NEW YORK (Reuters Health) – An infusion of dexamethasone-loaded autologous erythrocytes appears to be an effective treatment for mild-to-moderate ulcerative colitis that is refractory to mesalamine, new research suggests. Moreover, this treatment may offer a better safety profile than conventional steroid therapy.
Roughly one quarter of ulcerative colitis patients receiving oral steroids, the current first-line treatment for this condition, become steroid-dependent within 1 year and nearly all experience steroid-related side effects, Dr. Vito Annese, Ospedale “Casa Sollievo della Sofferenza” in San Giovanni Rotondo, Italy, and colleagues note. Using a patient’s own red blood cells to encapsulate the steroids may help localize the drugs to disease regions and reduce adverse events.
To investigate, Dr. Annese’s team assessed the outcomes of 40 patients who were randomized to receive two dexamethasone encapsulated erythrocyte (DEE) infusions 14 days apart, oral prednisolone, or sham infusions.
The researchers report their findings in the October issue of the American Journal of Gastroenterology.
At 8-week follow-up, 75% of DEE-treated patients and 80% given oral prednisolone were in clinical and endoscopic remission compared with just 10% of patients who received sham infusions (p < 0.001).
Relative to baseline values, C-reactive protein levels dropped significantly in both the DEE and prednisolone groups, but remained unchanged in the sham infusion group.
Eight of 10 patients treated with oral prednisolone experienced steroid-related adverse events compared with none of the 20 patients who received DEE, the report shows (p < 0.01).
“This study was small and follow-up was limited, but the findings are intriguing,” Dr. Michael F. Picco, from the Mayo Clinic in Jacksonville, Florida, comments in a related editorial. “These results should prompt further study of this method of drug delivery to confirm efficacy, assess short-term and possibly long-term side effects, and determine whether this translates into better overall safety.”
Am J Gastroenterol 2008;103:2509-2518.