MonitorNet: studio italiano osservazionale multicentrico per la valutazione del profilo rischio-beneficio dei farmaci biologici nella pratica clinica reumatologica

Over the last decade, several new biologic agents have become available for the treatment of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and psoriasis (Ps). In contrast to conventional disease modifying anti-rheumatic drugs (DMARDs), these biological agents have rapid onset of action and pronounced disease reducing activity when administered as monotherapy or in combination with MTX. Pre-registration randomised clinical trials have compared biological agents against placebo over a limited time span (1-3). Wider use of biologics has resulted in reports of a wide range of adverse events (4), including evidence of reactivation of latent tuberculosis, increased incidence..

Socio-demographic aspects and therapeutic pathways in patients with rheumatoid arthritis in Italy

The research carried out by Censis Foundation, in collaboration with SIR (Italian Society of Rheumatology) and ANMAR (National Association of Rheumatic patients), with the sponsorship of Roche S.p.A., involved more than 600 patients, diagnosed with arthritis by a rheumatologist according to ACR criteria. The patients were recruited through a representative sample of 300 general practitioners. A number of different research and survey tools were used to collect data, helping to identify several of the problems that affect Italian patients: a survey form to be filled by the GPs, in order to verify the diagnosis and the comorbidity level; a questionnaire for the self-assessment of the disease activity, Rheumatoid Arthritis Disease Activity Index (RADAI), and a sociological questionnaire set up for the analysis of the main aspects of the patients' path. Among the most serious criticalities found, the difficulties and the time needed for the patients to get a clear AR diagnosis, the problems in interacting with health structures, and the differences in accessing pharmaceutical therapies (only a slight majority of patients use DMARDs drugs, a small amount takes biological drugs, while a large number of patients is treated exclusively with symptomatic drugs) stand out. The differences in patients' condition appear then to be exaggerated, regarding the chances to get an early diagnosis, the access path to specialised centres, and in receiving the most appropriate treatments. Moreover, these differences appear to be strongly dependent on both the social characteristics of the patients and the supply arrangement in their area

The risk/benefit profile of biologic drugs in real-world rheumatology practice. From ANTARES to MonitorNet

Le principali artriti croniche ad eziopatogenesi immunoflogistica, nelle quali trovano applicazione i farmaci "biologici" (v. oltre) sono la reumatoide e le sieronegative: artrite psoriasica, spondilite anchilosante, artriti reattive ed artriti "enteropatiche" (1-7). L'artrite reumatoide (AR) è una malattia cronica progressiva delle articolazioni associata a significativa morbilità, deformità e riduzione della qualità di vita. La prevalenza nella popolazione, a livello mondiale, è compresa tra 0,3 ed 1%. Pur interessando in modo elettivo le articolazioni, l'AR è una malattia sistemica che può condurre a severa disabilità ed a complicanze talora fatali. La terapia farmacologica tradizionale si basa su varie combinazioni di farmaci definiti sintomatici, come gli anti-infiammatori non-steroidei (FANS), gli analgesici ed i corticosteroidi e quelli "di fondo" chiamati correntemente DMARDs (disease modifying anti-rheumatic drugs)..

Health-related quality of life in patients with rheumatoid arthritis: assessment by a Italian version of the Arthritis Impact Measurement Scales, Version 2 (AIMS2)

The research carried out by Censis Foundation, in collaboration with SIR (Italian Society of Rheumatology) and ANMAR (National association of rheumatic patients) involved 646 patients, diagnosed with rheumatoid arthritis (RA) by a rheumatologist according to ACR criteria. The patients were recruited through a representative sample of 300 general practitioners (GP). A cross-sectional survey was conducted to study the current status of health-related quality of life (HRQL) of patients using a revised Italian version of a revised version of the Arthritis Impact Measurement Scales 2 (AIMS2). The AIMS2 was administered to the 646 patients with (RA) attending arthritis clinics at various hospitals across the country. Self-report functional disability scores were calculated for all 12 specific scales, summary components, and overall impact measures. The AIMS2 has been validated for the Italian language. Ranging from 0 (perfect health) to 10 (poor health), the mean scores of the AIMS2 showed an important impact of the disease on the 4 components of the health status of these patients: walking and bending, mean score = 5.1; nervous tension = 5.0, arthritis pain = 5.0, and social activity = 4.6. Among other dimensions, the impact of RA was moderate for mood, work, hand and finger function and mobility (mean score: 3.7, 3.7, 3.5 and 3.4, respectively) and low for household tasks, arm function, self-care tasks and family support (3.0, 2.9, 2.5 and 2.1, respectively). There was a tendency for the scores of younger patients to be better than those of olders patients. In conclusion, RA have a clearly detrimental effect on the HRQL in both physical and mental components. Prevention and management of physical disability should be seriously planned in consideration of the changes in these conditions in RA patients. Use of the AIMS2 makes it easier and less costly to collect data and reduces the burden on RA patients

Phylogenetic analysis, based on EPIYA repeats in the cagA gene of Indian Helicobacter pylori, and the implications of sequence variation in tyrosine phosphorylation motifs on determining the clinical outcome

The population of India harbors one of the world’s most highly diverse gene pools, owing to the influx of successive waves of immigrants over regular periods in time. Several phylogenetic studies involving mitochondrial DNA and Y chromosomal variation have demonstrated Europeans to have been the first settlers in India. Nevertheless, certain controversy exists, due to the support given to the thesis that colonization was by the Austro-Asiatic group, prior to the Europeans. Thus, the aim was to investigate pre-historic colonization of India by anatomically modern humans, using conserved stretches of five amino acid (EPIYA) sequences in the cagA gene of Helicobacter pylori. Simultaneously, the existence of a pathogenic relationship of tyrosine phosphorylation motifs (TPMs), in 32 H. pylori strains isolated from subjects with several forms of gastric diseases, was also explored. High resolution sequence analysis of the above described genes was performed. The nucleotide sequences obtained were translated into amino acids using MEGA (version 4.0) software for EPIYA. An MJ-Network was constructed for obtaining TPM haplotypes by using NETWORK (version 4.5) software. The findings of the study suggest that Indian H. pylori strains share a common ancestry with Europeans. No specific association of haplotypes with the outcome of disease was revealed through additional network analysis of TPMs

Updated consensus statement on the use of rituximab in patients with rheumatoid arthritis

Background Since initial approval for the treatment of rheumatoid arthritis (RA), rituximab has been evaluated in clinical trials involving various populations with RA. Information has also been gathered from registries. This report therefore updates the 2007 consensus document on the use of rituximab in the treatment of RA. Methods Preparation of this new document involved many international experts experienced in the treatment of RA. Following a meeting to agree upon the core agenda, a systematic literature review was undertaken to identify all relevant data. Data were then interrogated by a drafting committee, with subsequent review and discussion by a wider expert committee leading to the formulation of an updated consensus statement. These committees also included patients with RA. Results The new statement covers wide-ranging issues including the use of rituximab in earlier RA and impact on structural progression, and aspects particularly pertinent to rituximab such as co-medication, optimal dosage regimens, repeat treatment cycles and how to manage non-response. Biological therapy following rituximab usage is also addressed, and safety concerns including appropriate screening for hepatitis, immunoglobulin levels and infection risk. This consensus statement will support clinicians and inform patients when using B-cell depletion in the management of RA, providing up-to-date information and highlighting areas for further research. Conclusion New therapeutic strategies and treatment options for RA, a chronic destructive and disabling disease, have expanded over recent years. These have been summarised in general strategic suggestions and specific management recommendations, emphasising the importance of expedient disease-modifying antirheumatic drug implementation and tight disease control. This consensus statement is in line with these fundamental principles of management

Socio-demographic aspects and therapeutic pathways in patients with rheumatoid arthritis in Italy

The research carried out by Censis Foundation, in collaboration with SIR (Italian Society of Rheumatology) and ANMAR (National Association of Rheumatic patients), with the sponsorship of Roche S.p.A., involved more than 600 patients, diagnosed with arthritis by a rheumatologist according to ACR criteria. The patients were recruited through a representative sample of 300 general practitioners. A number of different research and survey tools were used to collect data, helping to identify several of the problems that affect Italian patients: a survey form to be filled by the GPs, in order to verify the diagnosis and the comorbidity level; a questionnaire for the self-assessment of the disease activity, Rheumatoid Arthritis Disease Activity Index (RADAI), and a sociological questionnaire set up for the analysis of the main aspects of the patients’ path. Among the most serious criticalities found, the difficulties and the time needed for the patients to get a clear AR diagnosis, the problems in interacting with health structures, and the differences in accessing pharmaceutical therapies (only a slight majority of patients use DMARDs drugs, a small amount takes biological drugs, while a large number of patients is treated exclusively with symptomatic drugs) stand out. The differences in patients’ condition appear then to be exaggerated, regarding the chances to get an early diagnosis, the access path to specialised centres, and in receiving the most appropriate treatments. Moreover, these differences appear to be strongly dependent on both the social characteristics of the patients and the supply arrangement in their area

Purpura Fulminans As Clinical Manifestation of Atypical Sle With Antiphospholipid Antibodies: a case report

Purpura Fulminans and DIC were the main clinical manifestations of the antiphospholipid syndrome observed in a 62-year-old man. The patient was well until 44 years of age when he began to suffer from recurrent thrombophlebitis, without other symptoms suggestive of immune disease. At the time of hospital admission the pt. appeared acutely ill, showing high fever, severe anemia, massive urinary blood loss, multiple purpuric patches evolving to hemorrhagic bullae and gangrene rapidly spreading over about 30% of the total body area. No signs of neurological involvement or of visceral thrombotic occlusions were present. Clotting tests were consistent with a diagnosis of DIC, further confirmed by skin biopsy showing the presence of thrombi in dermal arterioles. The autoantibody research was positive as follows: Waaler-Rose 1:40, Anti-DNA 1:80; ANF 1:640, aCA IgG 100 GPL. LA was diagnosed according to standard criteria: prolonged KCT and RVVT not corrected by a mixture of normal plasma and abnormal TTI. Plasma exchange in association with heparin and prednisone was effective in arresting the progression of the skin lesion; nevertheless the patient died ten days after hospital admission for sepsi and acute renal failure

MonitorNet: studio italiano osservazionale multicentrico per la valutazione del profilo rischio-beneficio dei farmaci biologici nella pratica clinica reumatologica

Over the last decade, several new biologic agents have become available for the treatment of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and psoriasis (Ps). In contrast to conventional disease modifying anti-rheumatic drugs (DMARDs), these biological agents have rapid onset of action and pronounced disease reducing activity when administered as monotherapy or in combination with MTX. Pre-registration randomised clinical trials have compared biological agents against placebo over a limited time span (1-3). Wider use of biologics has resulted in reports of a wide range of adverse events (4), including evidence of reactivation of latent tuberculosis, increased incidence..