SARS-CoV-2 infection among psoriasis patients in Germany: Data from the German registries PsoBest and CoronaBest.

BACKGROUND: Limited data exist on the characteristics of SARS-CoV-2 infections in German patients with psoriasis or psoriasis arthritis (PsA). This study analyses COVID-19 prevalence and severity of symptoms in these patients. PATIENTS AND METHODS: Participants of the German registries PsoBest and CoronaBest were surveyed in February 2022. Descriptive analyses were conducted. RESULTS: 4,818 patients were included in the analysis, mean age of 56.4 years. Positive SARS-CoV-2 tests were reported by 737 (15.3%) patients. The most frequently reported acute symptoms were fatigue (67.3%), cough (58.8%), and headache (58.3%). Longer-lasting symptoms after COVID-19 were reported by 231 of 737 patients after the acute phase. For most patients (92.9%), systemic treatment for their psoriasis or PsA was not modified during the pandemic. Patients positively tested for SARS-CoV-2 were younger on average and had more often changes in the therapy of psoriasis than negatively tested patients (8.5% vs. 5.4%). CONCLUSIONS: In this cohort of patients with psoriasis or PsA undergoing systemic treatment, SARS-CoV-2 infections were common but less frequent than in the general German population. No risk signals for more severe COVID-19 or increased infection rates were observed in the patients. In addition, systemic treatments remained largely unchanged, so that no risks can be attributed to these therapies.

Perception and Impact of COVID-19 Pandemic in Psoriasis Patients: Data from the German PsoBest and the CoronaBest Registries.

Background: Limited data are available characterizing the impact of the SARS-CoV-2 pandemic on psoriasis care for patients in Germany. Objective: To analyze patient perception and impact of the pandemic on well-being and psoriasis management of German patients with moderate-to-severe psoriasis or psoriasis arthritis under systemic therapies. Methods: The CoronaBest registry captures events of SARS-CoV-2 infections and analyzes the impact of the pandemic on patients with psoriasis or psoriasis arthritis. In June 2020, and independently in February 2022, patients with psoriasis or psoriasis arthritis received a standardized questionnaire for current treatment, protective measures, well-being, and individual risks for COVID-19, among others. Results: Included were 4,194 patients in 2020 (mean age of 47.7 years and 41.8% women) and 4,818 patients in 2022 (mean age of 56.4 and 42.9% women). Treatment discontinuations were observed in 2.7% and 1.7% of patients in 2020 and 2022, respectively. In the vast majority of the cases (>92%), no additional measures were taken concerning the management of psoriasis treatments in either 2020 or 2022. Those patients with changes reported most frequently: telephone calls instead of face-to-face visits (80.2%, in 2020 vs 40.5% in 2022) or more frequent controls (27.1%, 2020 vs 22.0%, 2022). A majority (66.7%, 2020, and 70.6%, 2022) did not perceive the virus as a considerable threat. The proportion of patients feeling well informed about COVID-19 by physicians increased from 42.6% in 2020 to 51.8% in 2022. About 81.1% of patients in 2020 and 67.5% in 2022 stated that their overall personal condition was not affected due to the pandemic. Physicians attributed no special risk of contracting SARS-CoV-2 in most of the patients. Conclusion: A high rate of systemic treatment persistence and awareness of risks and protective measures indicate that health care for psoriasis largely followed current national and international recommendations during the COVID-19 pandemic.

The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus-associated disease in breakthrough infections in adults ≥60 years of age.

Background: Respiratory syncytial virus (RSV) is a contagious pathogen causing acute respiratory infections (ARIs). Symptoms range from mild upper respiratory tract infections to potentially life-threatening lower respiratory tract disease (LRTD). In adults ≥60 years old, vaccine efficacy of a candidate vaccine for older adults (RSVPreF3 OA) was 71.7% against RSV-ARI and 82.6% against RSV-LRTD (AReSVi-006/NCT04886596). We present the patient-reported outcomes (PROs) from the same trial at the end of the first RSV season in the northern hemisphere (April 2022). Methods: In this phase 3 trial, adults aged ≥60 years were randomized (1:1) to receive one dose of RSVPreF3 OA vaccine or placebo. PROs were assessed using InFLUenza Patient-Reported Outcome (FLU-PRO), Short Form-12 (SF-12), and EuroQol-5 Dimension (EQ-5D) questionnaires. Peak FLU-PRO Chest/Respiratory scores during the first 7 days from ARI episode onset were compared using a Wilcoxon test. Least squares mean (LSMean) of SF-12 physical functioning (PF) and EQ-5D health utility scores were estimated using mixed effects models. Results: In the RSVPreF3 OA group (N = 12,466), 27 first RSV-ARI episodes were observed versus 95 in the Placebo group (N = 12,494). Median peak FLU-PRO Chest/Respiratory scores were lower in RSVPreF3 OA (1.07) versus Placebo group (1.86); p = 0.0258. LSMean group differences for the PF and EQ-5D health utility score were 7.00 (95% confidence interval [CI]: -9.86, 23.85; p = 0.4125) and 0.0786 (95% CI: -0.0340, 0.1913; p = 0.1695). Conclusions: The RSVPreF3 OA vaccine, in addition to preventing infection, attenuated the severity of RSV-associated symptoms in breakthrough infections, with trends of reduced impact on PF and health utility.

Characterization of patients with psoriatic arthritis in dermatologic and rheumatologic care: analysis of two registries.

BACKGROUND AND OBJECTIVE: Psoriatic arthritis (PsA) is a chronic systemic inflammatory disease affecting the musculoskeletal system, skin and nails. The aim is to characterize sociodemographic and clinical patient profiles documented in dermatologic and rheumatologic care. PATIENTS AND METHODS: Data of 704 patients with PsA from the dermatological Psoriasis Registry PsoBest (PB) and 1066 patients from the rheumatological disease registry RABBIT-SpA (RS) were analyzed. Comparable anamnestic and clinical variables were identified and descriptively analyzed. RESULTS: The mean age was 51.7 years in PB and 51.9 in RS. Disease duration of psoriasis was longer, mean cutaneous severity was higher in PB. However, more patients in RS vs. PB had tender joints and swollen joints. Mean Dermatology Life Quality Index was higher in PB and mean Health Assessment Questionnaire in RS. Patient reported global disease activity and pain were lower in PB. IL-23 inhibitors were used more frequently in PB, and TNF inhibitors in RS. CONCLUSIONS: Clinical specialization was associated with different clinical and treatment patterns of PsA. This may indicate a selection by dominant manifestation of psoriatic disease and potentially by effects of health care access. Psoriatic arthritis should be treated in a multidisciplinary approach considering all facets of this complex disease.

The Value of Hybrid Teledermatology in German Prisons: Analysis of Routine Telemedical Data.

Introduction: German prisons face organizational and time-consuming difficulties in access to medical specialties. Since 2019, our institute offers interdisciplinary video consultations with spatially independent dermatological support for German prisons. Methods: Documentation of n = 200 consultations between February 2020 and July 2021 with retrospective analysis of dermatological conditions and consultation requests. Results: Most cases (98.0%; 196 of 200) were performed during a regular weekly teleclinic and only few cases on urgent demand. The average duration of the skin disease before request for consultation was 10.3 ± 26.9 months (mean ± standard deviation), the majority had first onset of their disease or acute recurrence of previously known skin diseases. With respect to medical complaints, 39.7% of patients reported severe itch and 7.7% indicated severe pain. For most cases (84.0%), topical treatment and for almost one-third (32.5%) we recommended systemic treatment. The predominant number of cases was only presented once (92.0%) and further treatment of the skin disease could be managed by the medical staff inhouse. Only few consultations could not be solved virtually and were referred to local physicians for face-to-face consultations or procedures. Discussion: Teledermatological care for prisoners effectively supports the inhouse medical resources of prisons. Our interdisciplinary approach enables general practitioners and medical staff of the respective prison to manage the case and shortens the time period until therapy starts.

Health services in older psoriasis patients before and after nursing home admission : A retrospective analysis of health insurance data.

BACKGROUND AND OBJECTIVE: Demographic change confers significance to healthcare management of chronic diseases like psoriasis. There are few studies on the care of older people with psoriasis, particularly for the nursing home setting. It was investigated whether the number of psoriasis patients with specialist contact changes before vs. after nursing home admission. MATERIAL AND METHODS: We analyzed claims data of a German health insurance company including a cohort of newly admitted nursing home residents aged 65 years and older between 2011 and 2014, who received a diagnosis of psoriasis 1 year before nursing home admission. Outpatient care was compared between the years before vs. after nursing home admission. We conducted a multivariate regression analysis for identifying predictors for dermatological care. RESULTS: The study cohort included 718 insured persons (Ø83 years). Proportion of patients who had contact to a dermatologist significantly decreased after nursing home entry (44.6% before vs. 40.1% after nursing home entry). Strongest predictors for dermatological care after entry were a previously existing dermatological contact (odds ratio, OR 3.87, 95% confidence interval, CI 2.70-5.54) and prescription for topical steroids (OR 1.61, 95% CI 1.14-2.28). CONCLUSION: The analysis of health insurance data showed a pertinent decrease in the use of outpatient dermatological care after institutionalization. The evaluation of the adequacy of care is difficult due to the used database without clinical information. As long as no further investigations of this vulnerable patient group are available, the care of psoriasis patients of old age should be closely monitored. Dermatological knowledge of the skin in old age is an essential prerequisite for this.

Switching from Adalimumab Originator to Biosimilar in Patients with Hidradenitis Suppurativa Results in Losses of Response-Data from the German HS Registry HSBest.

Since 2021, adalimumab biosimilar ABP 501 can be used alternatively to adalimumab originator (ADAO) in the treatment of hidradenitis suppurativa (HS). Effectiveness and safety data remain scarce. We investigated the impact of switching from ADAO to ABP 501 on disease severity and the occurrence of adverse events (AEs) in patients with HS. We analyzed clinical data on patients enrolled in the German HSBest registry. Evaluation outcomes were assessed at three time points (baseline of originator (t0), prior to switching to biosimilar (t1) and 12 to 14 weeks after switching (t2)) and included patient-reported AEs and disease severity using the International Hidradenitis Suppurativa Severity Score System (IHS4) score. In total, 94 patients were switched from ADAO to ABP 501. Overall, 33.3% (n = 31/94) of the patients developed AEs and/or loss of response (LoR) within 12 to 14 weeks after switching. Of these, 61.3% (n = 19/31) experienced LoR but no AEs, 22.6% (n = 7/31) LoR combined with AEs and 16.1% (n = 5/31) AEs only. Our study showed that switching HS patients from ADAO to ABP 501 does significantly affect treatment effectiveness. Switching patients who are on remission maintenance therapy should be viewed critically.

Medicinal Treatment of Elderly Psoriasis Patients before and after Entering a Nursing Home.

Psoriasis (PS) is a chronic inflammatory skin disease, and it increasingly appears also in the elderly population. There is a rising interest in drug therapy for PS, especially for people receiving care in nursing homes (NH). Which PS-related drugs are prescribed in the time before nursing home admission (NHA), and to what extent does the supply of drugs change after NHA? Which specialties prescribe PS-related drugs? Statutory health insurance data were examined for people with PS, aged ≥ 65 years, who were newly admitted to a NH in the period 2011-2014 and observed for one year before and after NHA. Changes in prescription prevalence (pre-post comparison) were examined for significant differences. Prescriptions of PS-relevant drugs were measured by defined daily dose and stratified according to the prescribing specialist group. The analysis included 718 insured persons with PS (76.2% female, mean age 83.3 years). Systemic therapeutics played a minor role (pre: 2.6% vs. post: 2.1%) in drug therapy. Topical steroids had a high share of about 40% in the pre-post comparison. Overall, the proportion of people with PS who received treatment remained at a comparable level before and after NHA. A structured assessment of the skin is crucial, specifically in people with cognitive impairment.

Pharmacovigilance pregnancy data in a large population of patients with chronic inflammatory disease exposed to certolizumab pegol.

Introduction: Chronic inflammatory diseases (CIDs), including rheumatic diseases and other inflammatory conditions, often affect women of reproductive age. Tumor necrosis factor inhibitors (TNFi) are widely used to treat CID, but there is limited information on outcomes of TNFi-exposed pregnancies. We evaluated pregnancy outcomes from 1392 prospectively reported pregnancies exposed to certolizumab pegol (CZP), a PEGylated, Fc-free TNFi with no to minimal placental transfer. Methods: CZP-exposed pregnancies in patients with CID from the UCB Pharmacovigilance global safety database were reviewed from the start of CZP clinical development (July 2001) to 1 November 2020. To limit bias, the analysis focused on prospectively reported cases with known pregnancy outcomes. Results: In total, 1392 prospective pregnancies with maternal CZP exposure and known pregnancy outcomes (n = 1425) were reported; 1021 had at least first-trimester CZP exposure. Live birth was reported in 1259/1425 (88.4%) of all prospective outcomes. There were 150/1425 (10.5%) pregnancy losses before 20 weeks (miscarriage/induced abortion), 11/1425 (0.8%) stillbirths, and 5/1392 (0.4%) ectopic pregnancies. Congenital malformations were present in 30/1259 (2.4%) live-born infants, of which 26 (2.1%) were considered major according to the Metropolitan Atlanta Congenital Defects Program criteria. There was no pattern of congenital malformations. Discussion and conclusion: No signal for adverse pregnancy outcomes or congenital malformations was observed in CZP-exposed pregnancies. Although the limitations of data collected through this methodology (including underreporting, missing information, and absence of a comparator group) should be considered, these data provide reassurance for women with CID who require CZP treatment during pregnancy, and their treating physicians.

Psoriasis comorbidities in Germany: A population-based study on spatiotemporal variations.

Psoriasis is a chronic disease with high impact on patients' health and their quality of life. Psoriasis often occurs along with other comorbidities, but it is not yet clear what role the comorbidities play in regional psoriasis prevalence. This study investigates the temporal and regional variation of the psoriasis comorbidities diabetes mellitus type II, obesity, hypertension, affective disorders in Germany and their association with psoriasis prevalence. This analysis based on the population set of ambulatory claims data (2010-2017) of the statutory health insurance (SHI) in Germany (approx. 70.3 million people in 2017). Psoriasis comorbidities rates were determined on county level. We performed descriptive spatiotemporal analyses of psoriasis comorbidity prevalence rates. In addition, we identified and compared spatial clusters and examined regional variations using spatial statistical methods. The results show strong regional variations (northeast to south gradient) and an increasing psoriasis prevalence (max. 28.8%) within the observation period. Considering the comorbidities, results indicate comparable spatial prevalence patterns for diabetes mellitus type II, obesity and hypertension. This means that the highest prevalence of comorbidities tends to be found where the psoriasis prevalence is highest. The spatiotemporal cluster analyses could once again confirm the results. An exception to this is to be found in the case of affective disorders with different spatial patterns. The results of the studies show the first spatiotemporal association between psoriasis prevalence and comorbidities in Germany. The causalities must be investigated in more detail in order to be able to derive measures for improved care.

Comparison of patient pathways in the early detection of skin cancer - a claims data analysis.

BACKGROUND: Regarding skin cancer screening, patients in Germany have the choice between a direct screening by dermatologists or an initial screening by general practitioners followed by dermatological screening if further examination is required. The aim of this study is to evaluate whether screening by general practitioners is associated with risk selection in subsequent dermatological screenings. PATIENTS AND METHODS: We conducted a retrospective observational study based on claims data from a German health insurance company (Barmer GEK). Patient pathways in skin cancer screenings between 2008 and 2016 were analyzed, and differences between the two groups were tested at 95 % confidence intervals. RESULTS: A total of 495,000 initial and 111,000 secondary examinations by dermatologists were analyzed. The proportion of subsequent excisions was lower in initial screenings by dermatologists. To diagnose one person with non-melanoma skin cancer or melanoma, five or 23 to 42 excisions were necessary, depending on the type of excision considered. The number of examinations to identify one patient ranged from 25 to 53 for non-melanoma skin cancer and 42 to 165 for melanoma. For melanoma, the number of excisions and screenings to diagnose skin cancer was lower in secondary examinations. CONCLUSIONS: The results indicate a risk selection through initial examinations by general practitioners. However, there are other aspects that should be taken into account when comparing the two pathways.

Considerations for patients with psoriasis travelling under immunosuppression.

With the establishment of modern systemic therapies for psoriasis, comprehensive consultation is required for travelling with immune modulation. Logistic aspects regarding transport and storage, climatic peculiarities of the country of travel and drug dependent risks regarding infections must be considered. Vaccinations and preventive measures are emphasized. Depending on the current national recommendations, special features of vaccinations while under immunosuppression must be taken into account.