Real-World Evidence of Tofacinitib in Ulcerative Colitis: Short-Term and Long-Term Effectiveness and Safety

Area of Science:

• Gastroenterology
• Immunology
• Pharmacology

Background:

• Ulcerative colitis (UC) is a chronic inflammatory bowel disease.
• Tofacitinib is an oral Janus kinase inhibitor used for UC treatment.
• Real-world data on tofacitinib's long-term effectiveness and safety in UC are crucial.

Purpose of the Study:

• To evaluate the durability, short-term and long-term effectiveness, and safety of tofacitinib in a real-world UC patient population.
• To identify factors associated with tofacitinib withdrawal and treatment response.

Main Methods:

• Retrospective, multicenter study design.
• Inclusion of UC patients who initiated tofacitinib at least 8 weeks prior.
• Assessment of clinical effectiveness using the partial Mayo score.

Main Results:

• 408 patients included; 45% withdrew tofacitinib, primarily due to nonresponse.
• Remission rates were 38% at week 4, 45% at week 8, and 47% at week 16.
• Adverse events occurred in 93 patients, including serious events like thromboembolisms; 29 led to discontinuation.

Conclusions:

• Tofacitinib shows both short-term and long-term effectiveness in ulcerative colitis patients in clinical practice.
• The safety profile aligns with previous findings, with key adverse events noted.
• Older age and higher disease severity at baseline are associated with poorer outcomes.