Effectiveness of cyclosporine A in patients with moderate to severe plaque psoriasis in a real-life clinical setting in Italy: the TRANSITION study.

BACKGROUND: Cyclosporine A (CsA) is one of the systemic therapeutic options for moderate-to-severe psoriasis, based on its efficacy and rapidity of action. The current study investigated the response to CsA in patients with moderate-to-severe plaque psoriasis. MATERIALS AND METHODS: TRANSITION was an observational, cross-sectional, multicentre study which evaluated the proportion of partial- and suboptimal-responders among patients with moderate-to-severe plaque psoriasis treated with continuous CsA for ≥12 weeks. Patients demonstrating a Psoriasis Area and Severity Index (PASI) response of ≥90, ≥75 and <90, ≥50 and <75 and <50 were defined as responders, suboptimal-responders, partial-responders, and non-responders, respectively. RESULTS: A total of 196 patients (mean age, 46.6 years; 62.8% males) from 14 sites in Italy were evaluated. At the study visit, the mean (SD) PASI score was 4.2(5.5) compared with 15.3(7.1) prior to the last CsA cycle. For response categories, 39.8%, 22.4%, 16.8%, and 20.9% of patients were responders, suboptimal-responders, partial-responders, and non-responders to CsA treatment. Overall, 28.6% of patients permanently discontinued treatment with CsA (lack of efficacy [10.2%], poor tolerability and voluntary discontinuation [3.6% each], and other [11.7%]). CONCLUSION: Patients were only partially satisfied with CsA treatment, reporting measurable impact on quality of life. Only 40% patients showed a satisfactory response to CsA.

Real-life experience on effectiveness and safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis.

BACKGROUND: Dupilumab, a fully human monoclonal antibody targeting the alpha subunit of IL-4 was recently approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients. OBJECTIVE: To assess dupilumab effectiveness and safety in adults with moderate-to-severe AD in a real-life Italian multicentre retrospective cohort. METHODS: Adult moderate-to-severe AD patients, referring to 39 Italian centers, received dupilumab in the context of a national patient access program. Disease assessment was performed at baseline, after 4 and 16 weeks of treatment using Eczema-Area-and-Severity-Index (EASI) score, itch and sleep numerical-rating-score (itch-NRS, sleep-NRS) and Dermatology-Life-Quality-Index (DLQI). RESULTS: A total of 109 (71 M/38F) patients was studied. There was a significant reduction in EASI score, itch-NRS, sleep-NRS and DLQI from baseline to week 4 and a further significant decline to week 16. EASI 50, EASI75 and EASI90 were achieved by 59.6%, 28.4% and 9.3% of patients at 4 weeks and by 87.2%, 60.6% and 32.4% of them at 16 weeks, respectively. Adverse events were experienced by 19.2% (21/109) of the patients and they were all mild in intensity, being conjunctivitis the most common side effect. CONCLUSIONS: Dupilumab significantly improved disease severity, pruritus, sleep loss and quality of life with an acceptable safety profile.

Cross-elicitation responses to 2-methoxymethyl-p-phenylenediamine in p-phenylenediamine highly allergic volunteers using allergy alert test: the Italian experience.

Summary: Background. Allergic contact dermatitis after exposure to p-phenylenediamine (PPD)-containing hair dye products is a common and important clinical problem. Because there is a high rate of cross-elicitation of allergic contact dermatitis to other important hair dye products (such as p-toluene diamine [PTD] and other aminophenol hair dyes) in PPD allergic patients, safer alternative dyes with excellent hair coloring options are needed. We studied 2-methoxy methyl-PPD (Me-PPD), a chemical derivative of PPD for tolerance versus cross-elicitation in a cohort of eight PPD-allergic volunteers. Objective. To study tolerance to Me-PPD in a PPD highly allergic Italian cohort. Methods. Eight volunteers with a history of contact dermatitis to hair dyes or other PPD-containing chemicals and positive patch tests to 1% PPD in petrolatum, were recruited to study their immediate and delayed skin reactivity to PPD, vehicle control and 2-methoxy-methyl-PPD (Me-PPD), using the allergy alert test (simulating hair dyeing conditions) on volar forearm skin. This is a short-contact open patch test. Results. All eight volunteers reacted to PPD allergy alert test (100%); none reacted to vehicle (0%), and seven of eight reacted to Me-PPD allergy alert test (88%). However, in those seven volunteers who exhibited cross-elicitation to Me-PPD, their aggregate skin test reactivity to Me-PPD was significantly less than that of PPD (figure 3, p minore 0.0062, highly significant, paired two-tailed, students t test). Conclusions. Me-PPD may offer a safer alternative for PPD-allergic patients with an absent or reduced elicitation response in the allergy alert test simulating hair dye use conditions. Even patients with strong patch test reactions, with appropriate selection by allergy alert test and counselling, may be able to tolerate hair dyeing with Me-PPD containing products.

A new high-throughput method to make a quality control on tattoo inks.

Nowadays, practice of tattooing is very common worldwide and, along with this increasing trend, there is also an increased risk of adverse reactions to tattoo pigments that are well known and described in literature. Previous studies have reported that cutaneous and allergic reactions to a particular pigment can manifest in several ways (allergic contact dermatitis and photo-allergic dermatitis). In this paper, a new high-throughput method is presented, in order to achieve a new system for the quality control on tattoo inks based on chromatographic-spectroscopic approach. The samples, twenty-one tattoo inks and three permanent makeup, comprised the following colors: black inks, yellow, blue, green, white, pink and various shades of red (pigment that gives many allergic responses) were analyzed through the combination of chromatographic and spectroscopic techniques, the HPTLC-Raman. In particular, Raman technique has been chosen because of its high sensitivity towards the inorganic and organic pigments, main constituents of tattoo inks. Moreover, the advantage of this hyphenated technique is to overcome the problem of analysing the complex mixture of tattoo inks, allowing to obtain a Raman spectrum of each single component, isolated by chromatographic separation. This approach aims at developing a powerful instrument to establish the nature of tattoo inks and substances that could be cause adverse reactions in tattooed patients.

Psoriasis Area and Severity Index response in moderate-severe psoriatic patients switched to adalimumab: results from the OPPSA study.

BACKGROUND: Few studies have compared the efficacy of switching to adalimumab in the real-life setting in plaque psoriasis patients. OBJECTIVE: To evaluate the effect of adalimumab in psoriasis patients previously treated with other biologics. METHODS: In this multicentre study, psoriasis patients (N = 262) treated with an anti-TNF-alpha agent, ustekinumab or naïve to biologics then switched to adalimumab were included. Disease severity was assessed by the Psoriasis Area and Severity Index (PASI) at baseline and after 3, 6, 12, 24 and 36 months. The association between clinical risk factors and achievement of PASI response was evaluated by logistic regression. RESULTS: Adalimumab treatment resulted in a decrease in PASI (15.1 ± 6.2 at baseline vs. 2.7 ± 4.8 at 6 months, P < 0.0001), regardless of previous biologic treatment. Furthermore, adalimumab allowed 92.5%, 79% and 56% of patients to achieve PASI response (PASI 50, 75 and 90, respectively) and complete remission (PASI 100 response) in 48.4% of patients, by 6 months and maintained over 3 years, independent of prior biologic treatment. The absence of metabolic syndrome, dyslipidemia, hypertension and lower PASI and lower age at baseline was associated with achievement of PASI response at 3, 6 and 12 months, whereas at later time points (24 and 36 months), PASI 90 and PASI 100 response was associated with diagnosis of psoriasis/psoriatic arthritis. CONCLUSION: Adalimumab was effective at reducing PASI score over 3 years, irrespective of whether patients were biologic naïve or previously treated with a TNF-alpha or IL-12/23 inhibitor.

Seborrheic keratoses mimicking melanoma unveiled by in vivo reflectance confocal microscopy.

BACKGROUND: Seborrheic keratoses (SebK) with atypical dermoscopy presentation are increasingly reported. These lesions do not exhibit typical dermoscopy features of SebK and sometimes mimic melanoma, thus complicating the differential diagnosis. Reflectance confocal microscopy (RCM) is a non-invasive tool, which allows an in vivo imaging of the skin. The study objectives were to evaluate the agreement between RCM classification and histological diagnoses, and the reliability of well-known RCM criteria for SebK in the identification of SebK with atypical dermoscopy presentation. MATERIALS AND METHODS: We retrospectively analysed at RCM excised lesions presenting in dermoscopy ≥1 score at revisited 7-point checklist. The study population consisted of cases showing no melanocytic RCM findings. Lesions were investigated for distinct non-melanocytic RCM features, blinded from histopathology diagnoses. Histopathology matching was then performed before statistical analysis. RESULTS: The study consisted of 117 cases, classified at RCM as SebK (71 cases), dermatofibroma (18 cases), basal cell carcinoma (13 cases), squamous cell carcinoma (2 cases), and "non-specific" (13 cases). Overall K strength of agreement at histopathology matching proved 0.76. Of the 71 cases classified at RCM with SebK, agreement was achieved in 97%. CONCLUSION: Reflectance confocal microscopy classification proved high agreement with histopathology for SebK with atypical dermoscopy presentations, allowing an early differential diagnosis. RCM features in this group of lesions were similar to those described for typical cases of SebK, and may assist clinician therapy decision making, whilst avoiding unnecessary excisions.

Plasticity of immune system vs. memory therapy IST

Background: Pharmacotherapy and immunotherapy are the main treatments for allergic diseases to inhalants. Objective: This study investigates whether to repeat short cycles of immunotherapy after 3 or 5 years the from interruption of the first therapeutic cycle, lasting 3-4 years, to maintain immune memory in individuals subjected to IST. Methods and Results: We have compared two groups, one of 452 patients who, after the first treatment for 3-4 years of IST, performed a cycle of four months after three and 10 years from the suspension, and a second group of 126 individuals who have performed only the IST treatment for 3-4 years. The best results were obtained in the first group. Conclusions: These results are due to the immune system's plasticity, a very important concept in clinical practice (AU)

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Successful of subcutaneous and oral hyposensitizing therapy in 30 patients.

SUMMARY: Background. Pharmacotherapy and immunotherapy are the main treatment modalities for respiratory allergy. The aim of this paper has been to evaluate the efficacy and tolerability of subcutaneous and sublingual immunotherapy in association in allergic patients, and to demonstrate that the patients who have performed a second oral vaccination cycle after 4-5 years from the first subcutaneous treatment, derive benefits that may last for years. This is due to immune system's plasticity. Methods. The study was conducted in 30 allergic patients which had previously executed a full cycle of classical subcutaneous immunotherapy, with a partial remission of symptoms. After 4-5 years, they were subjected to sublingual immunotherapy for the same allergen, improving the results obtained. Results. All the patients reported a decrease or absence of clinical symptoms, a reduction in the use of anti-allergic drugs, and lower values of PRIST and RAST after the treatment. Conclusions. The results of this clinical study confirm the improvement of results when subcutaneous and sublingual immunotherapy are associated.

Plasticity of immune system vs. memory therapy IST.

BACKGROUND: Pharmacotherapy and immunotherapy are the main treatments for allergic diseases to inhalants. OBJECTIVE: This study investigates whether to repeat short cycles of immunotherapy after 3 or 5 years the from interruption of the first therapeutic cycle, lasting 3-4 years, to maintain immune memory in individuals subjected to IST. METHODS AND RESULTS: We have compared two groups, one of 452 patients who, after the first treatment for 3-4 years of IST, performed a cycle of four months after three and 10 years from the suspension, and a second group of 126 individuals who have performed only the IST treatment for 3-4 years. The best results were obtained in the first group. CONCLUSIONS: These results are due to the immune system's plasticity, a very important concept in clinical practice.

Heavy metal and tattoo: an allergy and legislative problem.

We presented an interesting clinical case of a 23 years old man presented with a 2-week history of pruritus, erythema and papules on legs, arms and trunk. These lesions developed 2 months after tattooing. It showed positive patch test reaction to Copper and Disperse Blu.

Trends of thyroid function and autoimmunity to 5 years after the introduction of mandatory iodization in Italy.

Background. Mandatory iodine fortification of salt was introduced in Italy in 2005. The purpose of our study is to estimate the trend of thyroid diseases in Italy before and after mandatory iodization in Italy. Methods. 7976 patients (6802 females; 1174 males) were examined between 2003 and 2010. We divided the patients into categories according to their clinical diagnosis. Later, we evaluated for each patient if there was the positivity for antibodies anti TPO. Finally, we collected data about TSH values of all patients who did not use therapy for thyroid disease at the time of the examination. To evaluate the differences percentages for categorical variables, χ2-Pearson test was used; to evaluate the percentage differences of TSH values we used the Kruskal-Wallis test. Values were considered statistically significant at p < 0.05. Results. We considered diagnosis of "toxic adenoma / goiter", diagnosis of "Graves' disease" and diagnosis of "hyperthyroidism / thyrotoxicosis" before and after the introduction of mandatory iodization in Italy, to demonstrate the possible presence of iodine-induced hyperthyroidism. Diagnosis of toxic adenoma / goiter before 2005 were 3.7%, while after 2005 they were reduced to 3.1%. Diagnosis of Graves' disease before 2005 were 2.4%, and they remained unchanged after 2005. Finally, diagnosis of hyperthyroidism / thyrotoxicosis decreased from 2.5% to 2.1%. Comparing these results, there were no significant differences (P = 0.261) between the percentages of diagnosis of hyperthyroidism before and after the introduction of mandatory iodization. We considered diagnosis of Hashimoto's thyroiditis before and after 2005 to demonstrate a link between the administration of iodine and thyroid autoimmunity. Prevalence of Hashimoto's thyroiditis between 2003 and 2005 was 37%; prevalence between 2006 and 2010 dropped to 34.7%. This small difference has a borderline statistical significance (P = 0.049). Stratifying TSH values from year to year, we found a small increase in TSH value, which, in any case, remains in the normal range. TSH values passed from 1.37 in 2003, to 1.61 in 2010. Although this increase is modest, it is statistically significant (P values < 0.001). Conclusion. In this study there isn't a connection between iodine fortification and iodine-induced hyperthyroidism, and between iodine fortification and Hashimoto's thyroiditis. This small increase of TSH values can not find a clear explanation yet. We considered several mechanisms to explain this phenomenon: alterations of Na/I symporter reduce intracellular levels of iodine, and cause a state of hypothyroidism; excessive levels of iodine can increase apoptosis of thyrocytes, as it is demonstrated by several studies; interference from external agents (endocrine disruptors).

A case of hypersensitivity to progesterone presenting as an eczematous eruption.

Hypersensitivity to progesterone is a rare condition, and it represents a hypersensitivity reaction to endogenous progesterone. Here we report a case of a woman who presented to our attention for evaluation of a rash for a few years on her posterior elbows, forearms, and right lateral lower extremity. We report this case because it describes a rare clinical entity, with an atypical clinical presentation pemphigoid-like, that is rarely described in literature.

Chemical research on red pigments after adverse reactions to tattoo.

Currently, the incidence of tattooing is on the rise compared to the past, especially among adolescents, and it leads to the urgency of monitoring the security status of tattooing centers, as well as to inform people about the risks of tattoo practice. In our clinical experience, 20% of tattooed patients presented adverse reactions, like allergic contact dermatitis, psoriasis with Koebner's phenomena and granulomatous reactions, with the latter most prevalent and most often related to red pigment. Adverse reactions to tattoo pigments, especially the red one, are well known and described in literature. Great attention has to be focused on the pigments used, especially for the presence of new substances, often not well known. For this reason, we decided to perform a study on 12 samples of red tattoo ink, obtained by patients affected by different cutaneous reactions in the site of tattoo, to analyze their chemical composition.