Background Comprehensive data on the epidemiology and comorbidities of chronic urticaria (CU) in Germany are either limited, or not contemporary. Objectives To investigate the epidemiology of CU, overall comorbidities and healthcare resource utilized by patients with CU in Germany, using an anonymized statutory health insurance (SHI) database. Methods Anonymized SHI claims research database of the Institute for Applied Health Research, Berlin [InGef] (01 January 2015-30 September 2018) was used to analyse insured individuals with a confirmed diagnosis of CU (ICD-10-GM codes). Twelve-month diagnosed prevalence and incidence, comorbidities (vs. atopic dermatitis and psoriasis), and healthcare utilization by patients with CU were investigated. Results Of 4 693 772 individuals of all ages listed in the database, 3 538 540 were observable during 2017. Overall, 17 524 patients (similar to 0.5%) were diagnosed with CU; chronic spontaneous urticaria (CSU: 71.2%), chronic inducible urticaria (CIndU: 19.7%), CSU+CIndU (9.1%). Females, vs. males, had higher diagnosed prevalence (0.62% vs. 0.37%) and diagnosed incidence (0.18% vs. 0.11%) of CU among all patients. Patients most frequently visited general practitioners (41.3% of total visits). Hypertensive diseases (43.5%), lipoprotein metabolism disorders (32.1%) and affective disorders (26.0%) were the most frequently reported comorbidities of special interest. Rates of most comorbidities of special interests were similar to atopic dermatitis and psoriasis patients, and all higher vs. overall population. More than half (54.1%) of all CU patients were not prescribed any treatment. Second-generation H-1-antihistamines were the most commonly prescribed medication for adult (17.9%) and paediatric (27.9%) patients. Patients with CIndU (paediatric, 15.5%; adult, 7.8%) were more often hospitalized versus patients with CSU (paediatric, 9.9%; adult, 4.6%). Conclusions In Germany, prevalence of CU along with multiple comorbidities may pose increased burden on the healthcare system. Awareness of adhering to treatment guidelines, and aiming for complete control of urticaria, needs to be driven and may improve outcomes.

Introduction Psoriatic disease is associated with considerable impairment of Quality of Life (QoL). The PROSE study (NCT02752776) examined the impact of secukinumab on patient-reported outcomes in patients with moderate-to-severe psoriasis (PsO) stratified by previous exposure to systemic treatment. Methods In this prospective, non-randomized, multicentre study, patients were categorized at baseline according to previous exposure to systemic treatment: naive [naive to any systemic treatment (N = 663)], conventional systemic [previously exposed to >= 1 conventional systemic therapy (N = 673)] and biologics [previously exposed to >= 1 biologic (N = 324)]. Baseline demographics including age, gender, race, body weight and body mass index, disease characteristics and patient-reported QoL outcomes [Dermatology Life Quality Index (DLQI), Family DLQI (F-DLQI)] of patients enrolled in the study are reported here. Results Baseline demographic characteristics were well balanced across the three subpopulations. Naive patients had a shorter time since diagnosis (15.5 +/- 12.1 years) compared with the conventional systemic (19.1 +/- 12.5 years) and biologic patients (23.0 +/- 12.5 years), and lower rates of psoriatic arthritis (6.6% vs. 17.4% and 27.8%, respectively). Metabolic syndrome (37.6-43.5%), obesity (16.9-19.1%), hyperlipidaemia (15.3-21.9%) and diabetes mellitus (6.8-14.2%) were reported at numerically higher rate in the biologic group. The mean PASI (19.7 +/- 7.9), affected Body Surface Area (28.2 +/- 15.3%) as well as the Investigator Global Assessment score (patients with score 4: 33.7%) indicated severe disease at baseline and were comparable for the three groups. QoL impairment was evident from mean DLQI (14.1 +/- 7.1: naive = 13.5 +/- 6.8; conventional systemic = 14.3 +/- 7.0; biologic = 14.8 +/- 7.7) and mean F-DLQI (11.5 +/- 7.0: naive = 11.3 +/- 7.1; conventional systemic = 11.4 +/- 6.7; biologic = 12.1 +/- 7.7) also indicated derangement of QoL of patients and their families. Conclusion Patients naive to systemic treatment had shorter disease journey compared with patients previously exposed to systemic treatments; despite this, the severe impact of disease on patient and family QoL outcomes can be as apparent in naive patients as in systemically treated patients at baseline.

Objective: To compare the evolution of renal function of immunosuppressive regimens with different calcineurin inhibitor (CNI) exposure. Methods: 802 patients (pts) were included in this 1-year, prospective, open-label, randomized, and controlled multi-center study. After induction with Basiliximab all pts received Cyclosporine A (CsA), enteric-coated mycophenolate sodium (EC-MPS) and steroids. 3 months post tx 499 pts were randomized 1:1:1 to either a) continue standard CsA (100-180 ng/ml) with EC-MPS (n=166), b) convert to a CNI-free regimen with everolimus (EVE; 5-10 ng/ml) and EC-MPS (n=171) or c) convert to CNI-low regimen with EVE (3-8 ng/ml) and reduced CsA (50-75 ng/ml) (n=162). All pts continued on steroids. Renal function was assessed by Glomerular Filtration Rate (cGFR; Nankivell formula) as the primary endpoint. In addition, renal function was determined by Cockcroft-Gault and MDRD. Results: CsA trough level at Month 12 was 118.7 ± 33.3 ng/ml in standard and 79.5 ± 35.2 ng/ml in CNI-low pts. EVE trough level was 6.8 ± 2.2 ng/ml in CNI-free and 6.1 ± 2.7 ng/ml in CNI low pts. Renal function was similar at randomization 3 Month post tx with an significant (p< 0.0001) improvement by 5.6 mL/min/1.73m [95% CI 2.9; 8.3] in favor of the CNI-free regimen at Month 12 when compared to standard.Table: [Renal function]Results of renal function were confirmed by other formulas. 69.59 % of CNI-free, 53.8 % of CNI low and 54.0% of standard pts had an improvement in renal function. All three groups had a similar rejection rate (8.4% standard CNI, 10% CNI-free, 8,5% CNI-low) with an overall comparable safety profile data. Proteinuria was reported in 8.4%, 9.9% and 14.9% of pts (standard, CNI-free and CNI-low). Conclusion: The profound reduction of CsA in combination with EVE did not result in better renal function compared to standard therapy with EC-MPS. However, the results of this large trial confirm previous reports of an improved renal function after CsA withdrawal with EVE in combination with EC-MPS.