Maintenance Treatment Of Ulcerative Colitis Research Articles

Comparison of Long-term Outcomes of MMX Mesalamine Maintenance Treatment for Ulcerative Colitis (UC) between Patients (Pts) in Complete Remission (CR) and Partial Remission (PR) Following Induction

Comparison of Long-term Outcomes of MMX Mesalamine Maintenance Treatment for Ulcerative Colitis (UC) between Patients (Pts) in Complete Remission (CR) and Partial Remission (PR) Following Induction

Benefit-Risk Assessment of Adalimumab as Maintenance Treatment for Ulcerative Colitis: NEAR Analysis of Week 8 Responders in ULTRA 2

Benefit-Risk Assessment of Adalimumab as Maintenance Treatment for Ulcerative Colitis: NEAR Analysis of Week 8 Responders in ULTRA 2

P213 Benefit risk assessment of adalimumab as maintenance treatment for ulcerative colitis: Near analysis of week 8 responders in ULTRA 2

P213 Benefit risk assessment of adalimumab as maintenance treatment for ulcerative colitis: Near analysis of week 8 responders in ULTRA 2

Usefulness of salicylate and thiopurine coprescription in steroid-dependent ulcerative colitis and withdrawal strategies

5-aminosalicylic acid (5-ASA) and thiopurines (azathioprine and mercaptopurine) are the most common drugs used as a maintenance treatment for ulcerative colitis. A considerable proportion of these patients develop corticosteroid dependency, and thiopurines are the standard treatment in this scenario. Dual prescriptions of both thiopurines and 5-ASA are common practice in steroid-dependent ulcerative colitis, in an attempt to optimize the efficacy of therapy. On the one hand, the potential protective role of 5-ASA against colorectal cancer argues in favour of prescription of both medications. The possible synergism between the two drugs, because of the inhibition of thiopurine methyltransferase (TPMT) enzyme activity by 5-ASA, has been postulated as another justification for dual prescription. However, existing evidence does not support that this combined strategy is superior to monotherapy with thiopurines. On the other hand, in patients showing prolonged disease remission, the possibility of discontinuing maintenance treatment can be considered on an individualized basis. The high frequency of relapses after thiopurine withdrawal should always be taken into account, but the potential adverse effects of the medication also need to be considered. A properly indicated treatment with thiopurines may need to be continued for life in many patients.

Clinical trial: ulcerative colitis maintenance treatment with 5‐ASA: a 1‐year, randomized multicentre study comparing MMX® with Asacol®

5-ASA-MMX (1.2 g/tablet) is a 5-aminosalicylic acid formulation, designed for once-daily dosing in the treatment of ulcerative colitis. To evaluate the efficacy and safety of 5-ASA-MMX (2.4 g/day, once daily), compared with Asacol (2.4 g/day, twice daily) in the maintenance of left-sided UC, through a double-blind, double-dummy, parallel-group, randomized, comparator study. In all, 331 patients with UC were randomized to receive either 5-ASA-MMX 2.4 g/day, once daily, or Asacol 2.4 g/day, twice daily, for 12 months. All patients were in remission for >or=1 month prior to the trial, with >or=1 documented relapse in the previous year. The co-primary endpoints of this study were the proportion of patients in clinical, and clinical and endoscopic remission following 12 months' treatment. In the intent-to-treat population, excluding those with major protocol deviations, 68.0 and 65.9% patients in the 5-ASA-MMX and Asacol groups, respectively, were in clinical remission (P = 0.69), and 60.9 and 61.7% of patients, respectively, were in clinical and endoscopic remission (P = 0.89). Diary card data revealed statistically significant treatment differences favouring 5-ASA-MMX. Both treatments were similarly tolerated. Once-daily 5-ASA-MMX is similarly effective with a comparable safety profile to Asacol administered twice daily, for the maintenance treatment of ulcerative colitis.

390 Maintenance Treatment of Ulcerative Colitis with 5-Aminosalicylic Acid (5-ASA): Results from the Italian Population of a One Year, Randomized, Multinational Study Comparing MMx® with Asacol®

Purpose: Basiliximab (BSX) is a chimeric monoclonal antibody that binds with high affinity to CD25, thereby inhibiting IL-2 binding, and IL-2 mediated proliferation of lymphocytes. Evidence suggests that IL-2 plays a role in the development of steroid-resistant T lymphocytes, and an open label study of BSX in steroid-resistant ulcerative colitis (UC) suggested benefits in reduced disease activity and steroid dose. We sought to determine the efficacy and safety of BSX in steroid-refractory UC. Methods: Adults with moderate to severe (Mayo score ≥6 and endoscopic subscore ≥2) UC extending above the rectum despite at least 14 days of oral prednisone (PRED) 40 to 50 mg/d prior to study entry. Concomitant 5ASA, 6MP/AZA were permitted with stable doses. Subjects with systemic features of toxicity, or who had received infliximab or cyclosporine within 3 months, or IV steroids or rectally administered medications within 2 weeks, were excluded. The first 135 subjects were randomized 1:1:1 to blinded BSX 40 mg, 20 mg, or placebo (PBO) IV at weeks 0, 2, 4. An additional 14 subjects were randomized to BSX 40 mg or placebo groups after the first 135 subjects were enrolled. All subjects received PRED 30 mg/d po from day 0 to week 2, then tapered by 5 mg weekly to 20 mg/d, and maintained this dose till week 8. The primary analysis was a comparison of the rate of clinical remission (Mayo score ≤2, no subscore >1) in the BSX 40 mg group compared to PBO at week 8. Secondary analyses compared BSX 20 mg to PBO at week 8, and clinical response (decrease in Mayo score by ≥3) for both groups to PBO at week 8 using Cochran-Mantel-Haenzel test stratified by Mayo Score (≤10, >10), use of 6MP/AZA, and geographic region of study site. Subjects were followed until week 12 for safety. The study had 80% power to detect a difference of 21% assuming PBO clinical remission rate of 19% with a 2-sided alpha of 0.1. Results: A total of 149 subjects were randomized and received at least 1 dose of study drug. Results are shown in the table below. Six subjects (2 in each group) had serious adverse events, including 1 patient assigned to BSX 20 mg who died with disseminated tuberculosis and previously undiagnosed HIV. Forty-five percent of subjects who received BSX developed neutralizing anti-BSX antibodies. Conclusions: Basiliximab was not effective for steroid sensitization and induction of remission in outpatients with steroid-resistant moderate-to-severe UC.

What is the optimal maintenance treatment for ulcerative colitis?

What is the optimal maintenance treatment for ulcerative colitis?

What is the optimal maintenance treatment for ulcerative colitis?

What is the optimal maintenance treatment for ulcerative colitis?

How long is it advisable to prolong maintenance treatment of patients with ulcerative colitis?

How long is it advisable to prolong maintenance treatment of patients with ulcerative colitis?

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...

Efficacy of Lactobacillus GG in maintaining remission of ulcerative colitis

Aminosalicylates are the mainstay of therapy to prevent relapse of quiescent ulcerative colitis. The rationale for using probiotics is based on the evidence implicating intestinal bacteria in the pathogenesis of this disorder. To evaluate the efficacy of Lactobacillus GG alone or in combination with mesalazine vs. mesalazine as maintenance treatment in ulcerative colitis. 187 ulcerative colitis patients with quiescent disease were randomized to receive Lactobacillus GG 18 x 10(9) viable bacteria/day (65 patients), mesalazine 2400 mg/day (60 patients) or Lactobacillus GG + mesalazine (62 patients). Disease activity index, endoscopic and histological scores were determined at 0, 6 and 12 months and in case of relapse. The primary end point was to evaluate sustained remission. Overall analysis showed no difference in relapse rate at 6 (P = 0.44) and 12 months (P = 0.77) among the three treatment groups. However, the treatment with Lactobacillus GG seems to be more effective than standard treatment with mesalazine in prolonging the relapse-free time (P < 0.05). Lactobacillus GG seems to be effective and safe for maintaining remission in patients with ulcerative colitis, and it could represent a good therapeutic option for preventing relapse in this group of patients.

Long‐term intermittent treatment with low‐dose 5‐aminosalicylic enemas is efficacious for remission maintenance in ulcerative colitis

Background: The standard remission maintenance treatment for ulcerative colitis (UC) is 5‐aminosalicylic acid (5‐ASA), given orally and topically and in different doses, with various frequencies and duration of administration. Both the efficacy of long‐term intermittent therapy with low‐dose 5‐ASA enemas in preventing UC relapses and its economic implications were evaluated. Methods: In accordance with a prospective case control study, 42 adult UC outpatients (29 M and 13 F) were treated with 5‐ASA tablets (1.6 g/day) and 5‐ASA enemas (2 g/50 mL) twice weekly, and 42 concurrent UC outpatients, matched for sex, age, extension and duration of disease, received only the oral therapy; the median treatment period was 6 years. Results: There was a significant reduction in the number (42%: P = 0.034) and incidence of relapses (43%: P = 0.022) in the patients receiving combined oral + topical 5‐ASA, who also had a significantly higher cumulative probability of not experiencing a first relapse (P = 0.001). There were no dropouts or side effects. Local therapy increased drug costs, but decreased the costs of relapses by 48% and completely precluded hospitalization costs. Conclusions: The scheduled oral + topical 5‐ASA treatment, at the lowest cumulative topical dosage tested over the longest known observation period, is efficacious in improving clinical outcome and decreasing overall costs in UC patients.

Long-term maintenance treatment in ulcerative colitis: a 10-year follow-up

With the extensive use of mesalamine, the natural history of ulcerative colitis is probably changed. To evaluate the relapse rate and the duration of remission in patients with ulcerative colitis on maintenance treatment with mesalamine. Enrolled in the study were 95 patients divided into 4 groups according to macroscopic location of the disease and treated with the same therapy starting from the date of enrolment. Patients in all 4 groups were followed-up until relapse occurred. The disease activity was evaluated by the Clinical Activity Index and Endoscopic Index. Patients suitable for recruitment showed a Clinical Activity Index and Endoscopic Index lower than 6 and 4, respectively. The patients with ulcerative pancolitis or left-sided colitis were treated with 1.6 g/day while the cases with proctosigmoiditis or proctitis were treated with 5-acetylsalicylic acid enemas 4 g/day Each patient was evaluated with clinical and endoscopic assessment at a 6-month interval. Relapse was defined as an increase in Clinical Activity Index and Endoscopic Index, of more than 6 and 4, respectively. Five patients dropped-out. All enrolled patients showed a clinical and/or endoscopic relapse within 10 years, the majority 2 or 3 years after diagnosis: pancolitis and left-sided colitis within 2-3 years and patients with distal colitis within 9-10 years. A relapse was observed in most cases within 3 years, and in all recruited patients within a space of ten years. The extent of the disease in the colon is an important prognostic factor, as patients with distal colitis showed a lesser tendency to relapse.

Hypersensitivity reaction to balsalazide

Balsalazide is used in short term and maintenance treatment of ulcerative colitis. It is a prodrug in which 5-aminosalicylic acid is linked via a diazo bond to 4-aminobenzoyl-β-alanine, an inert...

Probiotics and antibiotics in inflammatory bowel disease

Many experimental and clinical observations suggest a potential role for intestinal microflora in the pathogenesis of inflammatory bowel disease. Manipulation of the luminal content using antibiotics and/or probiotics may represent a potentially effective therapeutic option. Results of antibiotic treatment in inflammatory bowel disease are controversial, but this approach is frequently and successfully adopted in clinical practice. Recent data support the potential therapeutic role of probiotics in inflammatory bowel disease. In particular, a highly concentrated probiotic preparation was shown to be superior to placebo both on the prevention of pouchitis onset and of chronic pouchitis relapse. Its role in the maintenance treatment of ulcerative colitis and Crohn disease needs to be further assessed by large, double-blind, controlled trials. Future research needs to be focused on obtaining more precise information on the enteric microflora and the mechanisms of action of probiotics.

Hypersensitivity reaction to balsalazide

Balsalazide is used in short term and maintenance treatment of ulcerative colitis. It is a prodrug in which 5-aminosalicylic acid is linked via a diazo bond to 4-aminobenzoyl-β-alanine, an inert...

Guidelines for the treatment of ulcerative colitis in remission.

The role is reviewed of sulphasalazine, 5-aminosalicylic acid (5-ASA), immunosuppressive agents and corticosteroids in the maintenance treatment of ulcerative colitis in remission. Sulphasalazine and oral 5-ASA are the drugs of first choice in preventing relapses for patients suffering from intermittent chronic ulcerative colitis. Rectally administered 5-ASA may be a valid alternative for treating patients with proctitis and left-sided ulcerative colitis. The optimal dosage of oral 5-ASA in the maintenance therapy of ulcerative colitis in remission is not clear. However, there is evidence that a higher dose of 5-ASA is more effective than low dosage in preventing relapses in patients in remission. For patients with chronically active or steroid-dependent ulcerative colitis who have achieved remission while taking immunosuppressants, continuing azathioprine or 6-mercaptopurine is indicated. Existing data cast doubts as to whether or not continuous maintenance is still necessary in patients suffering from intermittent chronic ulcerative colitis with prolonged endoscopic, clinical and histological remission.

New salicylates as maintenance treatment in ulcerative colitis.

New salicylates as maintenance treatment in ulcerative colitis.

New salicylates as maintenance treatment in ulcerative colitis.

New salicylates as maintenance treatment in ulcerative colitis.

Newer Pharmacologic Agents for the Therapy of Inflammatory Bowel Disease

Topical 5-ASA Agents. Observations that 5-ASA may be the clinically active component of sulfasalazine have stimulated extensive pharmaceutical efforts to develop a new class of agents for the treatment of the inflammatory bowel diseases. Both oral and rectal forms of 5-ASA have been designed, tested, and released for use in Europe and Canada. Only one rectal 5-ASA formulation is now commercially available in the United States. Studies with topical 5-ASA have demonstrated that this formulation is safe and effective for distal colitis, even in patients with disease refractory to standard therapy. Adverse effects of topical 5-ASA are minimal. However, optimal treatment doses have not been defined, relapse is common after withdrawal of therapy, and issues regarding maintenance regimens are not yet resolved. Other disadvantages include the expense and inconvenience of enema therapy. However, rectally administered 5-ASA is an appropriate initial therapy for the treatment of distal ulcerative colitis, or as a therapeutic option for refractory distal colitis. Data are insufficient to make recommendations regarding the use of topical 5-ASA in Crohn's disease. Whether this class of agents will be of benefit for Crohn's proctitis or for perineal disease must await further clinical trials. Oral 5-ASA Agents. There appears to be a well-substantiated benefit equivalent to that of sulfasalazine achieved by the new oral formulations of 5-ASA when used for the treatment of acute mild to moderate ulcerative colitis, and as maintenance treatment of ulcerative colitis in remission. Adverse reactions to these agents are uncommon, usually mild, and infrequently require withdrawal of therapy. The major problem reported with these agents is watery diarrhea, most commonly associated with olsalazine, but the practical importance of this adverse effect is disputed. Rare occurrences of reversible pericarditis and acute pancreatitis have been encountered during clinical application of these agents. As more experience is obtained, these agents may become the initial therapy of choice for the treatment of mild to moderate ulcerative colitis and for maintenance in inactive disease. Currently available data have defined a role for these agents as an important alternative for the treatment of patients intolerant or allergic to sulfasalazine. As with sulfasalazine, these agents should not be used as the sole treatment for severely active ulcerative colitis. Many unanswered questions remain regarding therapy with these agents for ulcerative colitis. Still undefined are optimal drug dosages, appropriate dosing intervals, and the necessary duration of therapy.(ABSTRACT TRUNCATED AT 400 WORDS)