Mesalazine Therapy Research Articles

Rescate con sulfasalazina antes de inmunosupresores o agentes biológicos en la colitis ulcerosa mal controlada con mesalazina

IntroductionIn ulcerative colitis, aminosalicylates are the mainstay of maintenance therapy. Sulfasalazine was the first aminosalicylic used in the maintenance therapy of this disease. Later, mesalazine was preferred due to its supposedly better tolerability. However, recent studies indicate certain benefits of the use of sulfasalazine because of its possible superior effectiveness. The aim of this study was to determine whether patients with ulcerative colitis poorly controlled by mesalazine as maintenance therapy respond to sulfasalazine, thus avoiding the use of immunosuppressive or biological therapies. MethodsThe Inflammatory Bowel Disease Clinic of the Ramón y Cajal Hospital maintains a database in which all drug exposures are registered. We selected patients poorly controlled with mesalazine who had received sulfasalazine as rescue maintenance therapy. We determined the percentage of patients poorly controlled with mesalazine who responded to sulfasalazine. ResultsOf 415 patients with ulcerative colitis, 49 had been treated with sulfasalazine at some time. Of these, sulfasalazine was selected as an alternative therapy due to poor disease control with mesalazine. The median duration of mesalazine therapy until the switch was 20.8 months, with a median dose of 3.35g/day. In 21 of the 31 patients (67.7%), sulfasalazine was able to control symptoms and maintain remission. ConclusionDespite the limitations of this study, we found that 67.7% of patients with ulcerative colitis poorly controlled with mesalazine responded to a switch to sulfasalazine. These patients would normally have progressed to immunosuppressive, biological or surgical treatments. This option merits further studies. Meanwhile sulfasalazine should not be forgotten in the management of ulcerative colitis.

The clinical efficacy of mesalazine and bifid-triple viable combination therapy in patients with ulcerative colitis

Objective To observe the clinical efficacy of mesalazine and bifid-triple viable combination therapy in patients with ulcerative colitis (UC).Methods Thirty-eight UC patients were evenly divided into mesalazine group and combination group. Patients in mesalazine group were administrated with mesalazine (1.0 g/time,four times/day),and on the basis of this,the patients in combination group were added into bifid-triple viable (420 mg/time,three times/day).The course of treatment was eight weeks.The improvement of patients' clinical symptom and manifestation under colonoscope were observed at second day after hospitalization and eight weeks after medication.Mayo disease activity index was used for scoring.Before and after the treatment,the expression of intestinal mucosa nuclear factor kappa B (NF-κB),tumor necrosis factor-α (TNF-a) and cyclooxygenase-2 (COX-2) were tested by immunohistochemical staining and the levels of serum TNF-α,interleukin-8 (IL-8), interleukin-10 (IL-10) were determined by double antibody sandwich enzyme-linked immunosorbent assay.The level of serum superoxide dismutase (SOD) and malondialdehyde (MDA) was detected by nitrite method and thiobarbituric acid coloration method.Before and after treatment was compared with paired t-test,and qualitative data was analyzed with ordinal rank sum test.Results Mayo disease activity index score of the combination group decreased from 7.16±2.01 to 1.63± 1.30 while the mesalazine group from 7.42 ± 1.95 to 3.00 ± 1.25.The difference of reduction was statistically significant (t =2.093,P =0.043).The efficiency of the combination group was higher than that of mesalazine group (16/19 vs 10/19,Fisher's exact test,P=0.039).After treatment,the expressions of NF-κB,TNF-α and COX-2 in colonic mucosa of two groups were both lower than those of before treatment,and in combination group the decrease were more significant (t value was 2.262,2.607 and 2.522 respectively,P value was 0.027,0.012 and 0.014 respectively).After treatment,the concentration of IL-8 of mesalazine group and the combination group both significantly decreased,however IL-10 significantly increased. The difference between these two groups was statistically significant (t value of TNF-α,IL-8 and IL-10 was 4.244,6.858 and 6.802 respectively,all P＜ 0.01). After treatment,both SOD vitality of two groups increased compare with that before treatment,however the level of MDA was lower than that before treatment and the changes of combination group were more significant.Conclusion The combination therapy with mesalazine and bifid-triple viable can effectively suppress inflammatory response in mild and moderate ulcerative colitis,and bifid-triple viable may play a role as adjuvant therapy for patients with UC. Key words: Colitis, ulcerative; Cytokines; Reactive oxygen species; Mesalamine; Bifidobacterium ; Probiotics

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.

Mo1673 Evaluation of Mucosal Healing of Ulcerative Colitis by Using a Quantitative Fecal Immunochemical Test

Background and Aim: Evidence has been accumulated to show that achievement of mucosal healing (MH) is associated with sustained clinical remission, and reduced rates of hospitalization and surgical resection. The combination of oral and topical mesalazine is thought to be more effective than alone in patients with mild-to-moderate disatal colitis and mild-tomoderate extensive colitis. However, endoscopic evaluation of the combined treatment on colonic mucosa is scarce. We conducted conventional endoscopic evaluation as well as segmental endoscopic evaluation in mild-to-moderate ulcerative colitis (UC) patients treated with oral Pentasa® and Pentasa® enema. Materials and Methods: Patients with active mildto-moderate UC were included and treated with 4 g/day of mesalazine combined with 1 g/ day mesalazine enema for 8 wks. At both baseline and 8 wks patients were endoscopically asseseed using Mayo Endoscopic Score and using Segmental Endoscopic Score. Segmental endoscopic evaluation was performed for each of 8 contiguous anatomic segments (rectum below/above the peritoneal reflection, rectosigmoid, sigmoid, left colon, transverse, right colon, cecum). The criteria of segmental endoscopy included erythema, vascular pattern, friability and erosion/ulcer (score range per segment: 0 10). MH was defined as Mayo Endoscopic Score = 0, 1. Disease activity was also assessed at baseline and 8 wks using the UC Disease Activity Index (UCDAI), with clinical and endoscopic signs. Remission and improvement were defined as a UCDAI score < 2 and as a decrease of UCDAI score by ≥ 2 points from baseline, respectively. Abbreviated UCDAI score (aUCDAI) obtained from stool frequency, rectal bleeding and physician's global assessment was assessed at baseline, 4 and 8 wks. Result: Of the 31 patients included, 29 completed endoscopic evaluations at both baseline and 8 wks. Median disease duration was 72.7 months and mean baseline UCDAI score was 6.72. The extents of disease were 10.3% in proctitis, 34.5% in left-sided colitis and 55.2% in extensive colitis. Mayo endscopic score significantly decreased from 2.14 to 1.45 (p < 0.001) and MH rate was 51.7%. The segmental endscopic scores of every assessed area at 8 wks decreased significantly compared to that at baseline (Table). UCDAI significantly decreased from 6.72 to 3.00 (p < 0.001). Remission and improvement rates were 31.0% and 79.3%, respectively. aUCDAI significantly decreased from 4.59 at baseline to 1.76 at 4 wks and 1.55 at 8 wks (p < 0.001). Conclusion: These results demonstrate that the combination of oral and topical mesalazine ameliorates mucosal appearances of the whole colon with fast clinical improvement. Therefore, combined mesalazine therapy is thought to be the optimum first line therapy for mild-to-moderate UC patients independent of the extent of disease. Segmental Endoscopic Score

Mo1670 Segmental Endoscopic Evaluation of Combined Oral and Topical Mesalazine (Pentasa(r)) in Patients With Mild-to-Moderate Ulcerative Colitis

Background and Aim: Evidence has been accumulated to show that achievement of mucosal healing (MH) is associated with sustained clinical remission, and reduced rates of hospitalization and surgical resection. The combination of oral and topical mesalazine is thought to be more effective than alone in patients with mild-to-moderate disatal colitis and mild-tomoderate extensive colitis. However, endoscopic evaluation of the combined treatment on colonic mucosa is scarce. We conducted conventional endoscopic evaluation as well as segmental endoscopic evaluation in mild-to-moderate ulcerative colitis (UC) patients treated with oral Pentasa® and Pentasa® enema. Materials and Methods: Patients with active mildto-moderate UC were included and treated with 4 g/day of mesalazine combined with 1 g/ day mesalazine enema for 8 wks. At both baseline and 8 wks patients were endoscopically asseseed using Mayo Endoscopic Score and using Segmental Endoscopic Score. Segmental endoscopic evaluation was performed for each of 8 contiguous anatomic segments (rectum below/above the peritoneal reflection, rectosigmoid, sigmoid, left colon, transverse, right colon, cecum). The criteria of segmental endoscopy included erythema, vascular pattern, friability and erosion/ulcer (score range per segment: 0 10). MH was defined as Mayo Endoscopic Score = 0, 1. Disease activity was also assessed at baseline and 8 wks using the UC Disease Activity Index (UCDAI), with clinical and endoscopic signs. Remission and improvement were defined as a UCDAI score < 2 and as a decrease of UCDAI score by ≥ 2 points from baseline, respectively. Abbreviated UCDAI score (aUCDAI) obtained from stool frequency, rectal bleeding and physician's global assessment was assessed at baseline, 4 and 8 wks. Result: Of the 31 patients included, 29 completed endoscopic evaluations at both baseline and 8 wks. Median disease duration was 72.7 months and mean baseline UCDAI score was 6.72. The extents of disease were 10.3% in proctitis, 34.5% in left-sided colitis and 55.2% in extensive colitis. Mayo endscopic score significantly decreased from 2.14 to 1.45 (p < 0.001) and MH rate was 51.7%. The segmental endscopic scores of every assessed area at 8 wks decreased significantly compared to that at baseline (Table). UCDAI significantly decreased from 6.72 to 3.00 (p < 0.001). Remission and improvement rates were 31.0% and 79.3%, respectively. aUCDAI significantly decreased from 4.59 at baseline to 1.76 at 4 wks and 1.55 at 8 wks (p < 0.001). Conclusion: These results demonstrate that the combination of oral and topical mesalazine ameliorates mucosal appearances of the whole colon with fast clinical improvement. Therefore, combined mesalazine therapy is thought to be the optimum first line therapy for mild-to-moderate UC patients independent of the extent of disease. Segmental Endoscopic Score

Intensity of Proliferative Processes and Degree of Oxidative Stress in the Mucosa of the Ileum in Crohn’s Disease

The intensity of proliferative processes (estimated from Ki-67 expression) and degree oxidative stress (chemiluminescence assay) in biopsy specimens from the terminal portion of the ileal mucosa were studied in patients with Crohn's disease. Crohn's disease is characterized by hyper-regenerative processes in the ileal mucosa. The labeling index (Ki-67 expression) in biopsy specimens from the intact ileal mucosa in patients with the irritable bowel syndrome (reference group) was 10.64±0.62%. The corresponding values in patients receiving monotherapy with mesalazine (group 1) and combination therapy with mesalazine and dalargin (group 2) were 24.05±1.17 and 22.90±0.92%, respectively. Analysis of free radical oxidation showed that this state is accompanied oxidative stress. Spontaneous and H(2)O(2)-induced luminol-dependent chemiluminescence in biopsy specimens from the ileal mucosa was 1.8-2.3-fold higher compared to the reference group. After therapy, the labeling index in groups 1 and 2 decreased to 18.60±1.18 and 14.38±0.81%, respectively. Histologically, normalization of the disease symptoms was more pronounced after combination therapy. The decrease in free radical oxidation in this group of patients was more pronounced than after mesalazine monotherapy. Our results suggest that oxidative stress plays a role in the hyper-regenerative reaction.

Increasing Left-Side Acute Colonic Divertiulitis in Japan

Introduction: Recent evidence shows that inflammation is the main pathogenic mechanism for Colonic Diverticular Disease (CDD).(1) Mesalazine administration has shown clinical improvement in controlled studies (2,3). There are little data about histological changes after mesalazine therapy in CDD. In this study, we have evaluated if exist difference in colonic mucosa histology in patients with non-complicated symptomatic CDD (NCSCDD) treated with or without mesalazine. Objective: To evaluate the colonic mucosa histology from patients with NCSCDD treated with and without Mesalazine Methods: 27 adult (18 year or more) patients, 10 male and 17 female, with NCSCDD were included in this study. In addition to the clinical examination, the patients underwent an ova and parasite examination of stools, stool culture and imaging exams for the diagnosis of CDD. Patients on antibiotics and anti-inflammatory, currently or recently; and carriers of acute diverticulitis, cancer or other organic diseases were excluded. The patients were separated in 2 groups: Mesalazine Group (MG) 11 patients that had mesalazine administrated p.o. 800 mg, t.i.d. for 60 days; Control Group (CG) 16 patients that had only fiber supplements for 60 days. At the end of 60 days, colonoscopy was performed, with biopsy at the diverticulum's edges. On the histopathologic examination, a Histopathogical Score (HS) was used for histological evaluation and quantification regarding to epithelial cells, crypts, lamina propria mononuclear cells and lamina propria neutrophils (Max score =12 min sore=0). For statistical analysis, non paired t test and Fisher exact test were used, with statistical significance for p<0,05. Results: HS showed statistical significant results when compared MG x CG score (Mean+/SD, SEM), (0,45 +/0,69, 0,21) x (2,0 +/1,83, 0,46), (p=0.012).Also statistical significant results were seen when compared for absence (-) or presence (+) of inflammation signs : CG 13 (+) and 3 (-) X MG 3 (+) and 8 (-) p=0.0147 Colonic mucosal inflammation was absent on most of the patients of MG, fact that didn't happen on the CG. Conclusion:. The use of mesalazine on NCSCDD is associated with the normalization of the peridiverticular histology. 1 Di Mario F. et al., J Clin Gastroenterol. 2006 2 Gatta L.et al.,J Clin Gastroenterol. 2010 3 Tursi A and Papagrigoriadis S., Aliment Pharmacol Ther. 2009

Mesalazine and Peridiverticular Histology in Patients With Non-Complicated Symptomatic Colonic Diverticular Disease

Introduction: Recent evidence shows that inflammation is the main pathogenic mechanism for Colonic Diverticular Disease (CDD).(1) Mesalazine administration has shown clinical improvement in controlled studies (2,3). There are little data about histological changes after mesalazine therapy in CDD. In this study, we have evaluated if exist difference in colonic mucosa histology in patients with non-complicated symptomatic CDD (NCSCDD) treated with or without mesalazine. Objective: To evaluate the colonic mucosa histology from patients with NCSCDD treated with and without Mesalazine Methods: 27 adult (18 year or more) patients, 10 male and 17 female, with NCSCDD were included in this study. In addition to the clinical examination, the patients underwent an ova and parasite examination of stools, stool culture and imaging exams for the diagnosis of CDD. Patients on antibiotics and anti-inflammatory, currently or recently; and carriers of acute diverticulitis, cancer or other organic diseases were excluded. The patients were separated in 2 groups: Mesalazine Group (MG) 11 patients that had mesalazine administrated p.o. 800 mg, t.i.d. for 60 days; Control Group (CG) 16 patients that had only fiber supplements for 60 days. At the end of 60 days, colonoscopy was performed, with biopsy at the diverticulum's edges. On the histopathologic examination, a Histopathogical Score (HS) was used for histological evaluation and quantification regarding to epithelial cells, crypts, lamina propria mononuclear cells and lamina propria neutrophils (Max score =12 min sore=0). For statistical analysis, non paired t test and Fisher exact test were used, with statistical significance for p<0,05. Results: HS showed statistical significant results when compared MG x CG score (Mean+/SD, SEM), (0,45 +/0,69, 0,21) x (2,0 +/1,83, 0,46), (p=0.012).Also statistical significant results were seen when compared for absence (-) or presence (+) of inflammation signs : CG 13 (+) and 3 (-) X MG 3 (+) and 8 (-) p=0.0147 Colonic mucosal inflammation was absent on most of the patients of MG, fact that didn't happen on the CG. Conclusion:. The use of mesalazine on NCSCDD is associated with the normalization of the peridiverticular histology. 1 Di Mario F. et al., J Clin Gastroenterol. 2006 2 Gatta L.et al.,J Clin Gastroenterol. 2010 3 Tursi A and Papagrigoriadis S., Aliment Pharmacol Ther. 2009

Concomittant Mesalazine Therapy and Less Extensive Disease Protect Against Colectomy During Cyclosporine Rescue Therapy in Acute, Steroid-Refractory, Severe Ulcerative Colitis

Concomittant Mesalazine Therapy and Less Extensive Disease Protect Against Colectomy During Cyclosporine Rescue Therapy in Acute, Steroid-Refractory, Severe Ulcerative Colitis

Review article: delivery and efficacy of topical 5-aminosalicylic acid (mesalazine) therapy in the treatment of ulcerative colitis

The use of topical therapy in the treatment of ulcerative colitis has declined in recent years despite evidence of good efficacy. To review US prescription trends for 5-aminosalicylic acid (5-ASA) since the US approval of Asacol extended-release oral mesalazine (mesalamine) in 1992; to estimate the optimal level of 5-ASA exposure in the distal colon; to determine factors influencing distal colonic exposures; and to compare the effectiveness of different 5-ASA formulations (oral, topical suspension, foam, suppositories) in clinical trials. Review of clinical trials, physiologic studies and prescription trends of various mesalazine formulations for treatment of distal ulcerative colitis. Between 1992 and 2009, prescriptions for oral mesalazine increased sixfold, whereas topical suspensions declined by 10%. In clinical trials, topical therapy resulted in higher remission and clinical response rates than oral therapy, with trends to earlier improvement. The mucosal concentrations of 5-ASA achieved by topical agents in the distal colon were up to 200-fold higher than those achieved by oral administration alone. Despite active colitis, over 40% of a topically administered 4 g 5-ASA suspension (equal to 1.6 g) reached the sigmoid colon. This likely represents a therapeutic exposure of 5-ASA. Although topical therapies are less convenient than oral medications, treatment algorithms have failed to take into account quality of life improvements resulting from more rapid and complete treatment response. Topical mesalazine therapy is superior to oral therapy in distal ulcerative colitis for both therapeutic response and drug delivery. Practice patterns should be re-evaluated in light of this information.

The Efficacy of the Combination Therapy with Oral and Topical Mesalazine for Patients with the First Episode of Radiation Proctitis

Radiation proctitis is a common complication of pelvic radiation for which an optimal treatment remains undetermined. We assessed the efficacy of oral and topical mesalazine combination therapy for patients with naive radiation proctitis. A total of 23 patients with radiation proctitis were enrolled in the study over a period of 2 years. Three of these patients were excluded due to severe bleeding during the study. Twenty patients (mean age 60.3 years; two males, 18 females) were treated with oral mesalazine (3 × 1 g per day) plus a daily mesalazine suppository (1 g per day at bedtime) for 4 weeks. The efficacy of treatment was assessed according to the Subjective Objective Management Analytic (SOMA) scale for alleviation of clinical symptoms of rectal toxicity and sigmoidoscopic findings. The mean bleeding score improved significantly from 2.10 to 1.70 (p = 0.002) with mesalazine treatment. However, scores were not improved for pain (0.30-0.20, p = 0.163), tenesmus (0.50-0.45, p = 0.577), or stool frequency (0.35-0.30, p = 0.577). The improvements in the mean telangiectasia score (1.80-1.45, p = 0.005), bleeding point score (1.60-1.05, p < 0.001), and friable mucosa score (1.35-1.00, p = 0.005) were all statistically significant. No side-effects were noted in any of the patients. The combination of oral and topical mesalazine therapy for radiation proctitis may be a safe and effective treatment for naive radiation proctitis, especially for hemorrhagic proctitis. A large, randomized controlled trial is required to confirm the results of this pilot study.

Prolonged MMX® mesalazine therapy in patients with acute, mild-to-moderate ulcerative colitis who fail initial mesalazine treatment may prevent a requirement for therapeutic escalation

Introduction: MMX® mesalazine (Mezavant®, Shire Pharmaceuticals Inc., USA; MMX; Cosmo Technologies Ltd, Ireland) has been observed to successfully induce remission in patients with mild-to-moderate ulcerative colitis (UC) in two, phase III, placebo-controlled (parent) studies by Lichtenstein et al. (SPD476–301) and Kamm et al. (SPD476–302).

Mesalazine-Induced Multi-Organ Hypersensitivity

Mesalazine therapy for ulcerative colitis has been reported to be effective and safe. Rare cases of mesalazine-induced renal, pancreatic, myo-pericardial, pleuro-pulmonary and haematological toxicity have been described separately. We report a case characterized by the simultaneous presence of fever, pericarditis, peripheral eosinophilia, eosinophilic pneumonia, anaemia and haematuria (together with proteinuria and leukocyturia) due to mesalazine treatment in a patient with ulcerative colitis. No clinical response had been obtained with corticosteroids and various antibacterial agents. When mesalazine treatment was suspended, all symptoms rapidly and totally disappeared, confirming the direct responsibility of this drug in causing these adverse events. We conclude that mesalazine can induce multi-organ hypersensitivity, which must always be considered as a possible adverse effect during treatment with this drug. To resolve this adverse event it is essential to discontinue mesalazine treatment.

How to live with short bowel syndrome?

Introduction: Absorption of nutrients in short bowel syndrome (SBS) is seriously impaired. The adequate treatment of SBS are parenteral and enteral fluid, electrolyte, nutrient and vitamin substitutions. If more than 80 percent of the small bowel is resected, generally life-long total or supplementary parenteral nutrition is required. A 63 year-old male patient with the hystory of ulcerative colitis and mesalazine therapy since 1986 has been treated several times for entamoeba histolytica and dyspar infection. In 2003 the relapse of ulcerative colitis was treated with olsalazine and parenteral methyprednisolon, but on the second day of therapy acute abdomen developed. Laparotomy revealed ileal necrosis. Resection and later reresection was necessary due to progressive ileal necrosis. In 2004 subtotal colectomy, ileostomy with rectal restoration and also ileal segment resection were performed for necrosis. After the surgery only 80cm of small bowel remained. His weight decreased from 79 to 50kg, laboratory tests showed severe malnutrition, electrolyte disorder and frequent tetanic cramps occured. Initially parenteral infusion with calcium, potassium, magnesium and orally Protifar, Fantomal and Ensure were administered. Since 2005 the patient has been on methylprednisolone, oral and rectal mesalamine, high-dose oral potassium, calcium, magnesium, ferrous sulfate, folic acid, A, B1, B6, C, E vitamins. At present the patient is symptom-free, and only fed orally, and his laboratory parameters are normal. In the last 5 years his body weight has been constant at 55kg, and there was no need for hospitalization. Conclusion: Our case demonstrates possible adaptation in the absorption of small intestine, therefore the expansive and uncomfortable parenteral nutrition can be replaced to enteral nutrition.

A Case of Pyoderma Gangrenosum with Ulcerative Colitis Treated with Mesalazine

Pyoderma gangrenosum (PG) manifests as recurrent deep ulceration of the skin and PG is associated with a variety of disorders. Approximately 30% of the cases of PG develop in patients with inflammatory bowel disease. A 34-year-old woman presented with a one-week history of recurrent ulcers on the right cheek and back. She was diagnosed with ulcerative colitis (UC) 4 years previously and with PG 1 year previously. The clinical course of the skin lesions followed the status of her UC. The patient's skin lesions and bowel symptoms were not improved with prednisolone. After she was started on mesalazine, we observed rapid resolution of skin lesions and bowel symptoms. Herein, we report a case of recurrent PG with UC, and we discuss the possible association between these two conditions, and the efficacy of mesalazine therapy for the treatment of PG combined with UC.

Cheilitis granulomatosa as an early manifestation of Crohn's disease.

Cheilitis granulomatosa (CG) is a rare disease, which presents usually as a persistent swelling of the soft tissues in the orofacial region and is characterized histologically by a granulomatous inflammation. We report the case of a 19-year-old man who suffered from anal fistula. The patient had a 6-year history of asymptomatic and persistent swelling of the lower lip. Examinations for gastrointestinal lesions containing double-balloon total enteroscopy revealed erosions located longitudinally throughout the small intestine and the patient was diagnosed Crohn's disease (CD). Biopsy of the lower lip showed non-caseating granuloma and confirmed the diagnosis of CG. Despite an elemental diet and mesalazine therapy, the lip swelling persisted. The CG can be the first presenting symptom of CD. CG as a complication of CD is discussed.

W1220 What Factors Influence Adhesion to Therapy in Inflammatory Bowel Disease?

W1220 What Factors Influence Adhesion to Therapy in Inflammatory Bowel Disease?

W1221 Side Effects of Azathioprine in the Treatment of Chronic Inflammatory Bowel Disease

(age, gender, study level, working status, personal status), data concerning the disease (type of IBD, year of diagnosis, number of hospital admissions, IBD-related surgical procedures), data about therapy (drug, dose, interval), self-applied adhesion declaration and self-medication. An activity index was calculated on the spot (Harvey-Bradshaw/Truelove) Results: Mean age was 41.3±11 years, 60% were women. The number of years since IBD diagnosis was 8±7; 64% were Crohn's disease (71% inactive), 36% ulcerative colitis (70% inactive). A 66% was treated with aminosalicylates, 51%with immunosuppressors, 8% with glucocorticoids. A 66% needed an IBD-related hospital admission in the past, and 17% any IBD-related surgical procedure. A 69% (95%CI: 60-77%) showed some type of non-adhesion. A 66% (57-75%) acknowledged dome degree of involuntary non-adhesion: either forgetting to take their dose (63%) or being careless about having taken it (27%). A 16% (9-22%) showed some kind of voluntary non-adhesion: interrupting the therapy when feeling better (13%) or when feeling worse (6%). A 25% (17-33%) forgot at least a dose a week (mean weekly number of forgotten doses 1.6), and the most frequent cause was to be away form home when they were supposed to take the medication. This was more frequent under mesalazine therapy (30%) than with azathioprine (17%) (p=n.s.). A multivariate analysis identified as risk factors for a lower adhesion the dosing in three or more takes a day (OR 3; 95%CI 1.1-8.4; p= 0.03) and feeling little informed about their disease (OR 4.9; 95%CI 1.1-23.8; p=0.04). On the other hand, immunomodulator therapy was a predictive factor for better adhesion (OR 0.29; 95%CI 0.11-0.74; p=0.01). The concordance between patient recall and clinical records was complete in 86%, whereas in 10.3% the patients did not accurately remember the dose and in 3.7% there was confusion about the drug taken. A 9% acknowledged self-medication during flares Conclusions: In our setting, adhesion to therapy in IBD patients is not satisfactory. Patients treated with immunosuppressors have better adhesion. Optimizing the information on the disease and giving the medication in one or two daily doses could enhance therapeutic adhesion

Case of lacrimal gland inflammation associated with ulcerative colitis

We report a case of lacrimal gland pseudotumor as the presenting sign of ulcerative colitis. A 25-year-old woman presented with a right upper eyelid swelling and pain. Intravenous administration of prednisolone was initiated on suspicion of lacrimal gland inflammation (pseudotumor). Although the treatment markedly reduced her ocular symptoms, she developed lower abdominal cramping and diarrhea with the 5 mg/day of oral prednisolone. Sigmoid colonoscopy and colon biopsy led to make a diagnosis of ulcerative colitis. Ulcerative colitis improved significantly with increased dose of steroid and additive mesalazine therapy. Ulcerative colitis should be included in the differential diagnosis of lacrimal gland pseudotumor.

An economic evaluation comparing once daily with twice daily mesalazine for maintaining remission based on results from a randomised controlled clinical trial

Background and aimsStandard practice to maintain remission in ulcerative colitis (UC) consists of daily mesalazine therapy. However, frequent dosing is associated with poor adherence and increased failure rates. The PODIUM (Pentasa™ Once Daily In UC Maintenance) randomised control trial showed 2 g once daily (OD) to be superior to twice daily (BD) dosing for maintaining remission. We sought to determine whether this alternative dosing regimen is cost-effective. MethodsAn economic evaluation was conducted to compare costs and outcomes of OD with twice daily (BD) dosing. The main outcome considered was quality-adjusted life years (QALYs) based on health state utilities derived from the primary outcome measure, remission without relapse at 12 months defined by a UCDAI score ≤1. The economic evaluation consisted of two health states: (1) remission and (2) active UC. ResultsAnnual average treatment costs for OD and BD dosing were £654 (95% CI: £536–£759) and £747 (£620–£860), respectively with an average per person savings of £93 per year. Average annual costs of ancillary care for relapse for OD and BD dosing were £307 (£241–£383) and £396 (£320–£483), respectively. Treatment with OD 2 g mesalazine resulted in an incremental QALY improvement of 0.004 units, indicating that it was the dominant treatment option (i.e. improved outcomes and cost-saving). Variations in parameter estimates in the sensitivity analysis indicated that mesalazine had >0.95 probability of being cost-effective compared to BD based on accepted willingness to pay thresholds applied by the UK National Health Service. ConclusionsOnce daily 2 g mesalazine for maintaining remission in UC is cost-saving compared with 1 g twice daily. Cost-savings with 2 g once daily were achieved by differences in ancillary care attributed to higher failure rates observed with 1 g twice daily.