Psoriatic arthritis prevalence in the clinical practice of dermatologists in North-West Tuscany centers of excellence: a screening experience.

BACKGROUND: Psoriasis arthritis will develop during cutaneous psoriasis in a significant percentage. The aim of this study was to improve assistance to patients and to provide the most individualized care possible. METHODS: Patients: all consecutive subjects with psoriasis accessing the outpatients facilities of five dermatologic centers of excellence in the Tuscany region of Italy between December 2014 and February 2015. All subjects were screened for the presence of a previous diagnosis of arthritis and symptoms affecting the articular system, using some questions chosen and shared by dermatologists in charge of the centers. RESULTS: In the chosen three months period, 134 patients affected with psoriasis had been observed, 32 (24%) of which answered "yes" to the question "Have you ever been diagnosed with arthritis?". There have been differences in the characteristics of patients in the two groups, with and without arthritis. In particular, in the arthritis patients a statistically significant higher mean age, more ungueal psoriasis, less body surface cutaneous psoriasis extension, and a statistically significant higher percentage of patients treated with biological drugs (57% vs. 24.5%) have been observed. CONCLUSIONS: The results were consistent with the scientific literature in the field. The experience seems to confirm the opportunity of screening programs on arthropathy in cutaneous psoriasis patients. About a quarter of psoriasis patients had relevant arthropathic features, and more than half of these required challenging therapies like biologics.

Tuscan consensus on the diagnosis, treatment and follow-up of moderate-to-severe psoriasis.

BACKGROUND: Psoriasis is traditionally defined as an inflammatory chronic-relapsing disease of the skin. As widely demonstrated, this disease is also associated with multiple comorbidities: arthropathy, inflammatory bowel disease, metabolic, cardiovascular, ocular and psychological disorders. The disease also has a significant impact on patients' quality of life, whose work ability decreases considerably with clear consequences for the social costs. Therefore, if we consider that in Tuscany, more than 100,000 people out of 3,672,202 suffer from psoriasis, it is of paramount importance focusing the attention on a rational model of clinical and therapeutic management of the disease. All the leading experts in Tuscany have come together with the aim of defining unanimously accepted regional guidelines for the diagnosis, treatment, follow-up and management of psoriasis, and of providing practical guidance/protocol on diagnosis, treatment, follow-up and management of special cases of moderate-to-severe plaque psoriasis. METHODS: In a working group formed ad hoc, the main topics have been discussed and approved by plenary vote. RESULTS: Diagnosis must include a proper general health condition overview, a careful evaluation of skin and joints, the assessment and management of other comorbidities and the definition of disease severity. With regards to the therapy the best time to start a systemic treatment, the therapeutic goal, the most appropriate drug and blood tests to be performed in case of moderate severe-psoriasis have been taken into account. During follow-up, proper monitoring of systemic therapy and its management in the long term has also been suggested. Eventually, the experts have addressed the problem of how to manage the disease in special conditions, such as during surgery, pregnancy, in children and in case of infections (HBV, HCV, HIV). CONCLUSIONS: The main aim of this Consensus was to find agreement on the criteria for diagnosis, treatment and follow-up of psoriasis, shared by all the Dermatologic Therapy Units of Tuscany. A need to create an easier way for the patient to access specialized dermatology outpatient services, and to reduce the waiting list and costs related to the management of psoriasis has been stressed. Most importantly, during the Consensus all of the participants agreed on the central role of the patient, and on the need of a multidisciplinary management of the disease which requires communication among specialists and regional centers in order to build on existing experience.

Differential management of mild-to-severe psoriasis with biologic drugs: An Italian Delphi consensus expert panel.

BACKGROUND: In the management of moderate-to-severe psoriasis, increasingly complex clinical scenarios necessitate practical tools for appropriate biologic therapy selection in individual patients. An Italian Delphi consensus panel provided guidance on biologic use in selected clinical scenarios. METHODS: Ten experts defined statements under consideration, which were distributed as an online survey to a dermatologist panel. Plenary discussions of contentious statements were held to achieve consensus. RESULTS: The survey was sent to 30 clinicians. After plenary discussions, consensus was reached on all 20 statements on the following topics: special populations; infections; comorbidities; immunogenicity; extra-cutaneous involvement; pregnancy; and adherence. Three statements required further discussion in order to gain consensus: use of subcutaneous biologics in mild liver impairment (final 94% agreement), use of any biologic in discoid lupus erythematosus (final 100% disagreement), and use of etanercept in patients with history of hypersensitivity reactions to drugs and/or food (final 75% disagreement). CONCLUSIONS: This Delphi expert consensus on the use of biologics in psoriasis provides practical recommendations for dermatologists to use when choosing an appropriate biologic in challenging but common clinical scenarios. More data are required to clarify clinical differences of biologic drugs used to treat psoriasis.

The cost effectiveness of biologic therapy for the treatment of chronic plaque psoriasis in real practice settings in Italy.

BACKGROUND AND OBJECTIVES: Biologic therapies are considered to be cost effective by leading Health Technology Assessment (HTA) agencies and, therefore, eligible for reimbursement by public health services. However, biologic therapies entail sizable incremental costs and, besides, have a considerable financial impact that in Italy amounts to 13.7 % of the national health service's pharmaceutical expenditure. In the reimbursability decision process, an important role is played by both the drug efficacy data observed in pre-licensing RCTs and the economic modelling assumptions, as they give evidence on cost effectiveness. The administration of therapies in real practice settings is likely to produce a significant deviation from the results predicted by the models, theoretically outweighing the assumption on which the decision process is founded. This is a matter of concern for public health services and, consequently, an interesting topic to investigate. METHODS: To overcome the lack of knowledge concerning the actual cost effectiveness of biologic therapies for the treatment of plaque psoriasis in the clinical practice setting in Italy, an observational study was conducted in 12 specialist centres on patients switching to biologic therapy within a 6-month enrolment window. RESULTS: The study confirms in clinical practice the efficacy of the switch to biologic therapies, analysed using a number of clinical [Psoriasis Area and Severity Index (PASI), pain visual analogue scale (VAS) and itching VAS] and quality-of-life parameters. A general health-related quality of life (HR-QOL) improvement, with a 0.23 quality-adjusted life-year (QALY) mean gain per patient, has been reported in the 6-month observation period. The direct medical costs to treat plaque psoriasis with biologic therapies amount to 15,073.7 per year (prior to their enrolment, the same patients cost 2,166.2 on an annual basis). After the switch to biologic agents, the cost per QALY during the first year of treatment amounts to 28,656.3. CONCLUSION: At least in the short-term, the clinical practice of the specialised Italian centres taking part in the study confirms that switching patients to a biologic drug produces an incremental cost-effectiveness ratio comparable with the values predicted by the HTA bodies.

Phytophthora × pelgrandis Causes Root and Collar Rot of Lavandula stoechas in Italy.

In 2007, Phytophthora isolates with atypical morphological and biological characteristics were found associated with root and collar rot of potted plants of Stoechas lavender (Lavandula stoechas) in an ornamental nursery in Italy. A polyphasic approach, including morphological and cultural observations, sequencing the ITS-rDNA region, the Pheca and the mitochondrial coxI genes, multiplex PCRs with primers specific for P. nicotianae or P. cactorum, as well as random amplified polymorphic DNA-polymerase chain reaction, was used to characterize these isolates. On the basis of morpho-cultural and molecular analyses, the isolates from Stoechas lavender were identified as Phytophthora × pelgrandis, a natural hybrid of P. nicotianae × P. cactorum previously reported in other European countries, the Americas, and Taiwan, as a pathogen of ornamentals and loquat plants. In pathogenicity tests using potted plants of Stoechas lavender, the P. × pelgrandis isolates, similarly to the parental species P. nicotianae, induced the symptoms observed on plants with natural infections and were reisolated only from artificially inoculated plants. Dispersal of P. × pelgrandis on this host could exacerbate the damage caused by Phytophthora root and collar rot, of which the main causal agent presently is P. nicotianae on lavender in Europe. Application of hygienic measures is important to reduce the proliferation and spread of the Phytophthora hybrids.

Efficacy and tolerability of fitostimoline in two different forms (soaked gauzes and cream) and citrizan gel in the topical treatment of second-degree superficial cutaneous burns.

A total of 227 patients (mean age 41.3 years, 52% females) with at least one second-degree superficial cutaneous burn of thermal origin of a smallest transverse diameter ≥20 mm and a largest transverse diameter ≤90 mm were randomised to receive the topical application of aqueous extract of Triticum vulgare (Fitostimoline) in two different forms (soaked gauzes and cream) or catalase of horse origin in form of gel (Citrizan Gel), given up to healing or to a maximum of 20 days. The rate of lesion healing at end of study was significantly higher in patients treated with Fitostimoline (gauzes 97.3%, cream 91.5%) than in those receiving catalase (84.5%). The pooled Fitostimoline groups were also significantly more effective than catalase gel in reducing total symptoms score, pain at medication, pain at rest, and burning at end of study. Both formulations of Fitostimoline and catalase gel were well tolerated in terms of adverse effects in the site of application.

Incidence of psoriasis and association with comorbidities in Italy: a 5-year observational study from a national primary care database.

An observational study was conducted to estimate the incidence of psoriasis in Italy, as well as the utilization of healthcare resources and the association with selected comorbidities in psoriasis patients. The data source was the Health Search/Thales Database, containing computer-based patient records from over 900 primary care physicians (PCPs) throughout Italy. The study cohort comprised all adults receiving a first-ever diagnosis of psoriasis during the years 2001-2005. From a total sample of 511,532 individuals, the incidence of psoriasis was 2.30-3.21 cases per 1,000 person-years. Psoriatic arthritis was present in 8% of psoriasis patients. The comparison with matched controls showed that psoriasis patients were more likely to have comorbidities (e.g., chronic bronchitis, chronic ischemic heart disease, obesity and diabetes mellitus) and to undergo PCP visits and hospitalizations, and to refer for specialist visits. The use of non-steroidal anti-inflammatory drugs appeared to be significantly more prevalent in patients as compared to controls. Topical therapy with corticosteroids and non-steroidal preparations accounted for 45.3% and 47.2% of all cases, respectively. Only a minority of cases used systemic immunosuppressive drugs or acitretin. The incidence rate of psoriasis in our study was particularly high and might reflect an overestimation by PCPs. Our results show the association between psoriasis and multiple comorbidities.

Cost-effectiveness analysis of TNF-alpha blockers for the treatment of chronic plaque psoriasis in the perspective of the Italian health-care system.

The cost-effectiveness of biological treatments for psoriasis is not well determined and may vary from country to country. The objectives of this study was to perform a cost-effectiveness analysis of infliximab compared with other anti-tumor necrosis factor-alpha agents for the treatment of psoriasis in Italy. The incremental cost-effectiveness ratio per patients achieving at least 75% improvement in the psoriasis area and severity index assessed over 24- and 48-50-week periods was calculated. Efficacy data were drawn from randomized controlled trials when available or from open label studies. Considering patients achieving psoriasis area and severity index at week 24 and 48-50, infliximab was dominant (more effective and less costly) over etanercept given at 50 mg twice weekly. In contrast, infliximab was not dominant over etanercept at other dosages or over adalimumab. When considering the impact of therapy on quality of life at Week 12 using the Dermatology Life Quality Index equal to zero, infliximab resulted more effective and less costly than etanercept. Therefore, infliximab seems to be cost-effective in the therapy of psoriasis. Further cost-efficacy evaluations based on head-to-head trials are necessary to address health economic considerations.

Etanercept provides a more physiological approach in the treatment of psoriasis.

Psoriasis is a common chronic inflammatory disease affecting the skin and joints. Moderate to severe psoriasis is traditionally treated with systemic treatments, which can be effective but are often associated with relevant adverse effects, even when administered intermittently or rotationally. Biologic therapies may provide high and consistent efficacy over time, long-term safety, and simple administration schedules compared with nonbiologic therapies, and can be used in patients intolerant and/or resistant to these therapies. TNF-antagonists have a definite advantage over other biologic agents (e.g., T-cell targeting drugs) in the early and late manifestations of joint involvement. TNF-antagonists are a class of drugs with distinct pharmacokinetic and pharmacodynamic properties, and different safety profiles. Etanercept provides a more "physiological" mechanism of action compared to anti-TNF antibodies. Etanercept has less dramatic effects on TNF homeostasis although it has been proved to be highly effective in blocking psoriatic joint erosions. It maintains stable efficacy over time on skin psoriasis, also when used intermittently. Moreover, etanercept has been shown to be not immunogenic, and it only slightly increases the risk of granulomatous infections compared to anti-TNF antibodies. According to the "physiologic" paradigm of selection among TNF-antagonists linked to more or less physiologic mechanism of action, etanercept appears to be the anti-TNF of choice for treating most patients with moderate to severe plaque psoriasis and psoriatic arthritis, possibly even at an early stage.

Efficacy, safety and quality of life of calcipotriol/betamethasone dipropionate (Dovobet) versus calcipotriol (Daivonex) in the treatment of psoriasis vulgaris: a randomized, multicentre, clinical trial.

OBJECTIVE: A clinical trial was performed to evaluate the efficacy, speed of response, side effects and quality of life of patients treated with calcipotriol/betamethasone dipropionate (Dovobet) for 4 weeks followed by maintenance with calcipotriol for 8 weeks (group A) versus calcipotriol (Daivonex) alone for 12 weeks (group B) for the treatment of psoriasis. MATERIALS AND METHODS: A total of 150 patients were enrolled and randomized to groups A and B. PASI and Skindex-29 were considered the outcome measures. RESULTS: Ninety-six patients completed the trial. At weeks 2 and 4, both groups showed a significant clinical improvement compared to baseline; group A demonstrated a higher clinical response compared with group B (p< 0.001). Treatment with calcipotriol was associated with a gradual improvement in group B and maintenance of the results in group A. Similarly, the quality of life assessment showed a marked improvement in terms of Skindex-29 in both groups at weeks 2 and 4 compared to baseline. Both treatments were safe and well tolerated. CONCLUSIONS: Our results demonstrate a higher efficacy and more rapid onset of action with the two-compound ointment compared with calcipotriol cream alone in short-term treatment. However, sequential application of calcipotriol allows maintenance of the results.

Diffuse sterile pustular eruption with changing clinical features in a 2-year old.

We report a 2-year-old girl with diffuse pustular eruptions occurring in close association with respiratory tract infections. The pustular eruption had different clinical characteristics over time, evolving from circinate to von Zumbush pustular psoriasis, and finally to subcorneal pustular dermatosis. Treatment with acitretin 1 mg/kg/day gave good results. A relapse showing striking clinical characteristics of subcorneal pustular dermatosis was treated with dapsone (1 mg/kg/day) followed by ultraviolet B-narrowband (UV-B-NB) phototherapy. The patient subsequently had several relapses over 1 year, which were well controlled with short cycles of UV-B-NB. This patient's findings demonstrate that pustular eruptions can vary over time, assuming clearly different clinical patterns, and highlight the difficulty of classifying pustular eruptions as separate diseases.