OBSErve Germany was the first observational study of belimumab as add-on treatment for systemic lupus erythematosus (SLE) in routine clinical care in Germany, retrospectively collecting data from 102 SLE patients, 6 months before and after belimumab initiation. Most patients had moderate or severe SLE and several SLE manifestations. After 6 months of belimumab treatment, 78% of patients showed an improvement in overall disease activity of at least 20% in their physician’s judgment and for 42% of patients the improvement was at least 50%. Similar results were observed for the most common manifestations: arthritis, fatigue, rash, alopecia, increased anti-dsDNA antibody levels, and low complement. The SLE Disease Activity Index (SLEDAI/SELENA-SLEDAI) decreased from 10.6 to 5.6 (n = 65), with other indices also showing improvement. A notable dose reduction was seen for concomitant oral corticosteroids, from 13.7 to 7.6 mg/day overall (n = 91), and from 17.5 to 8.6 mg/day in patients with a high corticosteroid dose at belimumab initiation (≥7.5 mg; n = 63). Six patients discontinued belimumab therapy within 6 months. Overall, belimumab showed promising results for SLE patients in real-world settings. After 6 months of belimumab treatment, disease activity and corticosteroid use were reduced. The discontinuation rate was low and belimumab appeared to be well tolerated.
Funding GlaxoSmithKline UK.
BackgroundThe prevalence of tobacco smoking in Germany is high (~27%). Monitoring of national patterns of smoking behaviour and data on the “real-world” effectiveness of cessation methods are needed to inform policies and develop campaigns aimed at reducing tobacco-related harm. In England, the Smoking Toolkit Study (STS) has been tracking such indicators since 2006, resulting in the adaptation of tobacco control policies. However, findings cannot be directly transferred into the German health policy context. The German Study on Tobacco Use (DEBRA: “Deutsche Befragung zum Rauchverhalten”) aims to provide such nationally representative data.Methods/DesignIn June 2016, the study started collecting data from computer-assisted, face-to-face household interviews in people aged 14 years and older. Over a period of 3 years, a total of ~36,000 respondents will complete the survey with a new sample of ~2000 respondents every 2 months (=18 waves). This sample will report data on demographics and the use of tobacco and electronic (e-)cigarettes. Per wave, about 500–600 people are expected to be current or recent ex-smokers (<12 months since quitting). This sample will answer detailed questions about smoking behaviour, quit attempts, exposure to health professionals’ advice on quitting, and use of cessation aids. Six-month follow-up data will be collected by telephone.DiscussionThe DEBRA study will be an important source of data for tobacco control policies, health strategies, and future research. The methodology is closely aligned to the STS, which will allow comparisons with data from England, a country with one of the lowest smoking prevalence rates in Europe (18%).Trial registrationThis study has been registered at the German Clinical Trials Register (DRKS00011322) on 25th November 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-017-4328-2) contains supplementary material, which is available to authorized users.
BackgroundPersons with a first-degree relative (FDR) with cancer are at increased cancer risk. We investigated preventive behaviour, cancer risk perception and readiness to change an unhealthy lifestyle in persons with and without an FDR with cancer.MethodsUsing an online questionnaire, we conducted a cross-sectional study in Germany including persons (≥35 years) with an FDR with colorectal, lung, prostate, breast, stomach or cervical/uterine cancer (n = 621) and persons without cancer in FDRs (n = 303). Quota sampling ensured similar age and sex distributions in both groups.ResultsUnfavourable lifestyle factors were equally common in both groups. The proportion perceiving an increased cancer risk significantly differed (p < 0.0001) with 4% among respondents without cancer in FDRs and 18% (colorectal cancer) to 30% (stomach cancer) among cancer patients’ relatives. The proportion of smokers ready to quit smoking was significantly higher among those perceiving an increased vs. a lower cancer risk (64 vs. 46%, p = 0.04). There was a similar association for readiness to increase physical activity and consumption of fruits/vegetables and to reduce alcohol consumption.ConclusionsGiven the increased risk perception and motivation to change an unhealthy lifestyle, our study provides a strong rationale for research on the effectiveness of lifestyle interventions in cancer patients’ relatives.
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