The aim of this cross-sectional study was to establish an online inflammatory bowel disease (IBD) registry for a first picture of the situation of IBD outpatients' treatment in Germany. Between March 2006 and July 2007 IBD outpatients from 24 gastroenterological specialist practices and two hospitals in Germany were enrolled in an Internet-based registry to evaluate the outpatients' clinical status, psychological impairments, provided health care, as well as medical treatment and medication costs. 1032 IBD patients (ulcerative colitis/UC: 519; Crohn's disease/CD: 511; indeterminate colitis: 2) were enrolled in the study (age: 43 ± 14 years/M ± SD). Disease duration of all patients averaged 10 ± 8.5 years. In 519 UC-patients (49% male; 33% pancolitis), 66% were in remission as were 55% of CD patients (37 % male; 41 % active smokers). Associated with higher rates of disease activity (CDAI ≥ 150; CAI>4) were corticosteroids (CD, UC), topical medication (UC), relevant reported depressive symptoms (15%; 6-31%) and impairments in sexuality (21%; 9-42%). Relevant medication groups prescribed were oral aminosalicylates (UC: 70%; CD: 47%); immunosuppressive therapy - mostly azathioprine/6 MP (CD: 47%; UC: 26%), and Infliximab (CD: 8%; UC: 3%). Strongly associated with their clinical disease activity in UC as well as CD patients, 15% (6-31%) reported relevant depressive symptoms and 21% (9-42%) relevant impairments in sexuality. The registry constitutes a large complemental database for the patient population in Germany. About one third of the IBD patients were not in clinical remission (CDAI ≥150/CAI >4) (CD: 45%; UC: 27%), although high rates of immunosuppressive drugs (CD: 47%; UC 26%) were administered. This study shows a large burden of active disease associated with an unexpectedly high (co)morbidity and high psychosocial impairments, indicating a reduced health state in IBD patients.

Summary: Background: This observational real‐world evidence (RWE) study is based on prospectively collected data from the VEDO_IBDregistry study.Aim: To compare the effectiveness of vedolizumab and anti‐TNF agents in biologic‐naïve patients with ulcerative colitis (UC) at the end of induction and during maintenance treatment.Methods: Between 2017 and 2020, we enrolled 512 patients with UC starting therapy with vedolizumab or an anti‐TNF agent in 45 IBD centres across Germany. We excluded biologic‐experienced patients and those with missing partial Mayo (pMayo) outcomes; this resulted in a final sample of 314 (182 on vedolizumab and 132 on an anti‐TNF agent). The primary outcome was clinical remission measured using pMayo score; any switch to a different biologic agent was considered an outcome failure (modified ITT analysis). We used propensity score adjustment with inverse probability of treatment weighting to correct for confounding.Results: During induction therapy, clinical remission was relatively low and similar in vedolizumab‐ and anti‐TNF‐treated patients (23% vs. 30.4%,p = 0.204). However, clinical remission rates after two years were significantly higher for vedolizumab‐treated patients than those treated with an anti‐TNF agent (43.2% vs. 25.8%,p < 0.011). Among patients treated with vedolzumab, 29% switched to other biologics, versus 54% who had received an anti‐TNF agent.Conclusion: After two years of treatment, vedolizumab resulted in higher remission rates than anti‐TNF agents.

The aim of this observational, real-world evidence, modified intention-to-treat (mITT) study based on prospectively collected data from the VEDO_IBD registry was to compare the effectiveness of vedolizumab (VEDO) vs antitumor necrosis factor (anti-TNF) in biologic-naïve Crohn’s disease (CD) patients. Between 2017 and 2020, 557 CD patients starting therapy with VEDO or anti-TNF were consecutively enrolled in 45 IBD centers across Germany. Per study protocol, the analysis excluded biologic-experienced patients and those with a missing Harvey-Bradshaw Index score, resulting in a final sample of 327 biologic-naïve CD patients. Clinical remission was measured using the Harvey-Bradshaw Index at the end of induction therapy and after 1 and 2 years. Switching to a different therapy was considered an outcome failure. Propensity score adjustment with inverse probability of treatment weighting was used to correct for confounding. The effectiveness of both VEDO (n = 86) and anti-TNF (n = 241) was remarkably high for induction treatment, but VEDO performed significantly less well than anti-TNF (clinical remission: 56.3% vs 73.9%, P < .05). In contrast, clinical remission after 2 years was significantly better for VEDO compared with anti-TNF (74.2% vs 44.7%; P < .05; odds ratio, 0.45; 95% CI, 0.22-0.94). Remarkably, only 17% of patients switched from VEDO to another biologic vs 44% who received anti-TNF. The results of this prospective, 2-year, real-world evidence study suggest that the choice of VEDO led to higher remission rates after 2 years compared with anti-TNF. This could support the role of VEDO as a first-line biologic therapy in CD.

Hintergrund: Patienten mit einer chronisch entzündlichen Darmerkrankung (CED) erleben vielfältige körperliche und psychosoziale Beeinträchtigungen. Wir berichten aktuelle Daten eines Fragebogen-Surveys. Methodik: Die Querschnittsstudie wurde 2005 als postalischer Survey in 3 Regionen Deutschlands (Kiel/Lübeck, Halle [Saale], Regensburg) durchgeführt. Befragt wurden Morbus-Crohn- und Colitis-ulcerosa-Patienten (MC, CU) aus gastroenterologischen Praxen, Hochschulambulanzen und dem Mitgliederbestand der DCCV. Die Entwicklung des Fragebogens orientierte sich an der International Classification of Functioning, Disability, and Health. Der Fragebogen umfasst national und international etablierte Fragen und Skalen (u. a. HADS). Ergebnisse: Die Fragebögen wurden von 1083 CED-Patienten beantwortet (58 % MC; 65 % Frauen; Alter/MW: 42 Jahre; Erkrankungsdauer/MW: 13 Jahre). 25 % der CED-Patienten litten stark oder sehr stark an der Erkrankung, ein Drittel gab starke Müdigkeit und Erschöpfung an, 52 % fühlten sich stark von Stress beeinträchtigt. Eine klinisch relevante Angst oder Depressivität wiesen je 24 % auf. Auffällig ist eine höhere Prävalenz der Depressivität bei männlichen Respondenten. Schwere Einschränkungen in verschiedenen Bereichen sozialer Teilhabe berichteten ein Viertel der Befragten. Schlussfolgerungen: Die Ergebnisse der Studie zeigen die multiplen und psychosozialen Beeinträchtigungen der CED. Dies weist auf einen Bedarf einer multi- und interdisziplinären Versorgung hin. Background: Patients with inflammatory bowel diseases (IBD) experience various bodily and psychosocial impairments. We report data from a recent German questionnaire survey. Methods: The cross-sectional study was conducted in 2005 as a postal survey in three regions in West (Kiel and Luebeck, Regensburg) and East (Halle/Saale) Germany. Patients with Crohn’s disease and ulcerative colitis (CD, UC) were recruited from specialized gastroenterological practices, university outpatient clinics, and the registry of a prominent patient organization (DCCV). The questionnaire followed the concept and distinctions of WHO’s ICF and incorporated (inter-)nationally established items and scales (i. a. HADS). Results: Survey responders (n = 1083, CD: 58 %, 65 % female) had a mean age of 42 years with an average disease duration of 13 years. 25 % suffered severely or very severely from their disease in general, one third stated at least severe fatigue, and 52 % felt profoundly affected by stress. A clinically relevant anxiety was observed in 24 % with no relevant difference between males and females. Depression was more common in men (29 %) than in women (21 %). Restrictions in social participation (family life, work) were actually prominent in at least a quarter of the responders. Conclusions: Beside somatic ailments typical for the disease, patients also reported multiple psychosocial impairments and participation restrictions and should hence profit from a multi- and interdisciplinary team care.

Sustaining clinical remission is an important treatment goal in moderate-to-severe UC. This post hoc exploratory analysis assessed the long-term efficacy of vedolizumab in the subset of patients with UC in the GEMINI 1 study who were in clinical remission by week 14 after 3 induction doses, administered at weeks 0, 2, and 6. Sustained clinical remission (primary endpoint) was evaluated using 2 definitions: (1) a partial Mayo Score (pMS) of ≤2 with no subscore >1 and (2) a rectal bleeding subscore (RBS) of 0 throughout weeks 14, 26, 38, and 52. The proportion of patients in clinical remission at week 14 was significantly higher in patients receiving vedolizumab (n = 620) compared with placebo (n = 149) (pMS: 32.7% vs 20.1% [percentage-point difference (∆) 12.6%; 95% confidence interval [CI], 5.2–20.0]; RBS: 47.3% vs 28.9% [∆18.4%; 95% CI, 10.1–26.7]). Of patients in clinical remission at week 14, a significantly higher proportion of vedolizumab-treated patients achieved sustained clinical remission compared with placebo (pMS: 66.5% vs 26.7%; ∆39.8%; 95% CI, 22.7–56.9; RBS: 56.7% vs 20.9%; ∆35.7%; 95% CI, 22.3–49.1). Findings were consistent in tumor necrosis factor (TNF) antagonist-naive and antagonist-failure patients. Compared with placebo, 35%–40% more patients receiving a full induction course of vedolizumab had sustained clinical remission after 52 weeks of therapy. This result was observed irrespective of TNF antagonist treatment history. Clinical remission at week 14 may therefore be a predictor for sustained clinical remission with vedolizumab.