Real-world systemic treatment of patients with psoriasis: A retrospective study based on German claims data.

BACKGROUND AND OBJECTIVES: Psoriasis is a common skin disorder with a high physical and psychological burden for patients. Up to 30% of the patients are candidates for a systemic treatment. The aim of this study was to describe the characteristics and the real-world systemic treatment of psoriasis patients. PATIENTS AND METHODS: This study was based on German medical claims data. A cross-sectional analysis observed all psoriasis patients in 2020. A longitudinal analysis was conducted, addressing psoriasis patients who newly started a systemic treatment. RESULTS: In total, 116,507 prevalent psoriasis patients and 13,449 newly treated patients were followed. Of all prevalent patients, 15.2% received systemic treatment in 2020 (8.7% systemic corticosteroids). Of the newly treated patients, 95.2% started with conventional treatment (79.2% systemic corticosteroids), 4.0% with biologics and 0.9% with apremilast. The rate of treatment discontinuation/switch after one year was highest for corticosteroids (91.3%) and lowest for biologics (23.1%). CONCLUSIONS: Around 15% of psoriasis patients in Germany received a systemic treatment, with > 50% of these prescribed systemic corticosteroids. Therefore, we conclude that systemic treatment is not in line with guideline recommendations in a substantial number of observed patients. The lowest discontinuation/switch rates for biologics support their wider use.

Epidemiology and treatment of myasthenia gravis: a retrospective study using a large insurance claims dataset in Germany.

Myasthenia gravis (MG) is a rare, chronic autoimmune disease with symptoms of fluctuating muscular weakness and fatigability. The aim of this retrospective cohort study was to estimate the prevalence and incidence of MG in Germany, and to understand the burden of disease and treatment patterns, based on anonymized German claims data. Two patient samples were identified: (1) incident MG patients with newly onset disease between 2015 and 2019, and (2) prevalent MG patients in 2019. In total, 775 incident MG patients with a mean age of 66.9 years; and 1,247 prevalent MG patients with a mean age of 68.6 years were included. The prevalence for Germany was estimated to be 39.3/100,000 on 31/12/2019; the incidence in 2019 was 4.6 cases/100,000 persons. The 12-month mortality was 5.7. For 31.5% of the incident patients, no MG treatment was observed in the first year after the index date. Of all incident patients, 29.9% experienced an exacerbation, and 6.7% a myasthenic crisis during the observation. Our study indicates that a substantial proportion of MG patients remains untreated. Many MG patients still experience exacerbations / MG crises. MG seems to be associated with an excess mortality in comparison to the general non-MG population.

Treatment Patterns and Resource Utilization of Pregnant Women with Inflammatory Rheumatic Diseases or Psoriasis in Germany: A Claims Database Analysis.

BACKGROUND: Uncontrolled inflammatory disease activity can impact pregnancy outcomes and the health of the mother and child. This retrospective claims database analysis assessed treatment patterns before, during, and after pregnancy among women with inflammatory rheumatic disease (IRD; axial spondyloarthritis [axSpA], psoriatic arthritis [PsA], and rheumatoid arthritis [RA]) or psoriasis (PSO) in Germany. METHODS: Data were extracted from the BARMER sickness fund (2013-2017). Pregnant women (18-45 years) with documented IRD or PSO diagnoses were compared with age-matched controls from the same database for the analysis of patient characteristics, healthcare resource utilization, and pharmacological treatment during pregnancy. Reported measures included the proportion of women with pharmacological prescriptions or hospitalization/new prescription of corticosteroids or biologics in the 180 days before pregnancy, during pregnancy, and 180 days after delivery. Pre-specified prescription categories (such as disease-specific drugs [not including biologics]) were identified by anatomical therapeutic chemical classification codes. Extrapolated values to the German statutory health insurance population are reported. RESULTS: Overall, 2702 pregnant women with IRD (axSpA: 1063; PsA: 660; RA: 979) and 6527 with PSO were identified. The proportion of women with IRD receiving prescriptions for disease-specific drugs reduced during pregnancy and remained stable after delivery (before: 15.0%; during: 9.0%; after: 9.7%). The proportion of women with PSO receiving prescriptions for disease-specific drugs was low (before: 0.6%; during: 0.3%; after: 0.1%). The proportion of women with hospitalization/new prescription of corticosteroids or biologics decreased during pregnancy, compared with pre-pregnancy, and increased after delivery in women with IRD (before: 9.0%; during: 5.1%; after: 11.1%) and PSO (before: 3.5%; during: 1.9%; after: 2.7%). CONCLUSIONS: A reduction in pharmacological treatment during pregnancy was observed for women with IRD in Germany. Many women with IRD did not return to pre-pregnancy treatments after delivery, despite signs of disease exacerbation, such as hospitalization and initiation of treatment with corticosteroids/biologics, in this period.

Real-world treatment and fracture incidence in postmenopausal women with severe osteoporosis at high risk of fracture: a retrospective claims data analysis.

Background: Osteoporosis (OP) and its associated fractures have a significant impact on patients' quality of life and are impacting their morbidity and mortality. For OP patients at high risk of fracture, guidelines recommend a pharmacological OP treatment. The aim of this study was to describe the real-world medication treatment of postmenopausal women with severe OP at high risk of fracture, their risk to experience a new fracture after having at least one previous fracture, and to assess the associated healthcare resource use (HCRU). Methods: This retrospective cohort study was based on anonymized German claims data (AOK PLUS). All included OP patients were female, ≥55 years old, and had a vertebral and/or femoral fracture. We conducted a cross-sectional analysis in 2018 and a longitudinal analysis, starting with an incident vertebral/femoral fracture (after or simultaneously with the first observed OP diagnosis). In both analyses, patient characteristics, rate of new incident fractures, OP treatment patterns, and HCRU associated with the treatment of patients were investigated. Results: In the cross-sectional setting, 12,180 patients with a mean age of 83.59 years were observed. Of these patients, 14.30% sustained at least one new incident fracture and 34.54% received a pharmaceutical OP treatment during 2018. In this year, 58.50% of the patients had at least one OP-related outpatient visit, and 26.35% had a fracture-related visit. In 160 patients (1.31%), at least one OP-related hospitalization was documented, and in 1,293 patients (10.62%) a fracture-related hospitalization in 2018. In the longitudinal setting, 10,323 patients with a mean age of 83.22 years were included. Of these, 18.96% experienced at least one new incident fracture within the first 12 months after the index fracture, and in total 30.85% in the entire follow-up period (mean 2.03 years). During the 12-month baseline period, 22.12% of the patients received an OP treatment. Three months after the index fracture, the proportion of treated patients remained at 22.30%. During the total follow-up time, 35.54% were prescribed with an OP treatment. Conclusion: We observed a considerable proportion of untreated patients and a high rate of subsequent fractures. The awareness for a proper risk assessment and the appropriate use of available treatments should be increased.

Switching from an oral dopamine receptor agonist to rotigotine transdermal patch: a review of clinical data with a focus on patient perspective.

INTRODUCTION: Dopamine receptor agonists (DAs) are commonly used to treat Parkinson's disease (PD) and restless legs syndrome (RLS). In certain situations, switching from oral DAs to rotigotine transdermal patch may be beneficial for the patient (e.g., optimal symptom control/side effects/perioperative management, preference for once-daily/non-oral administration, RLS augmentation treatment). Areas covered: This narrative review summarizes available data on DA dose equivalency, dose conversions, switching schedules, safety, tolerability, efficacy and patient treatment preferences of switching from oral DAs to rotigotine (and vice versa) in patients with PD/RLS. The studies were identified in a PubMed search (up to 8 November 2016) using terms ('dopamine receptor agonist' OR 'rotigotine') AND 'switch'. Expert commentary: Randomized controlled studies often do not address the challenges clinicians face in practice, e.g., switching medications within the same class when dosing is not a one-to-one ratio. The authors describe three open-label studies in PD where oral DAs were successfully switched to rotigotine, and review three studies in RLS where oral DAs/levodopa were switched to rotigotine. Finally, the authors provide a suggested tool for switching from oral DAs to rotigotine, which includes dose conversion factors and switching schedules. The authors' view is that low-dose oral DAs (equivalent to ≤8 mg/24 h rotigotine) may be switched overnight.

Management of augmentation of restless legs syndrome with rotigotine: a 1-year observational study.

AIM: The aim of this study is to assess the effect of switching to rotigotine transdermal patch on severity of restless legs syndrome (RLS) in patients who experienced acute augmentation with previous oral dopaminergics. METHODS: In this 13-month observational study, adults with moderate-to-severe RLS and augmentation were switched to rotigotine per the physician's independent decision. Assessments included Clinical Global Impression severity score (CGI-1); (primary), treatment regimen for switching (secondary), RLS-6, International RLS Study Group Rating Scale (IRLS), and augmentation severity rating scale (ASRS). RESULTS: A total of 99 patients received rotigotine, of whom 46 completed observational period, and 43 were assessed for effectiveness. A total of 5 patients switched to rotigotine after a >1-day drug holiday, 23 switched overnight, 9 had an overlapping switch, and 6 received ongoing oral dopaminergics with rotigotine for ≥28 days. Of the 99 patients, 57 took concomitant RLS medications (excluding switching medications) on at least 1 day. At the final visit, median change in CGI-1 (Hodges-Lehman estimate [95% CI]) was -2.0 (-2.5, -1.50); 37 of the 43 patients improved by ≥1 CGI-1 category, and 16 of 43 were responders (≥50% improvement). RLS-6 and IRLS scores also improved. Patients had median ASRS of 0 at the final visit indicating "no worsening/occurrence of augmentation." ASRS item 1 showed a shift in mean time of symptom onset (24-h clock) from 12:38 (baseline) to 18:25 (final visit). Most common reasons for withdrawal of rotigotine were adverse events (26 patients) and lack of efficacy (14 patients). CONCLUSIONS: Switching from oral therapies to rotigotine was effective in improving RLS symptoms in 37 of the 43 patients (from the original population of 99 patients) who remained in the study over 13 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.govNCT01386944.