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An open-label trial of the PPAR-gamma ligand rosiglitazone for active ulcerative colitis
J D Lewis1, G R Lichtenstein, R B Stein
1Division of Gastroenterology, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia 19104-6021, USA.
Objectives:
Previous research has demonstrated that ligands for the gamma subtype of peroxisome proliferator-activated receptors (PPARs) reduce inflammation in two different murine models of colitis. This study was designed to examine the potential efficacy of rosiglitazone, a ligand for the gamma subtype of PPARs, as a therapy for active ulcerative colitis.
Methods:
Fifteen patients with mild to moderately active ulcerative colitis despite therapy with 5-aminosalicylic acid compounds were enrolled in an open-label study of rosiglitazone (4 mg b.i.d. p.o.) for 12 wk. Thirteen of 15 patients were receiving concomitant therapy with corticosteroids and/or immunomodulator medications. Disease activity was measured with the Disease Activity Index.
Results:
After 12 wk of therapy, four patients (27%) had achieved clinical remission, of whom three (20%) also had an endoscopic remission. Four additional patients (27%) had a clinical response without achieving remission. Two patients were hospitalized with worsened disease activity, and one patient was withdrawn for nephrotic syndrome.
Conclusions:
These data suggest that ligands for the gamma subtype of PPARs may represent a novel therapy for ulcerative colitis. A double blind, placebo-controlled, randomized trial is warranted.
Insights
Rosiglitazone, a PPAR-gamma ligand, showed potential in treating active ulcerative colitis. Further randomized trials are needed to confirm its efficacy as a novel therapy for this inflammatory bowel disease.
Area of Science:
- Gastroenterology
- Pharmacology
- Immunology
Background:
- Peroxisome proliferator-activated receptors gamma (PPARs) ligands reduce inflammation in colitis models.
- Ulcerative colitis (UC) is a chronic inflammatory bowel disease requiring new therapies.
Purpose of the Study:
- To evaluate rosiglitazone, a PPAR-gamma ligand, as a potential treatment for active ulcerative colitis.
- To assess the efficacy and safety of rosiglitazone in patients with UC.
Main Methods:
- Open-label study of 15 patients with active UC receiving rosiglitazone (4 mg b.i.d.) for 12 weeks.
- Patients had mild to moderate UC despite 5-aminosalicylic acid therapy; most also received corticosteroids/immunomodulators.
- Disease Activity Index (DAI) was used to measure disease activity.
Main Results:
- 27% of patients achieved clinical remission (20% with endoscopic remission) after 12 weeks.
- An additional 27% showed clinical response without remission.
- Two patients experienced disease worsening, and one withdrew due to nephrotic syndrome.
Conclusions:
- PPAR-gamma ligands, like rosiglitazone, may offer a novel therapeutic approach for ulcerative colitis.
- The preliminary findings warrant a larger, double-blind, placebo-controlled, randomized trial to confirm efficacy and safety.
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