BACKGROUND:Real-world evidence is needed to understand the comparative effectiveness of biologics in Crohn's disease (CD) under routine-care conditions. We conducted a pooled analysis of individual patient data from prospective German CD registries (BioCrohn, RUN-CD, VEDO-IBD) in the UMBRELLA-IBD data warehouse. METHODS:We included 1567 adults with CD who initiated anti-TNF therapy (adalimumab or infliximab), ustekinumab or vedolizumab. The main outcome was clinical remission (CR) at 24 months (HBI ≤ 4). Additional outcomes included HBI, EQ-VAS and treatment persistence over time. Between-group comparisons used propensity-score-based inverse probability of treatment weighting. RESULTS:After weighting, CR following induction was observed in a slightly higher proportion of patients initiating anti-TNF therapy (74.5%) than ustekinumab (69.4%) or vedolizumab (65.3%) (p = 0.035). Clinical response was 77.9%, 73.5% and 67.8%, respectively (p = 0.015). At 24 months, CR rates were similar in magnitude (anti-TNF, 53.4%; ustekinumab, 63.5%; vedolizumab, 58.7%) but were higher with ustekinumab than anti-TNF (p = 0.004). Over 24 months, treatment persistence differed (log-rank p < 0.001) and was highest for adalimumab (81.4%), lowest for infliximab (66.6%), and intermediate for ustekinumab (78.6%) and vedolizumab (76.9%). HBI decreased and remained low, and EQ-VAS improved, with no relevant between-group differences. CONCLUSION:Overall effectiveness in CD was high, with only small differences between biologic therapies. At the end of induction, CR was slightly higher with anti-TNF therapy than with vedolizumab, whereas at 24 months it was slightly higher with ustekinumab than with anti-TNF. Marked differences in treatment persistence among the evaluated biologics suggest that persistence as an endpoint is not fully explained by CR alone.
INTRODUCTION:European and National Celiac Disease (CeD) guidelines offer an easy pathway to diagnose CeD. The German CeD Registry aimed to assess symptoms and clinical findings before diagnosis, diagnostic delay, care during the diagnostic process, and factors associated with persistence of symptoms. METHODS:Individuals with CeD provided demographic, clinical, and healthcare-related information. Participants were divided into four subgroups according to age at diagnosis (>18 or <18 years) and year of diagnosis (before and since 2012). Factors associated with symptoms after at least 1 year on a gluten-free diet (GFD) were assessed using multivariate logistic regression. RESULTS:From 11/2019 to 10/2021, 2,333 participants were enrolled. After exclusion of 169 (7.2%), 2,164 remained for analysis, thereof 796 (36.8%) were diagnosed <18 years, and 1,283 (59.3%) since 2012. Most common symptoms before diagnosis included abdominal pain (83%), bloating (82%), fatigue (78%), and diarrhoea (71%). Diagnostic delay after 2012 was longer in adults than children (median 4.4 years [interquartile range; IQR: 1.2-13.0] versus 1.1 [IQR: 0.5-2.2], respectively) (p < 0.001). Guideline-conform diagnoses increased over time. After diagnosis, only 60% received professional dietary counselling. Factors associated with symptoms despite GFD included female gender (odds ratio [OR]: 1.79 [95% confidence interval: 1.34; 2.40], p < 0.001), same symptom before diagnosis (OR: 3.45 [2.45; 4.96], p < 0.001), insufficient information provided at diagnosis (OR: 1.25 [1.00; 1.57], p = 0.046), and age at diagnosis (per decade) (OR: 1.11 [1.04; 1.18], p < 0.001) but not time since diagnosis. CONCLUSIONS:Our findings revealed deficits in awareness, the diagnostic process, and post-diagnostic care that are linked to decreased clinical improvement over time.
The Competence Network Inflammatory Bowel Diseases (Kompetenznetz Darmerkrankungen) was established in Germany in 1999 through a 10-year funding programme by the German Ministry of Education and Research. It was created to address the growing gap between the rising prevalence and therapeutic complexity of inflammatory bowel disease (IBD) and the fragmented care structures and isolated academic initiatives of the time. The network’s continuing mission is to improve care for patients with Crohn’s disease and ulcerative colitis by more closely integrating clinical practice, translational science and patient involvement. This review summarises the history, governance, registries, biobanking, clinical trials, educational programmes and collaborations of the Competence Network IBD. Over the past 25 years, the Competence Network IBD has established prospective national registries (e.g. RUN-CD, RUN-UC, VEDO-IBD and FilgoColitis), developed pragmatic real-world cohorts (TARGET and GeCer) and contributed to the UMBRELLA-IBD data warehouse of the Competence Network IBD in Germany. The network played a central role in creating the German IBD DNA collection and supported the Kiel University biobank, both of which link biospecimens with longitudinal clinical data to support genetic and microbiome research. It also conducts and coordinates multicentre clinical trials and has supported the development of the German evidence- and consensus-based IBD guidelines. With more than 800 members from university centres, community practices, nursing and patient organisations, it now provides a robust platform for research and knowledge transfer across all levels of IBD care. The Competence Network IBD demonstrates how long-term interdisciplinary and cross-sectoral collaboration can improve the management of chronic inflammatory diseases. By integrating research infrastructures with education and patient involvement, the network serves as a scalable and sustainable model for national and international collaboration in IBD.
Background: The efficacy and safety of the anti-TNF inhibitor golimumab in ulcerative colitis (UC) have been demonstrated in pivotal randomized controlled trials (RCTs). However, real-world data are needed to assess its effectiveness and safety in routine clinical practice, where patient populations and treatment settings are more heterogeneous. Methods: This pooled, retrospective–prospective cohort analysis draws on primary data from four IBD registries that contribute UC data to the UMBRELLA-IBD data warehouse: BioColitis, RUN-UC, TARGET-IBD, and VEDO-IBD. Data for each registry were collected across multiple centers under routine clinical care conditions in Germany. Eligible patients had a confirmed diagnosis of UC according to DGVS/ECCO criteria, were ≥18 years of age, and had newly initiated treatment with golimumab between 2017 and 2023. In total, 222 patients met these criteria and were included in the analysis. Statistical analyses included descriptive summaries, group comparisons, and Kaplan–Meier analysis of treatment persistence. Adverse events (AEs) and serious adverse events (SAEs) were also assessed and compared to other anti-TNF therapies from UMBRELLA-IBD. Results: Of the 222 patients who newly initiated golimumab, 134 had a documented month 12 visit with a documented pMayo score and were included in the modified intention-to-treat (mITT) analysis. A high proportion of the patients in the study had previously received treatment with at least two biologics (81%). In this mITT population, clinical remission was achieved in 38.1% and steroid-free clinical remission (SFCR) in 36.6% at 12 months. In the full cohort, treatment persistence at 12 months was 67.2%. Safety data on adverse events (AEs) and serious adverse events (SAEs) were reported in 14.8% and 5.8% of cases, respectively, with no significant differences compared with other anti-TNF therapies. Conclusions: In addition to the positive findings from the pivotal RCTs, these real-world data further support the clinical effectiveness and safety of golimumab in routine care for UC.
BACKGROUND:Real-world evidence studies of ustekinumab (UST) in ulcerative colitis (UC) are needed because randomized controlled trials do not represent unselected patient populations in everyday clinical practice. Patients with UC were recruited when starting biologic therapy for the first time or switching to a new biologic therapy. This study assessed the effectiveness of maintenance therapy with UST in comparison to anti-TNF or vedolizumab (VDZ) at 12 months. METHODS:Between 2020 and 2022, 507 UC patients starting biologic therapy for the first time or switching to a new biologic therapy were enrolled at 34 inflammatory bowel disease (IBD)-specialized centers in Germany. After excluding patients receiving other biologics or small molecules, as well as those with stomas or missing outcomes, the final sample consisted of 476 patients. The outcomes were clinical response, clinical remission (CR), and steroid-free remission. Propensity score (PS) adjustment with inverse probability of treatment weighting was used to reduce the effect of confounding due to physician selection of therapy. RESULTS:A total of 476 patients with UC were included in the analysis (UST: 147, anti-TNF: 168, VDZ: 161). Treatment persistence over 12 months differed significantly (P < .001) between UST (93.9%), VDZ (87.0%), and anti-TNF (75.0%). The PS-weighted effectiveness of UST in the mITT analysis at month 12 was not significantly different from anti-TNF or VDZ (CR: UST 26.9%, anti-TNF 34.7%, VDZ 40.9%; P = .063). CONCLUSIONS:In the prospective RUN-UC study with PS-weighted groups, UST showed higher treatment persistence but no significant difference in maintenance effectiveness compared to anti-TNF or VDZ in UC.
Abstract Background Observational real-world evidence (RWE) studies on the effectiveness of ustekinumab (UST) in ulcerative colitis (UC) are needed in addition to RCTs, which may not represent everyday clinical practice. For this reason, the prospective, controlled, propensity score (PS)-adjusted RUN-UC study was conducted on UC patients starting a new biologic therapy with a follow-up period of up to 3 years. The aim of the present analysis was to evaluate the effectiveness of 2-year maintenance therapy with UST vs. anti-TNF or vedolizumab (VDZ). Methods Between 2020-2022, 507 UC patients starting a new therapy with UST or other biologics were enrolled in 34 IBD-experienced centres in Germany. After the exclusion of patients with a stoma, small molecules and missing outcomes, the final sample consisted of 483 patients. Clinical remission (CR) (pMayo ≤ 1 plus a bleeding subscore=0) and steroid-free remission (CR and no systemic use of steroids or oral budesonide) were considered as outcomes. PS adjustment with inverse probability of treatment weighting (IPTW) was implemented to reduce confounders' effect. Results A total of 483 UC-patients [153 UST (bio-naïve: 13), 165 anti-TNF (ADA: 30.3%, IFX: 61.8%, GOL: 7.9%) (bio-naïve: 114) and 165 VDZ (bio-naïve: 106)] were included in the analysis. The PS-adjustment reduced systemic differences in the baseline parameters (UST/anti-TNF/VDZ: 43.1/46.1/50.9% males, 23.5/24.2/20.6% EIMs), in particular, the "bio-experienced" characteristic was also equalised, between the groups. Treatment persistence over 24 months showed differences between UST (68.6%), VDZ (73.3%) and anti-TNF (58.8%) (p=0.012), but this was only statistically significant for VDZ vs anti-TNF (p=0.005) but not for UST vs VDZ (p> 0.05) and UST vs anti-TNF (p>0.05) (Figure 1). The PS-weighted 24-month effectiveness (n=367) of UST (mITT analysis) in terms of clinical remission and steroid-free remission (Table 1) differed between the following groups (CR: UST 33.3%, anti-TNF 30.2%, VDZ 48.0%) compared to VDZ (p=0.031), but not compared to anti-TNF (UST vs anti-TNF p>0.05 and anti-TNF vs VDZ p=0.005). A sub-analysis evaluating steroid-free remission in bio-experienced patients after one prior anti-TNF treatment showed no statistical difference. was (UST 41.5%, anti-TNF 20.0% and VDZ 43.8%; p=0.130). Conclusion In this prospective RUN-UC study with PS-weighted groups, UST, anti-TNF and VDZ showed a more variable 24-month effectiveness, favouring VDZ over UST and anti-TNF. However, in a subgroup of bio-experienced patients with only one anti-TNF before baseline, steroid-free remission was numerically but not statistically higher with UST and VDZ than with anti-TNF.
BACKGROUND:The prospective RUN-CD registry investigates the effectiveness of ustekinumab (UST) and other biologics in Crohn's disease (CD) across Germany. Based on data from the registry, this study presents the maintenance phase results of a 12-month real-world-evidence (RWE) comparison of CD patients initiating new biologic therapies with UST or anti-TNF. METHODS:After excluding patients using biologics other than UST and anti-TNF and those with missing outcomes, the final sample consisted of 618 CD patients. Clinical remission (CR), defined as a Harvey-Bradshaw Index (HBI) ≤4, was the prespecified endpoint at 12 months. Switching to another biologic therapy was considered an outcome failure. Propensity score adjustment was used to reduce the effect of confounders. RESULTS:The study included 343 CD patients treated with UST and 264 treated with anti-TNF. Over 12 months, the frequency of therapy switches was significantly higher for infliximab (28%) compared with UST (17%) and adalimumab (17%) (P =.045). There was no significant difference in CR rates at 12 months between the UST and anti-TNF groups (65.8% vs 60.0%, P =.262). However, in week-16 responders, CR rates at 12 months were significantly higher with UST (77.6%) versus anti-TNF (65.4%) (P =.041). The change in EQ-VAS (QoL) scores between UST and anti-TNF showed a 5.1-point difference favoring UST (P =.002). CONCLUSIONS:In this 12-month RWE comparison, overall CR rates were similar between UST and anti-TNF. However, among week-16 responders, CR rates were significantly higher with UST. Additionally, UST was associated with a significantly greater improvement in QoL compared with anti-TNF.
Background: The prevalence of obesity is rising globally. Evidence-informed guidance on preventing obesity is needed, but most existing obesity guidelines are focussed on treatment. METHODS:We developed an evidence- and consensus-based guideline on the prevention of obesity among adults. Following international best practice recommendations for guideline development, we systematically searched for relevant systematic reviews and conducted a structured consensus process involving 34 experts including 5 patient representatives. The guideline's target group is the adult population of Germany, but most recommendations are likely to be applicable internationally. RESULTS:We developed 24 recommendations for the general public, health care professionals, and policy makers. The guideline recommends, among others, a healthy diet in line with existing food-based dietary guidelines, regular physical activity, as well as appropriate sleep and stress management. Smoking cessation is recommended even when associated with weight gain. Offering qualified advice and counselling on diet and physical activity to all individuals in primary care is suggested. Potential effects of medication on body weight should be considered in prescription decisions. Implementation of evidence-informed policies for promoting healthy food and physical activity environments is recommended. CONCLUSIONS:Evidence-based approaches for preventing obesity on the individual and societal levels exist and should be implemented more widely. .
Background: This study investigated potential subgroups of children within the Kiel Obesity Prevention Study (KOPS) for differing treatment effects for the outcome measures of overweight or obesity at 4 years. The KOPS study delivered a multicomponent school intervention to cohorts of children in Kiel but found no overall effect on the weight status outcome. However, KOPS authors suggested there may be subgroup variations in treatment effect. Data were collected as part of the KOPS for samples of 6-year-olds between 1996 and 2001, with 4-year follow-up measurements between 2000 and 2004. Methods: The present study conducted a post hoc subgroup analysis of the odds of obesity or overweight at 4-year follow-up compared to normal weight (n = 1646). A generalized linear mixed-effects model, including a treatment–subgroup interaction term, was used to estimate subgroups as a moderator of the treatment effects on the outcomes of obesity or overweight at 4-year follow-up. Results: The findings indicated several subgroup–treatment interaction effects relating to physical activity indicators. TV or PC not being one of a child’s top 3 activities at baseline was associated with a significantly decreased odds ratio of obesity at 4 years in the intervention group (OR, 0.04; 95% CI, 0.004 to 0.45) compared to the non-intervention group (OR, 0.96; 95% CI, 0.29 to 3.14), p = 0.02. Weekly activity in a sports club at baseline was associated with a decreased odds ratio of overweight at 4 years in the intervention group (OR, 0.38; 95% CI, 0.16 to 0.85) compared to the non-intervention group (OR, 0.91; 95% CI, 0.70 to 1.17). This was a significant difference (p = 0.04). Conclusions: These findings suggest that children’s baseline physical activity may impact treatment effects on the outcomes of overweight and obesity, creating opportunities to increase the effectiveness of interventions on preventing obesity.
OBJECTIVE:The aim was to assess ultra-processed food (UPF) consumption, its impact on overweight and its association with weight trends from childhood and adolescence to young adulthood. METHODS:Long-term UPF consumption (13.3 years) by NOVA was analysed (children/adolescents and adults, n = 182) in the Kiel Obesity Prevention Study (KOPS, n = 10 750). RESULTS:In children/adolescents (13.1 ± 1.9 years), a UPF-based dietary pattern showed an inverse association with BMI-SDS and fat mass index (males: r = -0.301, p = 0.01; r = -0.376, p = 0.001; females: r = -0.315, p < 0.001; r = -0.282, p = 0.003). Longitudinal analysis indicated that UPF consumption in childhood and adolescence was correlated with UPF consumption in adulthood among females (r = 0.272; p = 0.004) but not among males. In young adults (26.7 ± 2.2 years), UPF consumption accounted for nearly 50% of daily energy intake and was higher with overweight compared to normal weight and in incident overweight compared to persistent normal weight (both p < 0.05). High UPF consumption was associated with markers of poor diet quality (lower intake of fibre, higher intake of salt and energy-dense food, all p < 0.05). CONCLUSIONS:High UPF consumption in young adults was associated with both prevalence and incidence of overweight from childhood and adolescence to adulthood.
Background: Inflammatory bowel disease (IBD) remains an incurable illness. Patients with IBD show gender-specific differences in various aspects of the disease. There is still uncertainty about the causality of the differences. Methods: The aim of this study was to determine the most relevant psychophysiological gender-specific differences in IBD. For this purpose, a questionnaire survey was conducted on disease activity and psychological concomitant diseases in patients with IBD (n = 300). Among the 218 patients with IBD who provided gender information, both genders were equally distributed. Results: Females with IBD are significantly more affected by IBD-related symptoms than men. Disease activity Scores Harvey-Bradshaw Index (HBI), Partial Mayo Score (pMAYO) showed no significant differences between the sexes in the subgroups with CD (HBI, m: 3 (IQR 1-6), w: 4 (IQR 2-8), p = 0.0677) and UC (pMAYO, m: 1 (IQR 0-4), w: 3 (IQR 0-5), p = 0.2118). IBD Questionnaire (IBDQ)shows significant differences in the gender-specific analysis. The mean value of the IBDQ total score of the female participants was 4.4 (SD 1.1) and that of men was 5.0 (SD 1.0) (p = 0.0002). Conclusions: There is a great need to investigate the causality of gender-specific differences in greater depth.
BACKGROUND The aim of this observational, real-world evidence, modified intention-to-treat (mITT) study based on prospectively collected data from the VEDOIBD registry was to compare the effectiveness of vedolizumab (VEDO) vs antitumor necrosis factor (anti-TNF) in biologic-naïve Crohn's disease (CD) patients. METHODS 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. RESULTS 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. CONCLUSIONS 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.
BACKGROUND:Filgotinib was approved in Germany for treating patients with moderate to severe active ulcerative colitis in November 2021. It represents a preferential Janus kinase 1 inhibitor. The FilgoColitis study began recruiting immediately after approval and aims to assess filgotinib effectiveness under real-world conditions with a particular focus on patient-reported outcomes (PROs). The novelty of the study design is the optional inclusion of 2 innovative wearables, which could provide a new layer of patient-derived data.OBJECTIVE:The study investigates quality of life (QoL) and psychosocial well-being of patients with active ulcerative colitis during long-term exposure to filgotinib. PROs related to QoL and psychometric profiles (fatigue and depression) are collected alongside with disease activity symptom scores. We aim to evaluate physical activity patterns collected by wearables as an addition to traditional PROs, patient-reported health status, and QoL in different phases of disease activity.METHODS:This is a prospective, single-arm, multicentric, noninterventional, observational study with a sample size of 250 patients. QoL is assessed with validated questionnaires: the Short Inflammatory Bowel Disease Questionnaire (sIBDQ) for the disease-specific QoL, the EQ-5D for the general QoL, and the fatigue questionnaire (Inflammatory Bowel Disease-Fatigue [IBD-F]). Physical activity data are collected from patients using wearables (SENS motion leg sensor [accelerometry] and smartwatch, GARMIN vívosmart 4).RESULTS:The enrollment started in December 2021 and was still open at the date of submission. After 6 months of study initiation, 69 patients were enrolled. The study is expected to be completed in June 2026.CONCLUSIONS:Real-world data for novel drugs are important to assess effectiveness outside of highly selected populations represented by randomized controlled trials. We examine whether patients' QoL and other PROs can be supplemented with physical activity patterns measured objectively. Use of wearables with newly defined outcomes represents an additional observational tool for monitoring disease activity in patients with inflammatory bowel disease.TRIAL REGISTRATION:German Clinical Trials Register DRKS00027327; https://drks.de/search/en/trial/DRKS00027327.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/42574.
Summary Objective Under the assumption of irreversibility, the Montreal classification provides a unidirectional assessment of the complications and behaviour of Crohn's disease (CD) that does not allow for downstaging. We examined the use of a bidirectional Montreal classification system that can capture disease regression. Design From the BioCrohn Registry, an inception cohort of patients with CD for ≤12 months duration was defined and followed up for 5‐years. Cumulative probabilities for developing complications were estimated using the Kaplan–Meier method. Potential associations of explanatory variables with disease progression were estimated with Cox regression. Results Among 393 incident CD patients (of whom 255 completed the entire follow‐up), the 5‐year cumulative probability of developing complications was 41.5% (15.6% and 25.9% for stricturing and penetrating complications respectively). Perianal disease (hazard ratio [95% confidence interval]: 8.45 [4.74–15.07]) and surgical resection of the intestine (2.71 [1.50–4.92]) in the very early phase of the disease were associated with a higher risk of developing a penetrating complication within the 5‐year follow‐up. The use of a bidirectional Montreal classification system which can account for disease regression demonstrated that 90% of patients exhibited inflammatory disease behaviour at 5 years, in contrast to 58%, if the hierarchical, unidirectional Montreal classification system was used. Conclusion An additional bidirectional disease behaviour assessment capturing reversed or fully controlled complications may provide a more realistic appraisal of the complexity and unmet needs of patients treated with advanced therapies.
SummaryBackgroundThis observational real‐world evidence (RWE) study is based on prospectively collected data from the VEDOIBDregistry study.AimTo 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.MethodsBetween 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.ResultsDuring 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.ConclusionAfter two years of treatment, vedolizumab resulted in higher remission rates than anti‐TNF agents.
LINKED CONTENTThis article is linked to Bokemeyer et al papers. To view these articles, visit https://doi.org/10.1111/apt.17616 and https://doi.org/10.1111/apt.17796
Itch is a common symptom, but there is limited evidence on the prevalence of itch in children. The aim of this study was to assess the prevalence of itch in schoolchildren. A questionnaire was developed by experts in the field and based on a literature search. The questionnaire was applied in a pilot study of 25 consecutively selected paediatric patients and their parents. It confirmed the high content validity of the questionnaire, and the questionnaire was comparable to hospital records regarding chronic itch (n = 19, mean consistency 89.47%). The questionnaire was distributed among German schoolchildren in 9/12 randomly selected primary schools in Kiel, Germany. Of 1,722 invited students, 443 schoolchildren aged 6–10 years participated, and 26.2% (n = 116) reported itch. The prevalence of acute itch was 20.0% (n = 87), and 14.7% (n = 65) reported chronic itch. Reduced sleep and mood were often related to chronic itch. This study demonstrated that itch is a common symptom in German schoolchildren.