Budget impact analysis of infliximab biosimilar: the Italian scenery

Chronic inflammatory diseases, while seriously impairing patients' quality of life, are a heavy financial cost to the National Health Service (NHS) and to society. The availability of biological drugs – among which infliximab (Remicade®) – greatly improved treatment efficacy. On the other hand, these drugs are an expensive resource. Infliximab patent protection is going to expire, and a biosimilar has been recently approved.A budget impact (BI) analysis was conducted to evaluate the favourable consequences – for the Italian NHS – of the biosimilar availability in terms of cost containment (savings), thanks to its lower price compared to the originator's. The analysis model expects that some patients in treatment with the originator will switch (according to a prudent assumption of the market uptake rate) to the biosimilar and that many naive patients will directly start treatment with the biosimilar (according to a bolder uptake rate assumed). Separately considering all the different diseases for which in..

Use of essential oils of cinnamon (Cinnamomum zeylanicum L.), lavender (Lavandula spp.) and peppermint (Mentha x piperita L.) for weed control

The indiscriminate use of synthetic chemical compounds for weed control has been often responsible of damage to both the environment and the human health. To challenge these problems, in the last years research has increased its effort to find out alternatives farming strategies. A feasible alternative could be the identification of natural substances with allelopathic effects for the realization of natural herbicides. Some research has already highlighted the possibility of using essential oils, extracted from aromatic plants, for weed control. The advantage in the utilization of such natural compounds is the quickly breaking down process into the environment and so the possible application in sustainable agriculture like organic farming. Objective of this research was the evaluation of the inhibition effect exerted by the essential oils of cinnamon, peppermint and lavender on seeds germination of some of the most common weeds species of the Mediterranean environment (pigweed, wild mustard and ryegrass). The results have highlighted a control in the weeds germination. Among the essential oils tested, cinnamon oil has exerted the highest inhibition effect compared with lavender and peppermint ones. The dicotyledonous species have been more susceptible compared with the monocotyledonous, even if it has been recorded only for redroot pigweed a dose able to inhibit totally the seed germination

Naturalness consumption and Biodiversity in an Ecoregion of Central Italy

Landscape naturalness and landscape biodiversity are closely connected with ecosystem sustainability. In this study, “naturalness consumption” and “induced biodiversity” created by human interference were evaluated in an ecoregion of Central Italy that represents a meaningful local example of land-use pattern in a Mediterranean environment. A core set of selected indicators and indexes applied to the database produced by GIS was used first to evaluate the landscape naturalness for each phyto-climatic unit and then to calculate the naturalness consumption. Moreover, the landscape biodiversity of each phyto-climate was evaluated, considering the ecomosaic space organization and taking into account the presence of some important ecological structures like ecotones and hedges. In the naturalness analysis, the highest naturalness consumption occurred in phyto-climates with a higher presence of cultivated areas. In the biodiversity analysis, the phyto-climates with a lower naturalness and a higher presence of agricultural land showed higher values of landscape biodiversity in comparison with the other phyto-climatic units. The results suggest that biodiversity in agro-ecosystems can compensate for naturalness consumption in terms of landscape sustainability. Indeed, natural landscapes carry out a conservative role, while more bio-diverse landscapes offer a balance between human requirements and native ecosystem conditions in a frame of co-evolutionary development

Habitat Patch Diversity Evaluation for Sustainability: a Case Study of a Rural Area in Central Italy

Landscape analysis is regarded as a new tool for monitoring and judging land use patterns in terms of sustainability of human activity systems at local level. A case study of evaluation for sustainability based on habitat patch diversity in an ecoregion of Central Italy is presented. In this region, ongoing land use patterns reflect both historical adaptation to local environmental constraints and positive, social-oriented management. More protective land use patterns are mostly widespread in fragile physiographic conditions like those of the mountain areas, where woodland, shrub, and grassland patches are larger and cover more than 90% of the land. This situation is regarded as a positive outcome of the traditional public ownership regime, because public lands amount to more than 70% in the mountain areas. The hilly areas, where public property drops to 28%, presents landscape metrics showing a well balanced situation between agricultural land use and protective native woods and grasslands, which provides a fine-grained and harmonious Mediterranean landscape. In the low-land areas, with anthropic pressure and more favourable conditions for crop productivity, there is much more agricultural land, even if some mitigation in terms of biodiversity maintenance is offered by the presence of hedgerow ecotones. In these areas, landscape analysis is not able to supply meaningful information about cropping system design and practices which can maintain a sustainable level of soil fertility and quality of natural resources and processes, and further analysis at cropping system level should be carried out

JAK ACADEMY in Rheumatoid Arthritis (RA)

The latest update of the EULAR recommendations for the treatment of RA maintain csDMARD (conventional systemic DMARDs) as the first line treatment, with methotrexate (MTX) still identified as the anchor drug, to which it is possible to add, in failure patients with negative prognostic factors, a biological drug or a tsDMARD (target synthetic DMARD), i.e JAK inhibitors

switching from intravenous to subcutaneous formulation of abatacept different results in a series of 21 patients

To the Editor: We read with interest the article by Reggia, et al 1, a monocentric study analyzing the efficacy and safety of switching from intravenous (IV) to subcutaneous (SC) formulation of abatacept (ABA) in patients with rheumatoid arthritis. The authors report a relatively high risk of disease relapse (27%) occurring in a mean of 11 weeks after switching to SC administration. The study did not find any significant predictive factor for a switch failure. The concern that patients with a higher body mass index could receive lower cumulative doses compared to weight-tiered monthly infusions, leading to a significant influence on treatment efficacy, was not confirmed by this study, or by previous dose-finding trials and … Address correspondence to Dr. S. Monti; E-mail: sara.saramonti{at}gmail.co

Autoantibody profile in rheumatoid arthritis during long-term infliximab treatment

The aim of the present study was to investigate the effect of long-term infliximab treatment on various autoantibodies in patients with rheumatoid arthritis. Serum samples from 30 consecutive patients, who were prospectively followed during infliximab and methotrexate therapy for refractory rheumatoid arthritis, were tested at baseline and after 30, 54 and 78 weeks. At these points, median values of the Disease Activity Score were 6.38 (interquartile range 5.30–6.75), 3.69 (2.67–4.62), 2.9 (2.39–4.65) and 3.71 (2.62–5.06), respectively. Various autoantibodies were assessed by standard indirect immunofluorescence and/or ELISA. Initially, 50% of patients were positive for antinuclear antibodies, and this figure increased to 80% after 78 weeks (P = 0.029). A less marked, similar increase was found for IgG and IgM anticardiolipin antibody titre, whereas the frequency of anti-double-stranded DNA antibodies (by ELISA) exhibited a transient rise (up to 16.7%) at 54 weeks and dropped to 0% at 78 weeks. Antibodies to proteinase-3 and myeloperoxidase were not detected. The proportion of patients who were positive for rheumatoid factor (RF) was similar at baseline and at 78 weeks (87% and 80%, respectively). However, the median RF titre exhibited a progressive reduction from 128 IU/ml (interquartile range 47–290 IU/ml) to 53 IU/ml (18–106 IU/ml). Anti-cyclic citrullinated peptide (CCP) antibodies were found in 83% of patients before therapy; anti-CCP antibody titre significantly decreased at 30 weeks but returned to baseline thereafter. In conclusion, the presence of anti-double-stranded DNA antibodies is a transient phenomenon, despite a stable increase in antinuclear and anticardiolipin antibodies. Also, the evolution of RF titres and that of anti-CCP antibody titres differed during long-term infliximab therapy

Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries

Objectives The aim of this pooled analysis of the TOZURA study programme was to evaluate the efficacy and safety of subcutaneous tocilizumab (TCZ-SC) as monotherapy or in combination with conventional synthetic DMARDs (csDMARDs) in patients with moderate to severe RA who had an inadequate response to csDMARD or anti-TNF agent therapy or who were MTX naïve. Methods TOZURA is a multinational, open-label, single-arm, common-framework, phase 4 study programme (11 protocols, 22 countries). Patients received TCZ-SC 162 mg each week for ⩾24 weeks, administered at the investigator’s discretion, as monotherapy or in combination with a csDMARD. Efficacy, safety and immunogenicity were evaluated; propensity score–based matching was used for between-group comparisons. Results Of 1804 patients, 353 (19.6%) received monotherapy and 1451 (80.4%) received combination therapy. The 28-joint DAS using ESR (DAS28-ESR) in both groups decreased significantly from baseline to week 24 (mean change: monotherapy −3.40, combination therapy −3.46), with no significant difference between groups (P = 0.46). The proportion of patients who achieved DAS28-ESR or Clinical Disease Activity Index remission or ACR 20/50/70/90 responses was similar between groups. Overall, 13.9% of patients withdrew—6.2% for safety reasons and 1.6% for insufficient therapeutic response; 5.8% of patients experienced one or more serious adverse events [14.6/100 patient-years (PY)]; six deaths occurred (0.64/100 PY). Conclusion In a common framework of 11 studies in 22 countries, this phase 4 study programme confirmed TCZ-SC’s known efficacy and safety profile with comparable effects as monotherapy and in combination with csDMARDs