Search

Introduction: Female sex has been shown to be a risk factor for the development of adverse drug reactions; however, this has not been studied for cyclosporine (CsA). The aim of this study was to investigate, in Italian dermatological practice, the influence of gender and menopause and related hormones on the incidence of adverse events (AEs) during CsA treatment in psoriatic patients. Methods: Multicenter, prospective, observational study conducted from May 2011 to June 2013. Patients with plaque psoriasis, undergoing a new CsA administration course, or about to start it, were enrolled in the outpatient clinics of Italian dermatological centers. During the 2–6 months of study duration, patients had to note all AEs that occurred in a diary that was reviewed by the investigators at the follow-up visit. Sex hormone levels were measured within 7 days from the start date of a menstrual cycle. Results: A total of 969 adult psoriatic patients were enrolled in the study, divided into four cohorts: fertile women and corresponding age-matched men; postmenopausal women and corresponding age-matched men. A significant difference in the percentage of patients with AEs was observed between fertile and postmenopausal women, but not between women and age-matched men. AE incidence rate was about 37% higher in fertile women than in age-matched men and about 18% higher in postmenopausal women than in age-matched men, but differences were not statistically significant. Incidence rate ratio of fertile vs. postmenopausal women was 0.67, reaching statistical significance. AEs were mild or moderate in severity in the great majority of patients of all cohorts and postmenopausal women had significantly less grade 1–2 AEs compared to fertile women, but more grade 3–4 AEs. FSH levels were significantly higher in postmenopausal women reporting no AEs, and DHEA sulfate levels were about 10% higher in men with no AEs, compared to those reporting at least one AE. Cortisol le

Background The past few years, the Italian National Health Service (INHS) has faced the challenge of ensuring sustainable costs for antineoplastic and immunomodulating drugs. The aim of this study was to analyse expenditure trends for these drugs in two Local Health Units during the period 2009-2011. Methods Data for this retrospective study were derived from the administrative databases of two Local Health Units in Northern Italy. A sample was built up by selecting all patients with at least one antineoplastic and immunomodulating drug prescription between 2009 and 2011. The study evaluated the annual, per capita and per user drug expenditure. The antineoplastic and immunomodulating drug expenditure was also analysed by therapeutic indication. Results The number of users (annual mean rate: 12.1%) and the antineoplastic and immunomodulating drug expenditure (annual mean rate: 15.7%) were increased in the three-year period. The mean annual per capita cost was €18.40 in the first year (2009), €22.18 in the second year (2010) and €24.23 in the last year (2011). Taking into account the last year of the analysis (2011), monoclonal antibody drugs showed the highest per capita drug spending (€9.36), followed by TNF-alpha inhibitors (€6.61) and tyrosine kinase inhibitors (€5.75). The highest mean annual expenditure was on cancer drugs (€15,046,773), followed by rheumatoid arthritis (€3,596,925), psoriatic arthritis (€925,510), ankylosing spondylitis (€626,050) and psoriasis (€622,332). Conclusions Spending on antineoplastic and immunomodulating drugs increased over the three-year period of the analysis and the oncological disease was the main therapeutic indication.

Delia Colombo,1 Emanuela Zagni,1 Mihaela Nica,1 Sara Rizzoli,2 Alessandra Ori,2 Gilberto Bellia1 1Patient Access, Novartis Farma S.p.A., Origgio, Varese, 2MediNeos Observational Research, Modena, Italy Background: MetaGeM is a wide gender-medicine project comprising post hoc and meta-analyses by gender of clinical outcomes, therapeutic approaches, and safety data from previously conducted observational studies to explore possible gender differences in real-life clinical settings. We report the results of the safety meta-analysis of seven MetaGeM studies, evaluating gender differences in adverse event (AE) incidence and severity. Methods: Data were collected between February 2002 and July 2013. Male and female patients were compared for the main safety variables, using Student’s t-test, χ² test, or Fisher’s exact test as appropriate. As supportive analysis, a logistic regression model was estimated to evaluate associations between gender and outcome. Results: In total, 4,870 patients (46% females, 54% males) were included in the analysis; age was higher for females (mean ± standard deviation 61.2±18.3 years) than males (56.3±16.6 years). Overall, 264 AEs were reported (59.1% in males). There were no significant gender differences in the percentage of patients with at least one AE: 3.0% for females versus 3.9% for males, χ² test P>0.05. According to the logistic regression model results, no association between gender and AEs occurrence seems to exist. A statistically significant gender difference in the percentage of drug-related AEs emerged (37.6% in females vs 20.8% in males, χ² P=0.0039). Slightly significantly more AEs in females were addressed with treatment compared with males (78.1% vs 66.7%, χ² P=0.0485). Total serious AEs (SAEs) were 47 (72% in males). The frequency of patients with ≥1 SAE was 0.6% in females versus 1

Background The past few years, the Italian National Health Service (INHS) has faced the challenge of ensuring sustainable costs for antineoplastic and immunomodulating drugs. The aim of this study was to analyse expenditure trends for these drugs in two Local Health Units during the period 2009-2011. Methods Data for this retrospective study were derived from the administrative databases of two Local Health Units in Northern Italy. A sample was built up by selecting all patients with at least one antineoplastic and immunomodulating drug prescription between 2009 and 2011. The study evaluated the annual, per capita and per user drug expenditure. The antineoplastic and immunomodulating drug expenditure was also analysed by therapeutic indication. Results The number of users (annual mean rate: 12.1%) and the antineoplastic and immunomodulating drug expenditure (annual mean rate: 15.7%) were increased in the three-year period. The mean annual per capita cost was €18.40 in the first year (2009), €22.18 in the second year (2010) and €24.23 in the last year (2011). Taking into account the last year of the analysis (2011), monoclonal antibody drugs showed the highest per capita drug spending (€9.36), followed by TNF-alpha inhibitors (€6.61) and tyrosine kinase inhibitors (€5.75). The highest mean annual expenditure was on cancer drugs (€15,046,773), followed by rheumatoid arthritis (€3,596,925), psoriatic arthritis (€925,510), ankylosing spondylitis (€626,050) and psoriasis (€622,332). Conclusions Spending on antineoplastic and immunomodulating drugs increased over the three-year period of the analysis and the oncological disease was the main therapeutic indication.

Delia Colombo,1 Gilberto Bellia,1 Donatella Vassellatti,1 Emanuela Zagni,1 Simona Sgarbi,2 Sara Rizzoli21Novartis Farma, Origgio, 2MediData, Modena, ltaly Abstract: Only recently has medical research begun to understand the importance of taking sex into account, recognizing that symptoms and responses to medical treatment may be very different between males and females. However, the analyses provided by the pharmaceutical industry to regulatory authorities often do not present safety and efficacy data by sex. Novartis has started a gender-medicine project called MetaGeM, which includes nine observational studies sponsored by Novartis Farma, Italy; conducted in Italy between 2002 and 2013 in a range of different clinical areas. The MetaGeM project aims to analyze and describe by means of post hoc analyses and meta-analyses, clinical outcomes, therapeutic approaches, and safety data of these studies, by sex: PSYCHAE; GENDER ATTENTION in psoriasis; Synergy in psoriatic arthritis; ICEBERG in HBsAg carriers; SURF and CETRA in liver- and renal transplanted patients, respectively; DEEP in Parkinson's disease; and EVOLUTION and AXEPT in Alzheimer's disease. The present paper describes the methodology of the MetaGeM project.Keywords: gender-medicine, MetaGeM project, methodology