Galcanezumab in the Treatment of Migraine: A Narrative Review of Real-World Studies.

OBJECTIVES: Randomized controlled trials (RCTs) have established the efficacy of galcanezumab, an antibody binding calcitonin gene-related peptide (CGRP) ligand, in the preventive treatment of migraine. The objective was to summarize real-world data evaluating galcanezumab in the preventive treatment of migraine, to complement RCT results with evidence observed in clinical practice. METHODS: A literature search was conducted to identify real-world studies evaluating galcanezumab in the treatment for patients with migraine. RESULTS: Twenty-five studies were identified; some only evaluated galcanezumab, and others used pooled data from multiple anti-CGRP antibodies. The studies recruited diverse patient populations, including patients who had failed multiple prior preventive therapies. Treatment was associated with significant reductions from baseline in monthly migraine days and monthly headache days by 4.3 to 12.9 and 3.1 to 13.9, respectively. These values were numerically greater than those reported in most galcanezumab RCTs. Significant decreases from baseline were evident within the first month of treatment, and efficacy was maintained throughout the follow-up periods, ranging from 3 to 12 months. Galcanezumab was also associated with improvements in other efficacy end points, including decreased headache pain intensity, reduction in analgesic use, and improvements in daily functioning and quality of life. Functionality scores, as assessed by the Migraine Disability Assessment Scale questionnaire, decreased by 27 to 75 points from baseline at 3 to 12 months. Galcanezumab was associated with a low discontinuation rate and higher rates of persistence compared with standard migraine preventive treatments. CONCLUSIONS: The results provide complementary data that galcanezumab is effective across the diverse patient populations observed in routine clinical practice.

Osteoporosis: Economic Burden of Disease in Italy.

BACKGROUND AND OBJECTIVE: Today, osteoporosis is the most common bone disease and an important public health problem in all developed countries. The objective of this study was to estimate the costs associated with the management and treatment of osteoporosis in order to assess the economic burden in Italy for 2017, in terms of direct medical costs and social security costs. METHODS: A cost of illness model was developed to estimate the average cost per year sustained by the NHS (National Health Service) and Social Security System in Italy. A systematic literature review was performed to obtain epidemiological, direct and indirect costs parameters where available. Hospitalisation costs were calculated considering the administrative database of the hospital discharge records for the period 2008-2016. Patients were enrolled in the analysis if they report the subsequent inclusion criteria: age ≥ 45 years and presence of osteoporosis in primary or secondary diagnosis (ICD9-CM 733.0) and/or presence of a major fracture in primary or secondary diagnosis (excluding road accidents) in the following locations: spine (codes ICD9-CM: 805;806), femur (codes ICD9-CM: 820; 821), radius and ulna (codes ICD9-CM: 813.4; 813.5), humerus (codes ICD9-CM: 812.0-812.5), pelvis (code ICD9-CM: 808), tibia and fibula (codes ICD9-CM: 823), ankle (code ICD9: 824) and ribs (codes ICD9-CM: 807.0; 807.1). Costs were estimated considering the diagnosis-related group (DRG) national tariff associated with each hospitalisation. Finally, the administrative databases of the Italian National Social Security Institute (INPS) (2009-2015) were analysed for the estimate the pension and disability costs from the social perspective. RESULTS: The model estimated an average annual economic burden of osteoporosis in Italy of €2.2 billion. Of this cost, approximately 80% (€1.8 billion) was associated with hospitalisations, 16% (€351 million) for pharmacological treatments, 3% (€71 million) for ambulatory visits, and 0.6% (€13 million) for social security costs. The average yearly cost per patient was equal to €8691 (€8591 for hospitalisations). Analysing severe patients, hospitalisation costs increase to €12,336 (+ 44% if compared to non-severe osteoporosis patients). CONCLUSIONS: The analysis showed that osteoporosis represents one of the main health problems in Italy and the ability to maintain patients in a non-severe health state could decrease the economic burden from both NHS and social perspective.