Small intestinal release mesalamine for the treatment of refractory celiac disease type I.
OBJECTIVE
The goal of this study is to evaluate the safety and efficacy of Small intestinal release mesalamine (SIRM) for symptom relief in refractory celiac disease (RCD).


BACKGROUND
Therapeutic options for the RCD are inadequate and treatment with corticosteroids and immunosuppressants is limited by side effects. SIRM has been shown to have local antiinflammatory action and excellent tolerability.


METHODS
We reviewed records of the RCD patients who received SIRM in an open-label therapeutic trial. Data included demographics, disease characteristics, dose and duration of SIRM therapy, and response. Response was categorized as complete if there was complete resolution of symptoms, partial if there was at least 50% improvement, and nonresponsive if there was less than 50% improvement.


RESULTS
Four patients were treated with SIRM alone and 6 received SIRM and oral budesonide. Within 4 weeks, 50% had complete response and an additional 10% had partial response. Two of the 6 patients were able to discontinue budesonide. One patient discontinued SIRM owing to headaches.


CONCLUSIONS
SIRM seems to be a safe and efficacious treatment option in patients with RCD. Larger, controlled trials of this agent are warranted.
Jamma
Shailaja
S
Celiac Center, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA. shailajajamma@yahoo.com
Leffler
Daniel A
DA
Dennis
Melinda
M
Najarian
Robert M
RM
Schuppan
Detlef B
DB
Sheth
Sunil
S
Kelly
Ciaran P
CP
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019819:Budesonide / Q000008:administration & dosage / Q000627:therapeutic use; D002446:Celiac Disease / Q000188:drug therapy*; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007421:Intestine, Small / Q000378:metabolism; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D005938:Glucocorticoids; D019804:Mesalamine; D019819:Budesonide