Addition of quantitative MRI to the routine clinical care of patients with multiple sclerosis-Results from the MAGNON project.

BACKGROUND: The revised Lublin classification offers a framework for categorizing multiple sclerosis (MS) according to the clinical course and imaging results. Diagnosis of secondary progressive MS (SPMS) is often delayed by a period of uncertainty. Several quantitative magnetic resonance imaging (qMRI) markers are associated with progressive disease states, but they are not usually available in clinical practice. METHODS: The MAGNON project enrolled 629 patients (early relapsing-remitting MS (RRMS), n = 51; RRMS with suspected SPMS, n = 386; SPMS, n = 192) at 55 centers in Germany. Routine magnetic resonance imaging (MRI) scans at baseline and after 12 months were analyzed using a centralized automatic processing pipeline to quantify lesions and normalized brain and thalamic volume. Clinical measures included relapse activity, disability, and MS phenotyping. Neurologists completed questionnaires before and after receiving the qMRI reports. RESULTS: According to the physicians' reports, qMRI results changed their assessment of the patient in 31.8% (baseline scan) and 27.6% (follow-up scan). For ∼50% of patients with RRMS with suspected SPMS, reports provided additional information that the patient was transitioning to SPMS. In >25% of all patients, this information influenced the physicians' assessment of the patient's current phenotype. However, actual changes of treatment were reported only in a minority of these patients. CONCLUSIONS: The MAGNON results suggest that standardized qMRI reports may be integrated into the routine clinical care of MS patients and support the application of the Lublin classification as well as treatment decisions. The highest impact was reported in patients with suspected SPMS, indicating a potential to reduce diagnostic uncertainty.

Omalizumab for the treatment of patients with severe allergic asthma with immunoglobulin E levels above >1500 IU/mL.

Immunoglobulin E (IgE) plays a critical role in the allergen-initiated inflammatory pathway and thus serves as a viable therapeutic target in allergic or IgE-mediated diseases such as asthma. Omalizumab, an anti-IgE biologic, has been approved in the United States (US, 2003) and in the European Union (EU, 2005) as an add-on therapy in patients with moderate-to-severe persistent asthma and severe allergic asthma (SAA) aged 6 years and older. The dose and frequency of omalizumab are adjusted based on the patient's body weight and baseline IgE levels, as recommended by its dosing tables. Currently, these dosing recommendations are limited to patients with baseline IgE levels of up to 1500 IU/mL in the European Union and 700 IU/mL in the United States. However, many patients with SAA have IgE levels >1500 IU/mL, highlighting an unmet need. This review presents the current evidence on the treatment benefits of omalizumab in patients with IgE levels >1500 IU/mL. The findings from the reviewed studies which included >3000 patients support the efficacy and effectiveness of omalizumab in reducing exacerbations, and improving asthma control, lung function, and quality of life in patients with severe asthma having IgE levels beyond the current dosing range. Omalizumab was well-tolerated in these patients, with no new safety signals. In addition, high IgE levels (>1500 IU/mL) are also reported in several comorbidities of asthma (allergic rhinitis, atopic dermatitis, allergic bronchopulmonary aspergillosis [ABPA], food allergy, and nasal polyposis) and omalizumab has demonstrated efficacy and safety in these indications. These data suggest that omalizumab may be considered for administration in SAA patients, with high IgE levels outside the current dosing tables. A detailed assessment of patients with high IgE levels is needed before deciding on the optimal treatment approach. A management algorithm for SAA patients with IgE >1500 IU/mL is proposed in this review and a suggestion to follow the Delphi consensus is advised.

Oral corticosteroid prescription for asthma by general practitioners: A three-year analysis in Germany.

BACKGROUND: Regular treatment of patients with asthma with oral corticosteroids (OCS) remains common despite potential severe side effects and alternative treatment options. However, there is limited data on the prevalence of OCS prescriptions for patients with asthma in Germany. METHODS: Records from 1039 General practitioners for the years 2015-2017 in the German IMS® Disease Analyzer database were retrospectively analysed for patients with at least two confirmed asthma diagnoses (ICD-10) per observed year, representing approximately 30,000 patients per year. Asthma treatment steps (1-5) were assigned according to the German national guideline, based on prescribed therapies. RESULTS: In the years 2015-2017, 20.3-21.3% of patients were classified as being in treatment step 1, 4.7-5.2% in step 2, 38.8-40.1% in step 3, 31.7-32.1% in step 4 and 2.7-3.2% in step 5. Proportions of patients treated with OCS >30 days/year were 9.4% (2015), 9.6% (2016) and 8.9% (2017), reducing to 8.1%, 8.2% and 7.4%, respectively, when patients with other inflammatory diseases possibly requiring OCS treatment were excluded. Use of OCS >30 days/year was more prevalent in patients aged >65 years (14.1-15.0%) than those aged 18-65 years (6.8-7.8%). Median daily prednisolone dose was 10-15 mg/day. Approximately 30% of patients treated with OCS >30 days/year were not in step 5 (based on their prescribed inhaled therapies). CONCLUSION: These data suggest that a substantial proportion of patients with asthma in non-specialised care in Germany receive OCS prescriptions regularly, despite the availability of less harmful alternative treatment options.