BACKGROUND & AIMS: The aim of this study was to evaluate the efficacy of LT-02, a novel modified-release phosphatidylcholine (PC) formulation, for induction and maintenance of remission in patients with mild to moderate ulcerative colitis (UC) and inadequate response to mesalamine. METHODS: LT-02 was evaluated in a multicenter double-blind, randomized, placebo-controlled study comprising a 12-week induction trial (PCG-2), followed by a 48-week maintenance trial (PCG-4). In PCG-2, patients were randomized 1:1:1 to treatment with 0.8 g LT-02 4 times daily (QID), 1.6 g LT-02 twice daily (BID), or placebo, respectively. All patients continued to take a standard dose of oral mesalamine ( >= 2.4 g/day). The primary end point in PCG-2 was deep remission. Patients achieving remission at week 12 were randomly assigned 2:1:1 to 1.6 g LT-02 BID, placebo, or 500 mg mesalamine (3 times daily), respectively, in PCG-4; the primary end point was remission at 48 weeks. RESULTS: PCG-2 was terminated early for futility after a prespecified interim analysis; 466 patients (of 762 planned) were randomized. There was no statistically significant difference in deep remission at week 12 (placebo, 13.5%; LT-02 BID, 14.2%; LT-02 QID, 9.7%). In PCG-4, 150 patients (of approximately 400 planned) were randomized. There was no statistically significant difference in remission rates at week 48 (LT-02 BID, 49.3%; mesalamine, 50.0%; placebo, 43.2%). LT-02 was safe. CONCLUSIONS: Despite prior evidence of beneficial effects of PC in phase 2 trials, our induction study with LT-02 in patients with mild to moderate UC was terminated prematurely for futility. Signals of ef fi cacy in maintenance therapy require con fi rmation in an adequately powered maintenance trial. LT-02 was safe and well-tolerated.

Die lymphozytäre Kolitis (LC) führt häufig zu chronisch-wässriger Diarrhö und weiteren Begleitsymptomen sowie zu einer signifikant reduzierten Lebensqualität (1). Der MCDAI ist ein neuer Aktivitäts-Score, der verschiedene Symptome der mikroskopischen Kolitis inkludiert (2). Wir untersuchten den Einfluss von Budesonid im Vergleich zu Mesalazin oder Placebo auf die Krankheitsaktivität und die Lebensqualität bei aktiver LC.

BACKGROUND & AIMS: Swallowed topical-acting corticosteroids are recommended as first-line therapy for eosinophilic esophagitis (EoE). Asthma medications not optimized for esophageal delivery are sometimes effective, although given off-label. We performed a randomized, placebo-controlled trial to assess the effectiveness and tolerability of a budesonide orodispersible tablet (BOT), which allows the drug to be delivered to the esophagus in adults with active EoE. METHODS: We performed a double-blind, parallel study of 88 adults with active EoE in Europe. Patients were randomly assigned to groups that received BOT (1 mg twice daily; n = 59) or placebo (n = 29) for 6 weeks. The primary end point was complete remission, based on clinical and histologic factors, including dysphagia and odynophagia severity <= 2 on a scale of 0-10 on each of the 7 days before the end of the double-blind phase and a peak eosinophil count <5 eosinophils/high power field. Patients who did not achieve complete remission at the end of the 6-week double-blind phase were offered 6 weeks of open-label treatment with BOT (1 mg twice daily). RESULTS: At 6 weeks, 58% of patients given BOT were in complete remission compared with no patients given placebo (P < .0001). The secondary end point of histologic remission was achieved by 93% of patients given BOT vs no patients given placebo (P < .0001). After 12 weeks, 85% of patients had achieved remission. Six-week and 12-week BOT administration were safe and well tolerated; 5% of patients who received BOT developed symptomatic, mild candida, which was easily treated with an oral antifungal agent. CONCLUSIONS: In a randomized trial of adults with active EoE, we found that budesonide oral tablets were significantly more effective than placebo in inducing clinical and histologic remission. Eudra-CT number 2014-001485-99;

s of the 13 th Congress of ECCO -European Crohn's and Colitis Organisation S491positive for binding antibodies at weeks 4, 12, or 26, with similar percentages in each treatment group (ABP 501, n = 101, 38.3%; adalimumab, n = 100, 38.2%) across all time points.A total of 53 (10.1%) of all randomised patients tested positive for neutralising antibodies at weeks 4, 12, or 26, which was also similar in each treatment group (ABP 501, n = 24, 9.1%; adalimumab, n = 29, 11.1%).The rate of seroconversion over time for both treatment groups was similar, progressively increasing throughout the study.For subjects testing ADA positive, the magnitude of both the binding and neutralising ADAs across the treatment groups were evenly distributed, with similar median S/N or titre values at each time point.Conclusions: Similar immunogenicity rates were observed and relative magnitude of the ADAs was similar between the ABP 501 and adalimumab RP treated patients.

Der Nachweis eines verringerten Phosphatidylcholin (PC)-Gehalts im intestinalen Mukus bei CU-Patienten [1] führte zu der Hypothese, dass eine orale Gabe von magensaft-resistentem PC mit anschließender Freisetzung im Ileum die Schutzfunktion der Mukosa wiederherstellen könnte.

BACKGROUND & AIMSLymphocytic colitis is a common cause of chronic, nonbloody diarrhea. However, the effects of treatment are unclear and randomized placebo-controlled trials were requested in a Cochrane review. We performed a randomized, placebo-controlled, multicenter study to evaluate budesonide and mesalazine as induction therapy for lymphocytic colitis.METHODSPatients with active lymphocytic colitis were randomly assigned to groups given budesonide 9 mg once daily (Budenofalk granules), mesalazine 3 g once daily (Salofalk granules), or placebo for 8 weeks in a double-blind, double-dummy design. The primary endpoint was clinical remission, defined as ≤21 stools (including ≤6 watery stools), in the 7 days before week 8.RESULTSThe final analysis included 57 patients (19 per group). Most patients were female (72%) and the mean age was 59 years. The proportion of patients in clinical remission at week 8 was significantly higher in the budesonide group than in the placebo group (intention-to-treat analysis, 79% vs 42%; P = .01). The difference in proportions of patients in clinical remission at week 8 between the mesalazine (63%) and placebo groups was not significant (P = .09). The proportion of patients with histologic remission at week 8 was significantly higher in the budesonide group (68%) vs the mesalazine (26%; P = .02) or placebo (21%; P = .008) groups. The incidence of adverse events was 47.4% in the budesonide group, 68.4% in the mesalazine group, and 42.1% in the placebo group.CONCLUSIONSIn a randomized multicenter study, we found oral budesonide 9 mg once daily to be effective and safe for induction of clinical and histologic remission in patients with lymphocytic colitis, compared with placebo. Oral mesalazine 3 g once daily was not significantly better than placebo. ClinicalTrials.gov no: NCT01209208.

Die lymphozytäre Kolitis ist eine zunehmend häufig erkannte Ursache für chronisch-wässrige Diarrhö. In 2 kleinen plazebo-kontrollierten Studien wurde eine Wirksamkeit von Budesonid gezeigt. Mesalazin wird als alternative Therapioption empfohlen, obwohl plazebo-kontrollierte Studen fehlen. Daher führten wir eine plazebo-kontrollierte multizentrische Phase 3 Studie durch, um die Wirksamkeit von Budesonid und Mesalazin in der Remissionsinduktion der lymphozytären Kolitis zu prüfen.

Objective This 1-year study aimed to assess low-dose budesonide therapy for maintenance of clinical remission in patients with collagenous colitis. Design A prospective, randomised, placebo-controlled study beginning with an 8-week open-label induction phase in which patients with histologically confirmed active collagenous colitis received budesonide (Budenofalk, 9 mg/day initially, tapered to 4.5 mg/day), after which 92 patients in clinical remission were randomised to budesonide (mean dose 4.5 mg/day; Budenofalk 3 mg capsules, two or one capsule on alternate days) or placebo in a 12-month double-blind phase with 6 months treatment-free follow-up. Primary endpoint was clinical remission throughout the double-blind phase. Results Clinical remission during open-label treatment was achieved by 84.5% (93/110 patients). The median time to remission was 10.5 days (95% CI (9.0 to 14.0 days)). The maintenance of clinical remission at 1 year was achieved by 61.4% (27/44 patients) in the budesonide group versus 16.7% (8/48 patients) receiving placebo (treatment difference 44.5% in favour of budesonide; 95% CI (26.9% to 62.7%), p<0.001). Health-related quality of life was maintained during the 12-month double-blind phase in budesonide-treated patients. During treatment-free follow-up, 82.1% (23/28 patients) formerly receiving budesonide relapsed after study drug discontinuation. Low-dose budesonide over 1 year resulted in few suspected adverse drug reactions (7/44 patients), all non-serious. Conclusions Budesonide at a mean dose of 4.5 mg/day maintained clinical remission for at least 1 year in the majority of patients with collagenous colitis and preserved health-related quality of life without safety concerns. Treatment extension with low-dose budesonide beyond 1 year may be beneficial given the high relapse rate after budesonide discontinuation. Trial registration numbers http://www.clinicaltrials.gov (NCT01278082) and http://www.clinicaltrialsregister.eu (EudraCT: 2007-001315-31).

Digital oral poster presentationsTable (abstract DOP076): Changes from baseline in HRQoL end points at Weeks 6 and 52 in patients with UC in the GEMINI 1 study (Intention-to-Treat population; last observation carried forward) a Change from baseline to Week 6 (end of induction phase) Change from baseline to Week 52 (end of maintenance phase) PBO (N = 149) VDZ (N = 225) Betweengroup difference b

Einleitung Es wurde eine generische Lösungen zur Datenkommunikation und asynchronen Bilddatenübermittlung für Aufgaben der Telemedizin entwickelt. Der Schwerpunkt liegt dabei auf der Vernetzung einer Klinik mit niedergelassenen Ärzten und der Implementierung eines adäquaten Datenschutzkonzeptes.