1,720,982 research outputs found
Comparison of clinical effects, trough and peak levels between branded and generic formulation of Cyclosporine in stable psoriatic patients.
No full textAbstract
BACKGROUND:
Cyclosporine A (CyA) is a drug for moderate-to-severe psoriasis. Recently, a generic formulation has been approved as bioequivalent to the branded one. The guidelines for the bioequivalence for critical-dose drugs with a narrow therapeutic range, such as CyA, are questionable. Therefore, it is important to assess the clinical outcome and the pharmacokinetics of different formulations in various patient groups. The current literature lacks of this information in dermatology. The primary objective of this prospective study is to investigate the clinical equivalence (in terms of maintenance of clinical effect) between the generic formulation of CyA and its branded one in patients with psoriasis. A secondary objective is to analyze their trough (C0) and peak levels (C2).
METHODS:
Twenty patients with stable psoriasis under treatment with the branded CyA were monitored in terms of clinical efficacy (Psoriasis Area Severity Index- PASI), safety (laboratory values), and their pharmacokinetics utilizing trough (C0) and peak plasma concentration (C2). The same patients were subsequently shifted to the generic formulation for comparison.
RESULTS:
In our sample the efficacy of the two formulations was equal in most cases (p=0.863). A non-significant difference between the C0 and C2 of the branded CyA compared to the generic one emerged (respectively p=0.738 and p=0.695).
CONCLUSIONS:
The branded and the generic formulations of CyA seem to be not only bioequivalent, but also comparable in terms of clinical efficacy in patients with psoriasis. However, larger samples are required to confirm these findings
Videocapillaroscopic findings in the microcirculation of the psoriatic plaque during etanercept therapy
No full textBACKGROUND: Vascular endothelial growth factor (VEGF) is a pivotal cytokine in the pathogenesis of psoriasis, and upregulation of VEGF by tumour necrosis factor (TNF)-α and inflammatory factors causes marked alterations in the cutaneous microcirculation. Etanercept is a fully soluble TNF receptor fusion protein that primarily binds soluble TNF-α, thus blocking its pro-angiogenic function.
AIM: To assess the modifications in the superficial capillary bed in psoriatic plaques during treatment with etanercept.
METHODS: The study enrolled 22 patients (13 men, 9 women; age range 31-74 years) with plaque psoriasis resistant to conventional therapy. The patients were stated on etanercept 50 mg/week, which was continued for 24 weeks. At the beginning of the study (baseline), and at weeks 6, 12, 18 and 24, in vivo videocapillaroscopy analysis of a selected plaque was performed. Levels of erythema, scaling and infiltration were assessed using a four-point plaque severity score, with an overall score obtained by the sum of these three scores. The Psoriasis Activity and Severity Index (PASI) was also determined.
RESULTS: Etanercept produced a significant reduction in PASI, plaque severity score and diameter of the basket-weave area at every time point. Four patients had complete remission, although none of the patients regained a normal capillaroscopic pattern.
CONCLUSIONS: Similar to other conventional therapies, etanercept is able to improve PASI, plaque severity score and basket-weave area diameter, but it is unable to induce normalization of the microcirculation in psoriatic plaques
Clinical and Capillaroscopic Modifications of the Psoriatic Plaque during Therapy: Observations with Oral Acitretin
No full textPsoriasis is considered to be an inflammatory autoimmune disease, where angiogenesis plays an undefined pathogenetic role. The well-known changes of the superficial microvasculature in the psoriatic plaque can be easily assessed in vivo by videocapillaroscopy. In the last years, several studies reported the clinical and capillaroscopic response of the psoriatic plaque during different topical and systemic treatments. In the present work we evaluated the effects of acitretin (0.8 mg/kg/day) on videocapillaroscopic alterations and the clinical response in 11 patients affected by plaque psoriasis at the baseline (T0) and after 4 (T1), 8 (T2), and 12 (T3) weeks. A clinical improvement during the treatment with a complete clinical healing of the plaque in 7 of the 11 patients was observed. The typical "basket-weave" capillaries of the psoriatic lesions showed a reduction of 65.4% in diameter at the end of the study; only 3 patients returned to a normal capillaroscopic pattern. As observed during previous our studies, we found a discrepancy between clinical and capillaroscopic results, with a far greater improvement in the first than in the second. This finding could be in agreement with a secondary role of blood vessels in the pathogenesis and persistence of psoriatic lesions
A multicenter retrospective case-control study on Suspension of TNF-inhibitors and Outcomes in Psoriatic patients (STOP study)
No full textBaCKGroUnd: there is limited information on patients undergoing withdrawal after long-term treatment with anti-tnF alpha drugs and their clinical evolution during the post-interruption period in real-life settings. the purpose of the present retrospective case-control study was to provide a clearer insight into the clinical management of psoriatic patients with adequate response to long-term adalimumab, etanercept and infliximab treatment once these biologic agents are interrupted. metHodS: a total of 270 patients undergoing anti-tnF alpha agents discontinuation and 253 controls treated with a continuous regimen were enrolled. The primary endpoint was the change in disease activity in each study group over six months (or until treatment of psoriatic recurrence) as measured by the PASI score every month. Then, we evaluated the rate of and time to relapse, the rate of clinical worsening (PASI≥5) and the clinical variables influencing the loss of response. reSUltS: our study showed that about 50% of patients achieving a long-term and optimal response to the aforementioned anti-tnF alpha agents did not experience any relapse over a 6-month follow-up period after withdrawal. We also observed that subjects displaying a complete remission (PASI=0) at anti-TNF alpha therapy withdrawal experienced less frequently disease worsening and/or relapse compared to subjects having a PaSi>0. CONCLUSIONS: Our findings confirmed that all three anti-TNF alpha agents tend to retain their effectiveness upon re-administration in case of recurrence, even if they have been previously used for long time. (Cite this article as: Stinco G, Balato n, Buligan C, Campanati a, dastoli S, di meo n, et al. a multicenter retrospective case-control study on Suspension of TNF-inhibitors and Outcomes in Psoriatic patients (STOP study). G Ital Dermatol Venereol 2019;154:392-9. DOI: 10.23736/S0392- 0488.18.06156-4
Myocardial infarction in a patient treated with anti-interleukin-12 biological agent for chronic plaque psoriasis.
No full textMultiple primary melanomas in Udine, northeastern Italy: A focus on epidemiology and new risk factors
No full textPatients diagnosed with melanoma are at an elevated risk of developing subsequent primary melanomas. The aim of this study was to assess the prevalence and identify the risk factors associated with multiple primary melanomas (MPMs) in patients referred to the melanoma outpatient service of the Dermatology Unit at the University Hospital of Udine, Italy. We conducted a retrospective analysis on patients with MPMs. For each patient demographic, clinical, and histological data were collected. For each excised melanoma, we recorded Breslow thickness, histological subtype, and anatomical site. A total of 233 patients with melanoma were included in the study, comprising a subgroup of 51 (22%) patients diagnosed with MPM. The mean Breslow thickness for patients with a single melanoma was significantly higher than the Breslow thickness for the first melanoma in the MPM subgroup. Furthermore, a statistically significant decrease in Breslow thickness between the first and second melanomas was observed. In our cohort, patients with MPM had a significantly higher prevalence of nonmelanoma skin cancers (NMSCs) compared with those with a single melanoma. Our study indicates that the prevalence of MPM in the province of Udine is among the highest reported globally. Our finding aligns with the broader literature, which consistently reports lower thickness in second melanoma compared with first melanoma. Finally, the higher prevalence of NMSC in these patients suggests a potential link to chronic ultraviolet exposure
Going Beyond Counting First Authors in Author Co-citation Analysis
Full text linkThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
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