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Tumor necrosis factor alpha blocking agents as treatment for ulcerative colitis intolerant or refractory to
Ruxi Lv1, Weiguang Qiao2, Zhiyong Wu3
1School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, People's Republic of China ; Research Institute of Traditional Chinese Medicine, Guangdong Medical College, Zhanjiang, Guangdong, People's Republic of China.
Background:
Efficacy of tumor necrosis factor alpha (TNF-α) blockers for treatment of ulcerative colitis that is unresponsive to conventional therapy is unclear due to recent studies yielding conflicting results.
Aim:
To assess the efficacy and safety of anti-TNF-α agents for treatment of ulcerative colitis patients who were intolerant or refractory to conventional medical therapy.
Methods:
Pubmed, Embase, and the Cochrane database were searched. Analysis was performed on randomized controlled trials that assessed anti-TNF-α therapy on ulcerative colitis patients that had previously failed therapy with corticosteroids and/or immunosuppressants. The primary outcome focused on was the frequency of patients that achieved clinical remission. Further trial outcomes of interest included rates of remission without patient use of corticosteroids during the trial, extent of mucosal healing, and the number of cases that resulted in colectomy and serious side effects.
Results:
Eight trials from seven studies (n = 2122) met the inclusion criteria and were thus included during analysis. TNF-α blockers demonstrated clinical benefit as compared to placebo control as evidenced by an increased frequency of clinical remission (p<0.00001), steroid-free remission (p = 0.01), endoscopic remission (p<0.00001) and a decrease in frequency of colectomy (p = 0.03). No difference was found concerning serious side effects (p = 0.05). Three small trials (n = 57) comparing infliximab to corticosteroid treatment, showed no difference in frequency of clinical remission (p = 0.93), mucosal healing (p = 0.80), and requirement for a colectomy (p = 0.49). One trial compared infliximab to cyclosporine (n = 115), wherein no difference was found in terms of mucosal healing (p = 0.85), colectomy frequency (p = 0.60) and serious side effects (p = 0.23).
Conclusion:
TNF-α blockers are effective and safe therapies for the induction and maintenance of long-term remission and prevention of treatment by colectomy for patients with refractory ulcerative colitis where conventional treatment was previously ineffective. Furthermore, infliximab and cyclosporine were found to be comparable for treating acute severe steroid-refractory ulcerative colitis.
Insights
Tumor necrosis factor alpha (TNF-α) blockers are effective for treating ulcerative colitis unresponsive to conventional therapies, improving remission rates and reducing colectomy needs. These agents are safe for induction and maintenance of long-term remission.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Efficacy of tumor necrosis factor alpha (TNF-α) blockers for ulcerative colitis (UC) refractory to conventional therapy remains debated.
- Conflicting results from recent studies necessitate a clear assessment of anti-TNF-α agents in this patient population.
Purpose of the Study:
- To evaluate the efficacy and safety of anti-TNF-α agents in ulcerative colitis patients intolerant or refractory to conventional medical therapy.
- To determine the impact of anti-TNF-α therapy on clinical remission, steroid-free remission, mucosal healing, colectomy rates, and serious side effects.
Main Methods:
- Systematic literature search of PubMed, Embase, and Cochrane databases.
- Analysis of randomized controlled trials (RCTs) in patients with ulcerative colitis previously treated with corticosteroids and/or immunosuppressants.
- Primary outcome: clinical remission; secondary outcomes: steroid-free remission, mucosal healing, colectomy, and serious adverse events.
Main Results:
- Eight trials (n=2122) showed TNF-α blockers significantly increased clinical remission (p<0.00001), steroid-free remission (p=0.01), and endoscopic remission (p<0.00001) compared to placebo.
- TNF-α blockers decreased colectomy frequency (p=0.03) without a significant increase in serious side effects (p=0.05).
- Infliximab showed comparable efficacy to corticosteroids and cyclosporine in specific subgroups regarding remission, mucosal healing, and colectomy rates.
Conclusions:
- TNF-α blockers are effective and safe for inducing and maintaining long-term remission in refractory ulcerative colitis patients.
- These agents can prevent colectomy in patients unresponsive to conventional treatments.
- Infliximab and cyclosporine demonstrate comparable outcomes for acute severe steroid-refractory ulcerative colitis.
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