MMX Mesalazine Research Articles

Comparative evaluation of the effectiveness of monotherapy of ulcerative colitis with mesalazine MMX and combination therapy with non-prolonged mesalazines with rectal forms

Introduction. According to clinical guidelines, the treatment of patients with ulcerative colitis (UC) is carried out as combination therapy with mesalazine in rectal forms.The aim was to compare the effectiveness of treatment of moderate severity UC patients receiving mesalazine MMH as monotherapy and mesalazine in combination with mesalazine for rectal use.Materials and methods. Comparative clinical analysis of the results of treatment of patients with moderate UC receiving mesalazine MMX as monotherapy (1st group, 44 patients) and mesalazine in combination with mesalazine for rectal use (microclysters, suppositories) (2nd group, 40 patients) was performed.Results and discussion. After 2 weeks of therapy with mesalazine MMX, 95.0% of the 1st group patients responded to therapy with mesalazine MMX and continued treatment with it as monotherapy (without microclysters and suppositories). In Group 2, 97.2% of patients responded to mesalazine therapy and continued treatment with topical forms of mesalazine - microglia and suppositories. After 12 weeks, 87.5% of the 44 patients in Group 1 who responded to mesalazine MMX therapy and 88.9% of the 40 patients in Group 2 who responded to mesalazine therapy achieved clinical remission. After 52 weeks, 82.5% of 44 Group 1 patients and 86.1% of 40 Group 2 patients remained in clinical remission. The Meio index decreased from 7.9 ± 0.13 to 2.4 ± 0.4 points in group 1 and from 8.0 ± 0.17 to 2.3 ± 0.2 in group 2. There was no statistically significant difference in the level o laboratory indices between the groups after 12 and 52 weeks (p > 0.05).Conclusion. Our study confirms that continuous regular administration of MMX mesalazine as monotherapy in doses according to the clinical guidelines is comparable in its effectiveness to combined therapy with non prolonged mesalazine and topical forms of mesalazine in patients with UC of moderate severity.

Prospects of MMX Mesalazine in Routine Outpatient Treatment of Ulcerative Colitis

Aim. A general review of treatment approaches to ulcerative colitis (UC) and the importance of oral 5-aminosalicylic acid (5-ASA) for its routine outpatient management.Key points. The choice of drug therapy for UC remission induction and maintenance is linked to the intestinal lesion extent and disease attack severity. The 5-ASA therapy remains the mainstay UC treatment in routine outpatient practice, with prescription rate of 80–90%. Oral 5-ASA drugs are often used in monotherapy or when oral and rectal 5-ASAs are recommended in combination. As a sustained-release medication, the MMX mesalazine multi-matrix delivery system provides for higher active substance dosages along entire colonic mucosa, including its distal portions. A higher active substance dosage per tablet reduces the number of intakes and ensures a better patient adherence, both in terms of daily and long-term therapy.Conclusion. The 5-ASA drugs are most commonly prescribed in outpatient practice. Sustained-release 5-ASAs provide for a more effective active ingredient distribution at higher dosages along colonic mucosa.

Real-world experience with MMX mesalazine use in Mexican patients with ulcerative colitis at two tertiary care centers

Introduction and aimsThe 5-aminosalicylates, especially mesalazine, are the first option in the treatment of mild-to-moderate ulcerative colitis (UC). High rates of remission induction and maintenance have been observed with the new multimatrix (MMX) mesalazine formulation, mainly in patients with distal disease. Our aim was to describe the real-world experience with MMX mesalazine in patients with UC at two tertiary care centers. Materials and methodsA retrospective cohort study was conducted that included 142 patients with confirmed UC diagnosis, analyzed in three study groups: 1) oral MMX mesalazine as monotherapy for remission induction, 2) oral MMX mesalazine as monotherapy for remission maintenance, and 3) oral MMX mesalazine plus topical therapy for remission induction. ResultsThe frequency of clinical remission induction in group 1 was 80.3%, with biochemical remission of 74.2%. Group 2 had 100% clinical and biochemical remission maintenance. The frequency of clinical remission induction in group 3 was 88.6%, biochemical remission was 85.7%, and topical therapy was suspended in 87.3% at the end of follow-up. No adverse events were documented. ConclusionsThere were high percentages of clinical and biochemical remission in the two corresponding study groups and topical therapy was suspended in the majority of patients in ashort follow-up period.

Evaluation of the efficacy of MMX mesalazine therapy for moderate ulcerative colitis

Introduction. Treatment of patients with ulcerative colitis (UC) requires continuous anti-relapse therapy. Mesalazines are the firstline disease-modifying drugs for the treatment of mild to moderate UC to manage exacerbations and to induce and maintain remission.This paper is aimed at comparing the efficacy of treatment of patients with pancolitis and left-sided ulcerative colitis of moderate severity, who received MMX mesalazine as monotherapy and MMX mesalazine combined with mesalazines in the form of microclysters and suppositories.Materials and methods. A comparative clinical evaluation of the outcomes of treatment of patients with moderate UC who received MMX mesalazine as monotherapy (group 1) and MMX mesalazine combined with topical mesalazine (microclysters, suppositories) (group 2) was carried out. 40 patients with UC (group 1) and 46 (group 2) were examined.Results and discussion. Two weeks after MMX mesalazine therapy initiation, 92.8% of patients in group 1 responded to MMX mesalazine therapy and continued using the drugs as monotherapy (without microclysters and suppositories). In group 1, 95.6% of patients responded to MMX mesalazine therapy and continued treatment with topical mesalazines (microclysters and suppositories). At week 12, 54.3% of 35 patients in group 1, who responded to MMX mesalazine therapy, achieved clinical remission, 45.7% achieved clinical endoscopic remission. The Mayo Score decreased from 8.0 ± 0.17 to 2.3 ± 0.3 points. At week 12, 57.1% of patients with UC in group 2, who responded to MMX mesalazine therapy, achieved clinical remission, and 42.9% achieved clinical and endoscopic remission. The Mayo Score decreased from 7.85 ± 0.14 to 2.4 ± 0.3 points. There was no statistically significant difference in the level of laboratory findings between the groups of patients at 12 weeks and at 52 weeks (p> 0.05).Conclusion. The long-term continuous administration of MMX mesalazine in patients with pancolitis and left-sided ulcerative colitis of moderate severity as monotherapy during the year is comparable in its efficacy with combined MMX mesalazine therapy and topical forms of mesalazine.

PGI20 MULTIMATRIX VERSUS TIME-DEPENDENT DELIVERY OF MESALAZINE FOR ULCERATIVE COLITIS THERAPY IN KAZAKHSTAN: A HEALTH ECONOMIC EVALUATION

Heavy costs associated with the treatment of unspecified ulcerative colitis necessitate the choice of drugs that provide the optimal treatment outcomes within the existing budget constraints. In this study, we compared the multimatrix (MMX) delivery type versus time-dependent delivery of mesalazine for treatment of unspecified ulcerative colitis in terms of their clinical and economic effectiveness. A review of clinical effectiveness was conducted using a sensitive search strategy. 5 high-quality trials identified and used to inform clinical effectiveness parameters in the model. The economic assessment involved the construction of a Markov model comparing the two delivery types over both a short-term (5 years) and a long-term horizon (30 years) using local treatment guidelines and costs, an additional budget impact analysis and a sensitivity analysis of model parameters. The exchange rate used is dated by June 2019 according to the current market rate in Kazakhstan. According to the model, MMX delivery of mesalazine as first-line therapy for unspecified ulcerative colitis was found to be the dominant therapy compared to time-dependent delivery, producing better outcomes at lower costs (additional 0.015 QALY) and averted costs of 193662 KZT (504.32 USD) per patient in the 5-year model, additional 0.038 QALY and averted costs of 1066659 KZT (2777.7 USD) per patient in the 30-year model). MMX mesalazine was associated with a longer remission stage and fewer relapses. The model was found to be sensitive to MMX mesalazine treatment response period, probability of progression to remission on MMX mesalazine and treatment-related costs. Using the MMX delivery of mesalazine in favor of time-dependent delivery for the treatment of unspecified ulcerative colitis appears to be a cost-effective option in the context of healthcare system of Kazakhstan, with potentially improved outcomes and considerable healthcare budget savings.

Multi Matrix System Mesalazine Plus Rectal Mesalazine in the Treatment of Mild to Moderately Active Ulcerative Proctitis

Background: Mesalazine 1 g suppository/die is used for mild to moderately active ulcerative proctitis (UP). Whether addiction of Multi Matrix System (MMX) mesalazine increases the remission rate of UP and prevents proximal extension of disease is unknown. Methods: This is a retrospective study on 116 outpatients with UP who had been treated with one of the following regimens: (1) MMX mesalazine 1.2 g/die plus mesalazine suppositories for 8 ± 2 weeks and, subsequently, MMX mesalazine 1.2 g/die plus rectal mesalazine 1 g every other day for at least 6 months; (2) mesalazine 1 g suppositories/die alone for 8 ± 2 weeks and, subsequently, rectal mesalazine 1 g every other day for 6 more months. Patients were evaluated clinically at 2 months (±2 weeks) and endoscopically at 6 months (±2 weeks). For categorical variables, Pearson chi-square test was used. Results: A total of 46 of 55 patients (84%) on combined therapy and 49 of 61 patients (80%) on rectal mesalazine reached clinical remission (p > 0.05; OR 0.79, 95% CI 0.30–2.07). At 6 months follow-up, proximal extension of disease was observed in 7 of 55 (14%) patients on combined therapy and in 18 of 61 (29%) patients on rectal mesalazine alone (p < 0.05; OR 2.87, 95% CI 1.09–7.53). Conclusions: Oral MMX mesalazine plus rectal mesalazine combined treatment is associated with prevention of proximal extension of the disease compared with rectal mesalazine alone.

Experiencia clínica en el tratamiento con mesalazina MMX en monoterapia en los pacientes con colitis ulcerosa

5-ASA are the first-line treatment of mild to moderate UC, the rectal being the most used for distal colitis and combination with oral formulations in the most extensive. Oral formulation is often patient preference and it affects crucially on patient adherence to the prescribed treatment. The MMX system allows the sustained release of the active ingredient throughout the colon allowing its use in monotherapy. A retrospective analysis was conducted to assess the degree of response to MMX mesalazine depending on the disease extension. At MMX mesalazine treatment beginning, 71% of patients had active UC and 29% were in remission. Regarding the extension, 31% of the cases were proctitis, 23% proctosigmoiditis and 46% left side colitis. The initial dose was 4.8g/day in most active UC cases (54.4%) and 2.4g/day (79.2%) in remission. After treatment initiation 55% resolved symptoms; no relation with the extension of the disease was observed.

Role of pharmacoepidemiology studies in addressing pharmacovigilance questions: a case example of pancreatitis risk among ulcerative colitis patients using mesalazine.

PurposeWell-designed pharmacoepidemiology studies address several limitations of postmarketing spontaneous reports in regard to signal evaluation. This study evaluated a signal of disproportionate reporting of acute pancreatitis cases observed in patients with ulcerative colitis (UC) treated with MMX Multi Matrix System® (MMX®) mesalazine and demonstrated how inherent limitations of postmarketing reports were overcome.MethodsAdults with UC who were new users of MMX mesalazine or another branded mesalazine (controlled-release, delayed-release, or extended-release mesalazine; balsalazide disodium; olsalazine sodium; sulfasalazine; or sulfasalazine delayed-release) were identified from a large US administrative healthcare claims database. Acute pancreatitis incidence rates were compared between patients on MMX mesalazine versus comparator therapies. Propensity scores were used to match patients on MMX mesalazine with patients on comparator drugs to achieve a balance of baseline patient factors.ResultsCrude incidence rates [95 % confidence interval (CI)] of acute pancreatitis among patients on MMX mesalazine were similar to those of patients on comparator therapies [8.55 (5.54–13.21) vs 10.05 (7.54–13.41) per 1000 person-years]; the resulting incidence rate ratio (IRR) was [0.85 (0.48–1.47)]. Propensity score-matching had little influence on the IRR [0.84 (0.46–1.55)]; nor did further adjustment by demographic characteristics, daily dose, and causes of acute pancreatitis [0.76 (0.41–1.43)].ConclusionFindings of no increase in pancreatitis risk with MMX mesalazine demonstrate the value of pharmacoepidemiology studies for evaluating a drug’s postmarket safety profile when confronted with spontaneous reporting data suggestive of a safety issue.Electronic supplementary materialThe online version of this article (doi:10.1007/s00228-014-1660-7) contains supplementary material, which is available to authorized users.

P394 Pooled clinical trial analysis of MMX mesalazine safety: Focus on 4.8 g/d dose long-term exposure

Background: Mesalazine (5-aminosalicylic acid) is standard first-line treatment for mild-to-moderate ulcerative colitis (UC), and has been studied for the treatment of diverticulitis (DV). Although there is some evidence of improved efficacy in induction of remission in UC with high-dose treatment, data are limited on the safety of long-term high-dose mesalazine treatment. This analysis examines the safety profile of highdose (4.8 g/d) MMX mesalazine administered for 2 years to patients with DV, pooled from 2 studies. Methods: Two Phase 3, randomized, double-blind, placebocontrolled, multicenter studies (PREVENT1, NCT00545740; PREVENT2, NCT00545103; sponsor, Shire Development LLC) evaluated the efficacy and safety of 3 dose regimens of oncedaily MMX mesalazine (1.2 g, 2.4 g, or 4.8 g) versus placebo in the prevention of recurrent DV in adult patients over a period of 104 wks. Results: A total of 1,182 total patients were enrolled in PREVENT1 and PREVENT2, and 301 were randomized to receive 4.8 g/d MMX mesalazine. Of these, 299 were administered 1 dose of MMX mesalazine (mean [SD] age, 55.6 [11.9] y; 46.8% male). Mean (SD) treatment exposure was 64.4 (42.7)wks. Among patients who received 1 dose of MMX mesalazine, 211 (70.6%) reported 1 treatment-emergent adverse event (TEAE; 1006 events reported); 59 (19.7%) patients experienced only mild TEAEs, 114 (38.1%) experienced TEAEs with a maximum severity of moderate, and 38 (12.7%) experienced severe TEAEs. Serious TEAEs were reported by 32 (10.7%) patients (38 events). A total of 51 (17.1%) patients experienced TEAEs determined to be related to study treatment (102 events), and 4 (1.3%) patients reported serious TEAEs related to study treatment (4 events). A total of 36 (12.0%) patients experienced TEAEs that led to withdrawal from their respective studies. The most frequently reported TEAEs (>5%) were abdominal pain (11.0%), diarrhoea (10.0%), headache (9.3%), back pain (6.3%), urinary tract infection (6.0%), nausea (5.3%), and upper respiratory tract infection (5.3%). Conclusions: Pooled analysis of adverse event data from longterm exposure to MMX mesalazine 4.8 g/d in patients with a history of DV showed that high-dose MMX mesalazine was welltolerated for 2 years.

P514 Disease-specific health-related quality of life in adult patients with mild to moderate ulcerative colitis receiving short-term and long-term daily treatment with MMX mesalazine

P514 Disease-specific health-related quality of life in adult patients with mild to moderate ulcerative colitis receiving short-term and long-term daily treatment with MMX mesalazine

P456 Impact of short-term and long-term daily therapy with MMX mesalazine on work-related outcomes in patients with mild-to-moderate ulcerative colitis

P456 Impact of short-term and long-term daily therapy with MMX mesalazine on work-related outcomes in patients with mild-to-moderate ulcerative colitis

Commentary: impact of MMX mesalazine on health‐related quality of life in ulcerative colitis

Solomon et al. present evidence that daily MMX mesalazine therapy is associated with improvement in disease-specific, health-related quality of life (HRQL), as measured by the short inflammatory bowel disease questionnaire (SIBDQ), in patients with mild-moderate active ulcerative colitis (UC) and that this HRQL is maintained in patients with quiescent UC, when treatment is continued.1 In addition to its central finding, this study adds evidence of the previously suggested relationship between HRQL and patient-reported measures of disease activity – including stool frequency (SF) and rectal bleeding score (RBS).2, 3 Ulcerative colitis carries a significant psychological and social burden.4, 5 Maintaining HRQL is therefore important in long-term management and increasingly recognised as a critical end-point in randomised controlled trials in UC. Patient-reported measures are non-invasive and may be simple, capturing features of importance to patients. The authors stressed the correlation between changes in the SIBDQ and the SF and RBS, suggesting that the improvements in HRQL are mediated through improvements in bowel symptoms. However, there were significant improvements in all domains of the SIBDQ over the acute phase, although more patients showed an improvement in the bowel symptoms domain than the other domains, implying a smaller effect size for these latter items. Interpretation of the data is limited by the lack of a comparator arm, variable treatment dose in the acute phase and incomplete data availability (only 103/137 had interpretable data at the beginning and end of the acute phase). Multiple statistical comparisons were made and it is not clear whether appropriate adjustments were made. Despite its limitations, this study helpfully documents improvement or maintenance of HRQL with MMX mesalazine treatment, but cannot confirm that the effect is due to treatment or its size. This - as the authors indicate - would require a randomised, controlled study. Declaration of personal and funding interests: None.

The impact of MMX mesalazine on disease‐specific health‐related quality of life in ulcerative colitis patients

Past studies with ulcerative colitis (UC) patients indicate that disease activity strongly predicts health-related quality of life (HRQL). To examine the degree to which daily treatment with MMX mesalazine predicts improved HRQL for patients with active UC and with stable HRQL for patients with quiescent UC. Data from two phases of a multicentre open-label trial were examined. In the acute phase, 132 patients with mild-to-moderate active UC received MMX mesalazine 2.4-4.8 g/day for 8 weeks, while 206 patients with quiescent UC received MMX mesalazine 2.4 g/day for a 12-month maintenance phase. Disease-specific HRQL was measured at baseline and endpoint of each phase using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Repeated-measures anova models examined baseline-endpoint changes in SIBDQ, stool frequency (SF), and rectal bleeding severity (RBS). Correlations assessed the associations between SIBDQ and SF/RBS scores, while ancova techniques tested the sensitivity of SIBDQ to disease recurrence. SIBDQ scores significantly increased for active mild-to-moderate UC patients following 8 weeks of treatment, while SIBDQ scores remained stable for quiescent UC patients following 12 months of treatment. Changes in SIBDQ scores correlated significantly with changes in SF and RBS scores. Patients with recurrent UC at maintenance phase endpoint had significantly lower SIBDQ scores than nonrecurrent patients. Daily MMX mesalazine therapy was associated with significant improvement in disease-specific HRQL for patients with mild-to-moderate active UC and with the maintenance of HRQL for patients with quiescent UC. In both patient groups, HRQL was significantly associated with disease activity.

MMX® Mesalazine

The Multi MatriX system (MMX®) formulation of mesalazine (Lialda®; Mesavancol®; Mezavant®) [henceforth referred to as MMX mesalazine] is an oral, high-dose, once-daily, gastro-resistant, prolonged-release formulation indicated for use in patients with mild to moderate ulcerative colitis. Mesalazine has numerous anti-inflammatory effects on the mucosa of the colon, parts of which are frequently inflamed in ulcerative colitis. MMX mesalazine is believed to act topically. Therapy with MMX mesalazine 2.4 or 4.8 g once daily for 8 weeks was superior to placebo in inducing clinical and endoscopic remission in patients with mild to moderate ulcerative colitis. In 12-month maintenance trials, MMX mesalazine 2.4 g/day maintained remission in about two-thirds of patients and was as effective as Asacol® 2.4 g/day (another oral formulation of mesalazine) as maintenance therapy. In general, MMX mesalazine was well tolerated in both short- and long-term clinical trials; its tolerability profile did not differ clinically to that of placebo or Asacol®. The majority of adverse events reported in clinical trials were gastrointestinal in nature. Therefore, MMX mesalazine appears to be a valuable option in the management of patients with mild to moderate ulcerative colitis.

A cost-effectiveness analysis of MMX mesalazine compared with mesalazine in the treatment of mild-to-moderate ulcerative colitis from a UK perspective

Objectives: To perform a cost-utility analysis of a new formulation of mesalazine (Mezavant XL, MMX mesalazine) versus an existing oral mesalazine (Asacol; mesalazine) from the UK National Health Service perspective.Methods: A 5-year Markov cohort model was developed. Costs were obtained from the literature and utilities from an independent study. Uncertainty was evaluated using one-way and probabilistic sensitivity analyses (PSA). The potential effect of dosing frequency on adherence and possible long-term effects of remission maintenance on colorectal cancer (CRC) rates were also investigated.Results: The model suggested that 5-year therapy with MMX mesalazine was likely to generate gains when compared with mesalazine, including a gain of 0.011 QALYs per patient, 19 more remission days, and 12% fewer hospitalizations and surgical episodes. These gains came at an increase in total NHS direct cost of £8, resulting in an incremental cost-effectiveness ratio (ICER) of £749. The PSA suggested that MMX mesalazine had a 62% chance of resulting in cost savings, and a 74% chance of being cost effective (£20,000 threshold). Extended analysis including adherence and CRC effects suggested further incremental benefit of MMX mesalazine over mesalazine could be expected. Limitations include uncertainty in extrapolation to a 5-year time horizon and impact of adherence and drug acquisition costs on outcomes.Conclusion: The pharmacoeconomic analysis suggested that MMX mesalazine is likely to produce small, but worthwhile, increases in total NHS direct cost while increasing time in remission and associated quality of life, when compared with mesalazine. Advantages in adherence to treatment with MMX mesalazine relative to mesalazine suggested that further health gains and cost savings can be obtained. Overall, these results suggest that MMX mesalazine is a cost-effective treatment for UC.

Mesalazine for ulcerative colitis: evidence for use

Ulcerative colitis is a chronic, idiopathic inflammatory disease of the colon characterized by periods of exacerbation and remission. Medical treatment aims to provide rapid effective relief from symptoms, modify the disease process and improve quality of life. Many oral preparations use multiple daily dosing regimens which can be inconvenient and affect treatment adherence leading to increased morbidity and risk of symptomatic relapse. This article examines the issues surrounding the use of mesalazine in ulcerative colitis, focusing on Mezavant XL (MMX mesalazine), a once-daily dosing formulation with patented multi-matrix system. The reader will gain an understanding of the pharmacology of the drug, evidence base for its use and implications for prescribing practice.

Maintenance of remission in patients with ulcerative colitis with once- or twice-daily MMX™ mesalazine: results of an international multicentre randomised trial

Introduction: MMX Multi Matrix System® (MMX) mesalazine (MEZAVANT™; MEZAVANT™ XL [UK and Ireland]; LIALDA™ [USA]) is a once daily, high-strength (1.2g/tablet), prolonged-release formulation of 5-aminosalicylic acid (5-ASA). In this study, the safety and efficacy of MMX mesalazine when dosed once or twice daily, was evaluated in patients whose ulcerative colitis (UC) was in remission.

MMX mesalazine for the induction of remission of mild‐to‐moderately active ulcerative colitis: efficacy and tolerability in specific patient subpopulations

Two phase III studies have evaluated mesalazine (mesalamine) with MMX (Multi Matrix System) technology in patients with active mild-to-moderate ulcerative colitis. To determine the efficacy of MMX mesalazine for the induction of clinical and endoscopic remission in specific subgroups of patients with active, mild-to-moderate ulcerative colitis. Data from two double-blind, placebo-controlled trials were analysed (517 out-patients). Patients were randomized to receive MMX mesalazine [2.4 g/day (once daily or 1.2 g twice daily) or 4.8 g/day (once daily)] or placebo for 8 weeks. The percentages of patients treated with MMX mesalazine, 2.4 or 4.8 g/day, in clinical and endoscopic remission at week 8 were similar and significantly (P < 0.05) greater than placebo in subgroups stratified by disease extent, disease severity and gender and among patients not previously receiving low-dose 5-aminosalicylic acid. Among patients transferring directly from prior low-dose oral 5-aminosalicylic acid, MMX mesalazine 4.8 g/day was significantly (P = 0.018) more effective than placebo in inducing clinical and endoscopic remission. Efficacy over placebo did not reach significance in patients transferring directly to MMX mesalazine 2.4 g/day. MMX mesalazine is effective in active UC regardless of disease extent, disease severity, gender and previous, low-dose, 5-ASA therapy.

Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis

Aim:Maintenance treatment in ulcerative colitis should be as convenient as possible, to increase the chance of compliance. MMX mesalazine is a once-daily, high-strength (1.2 g/tablet) formulation of 5-aminosalicylic acid. This...

MMX Multi Matrix System® mesalazine for the induction of remission in patients with mild‐to‐moderate ulcerative colitis: a combined analysis of two randomized, double‐blind, placebo‐controlled trials

MMX mesalazine [LIALDA (US), MEZAVANT XL (UK and Ireland) MEZAVANT (elsewhere)] utilizes MMX Multi Matrix System (MMX) technology which delivers mesalazine throughout the colon. Two phase III studies have already evaluated MMX mesalazine in patients with active, mild-to-moderate ulcerative colitis. Aim To provide more precise estimates of the efficacy of MMX mesalazine over placebo by combining the patient populations from the two phase III studies. Methods Combined data from two 8-week, double-blind, placebo-controlled trials were analyzed. Patients randomized to MMX mesalazine 2.4 g/day (once daily or 1.2 g twice daily), 4.8 g/day (once daily) or placebo were reviewed. The primary end point was clinical and endoscopic remission (modified Ulcerative Colitis-Disease Activity Index 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 a >/=1-point reduction in sigmoidoscopy score from week 0). Results Data from 517 patients were analysed. 8-week remission rates were 37.2% and 35.1% in the MMX mesalazine 2.4 g/day and 4.8 g/day groups, vs. 17.5% on placebo (P < 0.001, both comparisons). 8-week complete mucosal healing rates were 32% in both MMX mesalazine groups compared with 16% on placebo. Adverse event frequency was similar in all groups. Conclusion MMX mesalazine is effective and generally well tolerated for inducing clinical and endoscopic remission of active, mild-to-moderate ulcerative colitis.