Background: Selection of second-line therapy in Crohn’s disease (CD) patients after failure of first-line TNFα-inhibitor (TNFi) therapy to optimise outcomes remains challenging in real-world clinical practice. Objectives: This study aimed to provide real-world outcomes of CD patients who failed first-line TNFi therapy and switched to either another TNFi or to a biologic with a different mechanism of action. Patients were stratified as to whether they switched because of primary non-response or secondary loss of response to initial TNFi. Design: Retrospective cohort study. Methods: CD patients whose first biologic therapy was a TNFi and switched to another biologic therapy between 26 August 2015 and 31 March 2021 were identified in records held by the UK IBD Registry. Patients were enrolled at study sites, and data were validated by clinical teams. Patients were grouped as within-class switchers (WCS) if their second-line (index) biologic therapy was another TNFi, or out-of-class switchers (OCS) if their index therapy was vedolizumab or ustekinumab. Patients were followed up for at least 1 year. Time to drug discontinuation and outcomes at 1 year after index therapy start were analysed using Cox regression and binary logistic regression models, before and after baseline covariate adjustment through inverse probability of treatment weighting. Results: A total of 180 adult CD patients were included in the study. OCS were less likely to discontinue index therapy in both unweighted analysis (hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.42–0.96, p = 0.03) and weighted analysis (HR: 0.58, 95% CI: 0.38–0.90, p = 0.01), and more likely to show index drug persistence at 1 year in both unweighted analysis (adjusted odds ratio (aOR): 3.66, 95% CI: 1.81–7.67, p < 0.001) and weighted analysis (aOR: 3.95, 95% CI: 2.04–7.89, p < 0.001). These findings were consistent across all secondary endpoints of steroid-free and/or surgery-free index drug survival at 1 year. Conclusion: Patients switching from a TNFi to either vedolizumab or ustekinumab exhibited significantly higher rates of drug persistence compared to those switching to another TNFi, particularly among those experiencing primary non-response to the initial TNFi.

Objective This nationwide retrospective chart review study assessed ustekinumab treatment persistence and clinical outcomes of ustekinumab treatment in Finnish patients with ulcerative colitis in a real-world setting. Methods Data was collected retrospectively until April 2022 from patient charts for all patients with ulcerative colitis who started ustekinumab between September 2019 and December 2021 in 16 Finnish inflammatory bowel disease centers. The primary outcomes were persistence on ustekinumab and clinical remission/steroid-free clinical remission, defined as partial Mayo score <3 and a combined stool frequency and rectal bleeding subscore of ≤1 at 16 weeks and 1 year. Results The study included 221 patients with an average follow-up of 14.7 months and a median disease duration of 5.5 years. Disease status was endoscopically evaluated as severely active in more than 91% of the patients at baseline. Treatment persistence was 87% at 16 weeks and 63% at 1 year. The clinical/steroid-free remission rate was 49%/46% at 16 weeks and 68%/62% at 52 weeks, respectively. Decreases in fecal calprotectin and partial Mayo scores were observed. Concomitant corticosteroid use decreased from 60% at baseline to 28% at 16 weeks and to 16% at 1 year during ustekinumab maintenance therapy. Antibodies to ustekinumab were detected in very few patients (<5, <21%), and discontinuation was observed due to adverse effects even less frequently (<5, <6%). Conclusion This real-world study demonstrated that ustekinumab has sustained efficacy in the treatment of ulcerative colitis in a real-world setting.

Background: Biologic agents have demonstrated efficacy in treating ulcerative colitis (UC); however, treatment failure to tumor necrosis factor inhibitors (TNFi) is common in the real world. Data on preferential sequencing in clinical practice after failure remain limited. Objectives: This study aimed to evaluate real-world outcomes of patients cycling to TNFis or switching to non-TNFi biologics following first-line failure with TNFis. Design: Retrospective cohort study in Germany. Methods: Adult patients with UC were identified using administrative claims data from 1 May 2014 to 30 June 2022 provided by a statutory sickness fund. Patients newly initiating first-line therapy with TNFis and then switching to another agent were identified. Patients were defined as within-class switched (WCS), if they cycled to another TNFi, or outside-class switchers (OCS), if they switched to a non-TNFi biologic [ustekinumab (UST) or vedolizumab (VDZ)] and followed from index (switch date) to death, insurance end, or study end on 30 June 2022. Inverse probability of treatment weighting (IPTW) was performed to adjust for differences in baseline characteristics between groups, and weighted Cox regression models were used to compare primary (time to discontinuation and second treatment switch) and secondary outcomes (corticosteroid-free drug survival). Results: We identified 166 patients initiating TNFis and switching to a subsequent treatment (mean age: 42.9 years, 49.4% female). Following IPTW, there were 71 and 76 patients in the WCS and OCS groups, respectively. Compared to OCS, WCS were more likely to discontinue the new therapy [hazard ratio (HR), 1.82, 95% confidence interval (CI), 1.14–2.89, p = 0.012], and switch a second time (HR, 3.46, 95% CI, 1.89–6.36, p < 0.001). Moreover, WCS showed an increased likelihood of initiating prolonged corticosteroid therapy (HR, 1.42, 95% CI, 0.77–2.59, p = 0.260); however, the results were not significant. Conclusion: Following first-line TNFi failure, this study suggests that real-world outcomes among patients with UC are less favorable when cycling to another TNFi, compared to switching to a non-TNFi such as UST or VDZ.

Purpose The aim of this study was to investigate the burden of disease among a real-world cohort of patients with prevalent Crohn’s disease (CD) in Germany. Methods We conducted a retrospective cohort analysis using administrative claims data from the German AOK PLUS health insurance fund. Continuously insured patients with a CD diagnosis between 01 October 2014 and 31 December 2018 were selected and followed for at least 12 months or longer until death or end of data availability on 31 December 2019. Medication use (biologics, immunosuppressants (IMS), steroids, 5-aminosalicylic acid) was assessed sequentially in the follow-up period. Among patients with no IMS or biologics (advanced therapy), we investigated indicators of active disease and corticosteroid use. Results Overall, 9284 prevalent CD patients were identified. Within the study period, 14.7% of CD patients were treated with biologics and 11.6% received IMS. Approximately 47% of all prevalent CD patients had mild disease, defined as no advanced therapy and signs of disease activity. Of 6836 (73.6%) patients who did not receive advanced therapy in the follow-up period, 36.3% showed signs of active disease; 40.1% used corticosteroids (including oral budesonide), with 9.9% exhibiting steroid dependency (≥ 1 prescription every 3 months for at least 12 months) in the available follow-up. Conclusions This study suggests that there remains a large burden of disease among patients who do not receive IMS or biologics in the real world in Germany. A revision of treatment algorithms of patients in this setting according to the latest guidelines may improve patient outcomes.

OBJECTIVES:Medical emergencies in psychiatric inpatients are challenging due to the model of care and limited medical resources. The study aims were to determine the triggers and outcomes of a medical emergency team (MET) call in psychiatric wards, and the risk factors for MET activation and mortality.DESIGN:Retrospective multisite cohort study.SETTING:Psychiatry units colocated with acute medical services at three major metropolitan hospitals in Melbourne, Australia.PARTICIPANTS:We studied 487 adult inpatients who experienced a total of 721 MET calls between January 2015 and January 2020. Patients were relatively young (mean age, 45 years) and had few medical comorbidities, but a high prevalence of smoking, excessive alcohol intake and illicit drug use.OUTCOME MEASURES:We performed a descriptive analysis of the triggers and outcomes (transfer rates, investigations, final diagnosis) of MET calls. We used logistic regression to determine the factors associated with the primary outcome of inpatient mortality, and the secondary outcome of the need for specific medical treatment compared with simple observation.RESULTS:The most common MET triggers were a reduced Glasgow Coma Scale, tachycardia and hypotension, and 49% of patients required transfer. The most frequent diagnosis was a drug adverse effect or toxidrome, followed by infection and dehydration. There was a strong association between a leave of absence and MET calls, tachycardia and the final diagnosis of drug adverse effects. Mortality occurred in 3% after MET calls. Several baseline and MET clinical variables were associated with mortality but a model with age (per 10 years, OR 1.61, 95% CI 1.29 to 2.01) and hypoxia (OR 3.59, 95% CI 1.43 to 9.04) independently predicted mortality.CONCLUSION:Vigilance is required in patients returning from day leave, and drug adverse effects remain a challenging problem in psychiatric units. Hypoxic older patients with cardiovascular comorbidity have a higher risk of death.

The use of antipsychotic medications is associated with side effects, but the occurrence of severe tachycardia (heart rate ≥ 130 per minute) is not well described. The aim of this study was to determine the frequency and strength of the association between antipsychotic use and severe tachycardia in an inpatient population of patients with mental illness, while considering factors which may contribute to tachycardia. We retrospectively analyzed data from 636 Medical Emergency Team (MET) calls occurring in 449 psychiatry inpatients in three metropolitan hospitals co-located with acute medical services, and used mixed-effects logistic regression to model the association between severe tachycardia and antipsychotic use. The median age of patients was 42 years and 39% had a diagnosis of schizophrenia or psychotic disorder. Among patients who experienced MET calls, the use of second-generation (atypical) antipsychotics was commonly encountered (70%), but the use of first-generation (conventional) antipsychotics was less prevalent (10%). Severe tachycardia was noted in 22% of all MET calls, and sinus tachycardia was the commonest cardiac rhythm. After adjusting for age, anticholinergic medication use, temperature >38 °C and hypoglycemia, and excluding patients with infection and venous thromboembolism, the odds ratio for severe tachycardia with antipsychotic medication use was 4.09 (95% CI: 1.64 to 10.2).

Since the introduction of the Medicines Market Reorganization Act (AMNOG) in 2011, there have been some structural changes for pharmaceutical manufacturers, due to the early assessment of benefits in the market launch of innovative drugs. This means that the manufacturer is constantly faced with challenges in determining the target population by using prevalence and incidence. Even given the same indication, there are often different approaches and models used for estimating the target population. In bladder carcinoma, the fourth most common tumor in men, there have been many advances in the field of immunotherapy for the treatment of locally advanced or metastatic carcinomas. These can be used to compare existing dossiers. The aim of this study was to evaluate the quality of the prevalence and incidence calculations of the dossiers in the indication urothelial carcinoma and to identify the recommendations for action that can be derived for their future determination. This problem was examined based on the methods paper of the Institute for Quality and Efficiency in Health Care and the benefit assessments of the decisions on additional benefits. Our comparison showed similarities in the use of epidemiological measures, but identified mainly differences in the calculation steps of the target population. As a result, the target population was mostly underestimated or overestimated. The quality of the dossiers differed mostly in the traceability of the calculations and the origin of data. With regard to external validity and generalizability to the German health care system, there is still room for improvement.

ABSTRACT Background: Surgery plays an important role in the management of ulcerative colitis. Despite its curative intent, complications of the procedure are common and can have significant consequences to patients and care providers. We reviewed outcomes and rates of colectomy and its complications in ulcerative colitis (UC) patients in clinical practice. Materials and methods: MEDLINE, MEDLINE In-Process, Embase and Cochrane databases were searched for observational studies (January 2006–May 2017) reporting outcomes of surgery in moderate to severe UC in European countries. Studies were included if they reported colectomy rates, complications rate, predictors of colectomy and change in diagnosis in ulcerative colitis at the time of surgery. Results: 114 publications reporting either colectomy rates, postoperative complications or predictors of colectomy were identified. The overall rate of surgery from treatment initiation was reported in 20 articles and varied from 6% to 56% (follow-up time from 0.5 to 9 years). Early complications (≤30 days post-operatively) occurred in 0%–53% of patients undergoing surgery and late complications (>30 days post-operatively) occurred in 3.20%–58%. The common complications reported after colectomy (proctocolectomy or ileal pouch-anal anastomosis) were bowel obstruction, infectious complications and pouch-related complications (pouchitis, pouch failure). Three factors were found to be significant predictors of colectomy: a severe disease at baseline, being resistant to steroids and being frequently hospitalised. Conclusion: Colectomy rates vary widely among ulcerative colitis patients depending on type of patients (moderate, severe, refractory) and to patient's previous medical therapies. Surgery is still associated with a range of short and long term complications which might represent a source of burden in terms of cost and quality of life. Highlights:

Background The fully human monoclonal antibody guselkumab is an effective treatment option for patients with moderate to severe psoriasis. Objective The objective of this study was to examine the cost per responder of guselkumab compared with other targeted therapies for the treatment of moderate to severe plaque psoriasis in Germany. Methods A one-year cost per responder model was developed based on efficacy and safety data from a published network meta-analysis. Drug, treatment administration, resource use, and adverse event costs were included in the analysis. The primary analysis assessed the cost per Psoriasis Area and Severity Index (PASI) 90 responder at week 16. Additional analyses were conducted at year 1. In the year 1 analyses, treatment response was assessed at the end of the induction period (week 16) to determine which patients continued onto maintenance therapy (responders) and which patients moved onto a subsequent adalimumab or secukinumab therapy (non-responders). Results At week 16, the cost per PASI 90 responder was lower for guselkumab than all comparators except adalimumab and brodalumab. Similarly, in the year 1 analyses, guselkumab had a lower cost per PASI 90 responder than all comparators except brodalumab. Conclusions Guselkumab is a cost-effective therapy option in Germany.

ZusammenfassungDurch das Arzneimittelmarktneuordnungsgesetz (AMNOG) 2011 ergeben sich für die pharmazeutischen Hersteller strukturelle Veränderungen, begründet durch die frühe Nutzenbewertung bei der Markteinführung neuer Arzneimittel. Dadurch zeigen sich im Bereich der Bestimmung der Zielpopulation bei der Prävalenz- und Inzidenzbestimmung Herausforderungen. Selbst im selben Indikationsgebiet finden sich häufig unterschiedliche Modelle zur Schätzung der Zielpopulation. Für das Harnblasenkarzinom (ICD-10 C67), dem vierthäufigsten Tumor bei Männern, gab es für die Behandlung lokal fortgeschrittener oder metastasierter Karzinome zuletzt viele Fortschritte im Bereich der Immuntherapien, die sich zum Vergleich der bestehenden Dossiers anbieten. Das Ziel dieser Untersuchung war, die Qualität der Prävalenz- und Inzidenzbestimmung der Dossiers im Indikationsgebiet Urothelkarzinom zu bewerten und festzustellen, welche Handlungsempfehlungen sich für deren zukünftige Bestimmung ableiten lassen. Auf der Grundlage des Methodenpapiers des Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen sowie den Nutzenbewertungen und den Beschlüssen des G-BA wurde diese Problematik beleuchtet. Der Vergleich zeigte neben Gemeinsamkeiten bei der Nutzung der epidemiologischen Maße Unterschiede bei den Berechnungsschritten der Zielpopulation, die zu Variationen der Prävalenz und Inzidenz in den Dossiers führten. Die Qualität der Dossiers unterscheidet sich v. a. in der Nachvollziehbarkeit der Berechnungen und der Datengrundlage. Im Hinblick auf die externe Validität und Generalisierbarkeit auf das deutsche Gesundheitswesen besteht noch Verbesserungsbedarf.

Background: Biologics used to treat ulcerative colitis (UC) may lose their effect over time, requiring patients to undergo dose escalation or treatment switching, and systematic literature reviews of real-world evidence on these topics are lacking. Aim: To summarize the occurrence and outcomes of dose escalation and treatment switching in UC patients in real-world evidence. Methods: Studies were searched through MEDLINE, MEDLINE IN PROCESS, Embase and Cochrane (2006-2017) as well as proceedings from three major scientific meetings. Results: In total, 41 studies were included in the review among which 35 covered dose escalation and 12 covered treatment switching of biologics. Tumor necrosis factor antagonist (anti-TNF) escalation for all patients included at induction ranged from 5% (6 months) to 50% (median 0.67 years) and 15.2% to 70.8% (8 weeks) for anti-TNF induction responders. Mean/median time to dose escalation on anti-TNF ranged from 1.84 to 11 months. The most common switching pattern, infliximab -> adalimumab, occurred in 3.8% (median 5.6 years) to 25.5% (mean 3.3 years) of patients. Conclusions: Dose escalation and treatment switching of biologics may be considered as indicators of suboptimal therapy suggesting a lack of long-term remission and response under current therapies.

Background The economic burden of ulcerative colitis (UC), specifically related to indirect costs, is not extensively documented. Understanding and quantifying it is required by health care decision makers. Aim To assess the impact of indirect costs of UC in observation studies. Method A systematic literature search was conducted in MEDLINE®, Embase® and Cochrane Library to capture all relevant publications reporting outcomes on absenteeism, presenteeism and productivity losses in moderate to severe UC. Eligibility criteria for inclusion into the review were established using a predefined PICOS scheme. All costs were adjusted to 2017 currency values (USD dollars, $). Results In total, 18 studies reporting data on indirect costs were included in the analysis. Absenteeism costs were classified into three categories: sick leave, short-term and long-term disability. Most of the studies captured absenteeism costs related specifically to sick leave, which was experienced on average by 10 to 24% patients with UC. Only three studies captured presenteeism costs, as these are difficult to measure, however costs ranged from 1602 $ to 2947 $ per patient year. The proportion of indirect costs accounted for 35% of total UC costs (Total UC costs were defined as the sum of healthcare costs, productivity costs and out-of-pocket costs). Discussion A limited number of studies were identified describing the indirect costs in patients with moderate to severe UC. Insufficient data on different components of costs allowed a limited analysis on the impact of indirect costs in patients with UC. Further studies are needed to gain an understanding of the influence of UC on patients’ functional abilities.

BACKGROUND:Treatment of multidrug-resistant tuberculosis (MDR-TB) is complex, lengthy, and involves a minimum of four drugs termed a background regimen (BR), that have not previously been prescribed or that have proven susceptible to patient sputum culture isolates. In recent years, promising new treatment options have emerged as add-on therapies to a BR. The aim of this study was to evaluate the long-term costs and effectiveness of adding the novel or group 5 interventions bedaquiline, delamanid, and linezolid to a background regimen (BR) of drugs for the treatment of adult patients with pulmonary multidrug-resistant tuberculosis (MDR-TB), within their marketing authorisations, from a German healthcare cost-effectiveness perspective.METHODS:A cohort-based Markov model was developed to simulate the incremental cost-effectiveness ratio of bedaquiline plus BR, delamanid plus BR, or linezolid plus BR versus BR alone in the treatment of MDR-TB, over a 10-year time horizon. Effectiveness of treatment was evaluated in Quality-Adjusted Life-Years (QALYs) and Life-Years Gained (LYG), using inputs from clinical trials for bedaquiline and delamanid and from a German observational study for linezolid. Cost data were obtained from German Drug Directory costs (€/2015), published literature, and expert opinion. A 3% yearly discount rate was applied. Probabilistic and deterministic sensitivity analyses were conducted.RESULTS:The total discounted costs per-patient were €85,575 for bedaquiline plus BR, €81,079 for delamanid plus BR, and €80,460 for linezolid plus BR, compared with a cost of €60,962 for BR alone. The total discounted QALYs per-patient were 5.95 for bedaquiline plus BR, 5.36 for delamanid plus BR, and 3.91 for linezolid plus BR, compared with 3.68 for BR alone. All interventions were therefore associated with higher QALYs and higher costs than BR alone, with incremental costs per QALY gained of €22,238 for bedaquiline, €38,703 for delamanid, and €87,484 for linezolid, versus BR alone. In a fully incremental analysis, bedaquiline plus BR was the most cost-effective treatment option at thresholds greater than €22,000 per QALY gained. In probabilistic analyses, the probability that bedaquiline plus BR was the most cost-effective treatment strategy at a willingness-to-pay threshold of €30,000 was 54.5%, compared with 22.9% for BR alone, 18.2% for delamanid plus BR, and 4.4% for linezolid.CONCLUSIONS:In Germany, the addition of bedaquiline, delamanid, or linezolid to a BR would result in QALY gains over BR alone. Based on this analysis, bedaquiline is likely to be the most cost-effective intervention for the treatment of MDR-TB, when added to a BR regimen at thresholds greater than €22,000 per QALY.

Background Today's highly efficacious, low-toxicity interferon-free treatment regimens for chronic hepatitis C virus (HCV) can cure most patients with HCV in 12–24 weeks. The aim of this study was to understand how the introduction of shorter duration treatment regimens for HCV will impact the capacity for treatment and value to society. Methods A Markov model of HCV transmission and progression was constructed, incorporating nationally representative data on HCV prevalence, incidence and progression; mortality, treatment costs, medical expenditures, employment probabilities and disability payments in Germany. The model was stratified by HCV genotype and exposure route (1-time healthcare exposure, injection drug use and sexual activity). Treatment scenarios were based on German treatment guidelines and projected treatment capacity. The impact of different treatment scenarios on disease transmission and prevalence, quality-adjusted life years (QALYs), treatment costs, medical expenditures, employment and disability expenditures was calculated. Results Depending on their adoption profile, new treatment regimens and protocols introduced over the next several years will increase HCV treatment capacity in Germany by 8–30%, reducing disease transmission and prevalence, increasing QALYs and adding €94–310 million in discounted social value (QALYs plus medical savings net of treatment costs) over a 30-year horizon. Additional social value in the form of higher employment and lower disability would also result. Conclusions The introduction of shorter HCV treatment regimens and the resulting increased treatment capacity in Germany would result in large gains to society by reducing disease transmission and prevalence, resulting in longer, healthier, more productive lives for current and future generations.

Introduction of direct-acting antivirals in treatment of chronic hepatitis C virus (HCV) was a significant medical advance. Today, interferon-free treatment regimens with sustained virologic response (SVR) rates of >90%, a favorable toxicity profile and shorter treatment duration, allow most patients to achieve cure. Aim of the study was to understand how the introduction of shorter-duration treatment regimens for HCV will impact the capacity for treatment and value to society. A Markov model of HCV transmission and progression was constructed, incorporating nationally representative data on HCV prevalence, incidence, and progression; mortality, treatment costs, medical expenditures, employment probabilities, and disability payments in Germany. The model is stratified by HCV genotype and exposure route (one-time healthcare exposure, injection drug use, and sexual activity). Treatment scenarios were based on German treatment guidelines and projected treatment capacity. The impact of different treatment scenarios on disease transmission and prevalence, quality-adjusted life years (QALYs), treatment costs, medical expenditures, employment and disability expenditures was calculated. Depending on their adoption profile, new treatment regimens and protocols introduced over the next several years will increase HCV treatment capacity in Germany by 8-30%, reducing disease transmission and prevalence, increasing QALYs, and adding €94-310 million in discounted social value (QALYs plus medical savings net of treatment costs) over a 30-year horizon. Additional social value in the form of higher employment and lower disability would also result. While these results are specific to Germany, similar results may be expected in other countries facing capacity constraints in treating HCV patients. The introduction of shorter HCV treatment regimens and the resulting increased treatment capacity in Germany would result in large gains to society by reducing disease transmission and prevalence plus reducing end stage liver diseases, thus resulting in longer, healthier, more productive lives for current and future generations.

The emergence of multi-drug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) has re-established TB as a major worldwide health concern [1–3]. Compared with conventional TB drug regimens, treatments for MDR-TB and XDR-TB are more toxic, expensive and associated with poorer outcomes [3, 4]. In Germany, 102 (2.4%) of the 4318 TB cases reported for 2013 were MDR-TB, including 10 patients with XDR-TB [5], increasing from 54 (1.8%) cases in 2011 [5, 6]. An important factor behind the increase in Germany is migration, with more cases occurring in patients from the former Soviet Union than in native Germans [5]. Adding bedaquiline to the background regimen is likely to be cost-effective for treatment of MDR/XDR-TB in Germany

Multidrug-resistant tuberculosis (MDR-TB) is designated an orphan disease in Germany, with less than 100 patients per year. TB case reporting has been obligatory since 2001 due to the Protection against Infection act (IfSG). The objective of this study was to compare the incidence of MDR-TB from different epidemiological data sources in Germany with data collected by the Robert-Koch-Institute (RKI) according to the legal requirement. The following potential sources of epidemiological data of MDR-TB in Germany (for the year 2012) were searched: a systematic review of the literature, data from a statutory sickness fund (SHI) and data from the Federal Office of Administration (BVA) used for the risk adjustment scheme (Morbi-RSA) in the social health insurance system. Data from these sources were then compared with those collected by the RKI. The systematic literature review provided 445 relevant abstracts which were screened by two independent reviewers. Selection of 16 possible full text papers revealed no relevant publications on MDR-TB in Germany. Data from sickness funds as well as the BVA also showed no reported cases of MDR-TB, although both gave indications on the incidence of drug-sensitive TB (91 cases/100,000 & 52 cases/100,000, respectively). The data provided by the RKI reported 4,187 cases of TB (incidence: 5.2 cases/100,000) of which 65 cases (2.3%) were MDR-TB. Two factors are most striking: reports specific to MDR-TB are generally hard to find in SHI databases due to a lack of specific ICD-10 codes, but can be approximated with ICD-10 codes for drug-sensitive TB plus medication use. Furthermore, information on TB incidence differs widely among the various data sources in Germany, possibly due to the different ways in which data are collected.

The purpose of this study was to compare approved first-line therapies for patients with multiple myeloma.