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Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
Published on: April 7, 2023
Positioning of tofacitinib in treatment of ulcerative colitis: a global perspective
Shubhra Mishra1, Anuraag Jena2, Rinkalben Kakadiya2
1Department of Gastroenterology, Asian Institute of Gastroenterology Hospitals, Hyderabad, India.
Introduction:
Tofacitinib has emerged as a useful drug for the treatment of ulcerative colitis (UC).
Areas Covered:
There is an unmet need for cost-effective, non-immunogenic drugs with a safe adverse effect profile to treat patients with ulcerative colitis. In the present review, we evaluate the available literature to inform the appropriate positioning of tofacitinib in the current drug landscape and identify subsets where its use should be done with caution.
Expert Opinion:
Tofacitinib is helpful in the treatment of patients where the standard conventional or biological therapies have failed or were not tolerated. With lower costs of the generic drug than the biologicals (or biosimilars), it could be an important therapy in low- to middle-income countries. The risk of infections, especially Herpes Zoster and tuberculosis, needs to be addressed before initiation. Tofacitinib should be avoided in patients with venous thromboembolism and cardiovascular disease risk factors. Due to limited evidence, the use is not recommended in pregnancy, while it should be used with caution in elderly citizens. Future trials should look into the head-to-head comparison of tofacitinib with biologicals. The role of tofacitinib in acute severe colitis needs evaluation with comparative trials with current standards of care.
Insights
Tofacitinib offers a cost-effective treatment option for ulcerative colitis (UC) when other therapies fail. Caution is advised for specific patient groups due to potential risks like infections and cardiovascular issues.
Area of Science:
- Gastroenterology
- Pharmacology
- Immunology
Background:
- Ulcerative colitis (UC) treatment requires cost-effective, non-immunogenic drugs with favorable safety profiles.
- Tofacitinib presents a potential therapeutic option for UC patients.
- Existing therapies may be ineffective or poorly tolerated by some UC patients.
Purpose of the Study:
- To evaluate the existing literature on tofacitinib for ulcerative colitis treatment.
- To determine the appropriate positioning of tofacitinib within the current therapeutic landscape.
- To identify patient subsets requiring cautious use of tofacitinib.
Main Methods:
- Literature review of available studies on tofacitinib in ulcerative colitis.
- Analysis of efficacy, safety, and cost-effectiveness data.
- Assessment of tofacitinib's role compared to conventional and biologic therapies.
Main Results:
- Tofacitinib is effective for patients refractory to conventional or biologic therapies.
- Generic tofacitinib offers a lower-cost alternative, particularly beneficial for low- to middle-income countries.
- Key risks include infections (Herpes Zoster, tuberculosis), and contraindications exist for patients with venous thromboembolism or cardiovascular disease risk factors.
Conclusions:
- Tofacitinib is a valuable treatment for ulcerative colitis, especially in resource-limited settings.
- Careful patient selection is crucial, considering risks and contraindications.
- Further research, including head-to-head trials with biologics and evaluation in acute severe colitis, is warranted.
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