European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update.

BACKGROUND: Since the publication of the European League Against Rheumatism recommendations for the pharmacological treatment of psoriatic arthritis (PsA) in 2012, new evidence and new therapeutic agents have emerged. The objective was to update these recommendations. METHODS: A systematic literature review was performed regarding pharmacological treatment in PsA. Subsequently, recommendations were formulated based on the evidence and the expert opinion of the 34 Task Force members. Levels of evidence and strengths of recommendations were allocated. RESULTS: The updated recommendations comprise 5 overarching principles and 10 recommendations, covering pharmacological therapies for PsA from non-steroidal anti-inflammatory drugs (NSAIDs), to conventional synthetic (csDMARD) and biological (bDMARD) disease-modifying antirheumatic drugs, whatever their mode of action, taking articular and extra-articular manifestations of PsA into account, but focusing on musculoskeletal involvement. The overarching principles address the need for shared decision-making and treatment objectives. The recommendations address csDMARDs as an initial therapy after failure of NSAIDs and local therapy for active disease, followed, if necessary, by a bDMARD or a targeted synthetic DMARD (tsDMARD). The first bDMARD would usually be a tumour necrosis factor (TNF) inhibitor. bDMARDs targeting interleukin (IL)12/23 (ustekinumab) or IL-17 pathways (secukinumab) may be used in patients for whom TNF inhibitors are inappropriate and a tsDMARD such as a phosphodiesterase 4-inhibitor (apremilast) if bDMARDs are inappropriate. If the first bDMARD strategy fails, any other bDMARD or tsDMARD may be used. CONCLUSIONS: These recommendations provide stakeholders with an updated consensus on the pharmacological treatment of PsA and strategies to reach optimal outcomes in PsA, based on a combination of evidence and expert opinion.

Latent tuberculosis infection in patients with chronic plaque psoriasis: evidence from the Italian Psocare Registry.

BACKGROUND: The nationwide prevalence of latent tuberculosis infection (LTBI) in Italian patients with psoriasis has never been investigated. OBJECTIVES: To estimate the nationwide prevalence of LTBI in Italian patients with psoriasis who are candidates for systemic treatment. METHODS: Data were obtained from the Psocare Registry on those patients (n = 4946) with age > 18 years, systemic treatment at entry specified and tuberculin skin test (TST) performed according to the Mantoux method. LTBI diagnosis was based on a positive TST result in the absence of any clinical, radiological or microbiological evidence of active tuberculosis. RESULTS: Latent tuberculosis infection was diagnosed in 8·3% of patients with psoriasis (409 of 4946). The prevalence of LTBI was lower in patients on biologics than in those on conventional systemic treatments, ranging from 4·3% (19 of 444) of patients on adalimumab to 31% (eight of 26) of those on psoralen-ultraviolet A (P < 0·05). Independent factors associated with LTBI were male sex [odds ratio (OR) 1·30, 95% confidence interval (CI) 1·04-1·62; P = 0·02], age over 55 years (OR 2·93, 95% CI 2·18-3·93; P < 0·001) and being entered into a conventional treatment (OR 3·83, 95% CI 3·10-4·74; P < 0·001). Positive history of tuberculosis was seen in 1% of patients (n = 49). CONCLUSIONS: The nationwide prevalence of LTBI in Italian patients with psoriasis candidate to systemic treatment is high, and screening is recommended prior to biological treatment.

Metabolic abnormalities associated with initiation of systemic treatment for psoriasis: evidence from the Italian Psocare Registry.

OBJECTIVE: To evaluate variations in laboratory parameters and diagnoses of selected clinical conditions up to 16 weeks after starting a new systemic psoriasis treatment for Psocare Registry enrollees. DESIGN: Prospective cohort study. SETTING: Italian public referral centres for psoriasis treatment. PATIENTS: First-time recipients (n = 10,539) of continuous systemic psoriasis treatment for at least 16 weeks. MAIN OUTCOME MEASURE: Mean variations in (weeks 8 and 16) and proportions of patients reaching a clinically meaningful increase in serum levels (week 16) of total and low-density lipoprotein cholesterol, triglycerides, aspartate amino transferase, alanine amino transferase and creatinine, as well as week-16 cumulative incidences of new diagnoses of diabetes mellitus and arterial hypertension. RESULTS: Mean cholesterol and triglyceride levels significantly increased in patients treated with acitretin or cyclosporine. Mean triglyceride levels also increased in efalizumab- and etanercept-treated patients. Mean transaminase values increased in methotrexate-treated patients, and mean aspartate amino transferase levels increased in infliximab-treated patients. The average serum creatinine value increased in cyclosporine-treated patients. Acitretin and cyclosporine were associated with risk of hypercholesterolaemia (odds ratios 1.51 and 1.34) and acitretin with risk of hypertriglyceridaemia (odds ratio 1.43). Methotrexate and infliximab were associated with risk of more than doubling the upper normal aspartate amino transferase (odds ratios 2.06 and 1.87) and alanine amino transferase (odds ratios 2.38 and 1.74) values. The relative risk of developing arterial hypertension and diabetes was increased for patients receiving cyclosporine (odds ratios 3.31 and 2.88). CONCLUSION: Systemic treatments for psoriasis resulted in heterogeneous effects on the parameters analysed.

European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies.

BACKGROUND: Psoriatic arthritis (PsA) is a clinically heterogeneous disease. Clear consensual treatment guidance focused on the musculoskeletal manifestations of PsA would be advantageous. The authors present European League Against Rheumatism (EULAR) recommendations for the treatment of PsA with systemic or local (non-topical) symptomatic and disease-modifying antirheumatic drugs (DMARD). METHODS: The recommendations are based on evidence from systematic literature reviews performed for non-steroidal anti-inflammatory drugs (NSAID), glucocorticoids, synthetic DMARD and biological DMARD. This evidence was discussed, summarised and recommendations were formulated by a task force comprising 35 representatives, and providing levels of evidence, strength of recommendations and levels of agreement. RESULTS: Ten recommendations were developed for treatment from NSAID through synthetic DMARD to biological agents, accounting for articular and extra-articular manifestations of PsA. Five overarching principles and a research agenda were defined. CONCLUSION: These recommendations are intended to provide rheumatologists, patients and other stakeholders with a consensus on the pharmacological treatment of PsA and strategies to reach optimal outcomes, based on combining evidence and expert opinion. The research agenda informs directions within EULAR and other communities interested in PsA.

Current psoriasis treatments in an Italian population and their association with socio-demographical and clinical features.

BACKGROUND: Patient adherence is a key element for therapeutic success and represents a major concern for all healthcare professionals. OBJECTIVE: Aim of our study was to assess the frequency of use of treatments currently available for psoriasis and its association with specific socio-demographical and clinical variables. METHODS: The study population consisted of 1689 patients, aged 12-85 years. Information concerning socio-demographical variables, clinical features and the type of current treatment was collected. Items on patients' satisfaction of current treatments and of dermatologist-patient relationship were also included. The chi-squared test was used to estimate the association between the categorical variables, whereas Wilcoxon and Kruskal-Wallis tests were applied to the interval and ordinal variables. The Cochran-Mantel-Haenszel chi-squared trend test was used to evaluate the degree of satisfaction related to dermatologist-patient relationship. RESULTS: Of the 1689 psoriatic patients, 54.1% did not use any treatments and 45.9% used at least one treatment. The use of drugs was significantly associated exclusively to severity of disease and affected body surface area. Systemic therapies, both traditional treatments and biological agents, were mainly used in patients with disease duration >10 years and disease severity. Treatment adherence was significantly associated to the degree of patient's satisfaction of his/her relationship with the dermatologist. Alternative treatment such as over the counter medications and acupuncture were used by 33% of patients. CONCLUSION: The majority of psoriatic patients do not use any treatments. However, treatment adherence significantly increases when dermatologists clarify the treatment schedule, inform patients and meet the patients' needs.

From in vitro research to real life studies: an extensive narrative review of the effects of balneotherapy on human immune response.

PURPOSE: The biologic mechanisms by which balneotherapy (BT) alleviates symptoms of different diseases are still poorly understood. Recently, preclinical models and clinical trials have been developed to study the effects of BT on the immune system. This review summarizes the currently available evidence regarding the effects of spa therapy on the immune response, to confirm the role of BT in the enhancement of immune system and open interesting research fields. METHODS: PubMed and Google Scholar were searched from 1997 up to June 2020, with search criteria including terms related to BT and immune system. We selected only in vitro research, randomized controlled trials (RCTs) or clinical trials. RESULTS: In vitro studies on human and animal samples have demonstrated that thermal waters exert anti-inflammatory and immunomodulatory effects. In particular, H2S donors seem to counteract the inflammatory processes in psoriatic lesions, arthritic fibroblast-like synoviocytes and chondrocytes, and regulate important factors implicated in osteoarthritis pathogenesis and progression. RCTs and clinical trials revealed, after BT, a reduction in circulating levels of pro-inflammatory molecules, such as TNF-α, IL-1ß, and C-reactive protein, and an increase in anti-inflammatory molecules such as the IGF-1 growth factor especially in musculoskeletal diseases. CONCLUSION: Further preclinical studies and RCTs could help to exploit BT in real life for preventive and therapeutic treatments.

European S3-guidelines on the systemic treatment of psoriasis vulgaris.

Of the 131 studies on monotherapy or combination therapy assessed, 56 studies on the different forms of phototherapy fulfilled the criteria for inclusion in the guidelines. Approximately three-quarters of all patients treated with phototherapy attained at least a PASI 75 response after 4 to 6 weeks, and clearance was frequently achieved (levels of evidence 2 and 3). Phototherapy represents a safe and very effective treatment option for moderate to severe forms of psoriasis vulgaris. The onset of clinical effects occurs within 2 weeks. Of the unwanted side effects, UV erythema from overexposure is by far the most common and is observed frequently. With repeated or long-term use, the consequences of high, cumulative UV doses (such as premature aging of the skin) must be taken into consideration. In addition, carcinogenic risk is associated with oral PUVA and is probable for local PUVA and UVB. The practicability of the therapy is limited by spatial, financial, human, and time constraints on the part of the physician, as well as by the amount of time required by the patient. From the perspective of the cost-bearing institution, phototherapy has a good cost-benefit ratio. However, the potentially significant costs for, and time required of, the patient must be considered.

Home infusion program with enzyme replacement therapy for Fabry disease: The experience of a large Italian collaborative group.

Fabry disease (FD) [OMIM 301500] is an X-linked lysosomal storage disorder caused by a deficiency of the lysosomal enzyme alpha-galactosidase A, resulting in progressive multisystem accumulation of globotriaosylceramide (Gb3). Although the introduction of Enzyme Replacement Therapy (ERT) resulted in a variety of clinical benefits, life-long intravenous (IV) treatment with ERT with an every other week schedule, may interfere with daily life activities and impact on QoL. We report here a multicentric, observational, longitudinal data analysis on a large cohort of 85 Italian FD patients (45 males, 40 females) from 11 out of 20 Italian regions, who received a cumulative number of 4269 home infusions of agalsidase alfa. For the whole cohort, the average duration of home therapy was 1 year and 11 months (range 3 months-4 years and 6 months), and during this period, compliance to treatment (number of infusions performed vs scheduled) reached 100%. The EQ-5 VAS scale was administered to patients to evaluate the self-reported QoL, 58% of patients showing an increase of EQ-5 VAS score at follow up compared to baseline (home treatment start) or remaining stable. A mild increase of average disease severity, measured through Mainz Severity Score Index (MSSI), was found during hospital treatment (p < 0,007), while it remained stable between the first home therapy infusion and last follow up. Interestingly, 4 out of 7 (57%) patients, showing an improvement in FD-related clinical status after starting home therapy, had previously a sub-optimal compliance to treatment during the period of hospital treatment management. Only 4 adverse non serious reactions (0,093%) were reported totally in 2 patients during home treatment. We conclude that home infusions in eligible patients with FD are safe, contribute to improve treatment compliance and therapeutic clinical outcomes, and may have a positive impact on self-perceived QoL.

["Banding" of the venous side of an arteriovenous fistula for hemodialysis complicated with steal syndrome: a clinical case]. / "Banding" del versante venoso di fistola artero-venosa per emodialisi complicata da sindrome di furto periferico: un caso clinico.

The duration of an arteriovenous fistula has a limit. In fact there are some complications that compromise a good working of them. We have dealed on of these complications, a steal syndrome of an omero-cephalic fistula by a simple operation of "banding" using a ring of Teflon around the arterialized vein getting a good clinical result with a good preservation of the blood flow trans-fistula.

[Encapsulating sclerosing peritonitis: report of 2 cases]. / Peritonite sclerosante incapsulante: report di due casi.

SEP is an increasingly seen complication of CAPD; we have the occasion to see again this condition because two patients came under our observation. We have remarked the unknown etiology and pathogenesis, the difficult diagnosis and therapy, and the often poor prognosis.

The natural history of uremic neuropathy.

The results obtained by electrophysiological recording allow to discover the constant presence of alterations to the central and/or peripheral nervous system in the uremic syndrome. Thus, it becomes possible to demonstrate the existence of an actual 'uremic neuropathy'. Moreover, the results show the persistence and progression of uremic involvement in the course of dialytic treatment; only after kidney transplantation a return to normal takes place. Methodological and interpretative progress will allow us in the future to broaden our knowledge of uremia by providing a useful guide to therapeutic strategies.

HCV in a group of chronic hemodialysis patients.

Since HCV appears to be the major cause of post-transfusion non-A, non-B hepatitis in Italy, this study determines the presence of anti-HCV in a risk group. Among 26 patients, 9 were anti-HCV in a risk group. Among 26 patients, 9 were anti-HCV positive with the ELISA test and all of them were confirmed with the RIBA test of 2nd generation. Only 1 had a poussés movement of ALT levels. Hemodialyzed patients are reactive for HCV probably for the transfusional therapy.