The Effect of Prolonged Therapy with MMX™ Mesalamine in Patients with Acute, Mild-to-Moderate Ulcerative Colitis
Bibliographic record
Abstract
Purpose: MMX mesalamine (LIALDA™[ US] MEZAVANT™ XL [UK & Ireland] MEZAVANT™[ elsewhere]), a novel, high-strength formulation of 5-aminosalicylic acid (5-ASA), has demonstrated induction of remission of mild-to-moderate ulcerative colitis (UC) in two phase III, placebo (pb)-controlled studies (SPD476–301 and -302 [parent studies]). The purpose of this analysis was to determine the proportion of patients (pts) not responding to acute treatment in these parent studies who could achieve remission in an 8-week extension study. Methods: Pts in the parent studies received MMX mesalamine 2.4 g/d (once daily [QD; 302] or 1.2 g twice daily [BID; 301]), 4.8 g/d (QD [301 and 302]), ASACOL® (mesalamine) delayed-release tablets (Procter & Gamble Pharmaceuticals, Cincinnati, OH, USA) 2.4 g/d (0.8 g three times daily [TID; 302]) or pb [301 and 302] for 8 weeks. Pts not in remission after the parent studies could receive an additional 8 weeks’ high-dose (4.8 g/d [2.4 g BID]) MMX mesalamine therapy in the extension phase of this open-label trial (SPD476–303). Remission rates (modified UC Disease Activity Index score of ≤1, calculated as: rectal bleeding and stool frequency scores of 0; a combined Physician's Global Assessment and sigmoidoscopy score of ≤1; no mucosal friability; and ≥1-point reduction in sigmoidoscopy score from baseline) were calculated at week 8 of the extension study. Results: A total of 304 pts entered the 8-week extension phase and were included in the efficacy population. Overall, 59.5% of pts achieved stringently defined remission. Remission rates were similar regardless of previous treatment in the parent studies: pb = 57.0%; MMX mesalamine 2.4 g/d (QD or BID) = 61.5%; MMX mesalamine 4.8 g/d (QD) = 60.3%; ASACOL 2.4 g/d (0.8 g TID) = 61.0%. Conclusion: An additional 8 weeks’ MMX mesalamine therapy was able to induce stringently defined remission in a large proportion of pts failing an initial 8 weeks of 5-ASA therapy. Some pts may therefore avoid therapeutic escalation by continuing 5-ASA treatment beyond 8 weeks; although further studies are required to confirm this.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".