) and Calprotectin (1155.6 vs 452.7 mg/l, p= 0.001) significantly decreased at week 8. The mean Mayo score decreased from 10.1 to 4.2 (p= 0.001). The clinical response occurred in 73.2% of patients. No relation found between gender and clinical response. Pancolitis decreased from 75.6% to 43%.8. There were 11 minor AEs of increased bloating (6) skin dryness and acne (3) and nasopharyngitis (2). Serious infection occurred in one patients and none of patients developed herpes zoster infection

 

Conclusion:

In patients with moderate-to-severe UC, short-term treatment with Tofacitinib significantly improved the severity of disease with no gender preference. Our results is comparable with other results showing that Tofacitinib is effective for induction of remission and improvement of quality of life.

 

Keywords:

Ulcerative Colitis, Tofacitinib, Clinical response