(9R)-9-chloro-11-17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10-13-16-trimethyl-6-7-8-11-12-14-15-16-octahydrocyclopenta[a]phenanthren-3-one and Colitis--Ulcerative

There are a limited number of treatment options for people with corticosteroid-refractory ulcerative colitis. Animal models of inflammatory bowel disease and uncontrolled studies in humans suggest that tacrolimus may be an effective treatment for ulcerative colitis.. To evaluate the efficacy and safety of tacrolimus for induction of remission in people with corticosteroid-refractory ulcerative colitis.. We searched the Cochrane Gut group specialised register, CENTRAL, MEDLINE (PubMed), Embase, Clinicaltrials.gov and WHO ICTRP from inception to October 2021 to identify relevant randomised controlled trials (RCT).. Two review authors independently selected potentially relevant studies to determine eligibility based on the prespecified criteria.. Two review authors independently extracted data and analysed them using Review Manager Web. The primary outcomes were induction of remission and clinical improvement, as defined by the studies and expressed as a percentage of the participants randomised (intention-to-treat analysis).. This review included five RCTs with 347 participants who had active ulcerative colitis or ulcerative proctitis. The duration of intervention varied between two weeks and eight weeks. Tacrolimus versus placebo Tacrolimus (oral and rectal) may be superior in achieving clinical remission compared to placebo (oral and rectal) (14/87 participants with tacrolimus versus 1/61 participants with placebo; risk ratio (RR) 3.76, 95% confidence interval (CI) 1.03 to 13.73; 3 studies). These results are of low certainty due to imprecision and risk of bias. Tacrolimus (oral and rectal) may be superior for clinical improvement compared to placebo (oral and rectal) (45/87 participants with tacrolimus versus 7/61 participants with placebo; RR 4.47, 95% CI 2.15 to 9.29; 3 studies). These results are of low certainty due to imprecision and risk of bias. The evidence is very uncertain about the effects of tacrolimus (oral and rectal) on serious adverse events compared to placebo (oral and rectal) (2/87 participants with tacrolimus versus 0/61 participants with placebo; RR 2.44, 95% CI 0.12 to 48.77; 3 studies). These results are of very low certainty due to high imprecision and risk of bias. Tacrolimus versus ciclosporin One study compared oral tacrolimus to intravenous ciclosporin, with an intervention lasting two weeks and 113 randomised participants. The evidence is very uncertain about the effect of tacrolimus on achievement of clinical remission compared to ciclosporin (15/33 participants with tacrolimus versus 24/80 participants with ciclosporin; RR 1.52, 95% CI 0.92 to 2.50). The results are of very low certainty due to risk of bias and high imprecision. The evidence is very uncertain about the effect of tacrolimus on clinical improvement compared to intravenous ciclosporin (23/33 participants with tacrolimus versus 62/80 participants with ciclosporin; RR 0.90, 95% CI 0.70 to 1.16). The results are of very low certainty due to risk of bias and imprecision. Tacrolimus versus beclometasone One study compared tacrolimus suppositories with beclometasone suppositories in an intervention lasting four weeks with 88 randomised participants. There may be little to no difference in achievement of clinical remission (16/44 participants with tacrolimus versus 15/44 participants with beclometasone; RR 1.07, 95% CI 0.60 to 1.88). The results are of low certainty due to high imprecision. There may be little to no difference in clinical improvement when comparing tacrolimus suppositor. There is low-certainty evidence that tacrolimus may be superior to placebo for achievement of clinical remission and clinical improvement in corticosteroid-refractory colitis or corticosteroid-refractory proctitis. The evidence is very uncertain about the effect of tacrolimus compared to ciclosporin for achievement of clinical remission or clinical improvement. There may be no difference between tacrolimus and beclometasone for inducing clinical remission or clinical improvement. The cohorts studied to date were small, with missing data sets, offered short follow-up and the clinical endpoints used were not in line with those suggested by regulatory bodies. Therefore, no clinical practice conclusions can be made. This review highlights the need for further research that targets the relevant clinical questions, uses appropriate trial methodology and reports key findings in a systematic manner that facilitates future integration of findings with current evidence to better inform clinicians and patients. Future studies need to be adequately powered and of pertinent duration so as to capture the efficacy and effectiveness of tacrolimus in the medium to long term. Well-structured efficacy studies need to be followed up by long-term phase 4 extensions to provide key outputs and inform in a real-world setting.

Topics: Adrenal Cortex Hormones; Beclomethasone; Colitis, Ulcerative; Cyclosporine; Humans; Proctitis; Remission Induction; Suppositories; Tacrolimus

Topics: Anti-Inflammatory Agents; Beclomethasone; Biological Availability; Budesonide; Chemistry, Pharmaceutical; Colitis, Ulcerative; Delayed-Action Preparations; Humans; Remission Induction

Beclomethasone dipropionate (BDP) is a second-generation corticosteroid that uses novel drug technologies to ensure colonic targeting and potentially reducing systemic corticosteroid concentrations. It is approved for treatment of patients with mild-to-moderate ulcerative colitis (UC) who do not respond to mesalazine. The gut-selective mechanism of action has the potential to improve the safety profile of BDP compared with other conventional corticosteroids. Areas covered: We reviewed the mechanism of action, efficacy, and safety of BDP in the treatment of UC. The positioning of BDP in management algorithms is also discussed. Expert opinion: The highly selective mechanism of action of BDP restricts the steroid-related side effects. BDP is efficacious in the treatment of active UC. Topical formulation is the first choice in distal UC, while oral formulation is used in patients with an extensive involvement of the colon. The rates of adverse events (AE), serious AEs, and steroid-related side-effects are similar to placebo and mesalamine and slightly inferior to traditional corticosteroids.

Topics: Administration, Oral; Administration, Topical; Algorithms; Anti-Inflammatory Agents; Beclomethasone; Colitis, Ulcerative; Glucocorticoids; Humans; Mesalamine

The risk of corticosteroid-associated adverse events can limit the use of systemic corticosteroids. Oral, topically acting, second-generation corticosteroids that deliver drug to the site of inflammation, and biologic therapies, are effective treatment alternatives. The aim of this review was to evaluate the safety and tolerability of topically acting corticosteroids and biologic therapies versus oral systemic corticosteroids for ulcerative colitis (UC).. The PubMed database was searched for clinical and observational trials, systematic reviews, and case reports/series published between January 1950 and September 30, 2016. Search terms used included "corticosteroids," "beclomethasone dipropionate," "budesonide," "infliximab," "adalimumab," "golimumab," and "vedolizumab" in combination with "ulcerative colitis" or "inflammatory bowel disease.". A total of 582 studies were identified from PubMed searches. Only 1 direct comparative trial for oral topically acting corticosteroids and systemic corticosteroids was available, and no comparative trials versus biologic therapies were identified. In patients with mild-to-moderate UC, short-term (4-8 wk) oral beclomethasone dipropionate or oral budesonide multimatrix system demonstrated safety profiles comparable with placebo with few corticosteroid-related adverse events reported. Based on long-term data in patients with moderate-to-severe UC, biologics have a generally tolerable adverse event profile, although infections, infusion reactions, and autoimmune disorders were frequently reported.. Second-generation corticosteroids, beclomethasone dipropionate and budesonide multimatrix system, exhibited a favorable safety profile in patients with mild-to-moderate UC. For biologics, which are only indicated in moderate-to-severe UC, additional studies are needed to further ascertain the benefit to risk profile of these agents in patients with mild-to-moderate disease (see Video Abstract, Supplemental Digital Content, http://links.lww.com/IBD/B653).

Topics: Adrenal Cortex Hormones; Antibodies, Monoclonal; Beclomethasone; Budesonide; Colitis, Ulcerative; Humans; Randomized Controlled Trials as Topic; Severity of Illness Index

Ulcerative colitis (UC) is a chronic and remitting inflammatory disease that is characterized by chronic idiopathic inflammation of the colon and bloody diarrhea. Currently drug treatment is the main intervention for patients with mild to moderate UC. Mesalazine (5-ASA) and beclomethasone dipropionate (BDP) have been widely used for the treatment of UC and have yielded satisfactory results. This study compared the effectiveness of 5-ASA and BDP in the treatment of UC.. The PubMed, Medline, SinoMed, Embase, and Cochrane Librinary databases were searched for eligible studies. Data were extracted by two of the coauthors independently and were analyzed using RevMan statistical software, version 5.3. Weighted mean differences (WMDs), odds ratios (ORs), and 95% confidence intervals (CIs) were calculated. Cochrane Collaboration's Risk of Bias Tool was used to assess the risk of bias.. Seven randomized controlled trials that compared BDP with 5-ASA in treating UC were identified as eligible. The methodological quality of the trials ranged from low to moderate. A pooled analysis of effectiveness based on the Disease Activity Index (DAI) or other assessment method after treatment revealed that in the treatment of UC, there are no obvious differences between BDP and 5-ASA in inducing remission and clinical improvement (OR = 0.76, 95% CI = 0.56-1.03, P = 0.08). The total numbers of adverse events associated with BDP and 5-ASA treatments for UC were similar (OR = 1.21, 95% CI = 0.71-2.09, P = 0.48). The safety profiles for these two drugs are good. According to subgroup-analysis, we found no obvious differences of clinical efficacy between BDP and 5-ASA no matter oral or enema administration was used in the treatment of UC. A sensitivity analysis demonstrated the stability of the pooled results.. During induction treatment of mild to moderate UC, there is no obvious difference between the two groups with respect to remission and clinical improvement. Given that the upper confidence limit for the OR barely exceeds 1.0 and that the p-value is close to 0.05 for this primary efficacy outcome as well as that the horizontal block lies to the left of the vertical line, it indicates that the clinical efficacy of BDP may be better than 5-ASA. However, taking into account that BDP has the risk of hypothalamic-pituitary-adrenal axis (HPA) suppression, 5-ASA has a potential advantage of safety in the treatment of mild to moderate UC.

Topics: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Beclomethasone; Colitis, Ulcerative; Gastrointestinal Agents; Gastrointestinal Hemorrhage; Humans; Mesalamine; Randomized Controlled Trials as Topic; Treatment Outcome

We performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate (BDP) to active oral controls in patients with mild-to-moderate ulcerative colitis (UC). A subgroup-analysis compared the effectiveness of BDP and 5-ASA.. Literature research was performed in different databases, as well as manual search to identify abstracts from international meetings with data not included in extensive publications. Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes. Dichotomous data were pooled to obtain odds ratio meta-analysis.. Five randomized controlled trials that compared oral BDP 5mg/day vs. all oral active controls in treating UC were identified as eligible. Efficacy and safety have been addressed after 4-week treatment period. One study evaluated efficacy and safety of BDP vs. prednisone and 4 of BDP vs. 5-ASA. Treatment with oral BDP 5 mg/day induces a significant better clinical response compared to oral 5-ASA (OR 1.86, 95% CI = 1.23-2.82, P = 0.003). The effect is detectable even when the comparison to prednisone is added (OR 1.41, 95% CI = 1.03-1.93, P = 0.03). Data on remission indicate that the potential clinical efficacy of BDP may be better than 5-ASA (OR 1.55, 95% CI = 1.00-2.40, P = 0.05). This difference is lost when the comparison with prednisone is added (OR 1.30, 95% CI = 0.76-2.23, P = 0.34). The safety analysis showed no differences between BDP and 5-ASA (OR 0.55, 95% CI = 0.24-1.27, P = 0.16). The lack of difference is maintained even when the study with prednisone is added (OR 0.67, 95% CI = 0.44-1.01, P = 0.06). However, the trend of difference is clear and indicates a more favourable safety profile of BDP compared to 5-ASA and PD.. Oral prolonged release BDP showed a superior efficacy vs. oral 5-ASA in inducing clinical improvement of mild-to-moderate UC with a similar safety profile.

Topics: Administration, Oral; Anti-Inflammatory Agents, Non-Steroidal; Beclomethasone; Colitis, Ulcerative; Drug Administration Schedule; Humans; Mesalamine; Patient Safety; Prednisone; Randomized Controlled Trials as Topic; Treatment Outcome

IBD is a chronic and relapsing inflammatory disorder of the gut that demands long-lasting treatment targeting both flare-up periods and maintenance of remission. Oral systemic steroids have been used to induce remission in patients with active IBD for over 50 years due to their potent anti-inflammatory effects. The efficacy of systemic steroids in this setting has been largely demonstrated. However, the wide range of adverse events associated with these drugs has prompted the development of equally effective but less toxic steroid compounds. Currently, topically acting oral steroids are an important therapeutic option for Crohn's disease, ulcerative colitis and microscopic colitis, being oral budesonide and oral beclomethasone established elements of the IBD armamentarium. At present, oral budesonide is the first-line therapy to induce remission in microscopic colitis and mild to moderate ileocaecal CD patients and oral beclomethasone is effective treating mild to moderate UC patients with left-sided or extensive disease. This review aims at evaluating the current role of these compounds in IBD clinical practice.

Topics: Administration, Oral; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Colitis, Microscopic; Colitis, Ulcerative; Crohn Disease; Humans; Induction Chemotherapy; Inflammatory Bowel Diseases; Maintenance Chemotherapy

Crohn's disease and ulcerative colitis are inflammatory bowel diseases characterised by a chronic relapsing course. Corticosteroids represent the mainstay of medical treatment of inflammatory bowel disease for the induction of remission. Despite the high efficacy of systemic steroids, their use is limited by the high incidence of potentially serious adverse effects. The topically acting steroids are synthetic compounds characterised by high anti-inflammatory activity and low systemic effects by virtue of efficient first-pass hepatic inactivation. Budesonide and Beclomethasone Dipropionate are the two most studied topically acting steroids in inflammatory bowel disease. Oral Budesonide has been extensively studied in the treatment of mild to moderate ileo-caecal Crohn's disease but few data are available concerning oral Beclomethasone Dipropionate. This review focuses on the available evidence of efficacy and safety of oral Beclomethasone Dipropionate in the management of ulcerative colitis and Crohn's disease and a possible role of this steroid in clinical practice is suggested.

Topics: Administration, Oral; Beclomethasone; Budesonide; Colitis, Ulcerative; Crohn Disease; Glucocorticoids; Humans

Although new salicylates are now available for the treatment of ulcerative colitis, sulphasazaline still has an important therapeutic role. The role of salicylates in Crohn's disease is limited to the mild activity phase; further data are required to clarify its role in maintenance on remission. New steroids are a real alternative to traditional steroids in active ulcerative colitis and Crohn's disease.

Topics: Acute Disease; Aspirin; Beclomethasone; Budesonide; Colitis, Ulcerative; Crohn Disease; Drug Therapy, Combination; Glucocorticoids; Humans; Inflammatory Bowel Diseases; Prednisolone; Randomized Controlled Trials as Topic; Salicylates; Sulfasalazine

Topics: Administration, Topical; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Clinical Trials as Topic; Colitis, Ulcerative; Crohn Disease; Fluticasone; Humans; Hydrocortisone; Prednisolone; Pregnenediones

Bronchectasis is a rare complication of haemorrhagic rectocolitis, 28 case have been reported in the literature. We report a case in a 40-year-old patient who presented respiratory signs 13 years after the onset of haemorrhagic rectocolitis. The diagnosis was confirmed on the bronchogram showing involvement of the lower lobes on the right and the left. Local corticosteroids given by inhalation decreased the volume of the expectorations and improved bronchial obstruction. Abundant bronchorrhoea is characteristic of bronchectasia in haemorrhagic rectocolitis as in primary bronchectasia. Response to inhaled or systemic corticosteroids is good.

Topics: Adrenal Cortex Hormones; Adult; Ampicillin; Beclomethasone; Bronchiectasis; Bronchography; Colitis, Ulcerative; Female; Gastrointestinal Hemorrhage; Humans

Ulcerative proctitis (UP) refractory to 5-aminosalicylic acid (5-ASA) suppositories is a challenge to treat, often requiring step up to immunomodulator or biological therapy. Topical tacrolimus is effective and safe in patients with refractory UP. However, it is not clear how tacrolimus suppositories fit into in the treatment algorithm of UP.. We performed a randomized controlled, double-blind study at 8 hospitals in the Netherlands and Belgium from 2014 through 2017. Eighty-five patients with refractory UP (65% women) were randomly assigned to groups given once daily tacrolimus suppositories (2 mg; n = 43) or beclomethasone (3 mg; n = 42) for 4 weeks. The primary outcome was clinical response (decrease in Mayo score of 3 or more). Secondary outcomes included clinical remission, endoscopic response and remission, adverse events and quality of life. Outcomes were compared using Fisher's exact test and Mann-Whitney U test.. Proportions of patients with clinical responses were 63% in the tacrolimus group and 59% in the beclomethasone group (P = .812); proportions of patients in clinical remission were 46% and 38%, respectively (P = .638). Proportions of patients with an endoscopic response were 68% and 60% in the tacrolimus group and in the beclomethasone group (P = .636); proportions in endoscopic remission rates were 30% and 13%, respectively (P = .092) Median increases in the inflammatory bowel disease questionnaire score were 18.0 in the tacrolimus group and 20.5 in the beclomethasone group (P = .395). Adverse event rates did not differ significantly between groups.. In a 4-week randomized controlled trial, tacrolimus and beclomethasone suppositories induce comparable clinical and endoscopic responses in patients with UP refractory to 5-ASA. There were no significant differences in adverse events rates. Tacrolimus and beclomethasone suppositories are therefore each safe and effective treatment options for 5-ASA refractory disease. EUDRACT 2013-001259-11; Netherlands Trial Register NL4205/NTR4416.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Beclomethasone; Colitis, Ulcerative; Female; Humans; Male; Mesalamine; Proctitis; Quality of Life; Suppositories; Tacrolimus

Double-blind study comparing efficacy and safety of the topically acting corticosteroid beclomethasone dipropionate (BDP) to prednisone (PD) in patients with active, mild-to-moderate ulcerative colitis (UC).. Overall, 282 patients were randomized to receive BDP-prolonged release tablets 5 mg once daily for 4 weeks and then every other day for an additional 4 weeks or oral PD 40 mg once daily for the initial 2 weeks tapered of 10 mg every 2 weeks during the 8-week study period. Efficacy end point was the non-inferiority of BDP vs. PD in terms of Disease Activity Index (DAI) score <3 or reduction by at least 3 points for patients with a baseline DAI ≥7 at week 4. Safety end point was the proportion of patients with steroid-related adverse events (AEs) and cortisol <150 nmol/l at week 4.. DAI response rates at week 4 were 64.6% and 66.2% with BDP and PD, respectively, demonstrating non-inferiority of BDP vs. PD (delta: -1.56; 95% confidence interval (CI) -13.00-9.88, P=0.78). Patients with steroid-related AEs and cortisol <150 nmol/l at week 4 were 38.7% in the BDP group and 46.9% in the PD group (P=0.17 between groups). No safety signals were observed in both the groups.. BDP was non-inferior to PD in the treatment of active UC, with a good safety profile in both the groups.

Topics: Administration, Oral; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Beclomethasone; Colitis, Ulcerative; Double-Blind Method; Drug Administration Schedule; Female; Humans; Hydrocortisone; Intention to Treat Analysis; Male; Middle Aged; Prednisone; Severity of Illness Index; Tablets, Enteric-Coated; Young Adult

Mesalazine or Beclomethasone dipropionate (BDP) enema have been shown effective in treatment of distal active ulcerative colitis (UC). This study was aimed to determine whether the combination of topical mesalazine and BDP is superior to topical mesalazine or BDP used alone in patients with distal active UC. PATIENTS AND METHODS: One-hundred and twenty patients with clinical, endoscopic and histological diagnosis of distal active UC were randomly assigned to a regimen with mesalazine tablets 2.4 g/day associated to either mesalazine enema 4 g/day (group A, n=40), BDP 3 mg/60 ml every day (group B, n=40) or the combination treatment with the two compounds in a single administration (group C, n=40) for eight weeks. After four weeks of treatment all patients underwent clinical controls but only 109 patients returned back for clinical, endoscopic and histological controls at the end of the treatment period.. After eight weeks, complete remission rates were of 52%, 47% and 65% respectively, in group A, B and C. From baseline to 4 and 8 weeks the CAI score decreased significantly in all the three groups (p < 0.0001).. All the three combinations achieved equivalent results in terms of symptoms in inducing symptoms relief and mucosa healing in distally active UC.

Topics: Adult; Aged; Anti-Inflammatory Agents; Beclomethasone; Colitis, Ulcerative; Drug Therapy, Combination; Enema; Female; Follow-Up Studies; Humans; Male; Mesalamine; Middle Aged; Remission Induction; Single-Blind Method; Treatment Outcome

The objective of the study was to evaluate the clinical efficacy of oral beclomethasone diproprionate (BDP) in inducing clinical and endoscopic remission in children with mild to moderate active ulcerative colitis (UC).. Thirty patients with active UC (pancolitis or left-sided colitis) were enrolled in an open-labeled, randomized, head-to-head study. Group 1 (n = 15) received oral BDP (5 mg/day) for 8 weeks, followed by maintenance therapy with oral mesalazine, 5-aminosalycilate (5-ASA); group 2 (n = 15) received oral 5-ASA (80 mg . kg . day). Assessments were carried out (at 4, 8, and 12 weeks) for clinical scores and for endoscopy (at 12 weeks), together with a final clinical assessment after 1 year follow-up.. Patients treated with BDP showed a significant reduced clinical activity within 4 weeks (P < 0.001 vs pretreatment values) with 80% achieving clinical remission compared with 33% treated with only 5-ASA (P < 0.025). A significant reduction in clinical activity was achieved by 5-ASA after 8 weeks. Comparing clinical activity between BDP and 5-ASA, the former did significantly better at 8 (P < 0.003) and at 12 weeks (P < 0.015). In 73% of BDP-treated patients colonoscopy showed remission compared with 27% of 5-ASA (P < 0.025). Both treatments led to better scores compared with pretreatment values (P < 0.001, both). Erythrocyte sedimentation rate was significantly reduced (P < 0.025 or less) with both treatments, whereas C-reactive protein dropped significantly (P < 0.02) only in BDP.. Oral BDP was well tolerated and acts significantly faster and more effectively than 5-ASA in inducing clinical remission and endoscopic improvement in pediatric mild-to-moderate UC.

Topics: Administration, Oral; Anti-Inflammatory Agents; Beclomethasone; Blood Sedimentation; C-Reactive Protein; Child; Colitis, Ulcerative; Colon; Colonoscopy; Female; Humans; Male; Mesalamine; Severity of Illness Index; Treatment Outcome

Topical beclomethasone diproprionate has shown efficacy in ulcerative colitis.. To assess, in a multicenter, randomized, double-blind study, the tolerability and safety of topical beclomethasone diproprionate (3mg) enema and foam versus mesalazine (2g) enema and foam in mild-moderate distal ulcerative colitis.. In 15 referral gastrointestinal units, 99 patients with distal ulcerative colitis were enrolled. This number was lower than planned according to the statistical analysis, due to a low recruitment rate.. Patients were randomly assigned to random preparations (beclomethasone diproprionate enema, beclomethasone diproprionate foam, mesalazine enema, mesalazine foam) once nightly for 8 weeks, with clinical and endoscopical assessment (Disease Activity Index score) at baseline (T0), 4 (T4) and 8 weeks (T8). Results were expressed as median and range (95% confidence interval). The efficacy was assessed by comparing the Disease Activity Index value at T4 and T8 by using the Student's t-test or the Wilcoxon-Mann-Whitney test.. Efficacy was comparable in the beclomethasone diproprionate or mesalazine groups at both T4 and T8 (response at T4: beclomethasone diproprionate 78% [95% confidence interval 0.6-0.8] versus mesalazine 79% [95% confidence interval 0.6-0.8]; T8: beclomethasone diproprionate 84% [95% confidence interval 0.7-0.9] versus mesalazine 90% [95% confidence interval 0.7-1.0]; p=n.s.; remission at T4: beclomethasone diproprionate 24% [95% confidence interval 0.1-0.3] versus mesalazine 28% [95% confidence interval 0.1-0.3]; remission at T8: beclomethasone diproprionate 36% [95% confidence interval 0.2-0.5] versus mesalazine 52% [95% confidence interval 0.3-0.6]; p=n.s.). The Disease Activity Index lowered at T4 and T8 versus T0 in the four groups (T4 versus T0: beclomethasone diproprionate foam Disease Activity Index 2 versus 6 p<0.0001; beclomethasone diproprionate enema 4 versus 6, mesalazine enema 3 versus 6, mesalazine foam 3.5 versus 7, p<0.001 for all three groups; T8 versus T0: p<0.01). The Disease Activity Index lowered at T8 versus T4 in the beclomethasone diproprionate enema and foam (Disease Activity Index: 2 versus 4 and 1 versus 4, respectively; p<0.05) and in the mesalazine enema (Disease Activity Index: 1.5, range 0-4 versus 3, range 0-12; p<0.01), but not in the mesalazine foam group (Disease Activity Index: 1, range 0-9 versus 3.5, range 0-8; p=n.s.). The safety profile was favourable for all groups.. Beclomethasone diproprionate and mesalazine enema and foam show a comparable tolerability and efficacy in mild active distal ulcerative colitis.

Topics: Adult; Aged; Anti-Inflammatory Agents; Beclomethasone; Colitis, Ulcerative; Colonoscopy; Diarrhea; Double-Blind Method; Enema; Female; Humans; Male; Mesalamine; Middle Aged; Occult Blood; Quality of Life; Severity of Illness Index; Treatment Outcome

Therapy for active ulcerative colitis (UC) usually involves rectal formulations of corticosteroids (CS), which are characterized by the risk of systemic steroid-related adverse effects.. To compare the efficacy and safety of the topically acting CS beclomethasone dipropionate (BDP) versus mesalamine (5-ASA) in the treatment of active UC.. Patients with mild to moderate distal active UC were randomized to a 6-week treatment with BDP 3 mg enema o.d. or 5-ASA 1 g enema daily in a single-blind, multicenter, parallel-group, controlled study. The primary efficacy variable was the decrease in Disease Activity Index (DAI) score. Safety variables were adrenal function, monitoring of adverse events, vital signs, and laboratory parameters.. A total of 217 patients were enrolled and treated with BDP (n = 111) or 5-ASA (n = 106). A significant decrease in the DAI score (P < 0.05) was observed in both treatment groups, with a clinical remission rate of 36.7% in the BDP group and of 29.2% in the 5-ASA group. Both treatments were well tolerated. No changes from baseline in morning cortisol levels were observed in the BDP group.. BDP administered as a rectal enema over a 6-week treatment period was efficacious and safe in patients with active UC, without interference with pituitary adrenal axis.

Topics: Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Beclomethasone; Biomarkers; Blood Sedimentation; Colitis, Ulcerative; Colonoscopy; Erythrocyte Count; Female; Follow-Up Studies; Glucocorticoids; Humans; Intestinal Mucosa; Leukocyte Count; Male; Mesalamine; Middle Aged; Remission Induction; Retrospective Studies; Safety; Severity of Illness Index; Single-Blind Method; Treatment Outcome

To explore the efficacy and safety of the topically acting steroid beclometasone dipropionate (BDP) in an oral controlled release formulation in the treatment of extensive or left-sided ulcerative colitis.. In a multicentre, randomised, parallel-group, single-blind study, patients with active mild to moderate ulcerative colitis were randomised to a 4-week treatment with BDP 5 mg/day o.d. vs. 5-ASA 0.8 g t.d.s. The primary efficacy variable was the decrease of Disease Activity Index (DAI) (clinical symptoms and endoscopic appearance of mucosa). Safety was evaluated by monitoring adverse events, vital signs, haematochemical parameters and adrenal function.. One hundred and seventy-seven patients were enrolled and randomly treated with BDP (n = 90) or 5-ASA (n = 87). Mean DAI score decreased in both treatments groups (P < 0.0001 vs. baseline for both groups). Clinical remission was achieved in 63.0% of patients in the BDP group vs. 62.5% in the 5-ASA group. A significant DAI score improvement (P < 0.05) in favour of BDP was observed in patients with extensive disease. Both treatments were well tolerated. Mean plasma cortisol levels were significantly reduced vs. baseline in BDP recipients, but without signs of pituitary-adrenal function depletion.. Oral BDP gave an overall treatment result in patients with active ulcerative colitis without signs of systemic side-effects.

Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Beclomethasone; Colitis, Ulcerative; Delayed-Action Preparations; Female; Humans; Male; Middle Aged; Single-Blind Method; Treatment Outcome

To evaluate efficacy and safety of oral beclometasone dipropionate (BDP) when added to 5-ASA in the treatment of patients with active ulcerative colitis.. In a 4-week, placebo-controlled, double-blind study, patients with extensive or left-sided mild to moderate active ulcerative colitis were randomized to receive oral 5-ASA (3.2 g/day) plus BDP (5 mg/day) or placebo. Clinical, endoscopic and histologic features, and haematochemical parameters were recorded at baseline and at the end of the study.. One hundred and nineteen patients were enrolled and randomly treated with BDP plus 5-ASA (n = 58) or placebo plus 5-ASA (n = 61). Both treatment groups showed a statistically significant decrease of disease activity index (DAI) and histology score at the end of treatment (P = 0.001, each). DAI score was lower in the BDP group than in the placebo group (P = 0.014), with more patients in clinical remission in the BDP group (58.6% vs. 34.4%, P = 0.008). Serum cortisol levels significantly decreased in BDP group vs. baseline (P = 0.002), but without signs of pituitary-adrenal function depletion. A low incidence of adverse events was observed in both groups.. Oral BDP in combination with oral 5-ASA is significantly more effective than 5-ASA alone in the treatment of patients with extensive or left-sided active ulcerative colitis.

Topics: Administration, Oral; Adult; Anti-Inflammatory Agents; Beclomethasone; Colitis, Ulcerative; Double-Blind Method; Female; Humans; Hydrocortisone; Male; Middle Aged; Placebos; Severity of Illness Index; Treatment Outcome

The use of steroids was recently extended to the various forms of ulcerative rectocolitis by the introduction of topical formulations, above all steroids with an hepatic "first pass" devoid of systemic interference. The aim of this study was to evaluate the efficacy and tolerability of Beclomethasone dipropionate (BDP) in a rectal foam formulation, in the treatment of patients suffering from ulcerative colitis.. The experimental protocol took the form of a 28-day open prospective trial using BDP rectal foam in patients suffering from ulcerative colitis. Endoscopic, histological, clinical and tolerability parameters were evaluated. The centres taking part in the trial collected data for 60 cases out of a total of 80 patients enrolled in the study, of both sexes and aged between 20 and 81 years old, suffering from proctosigmoiditis (46.7%) and ulcerative rectocolitis (53.3%).. Endoscopic parameters showed an improvement after 28 days of treatment in 74.5% of patients; a clinical improvement was achieved in 65.2% of cases. In percentage terms of the mean value of all the improved parameters, histological parameters were altered in 56.9% of patients. With regard to tolerability 82% of patients judged the treatment to be good/excellent.. In conclusion, in line with recent reports regarding other pharmaceutical forms of BDP, including the use of rectal foam, these data confirm the efficacy and tolerability of this molecule and emphasise the validity of its use in the treatment of ulcerative colitis and proctosigmoiditis.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Beclomethasone; Chi-Square Distribution; Colitis, Ulcerative; Colonoscopy; Female; Glucocorticoids; Humans; Italy; Male; Middle Aged; Prospective Studies; Remission Induction

To compare beclomethasone dipropionate 3 mg/60 mL enema (BDP) and prednisolone sodium phosphate 30 mg/60 mL enema (PP) once daily in patients with active distal ulcerative colitis.. One hundred and fifty-seven patients were enrolled in a multicentre, 4-week, randomized, double-blind trial. Patients were assessed at baseline, 2 and 4 weeks.. Both treatment groups showed statistically significant improvement of clinical activity after 2 and 4 weeks. Endoscopy and biopsy showed a reduction in the activity score at the end of the treatment period in both groups. No statistically significant difference was observed between the two treatment groups. After 4 weeks, 29% of patients in the BDP group and 25% in the PP group were considered to be in clinical remission; an improvement was observed in 40% of patients on BDP and in 47% on PP. Mean morning plasma cortisol levels showed a slight but significant reduction in the PP group, while the ACTH test showed that neither drug interfered with the hypothalamic-pituitary-adrenal (HPA) axis function. No significant changes were observed in the laboratory tests. Finally, there was a low incidence of adverse events in both groups.. It is concluded that, in the topical treatment of active distal ulcerative colitis, BDP 3 mg enemas are as efficacious as PP 30 mg enemas, without interference with the HPA axis.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Beclomethasone; Colitis, Ulcerative; Double-Blind Method; Enema; Female; Glucocorticoids; Humans; Male; Prednisolone; Treatment Outcome

Beclomethasone dipropionate is one of the topical corticosteroids which appear to have minimal systemic effects. We evaluated whether combined therapy with Beclomethasone dipropionate enemas and oral 5-aminosalicylic acid could be effective in patients suffering from ulcerative colitis not responsive to oral 5-aminosalicylic acid as monotherapy.. In twenty patients, non responders to 5-aminosalicylic acid treatment (2.4-3.6 g/day) given for at least 6 weeks, Beclomethasone dipropionate enemas (3 mg/60 ml/day) were added for 4 weeks.. Efficacy of the combination was evaluated before and at the end of the treatment using a clinical, endoscopic and histological score.. After a four-week treatment period, a significant clinical improvement in stool frequency (p < 0.01), stool consistency (p < 0.001), blood (p < 0.001) and mucus in stools (p < 0.05), was observed. Endoscopy and biopsy confirmed an improvement in the activity score at the end of the treatment (p < 0.001). Six patients (30%) achieved remission, ten patients showed an improvement (50%) and four (20%) showed no benefits. No adverse event was observed.. Beclomethasone dipropionate enemas combined with oral 5-aminosalicylic acid may be a safe and useful therapeutic approach in the treatment of ulcerative colitis not responsive to oral 5-aminosalicylic acid alone.

Topics: Administration, Oral; Administration, Topical; Adult; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Beclomethasone; Colitis, Ulcerative; Drug Therapy, Combination; Enema; Female; Glucocorticoids; Humans; Male; Mesalamine; Treatment Outcome

Sixty patients with active distal ulcerative colitis participated in a multicentre randomized double-blind trial to compare the effect of a beclomethasone dipropionate (BDP) enema (3 mg/100 ml) with 5-aminosalicylic acid (5-ASA) enemas (2 g/ 100 ml) and enemas with a combination of BDP/5-ASA (3 mg/2 g/100 ml). The patients were treated for 4 weeks and the efficacy of the drugs was evaluated by sigmoidoscopy, histology and subjective symptoms after that time. The overall results after 28 days of treatment were: clinical improvement 100% (BDP/5-ASA) vs. 70% (BDP) and 76% (5-ASA); endoscopic improvement 100% (BDP/5-ASA) vs. 75% (BDP) and 71% (5-ASA); histological improvement 95% (BDP/5-ASA) vs. 50% (BDP) and 48% (5-ASA). After 4 weeks of treatment seven of 19 patients (37%) receiving BDP/5-ASA had healed endoscopically, compared with six of 20 receiving BDP (30%) and two of 21 receiving 5-ASA (10%). Two patients on 5-ASA and three on BDP had a marked deterioration during treatment. The combination of BDP and 5-ASA was significantly superior to single-agent therapy in terms of both improved sigmoidoscopic and improved histological score. No differences in improvement between the 5-ASA vs. BDP-treated patients were noticed. No side effects were seen. The results of the study show that topical treatment of active distal ulcerative colitis with either 5-ASA or BDP is equally efficacious. So far, no data on topical combination therapy have been described. However, combination therapy with BDP/5-ASA seems superior to single-agent therapy and causes no adverse reactions.

Topics: Adult; Aminosalicylic Acids; Analysis of Variance; Anti-Inflammatory Agents; Beclomethasone; Colitis, Ulcerative; Double-Blind Method; Drug Therapy, Combination; Enema; Female; Humans; Male; Middle Aged; Proctitis; Treatment Outcome

Steroid enemas are widely used in distal inflammatory bowel disease (IBD). They are partly absorbed and suppress adrenocortical function. Beclomethasone dipropionate (BD) is a topically active steroid that undergoes rapid first-pass inactivation in the liver and is practically devoid of systemic side effects. We treated 32 consecutive patients with active distal ulcerative colitis (40 attacks) with 0.5 mg BD and/or 5 mg betamethasone phosphate (BP) enemas for 28 days. Clinical, laboratory, sigmoidoscopic, and histologic data were recorded before, during, and after the trial. The clinical efficacy of both treatments was similar. Betamethasone was slightly more effective in relation to the histologic improvement and disappearance of blood from the stools. Clinical signs of steroid overdosage were noted in patients on BP but not in patients on BD. Mean fasting plasma cortisol at the end of the trial was 2.9 micrograms/dl in the BP group and 15.3 micrograms/dl in the BD group. The adrenocorticotropin test was markedly suppressed in the BP group but not in the BD group. The absence of systemic steroid side effects makes BD enemas a useful addition in the therapy of IBD. Its oral administration should also be considered.

Topics: Adult; Aged; Beclomethasone; Betamethasone; Colitis, Ulcerative; Double-Blind Method; Enema; Female; Humans; Hydrocortisone; Male; Middle Aged

Twenty-three patients with attacks of distal ulcerative colitis were treated randomly with either 2 or 3 mg of topically administered beclomethasone dipropionate (BDP) or 30 mg of prednisolone sodium phosphate (PP). The effect of the steroid enemas on adrenocortical function was assessed by ACTH tests, which were performed before and after treatment. Endoscopic, clinical and histological scores were comparable in the three treatment groups in this pilot trial. Fasting cortisol in the PP group decreased significantly from 0.47 +/- 0.12 mumol/l before to 0.22 +/- 0.14 mumol/l (P less than 0.05) after therapy; in the BDP group no significant changes were found. Urinary cortisol excretion in the PP group was not detectable after therapy; in the BDP group no changes were found. It is concluded that in the topical treatment of ulcerative colitis, BDP may be preferable to PP because it exerts a promising anti-inflammatory action without affecting adrenocortical function.

Topics: Adult; Aged; Beclomethasone; Colitis, Ulcerative; Enema; Female; Humans; Hydrocortisone; Male; Middle Aged; Prednisolone; Proctitis

Sixteen patients with 18 attacks of distal ulcerative colitis were treated randomly with either 0.5 mg topically administered beclomethasone dipropionate (BDP) or 5 mg betamethasone phosphate (BMT). The effect of the steroid enemas on adrenocortical function was examined by ACTH tests, which were performed before and 20 days after treatment. At completion of the trial, a marked suppression of the adrenocortical function was found in seven of eight patients treated for nine attacks with BMT but not in any patients in the BDP group (P less than 0.01). The mean posttreatment basal and stimulated plasma cortisol levels in the BMT group were significantly lower as compared with the BDP group. The overall therapeutic response assessed by score systems was comparable in the two treatment groups. It is concluded that, in the topical treatment of ulcerative colitis, BDP is preferable to BMT because it exerts an equal anti-inflammatory action without affecting adrenocortical function.

Topics: Adrenocorticotropic Hormone; Adult; Beclomethasone; Clinical Trials as Topic; Colitis, Ulcerative; Double-Blind Method; Enema; Female; Humans; Hydrocortisone; Intestinal Mucosa; Male; Middle Aged; Prospective Studies; Random Allocation; Statistics as Topic

Since beclomethasone dipropionate (BDP) is a very potent glucocorticoid and since small oral doses (1 mg) seem to be metabolised (possibly in the gut wall or liver) before they reach the systemic circulation, a study was conducted to find out whether patients with inflammatory bowel disease could be treated with enemas containing small doses of BDP without their acquiring Cushing's syndrome or hypothalamic pituitary adrenal (HPA) suppression. The BDP in the 100 ml enemas used was stable and present in a concentration likely to be therapeutic (0.5 mg/dl). Single overnight BDP enemas, unlike conventional betamethasone (5 mg) enemas, did not interfere with the HPA axis in 6 healthy volunteers. In the double-blind randomised part of the study 2-week courses of BDP or betamethasone enemas were assessed in 9 patients having exacerbations of distal inflammatory bowel disease. The clinical and sigmoidoscopic responses as well as adrenocortical function (judged by the 'Cosyntropin' test) were evaluated on the morning after the last day of a course of enemas. Both types of enemas had similar beneficial effects, but only BDP enemas did not interfere with HPA function. Over a prolonged period, a patient with distal ulcerative colitis had been completely dependent on regular treatment with betamethasone enemas to control his symptoms. Substitution with BDP enemas successfully controlled his bowel symptoms, whilst his cushingoid features and HPA suppression regressed.

Topics: Adult; Beclomethasone; Clinical Trials as Topic; Colitis, Ulcerative; Cushing Syndrome; Double-Blind Method; Enema; Female; Humans; Hypothalamo-Hypophyseal System; Male; Pituitary-Adrenal System; Random Allocation

We aimed to investigate the oral beclomethasone dipropionate's (BDP) efficacy as an add-on therapy and to clarify the predictive factor for response to oral BDP in Korean ulcerative colitis (UC) patients.. Patients with a stable concomitant drug regimen with exposure to oral BDP (5 mg/day) within 30 days before BDP initiation were included. Partial Mayo score (pMS) was used to evaluate response to oral BDP. Clinical remission (CREM) was defined as a post-treatment pMS ≤ 1 point. Clinical response (CRES) was defined as an at least 2-point decrease in post-treatment pMS and an at least 30% decrease from baseline pMS. Patients without CREM or CRES were considered nonresponders (NRs).. Of all, 37 showed CREM, 19 showed CRES, and 44 were NRs. The CREM group included more patients with mild disease activity (75.7% vs. 43.2%, p = 0.011) than NRs. In contrast to NRs, CREM and CRES patients showed significant improvement of post-treatment erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) (ESR with p = 0.001, CRP with p = 0.004, respectively). Moreover, the initial rectal bleeding subscore (RBS) was significantly different between CREM and CRES, or NR (both with p < 0.001). In multivariate analyses, initial stool frequency subscore (SFS) of 0 and RBS of 0 were predictive factors for CREM (odds ratio [OR], 15.359; 95% confidence interval [CI], 1.085 to 217.499; p = 0.043 for SFS, and OR, 11.434; 95% CI, 1.682 to 77.710; p = 0.013 for RBS).. Oral BDP is an efficacious add-on therapy in Korean UC patients. Patients with initial SFS or RBS of 0 may be particularly good candidates for oral BDP.

Topics: Administration, Oral; Beclomethasone; C-Reactive Protein; Colitis, Ulcerative; Gastrointestinal Hemorrhage; Humans; Republic of Korea; Treatment Outcome

Off-label prescribing is encountered across various fields of medicine and creates alternative treatment options, but is associated with unknown safety risks. The use of off-label drugs for the treatment of patients with inflammatory bowel diseases (IBD) has not been characterised before.. To assess the proportion and characteristics of off-label prescribing for IBD in tertiary care centres in the Netherlands.. A prospective database of IBD patients from all Dutch university hospitals was used to collect data on drug prescriptions for IBD and demographics. Drugs were classified as off-label if they were unlicensed for Crohn's disease and/or ulcerative colitis by the Medicines Evaluation Board. Uni- and multivariable analyses were used to identify patient-specific characteristics predictive of increased off-label use.. For the induction and/or maintenance treatment of 4583 IBD patients, 12 651 historical and current drug records were available in the database. Of these, 2374 (19%) were considered off-label prescriptions. Out of 4583 IBD patients, 1477 (32%) were exposed to off-label drugs. Commonly prescribed off-label IBD drugs were mercaptopurine (18%), beclomethasone (12%), thioguanine (4%) and allopurinol (3%). Non-thiopurine/methotrexate off-label drugs were prescribed in 243 patients (6%), including biological agents or tofacitinib in 47 IBD patients (1%). Off-label prescriptions were more common in ulcerative colitis than Crohn's disease (37% vs 29%, P < 0.001). Smokers and patients that received ≥5 drug types during their disease course were more likely to be exposed to off-label drugs (smoking 33% vs 27% and multiple drug use 66% vs 22%, both P < 0.001).. About one-fifth of prescriptions for IBD were off-label and one-third of IBD patients, especially ulcerative colitis patients, were exposed to off-label drugs.

Topics: Adolescent; Adult; Allopurinol; Beclomethasone; Colitis, Ulcerative; Crohn Disease; Databases, Factual; Female; Humans; Male; Mercaptopurine; Methotrexate; Netherlands; Off-Label Use; Thioguanine; Young Adult

To evaluate how Italian gastroenterologists use corticosteroids in clinical practice for the treatment of Crohn's disease (CD) and ulcerative colitis (UC).. All members of the Italian Group for Inflammatory Bowel Disease (IG-IBD) were invited to fill in a web-based questionnaire.. 131/448 (29.2%) members completed the survey. In mild-to-moderate UC and CD relapses, low-bioavailability steroids (LBS) are first-line therapy for 37% and 42% of clinicians, respectively. In case of failure, immediate step-up to biologics or immunosuppressants is considered by 23% and 29%. Regarding conventional corticosteroids (CCS), a fixed starting dose is prescribed by 50%, and a weight-based dose by 22%. Tapering is started after 7-10days by 41% and after 14days by 32%. The preferred tapering schedule is 5mg/week. In case of CCS failure, 47% switch to parenteral steroids before considering shifting to different drug classes. In case of symptoms recurrence during tapering, 14% re-increase the dose and try tapering again. Before prescribing steroids, 72% do not prescribe any specific evaluation whereas during treatment some evaluation is performed by 85%. Vitamin D and calcium supplements are routinely prescribed along with steroids by 38%.. Several discrepancies and some deviation from the available guidelines were recorded among Italian gastroenterologists regarding corticosteroids use in IBD patients.

Topics: Administration, Intravenous; Administration, Oral; Adrenal Cortex Hormones; Adult; Anti-Inflammatory Agents; Beclomethasone; Biological Availability; Biological Products; Budesonide; Calcium; Colitis, Ulcerative; Crohn Disease; Dietary Supplements; Drug Administration Schedule; Health Care Surveys; Humans; Immunosuppressive Agents; Italy; Middle Aged; Practice Patterns, Physicians'; Prednisone; Recurrence; Severity of Illness Index; Vitamin D

Our aim was to evaluate the efficacy and safety of oral beclomethasone dipropionate (BDP) in Korean patients with ulcerative colitis (UC).. The medical records of patients with active UC who were treated with BDP were retrospectively reviewed. Partial Mayo Clinic score (pMS) was calculated to determine disease activity. After 4 weeks of therapy, clinical remission, clinical response, and response failure rates were evaluated. Clinical remission was defined as a post-treatment pMS of 0 or 1, clinical response as a decrease of two of three points in pMS and >30% from baseline, and response failure as a lack of clinical response. Also, we considered that clinical remission was included in clinical response.. Between July 2013 and April 2015, 95 patients with UC received BDP therapy at our institution (median age, 44 years; range, 12-81 years). After 4 weeks of therapy, clinical remission and clinical response rates were 50.5% and 73.7%, respectively. Mean change of pMS before and after BDP therapy was 2.4. There was no significant side effect reported. In multivariate analysis, disease activity was the only factor associated with a favorable response. Clinical remission rate was significantly higher in the mild disease activity group (66.7%) than that in the moderate or severe disease activity group (41.9%) (p=0.024).. BDP is efficacious in inducing a clinical response or remission in Korean patients with UC. Patients with mild UC were more likely to be in remission than those with moderate or severe UC after receiving BDP for 4 weeks. BDP exhibited a good safety profile.

Topics: Administration, Oral; Anti-Inflammatory Agents; Beclomethasone; Colitis, Ulcerative; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Male; Medical Records; Remission Induction; Republic of Korea; Retrospective Studies; Safety; Treatment Outcome; Young Adult

Topics: Anti-Inflammatory Agents; Beclomethasone; Bone and Bones; Budesonide; Calcium Compounds; Colitis, Ulcerative; Crohn Disease; Glucocorticoids; Humans; Inflammatory Bowel Diseases; Primary Health Care; Spain; Vitamin D; Vitamins

Aminosalicylates (5-ASA) are first-line treatment for mild-moderate ulcerative colitis (UC). Systemic corticosteroids (CS) are considered for patients in whom 5-ASA has been unsuccessful, but their use is limited by adverse effects. Beclomethasone dipropionate (BDP), a topically acting steroid with low systemic bioavailability, has a more favorable safety profile, but its role in clinical practice is not yet well established.. The aim of the present study is to assess whether oral BDP can be an alternative treatment to systemic CS for patients with mild-moderate UC not responding to first-line therapy with 5-ASA.. From 2003 to 2006, all consecutive patients with mild-moderate UC unresponsive to oral and topical 5-ASA (+/-topical CS) administered for at least 3 weeks received an 8-week course of oral BDP (10 mg/day for 4 weeks and 5 mg/day for an additional 4 weeks). Co-primary end-points were: (1) clinical remission within 8 weeks, without need of systemic CS; (2) steroid-free remission for 12 months.. Sixty-four patients were included. In this study, within 8 weeks, 48/64 patients (75%) entered remission without systemic CS, while 16/64 (25%) failed to enter remission. Within 12 months, 37/64 patients (58%) had prolonged steroid-free remission, while 11/64 (17%) relapsed. During 1 year, 75% of patients receiving oral BDP could avoid systemic CS.. Oral BDP can avoid the use of systemic CS in the vast majority of patients with mild-moderate UC not responding to 5-ASA and could be considered as a second-line treatment for these patients.

Topics: Administration, Oral; Adolescent; Adult; Aged; Aspirin; Beclomethasone; Cohort Studies; Colitis, Ulcerative; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Intestinal Mucosa; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Probability; Recurrence; Remission Induction; Retrospective Studies; Risk Assessment; Severity of Illness Index; Statistics, Nonparametric; Treatment Outcome; Young Adult

Beclometasone dipropionate (BDP) is a relatively new topically acting oral steroid to treat mild to moderately active ulcerative colitis (UC). We estimate that 20,000 patients have received oral BDP in Spain in the last two years. Our aim was to evaluate the efficacy and safety of oral BDP in clinical practice.. Retrospective and multicenter study that included 434 patients with active UC treated with BDP. The partial Mayo Clinic score (pMS, 0-9) was used to measure disease activity. Remission was defined as post-treatment pMS of 0 or 1; response as a decrease in pMS of 3 points or 2 points and >30%, and failure as lack of remission or response.. BDP dose was 5 mg/day in 88% of patients and mean treatment duration was 6.2 weeks. BDP achieved remission in 44.4%, response in 22.3% and failed in 33.2% of patients. Mean pMS decreased from 4.9 ± 1.3 to 2.4 ± 2.3 (p<0.0001). Remission rate was higher in mild and moderate than in severe UC (p<0.043) and tended to be higher in left-sided and extensive UC than in proctitis (p<0.06). Failure was less frequent in patients treated for >4 weeks (p<0.02). Mild adverse events were reported in 7.6% of patients.. BDP induces response or remission in two thirds of active UC patients, with a good safety profile. Patients with mild to moderate, left-sided or extensive UC, receiving BDP for more than 4 weeks are most likely to benefit from this treatment.

Topics: Administration, Oral; Adult; Anti-Inflammatory Agents; Beclomethasone; Colitis, Ulcerative; Drug Administration Schedule; Female; Humans; Male; Remission Induction; Retrospective Studies; Severity of Illness Index; Treatment Outcome

Topics: Anti-Inflammatory Agents; Beclomethasone; Colitis, Ulcerative; Enema; Humans; Mesalamine; Remission Induction; Severity of Illness Index

Topics: Administration, Oral; Administration, Rectal; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Beclomethasone; Colitis, Ulcerative; Colon; Drug Therapy, Combination; Humans; Intestinal Mucosa; Mesalamine

Bronchopulmonary involvement is uncommon in ulcerative colitis. Bronchiectasis is a rare manifestation of the disease. We report a case of a 65-year-old patient with ulcerative colitis in whom we diagnosed bronchiectasis. The evidence of a relationship between bronchiectasis and ulcerative colitis was established on the basis of 3 criteria: the late occurrence of bronchiectasis in a patient without pulmonary history, their appearance after the ulcerative colitis developed and their improvement after inhaled corticosteroid treatment. This observation points out that ulcerative colitis investigations should be extended to the respiratory structures. The respiratory involvement is not always concomitant with the bowel disease. This observation suggests the efficiency of the inhaled corticosteroids in this disease.

Topics: Aged; Anti-Inflammatory Agents; Beclomethasone; Bronchiectasis; Colitis, Ulcerative; Follow-Up Studies; Humans; Male; Radiography, Thoracic; Respiratory Therapy; Time Factors; Tomography, X-Ray Computed

Beclomethasone dipropionate was administered via a cecostomy to four patients with active ulcerative colitis that was refractory to conventional glucocorticosteroid therapy. From a tube cecostomy, beclomethasone dipropionate solution was administered continuously throughout the day. Clinical manifestations, laboratory examinations, and endoscopic and/or radiographic findings markedly improved within 1-2 wk. A serial decrease in the index of disease activity was observed from the time administration began (mean score, 226.0) to 2 wk later (137.4 points). An excellent clinical response was recognized without any significant side effects, and the urgent need for total colectomy was avoided in all four patients.

Topics: Adult; Anti-Inflammatory Agents; Beclomethasone; Cecostomy; Colitis, Ulcerative; Female; Humans; Male; Middle Aged

Topics: Beclomethasone; Colitis, Ulcerative; Cutaneous Fistula; Humans; Instillation, Drug; Intestinal Fistula; Male; Middle Aged

Two men with severe ulcerative colitis developed ulcerative tracheobronchitis 4 and 8 years after total colectomy. Intense plasma cell infiltration of tracheal mucosa and submucosa and destruction of mucous glands occurred, with partial relief of symptoms with corticosteroids. We compare them with the only other case reported, also years after colectomy.

Topics: Beclomethasone; Bronchitis; Colectomy; Colitis, Ulcerative; Humans; Male; Middle Aged; Prednisolone; Time Factors; Tracheitis

Topics: Administration, Topical; Androstadienes; Anti-Inflammatory Agents; Beclomethasone; Betamethasone Valerate; Budesonide; Colitis, Ulcerative; Fluticasone; Glucocorticoids; Humans; Hydrocortisone; Prednisolone; Pregnenediones