Golimumab for moderately to severely active ulcerative colitis.
Saurabh Kedia1, Vineet Ahuja1, Govind K Makharia1
1a Department of Gastroenterology and Human Nutrition , All India Institute of Medical Sciences , New Delhi , India.
Expert Review of Clinical Pharmacology
|August 9, 2016
Summary
Golimumab, a new anti-TNF agent, shows efficacy and safety in treating ulcerative colitis (UC). It offers advantages in administration route and dosing frequency compared to existing therapies.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Anti-tumor necrosis factor (TNF) agents are crucial for moderate to severe ulcerative colitis (UC) unresponsive to conventional therapies.
- A significant therapeutic gap exists with current anti-TNF agents like infliximab and adalimumab, necessitating novel treatments.
- This review focuses on golimumab, a new anti-TNF agent, for UC management.
Purpose of the Study:
- To review the literature on the efficacy and safety of golimumab in ulcerative colitis.
- To evaluate golimumab's role in bridging the therapeutic gap in UC treatment.
- To compare golimumab with existing anti-TNF therapies.
Main Methods:
- A comprehensive literature search was conducted on PubMed using terms 'golimumab' and 'ulcerative colitis' up to March 2016.
- In vitro studies assessing golimumab's affinity and neutralization of TNF-α were reviewed.
- Data from two registration trials on golimumab's effectiveness and safety in UC patients were analyzed.
Main Results:
- Golimumab, a fully human monoclonal antibody, was FDA-approved for UC in 2013.
- In vitro, golimumab demonstrated superior affinity and neutralization of TNF-α compared to infliximab and adalimumab.
- Golimumab proved effective and safe for inducing and maintaining clinical remission, response, and mucosal healing in UC patients.
Conclusions:
- Golimumab is a valuable new therapeutic option for moderate to severe ulcerative colitis.
- While efficacy is comparable to infliximab and adalimumab, golimumab offers improved administration (subcutaneous) and dosing frequency (every 4 weeks).
- Golimumab helps address the unmet need in UC patients with suboptimal response to existing therapies.
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