Modelling of patient journey in chronic spontaneous urticaria: Increasing awareness and education by shorten patients' disease journey in Germany.

BACKGROUND: Chronic spontaneous urticaria (CSU) is both physically and emotionally stressful, and guideline recommendations are often not optimally implemented in clinical practice. The objective of this study was to provide an overview on the patient journey in CSU and to develop a mathematical model based on solid data. METHODS: The journey of CSU patients in Germany was traced through literature review and expert meetings that included medical experts, pharmacists and representatives of patient organizations. The current situation's main challenges in the patient journey (education, collaboration and disease management) were discussed in depth. Then, a probabilistic model was developed in a co-creation approach to simulate the impact of three potential improvement strategies: (1) patient education campaign, (2) medical professional education programme and (3) implementation of a disease management programme (DMP). RESULTS: Chronic spontaneous urticaria patients are severely burdened by delays in diagnosis and optimal medical care. Our simulation indicates that in Germany, it takes on average of 3.8 years for patients to achieve disease control in Germany. Modelling all three optimization strategies resulted in a reduction to 2.5 years until CSU symptom control. On a population level, the proportion of CSU patients with disease control increased from 44.2% to 58.1%. CONCLUSION: In principle, effective CSU medications and a disease-specific guideline are available. However, implementation of recommendations is lagging in practice. The approach of quantitative modelling of the patient journey validates obstacles and shows a clear effect of multiple interventions on the patient journey. The data generated by our simulation can be used to identify strategies for improving patient care. Our approach might helping in understanding and improving the management of patients beyond CSU.

S2k guideline: Diagnosis and treatment of chronic pruritus.

Pruritus is a cross-disciplinary leading symptom of numerous diseases and represents an interdisciplinary diagnostic and therapeutic challenge. In contrast to acute pruritus, chronic pruritus (CP) is a symptom of various diseases that is usually difficult to treat. Scratching and the development of scratch-associated skin lesions can alter the original skin status. In the presence of an itch-scratch-cycle, even secondary diseases such as chronic prurigo can develop. Chronic pruritus leads to considerable subjective suffering of those affected, which can result in restrictions on the health-related quality of life such as sleep disturbances, anxiety, depressiveness, experience of stigmatization and/or social withdrawal up to clinically relevant psychic comorbidities. Medical care of patients should therefore include (a) interdisciplinary diagnosis and therapy of the triggering underlying disease, (b) therapy of the secondary symptoms of pruritus (dermatological therapy, sleep promotion, in the case of an accompanying or underlying psychological or psychosomatic disease an appropriate psychological-psychotherapeutic treatment) and (c) symptomatic antipruritic therapy. The aim of this interdisciplinary guideline is to define and standardize the therapeutic procedure as well as the interdisciplinary diagnosis of CP. This is the short version of the updated S2k-guideline for chronic pruritus. The long version can be found at www.awmf.org.

Unmet medical needs in the treatment of atopic dermatitis in infants: An Expert consensus on safety and efficacy of pimecrolimus.

Atopic dermatitis (AD) is a common skin disease during infancy, which imposes a considerable burden on patients, their families, and the society, requiring effective treatment options that result in rapid and sustained symptom relief. Additionally, early treatment may prevent the development of atopic comorbidities by restoring the skin barrier. Currently, topical standard-of-care for AD in infants includes emollients and topical corticosteroids (TCS) to treat and reduce the risk of flares. However, only few have been approved for infants and long-term maintenance therapy with TCS is not indicated due to potential local and systemic side effects, including skin atrophy. Accordingly, the recently updated European guidelines for treatment of AD recommend topical calcineurin inhibitors (TCIs) for long-term use, treatment of sensitive skin areas, and for use in the pediatric population. Evidence on the use of TCIs for infants has almost been exclusively collected for pimecrolimus, with >4000 infants evaluated in clinical trials, consistently confirming that pimecrolimus is a safe and effective treatment for infants with AD. Nevertheless, its use is still restricted in most countries to children above the age of 2 years due to initial and mostly theoretical safety concerns. Based on a careful review of the available evidence of clinical trials, post-marketing surveillance, and epidemiological studies, an Expert Panel of European dermatologists and pediatric allergologists concluded that these safety concerns are no longer valid. Therefore, pimecrolimus offers a safe and effective alternative to TCS in infants aged 3 months and above, and labeling restrictions in this age group are no longer justified.

Ixekizumab treatment and the impact on SF-36: results from three pivotal phase III randomised controlled trials in patients with moderate-to-severe plaque psoriasis.

PURPOSE: To assess improvements in health-related quality of life (HRQoL) with ixekizumab treatment in patients with moderate-to-severe psoriasis. METHODS: Adults with plaque psoriasis were enrolled in phase III, double-blind, randomised, controlled trials (UNCOVER-1, UNCOVER-2, or UNCOVER-3). All 3 protocols included a 12-week, placebo-controlled induction period; UNCOVER-2 and UNCOVER-3 also had an active-control group (50 mg etanercept) during induction. After induction, patients in UNCOVER-1 and UNCOVER-2 entered a 48-week withdrawal (maintenance) period (Weeks 12-60), during which Week-12 sPGA (0,1) responders were rerandomized to receive placebo, or 80 mg ixekizumab every 4 weeks (Q4W) or 12 weeks. As a secondary objective, HRQoL was measured by the generic Medical Outcomes Survey Short Form-36 (SF-36) at baseline and Weeks 12 and 60. Changes in mean SF-36 Physical and Mental Component Summary (PCS and MCS) and domain scores and proportions of patients reporting improvements ≥ minimal important differences in SF-36 scores were compared between groups. RESULTS: At Week 12, ixekizumab-treated patients (both dose groups in UNCOVER-1, -2, and -3) reported statistically significantly greater improvements in mean SF-36 PCS and MCS and all 8 SF-36 domain scores versus placebo. Further, more ixekizumab-treated patients than placebo-treated patients reported at least minimal treatment responses in SF-36 PCS and MCS scores and domain scores. Overall improvements in SF-36 PCS and MCS scores were maintained through Week 60. CONCLUSIONS: Ixekizumab-treated patients reported statistically significant improvements in HRQoL at 12 weeks that persisted through 1 year.

[Sucrose octasulfate-evidence in the treatment of chronic wounds]. / Sucrose Octasulfat ­ Evidenz in der Behandlung chronischer Wunden.

Patients with chronic wounds should receive wound treatment in addition to causative therapy. In this context, the lack of adequate evidence for wound healing products has been repeatedly discussed. Using the example of TLC-sucrose octasulfate (TLC: technology lipido-colloid), the present review shows that there is significant data with good evidence and comparability in this area. One therapeutic approach to promote wound healing is the inhibition of matrix-metalloproteinases, for example by sucrose octasulfate. For wound products containing TLC-sucrose octasulfate, several sequential clinical studies have been conducted in recent years. The WHAT study was an open randomized controlled trial (RCT) with 117 patients with venous leg ulcers (VLU). The CHALLENGE study was a double-blind RCT with 187 patients with VLU. The SPID study was a pilot study with 33 patients with diabetic foot ulcers (DFU). The two prospective, multicenter clinical pilot studies NEREIDES and CASSIOPEE examined a total of 88 patients with VLU in different phases of healing. In the REALITY study, a pooled data analysis was performed on eight observational studies with 10,220 patients with chronic wounds of different genesis. In the double-blind, two-armed EXPLORER RCT, 240 patients with neuro-ischemic DFU were followed from first presentation until complete healing. In all studies, a significant promotion of wound healing could be shown by the use of wound healing products with TLC-sucrose octasulfate.

Ustekinumab in the treatment of palmoplantar pustular psoriasis - a case series of nine patients.

BACKGROUND: Palmoplantar pustular psoriasis is a chronic inflammatory skin disease that is associated with considerable impairment in quality of life and resilience. Given the lack of approved pharmacological agents for this indication and the frequently recalcitrant disease course, therapeutic options are limited. PATIENTS AND METHODS: Following unsatisfactory therapeutic attempts with other treatment modalities, nine patients (six women; three men) were treated with ustekinumab (45 mg in individuals < 100 kg body weight, 90 mg in individuals > 100 kg) at weeks 0, 4, 12, and 24. Latent tuberculosis was ruled out prior to treatment. Regular follow-up was done at week 4 and 12, and every 12 weeks thereafter. RESULTS: Average age at the beginning of treatment was 48 years. Four patients achieved 75 % improvement in the palmoplantar Psoriasis Area Severity Index (PASI). Overall, there was an average improvement in the palmoplantar PASI of 71.6 % after 24 weeks. Two patients exhibited complete resolution after 24 weeks. Besides local injection site reactions and mild infections, no adverse effects were observed. CONCLUSIONS: This case series provides further evidence for the effectiveness and tolerability of ustekinumab in the treatment of palmoplantar pustular psoriasis. Controlled studies and observations in the context of patient registries are required to assess long-term efficacy and safety as well as the potential therapeutic benefit of intermittent therapy.

Importance of basic therapy in psoriasis.

Basic therapy plays an important role in the management of psoriasis, regardless of disease severity or the therapeutic concept used. It helps reduce symptoms such as pruritus and scaling, decreases exacerbations, and may therefore prolong the remission period after successful antipsoriatic treatment. Accordingly, adequate basic therapy can also have a positive effect on patients' severely impaired quality of life. Unfortunately, the importance of basic therapy in psoriasis is still underestimated. Based on clinical trial data, the present review highlights the efficacy and potential of basic therapy, and focuses on new data and developments in this field.

[Care and medical costs of urticaria in children in Germany : Drugs, medical and inpatient services]. / Versorgung und Krankheitskosten der Urtikaria bei Kindern in Deutschland : Arzneimittel, ärztliche und stationäre Leistungen.

BACKGROUND: Data on the course of urticaria in children exist, but there is a lack of sound data on patient management to ensure high-quality care. METHODS: Retrospective secondary data analysis in the field of health care and epidemiology in children with urticaria based on routine data from a German health insurance company (DAK-Gesundheit). Data from insured persons under 18 years of age who were treated as outpatients or inpatients with a diagnosis of urticaria (according to ICD-10 classification) in 2010-2015 were included. The control group consisted of children without a corresponding diagnosis, in order to clarify health economic and care-related differences after adjusting for age and gender. RESULTS: In 2015, 1904 (1.3%) of 151,248 insured minors had a diagnosis of urticaria. Of the children with urticaria, 70.9% visited at least one physician on an outpatient basis. Of these visits, 70.9% were made to a pediatrician, 52.5% to a general practitioner and 33.0% to a dermatologist; 11% were treated as inpatients. With a total of 151,248 insured persons, 1904 of whom were diagnosed with urticaria, 72.9% of children and adolescents with versus 28.9% without urticaria were treated topically or systemically in 2015, including 10.5% of children with urticaria vs. 2.6% without urticaria received topical therapy and 70.0% with urticaria received systemic therapy vs. 27.5% without urticaria with systemic therapy. The most commonly used oral medications for urticaria were cetirizine (44.2%), prednisolone (9.8%), and dimetindene (2.0%) . Topical methylprednisolone aceponate (49.8%) was prescribed most frequently. The therapy costs for systemic drugs was €â€¯24.00 per patient, while topical drugs cost €â€¯1.58 per patient. CONCLUSION: The lack of guidelines for the standardization of treatment in children still leads to ambiguities and different treatment concepts among the specialist groups, which must be eliminated in order to enable more efficient therapies. The treatment of chronic urticaria in children and adolescents is mainly carried out by pediatricians, general practitioners and dermatologists. Systemic and topical medications as well as inpatient services are the most important cost factors.

The IMPACT of the COVID-19 Pandemic on Prescription Drug Use in Patients with Psoriasis Vulgaris in Germany.

INTRODUCTION: Real-world evidence (RWE) data is increasingly important to generate rapid insights to effectively manage patient populations. Disruptions like the coronavirus disease 2019 (COVID-19) pandemic may negatively impact the choice of medications used for managing chronic diseases such as psoriasis (PSO). Here, we explored the effect of the COVID-19 pandemic on the sales volumes of treatment guideline-based PSO medication in Germany. METHODS: Patient-level pharmacy dispensing data from the Permea platform, covering approximately 44% of all community pharmacy dispensing in Germany, were analysed from 2019 through to 2021. Patient demographics and PSO indicated medication sales were assessed specifically before and during the pandemic in Germany. RESULTS: We included 6,865,852 sold PSO related drugs from April 2019 to March 2021. Medication sales increased during the pandemic compared with before the pandemic for treatment classes of first-line biological and second-line drugs. The increase was observed across all age groups, but monthly variations could not be detected. Furthermore, we observed increased sales in first-line biological and second-line medications when comparing low to high COVID-19 incidence state. CONCLUSION: Throughout the COVID-19 pandemic the PSO indicated medication sales increased for first-line biological and second-line treatment. This shows that despite the pandemic impact, there continues to be an increase in sales volume for biologics. Only German federal states with intermittently very high COVID-19 incidences show a stagnation in sales volume. The reasons for this need to be investigated in further studies to possibly gain a better understanding of the concerns and uncertainties of patients with PSO.

Efficacy, tolerability and patient benefit of ultrasound-assisted wound treatment versus surgical debridement: a randomized clinical study.

BACKGROUND: Low-frequency ultrasound has been shown to be an alternative to surgical wound debridement (WD) to stimulate wound healing; however, few data are available. OBJECTIVE: To compare the efficacy, tolerability and benefit of both wound treatment methods. METHODS: A monocentric prospective randomized-controlled clinical study assessing patient-reported outcomes and clinical efficacy of ultrasound-assisted wound treatment (UAW) compared to WD. RESULTS: In total, 67 patients were treated. Efficacy and tolerability were found to be good for both treatments, with 88% of UAW and 85.2% of WD patients experiencing more-than-minimal patient benefit. Quality of life improved significantly. Wound status improved and pain decreased in both groups. CONCLUSION: Compared to the gold standard (i.e. WD), UAW displays the same high efficacy, comparable patient benefit and improved quality of life. Both procedures are equally suitable for highly beneficial guideline-based treatment of chronic wounds.

Systemic treatment with corticosteroids in psoriasis--health care provision far beyond the S3-guidelines.

BACKGROUND: The basis of induction therapy for psoriasis in Germany is the S3-guideline which for moderate to severe psoriasis recommends the systemic agents fumaric acid esters, methotrexate, cyclosporine and the biologicals infliximab, etanercept, adalimumab and ustekinumab. Systemic glucocorticosteroids (GCS) are not proposed. QUESTION: To what extend are systemic glucocorticosteroids prescribed in psoriasis therapy? METHODS: The database of a German nationwide statutory health insurance 2007 was analyzed. Prescriptions of systemic glucocorticosteroids were identified by ATC-encoding. Psoriasis patients with comorbidities requiring systemic glucocorticosteroid medication were analyzed separately. RESULTS: Among 1,423,308 continuously insured patients in 2007 n = 34,728 (2.4 %) were patients with psoriasis. The most prescribed systemic agents were corticosteroids (2774 patients), followed by methotrexate (853), fumaric acid esters (342), retinoids (110) and cyclosporine A (105). Even after excluding patients with psoriatic arthritis, systemic corticosteroids were still the most often prescribed systemic drugs. The average number of DDD (Defined Daily Doses) per insured patient was 120 (general practitioners), 141 (internists) and 68 (dermatologists). These results were confirmed by a control analysis with IMS data. CONCLUSIONS: In Germany, psoriasis is often treated with systemic corticosteroids though these are not recommended by the S3-guideline. General practitioners and internists are the main prescribers.

Prevalence and Medications of Atopic Dermatitis in Germany: Claims Data Analysis.

BACKGROUND: Information on the prevalence of atopic dermatitis (AD) varies greatly, and so far, only a few studies describe the healthcare of patients with AD in Germany. OBJECTIVE: The aim of the study is to describe the prevalence and medications of people with AD in Germany. METHODS: Health insurance data for the year 2019 were examined. Prevalence rates, the severity of disease, comorbidities and pharmaceutical supply were analyzed. Insured persons with AD were identified with at least one outpatient or inpatient International Classification Code of Diseases (L20). RESULTS: In 2019, 4.21% [95% CI 4.21-4.22%] of insured persons had AD (3.6 million). Women were affected slightly more frequently than men (4.74% [95% CI 4.73-4.74%] and 3.64% [95% CI 3.64-3.65%]). Adolescents and children under the age of 15 had the highest prevalence of AD compared to other age groups (9.44% [95% CI 9.42-9.46%]). Majority of the insured persons with AD were affected by a mild to moderate form of the disease. The most common co-morbidity was infections of the skin (RR 5.00 [95% CI 4.97-5.02%]). Some patients were treated by a dermatologist, while others by a general practitioner, 39.10% and 36.74%, respectively. Of the anti-inflammatory drugs, systemic glucocorticosteroids preparations were used most frequently and were most frequently prescribed by the general practitioner. With a total of 42,841 prescriptions (1.53%), methotrexate (third-line treatment option) was prescribed more frequently than ciclosporin with 19,628 prescriptions (0.70%) or azathioprine with 25,696 prescriptions (0.92%). Ciclosporin (first-line treatment option) was prescribed much more frequently by a dermatologist (44.00% versus 14.32% by general practitioner). The biological dupilumab was prescribed 30,801 times (1,10%) and was also primarily prescribed by a dermatologist (66.67%). CONCLUSION: The present results reveal that a specialist treats approximately one-third of the patients with AD and that there is still a drug undersupply in some cases, especially concerning innovative drugs.

Digital Health meets Hamburg integrated medical degree program iMED: concept and introduction of the new interdisciplinary 2nd track Digital Health.

Digitalization in medicine is transforming the everyday work and the environment of current and future physicians - and thereby brings new competencies required by the medical profession. The necessity for a curricular integration of related digital medicine and, in more general, digital health topics is mostly undisputed; however, few specific concepts and experience reports are available. Therefore, the present article reports on the aims, the implementation, and the initial experiences of the integration of the topic Digital Health as a longitudinal elective course (2nd track) into the integrated medical degree program iMED in Hamburg.