Effect of extended MMX mesalamine therapy for acute, mild-to-moderate ulcerative colitis.
BACKGROUND
Many patients with ulcerative colitis (UC) respond to mesalamine therapy within 8 weeks. Those not achieving remission after 8 weeks are often treated with steroids or other immunosuppressive therapies. This study aimed to determine the effect of 8 weeks' high-dose MMX mesalamine extension therapy in patients with active, mild-to-moderate UC who had previously failed to achieve complete remission in 2 phase III, double-blind, placebo-controlled studies of MMX mesalamine (SPD476-301 and -302).


METHODS
Patients with active, mild-to-moderate UC who did not achieve clinical and endoscopic remission after <or=8 weeks' treatment with MMX mesalamine (2.4 or 4.8 g/day), ASACOL (mesalamine) delayed-release tablets 2.4 g/day, or placebo in the phase III studies received MMX mesalamine 4.8 g/day for 8 weeks. The aim was to assess remission at week 8, defined as a total modified UC Disease Activity Index score of <or=1, calculated as: scores of 0 for rectal bleeding and stool frequency, a combined Physician's Global Assessment score and sigmoidoscopy score of <or=1, no mucosal friability, and a >or=1 point reduction from baseline in sigmoidoscopy score.


RESULTS
Overall, 304 patients who entered this acute extension study were evaluated; 59.5% achieved remission at week 8. Remission rates were similar irrespective of prior treatment in the initial acute phase III studies.


CONCLUSIONS
Most patients with mild-to-moderate UC who fail to achieve remission with up to 8 weeks' initial mesalamine therapy can achieve clinical and endoscopic remission following a further 8 weeks' treatment with high-dose MMX mesalamine therapy, thereby avoiding step-up therapy.
Kamm
Michael A
MA
St Vincent's Hospital, Department of Medicine, University of Melbourne, Melbourne, Australia. kamm@medstv.unimelb.edu.au
Lichtenstein
Gary R
GR
Sandborn
William J
WJ
Schreiber
Stefan
S
Lees
Kirstin
K
Barrett
Karen
K
Joseph
Raymond
R
D000208:Acute Disease; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007390:International Agencies; D008297:Male; D020714:Maximum Tolerated Dose; D019804:Mesalamine / Q000627:therapeutic use*; D011379:Prognosis; D012074:Remission Induction; D012812:Sigmoidoscopy; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D019804:Mesalamine