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Long-term outcomes of thalidomide in refractory Crohn's disease
M E Gerich1, J L Yoon, S R Targan
1Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Insights
Thalidomide shows potential for treating refractory Crohn's disease (CD), with over half of patients responding. However, side effects like neuropathy are common, potentially limiting long-term use.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Previous studies suggest thalidomide may benefit refractory Crohn's disease (CD).
- Refractory CD presents a significant challenge in patient management.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of thalidomide in adults with refractory CD.
- To assess clinical response and remission rates in this patient population.
Main Methods:
- Retrospective study of 37 adults with refractory CD treated with thalidomide.
- Defined clinical response and remission criteria.
- Monitored clinical and safety outcomes over a median follow-up of 58 months.
Main Results:
- A 54% clinical response rate and 19% remission rate were observed.
- Higher response rates (85%) were seen with doses >50 mg/day compared to ≤50 mg/day (40%).
- Adverse events occurred in 68% of patients, with neuropathy reported in 38%.
Conclusions:
- Thalidomide demonstrates potential for significant clinical response in refractory CD.
- While generally safe and effective for some, side effects may impact long-term treatment.
- Dose-dependent response suggests optimized dosing may improve outcomes.
Background:
Several open-label and retrospective studies have indicated that thalidomide may be beneficial in patients with refractory Crohn's disease (CD).
Aim:
To report our long-term experience with the use of thalidomide for adults with refractory Crohn's disease.
Methods:
We conducted a retrospective study of long-term clinical and safety outcomes among adults treated with thalidomide for refractory Crohn's disease. Response was defined as a clinician's assessment of improvement after at least 7 days treatment of one or more of the following: bowel movement frequency, fistula output, rectal bleeding, abdominal pain, extraintestinal manifestations, or well-being. Remission required all of the following: <3 stools/day, no bleeding, abdominal pain or extraintestinal manifestations and increased well-being.
Results:
Thirty-seven adults with refractory Crohn's disease were treated with thalidomide for a median of 4.4 months and followed up for a median of 58 months. Clinical response and remission rates were 54% and 19%, respectively. About 40% of patients were able to stop steroids. Response rates were higher for those treated with more than 50 mg/day (85%) than for those treated with a maximum of 50 mg/day (40%; P = 0.01). An adverse event occurred in 68% of patients. Approximately one-third of patients (38%) experienced neuropathy.
Conclusions:
Thalidomide appears to be safe and effective in some patients with refractory Crohn's disease. Although side effects may limit long-term use, thalidomide has potential to induce significant clinical responses.
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