Living with Chronic Spontaneous Urticaria in Italy: A Narrative Medicine Project to Improve the Pathway of Patient Care.

Chronic spontaneous urticaria (CSU) is perceived as a difficult to manage disease with negative impact on quality of life. The aim of this study was to highlight how to improve the care of people with CSU, using the methodology of narrative medicine. From June 2014 to March 2015, CSU-diagnosed patients and their physicians were asked to record their experiences of the condition in writing. Fourteen healthcare teams participated: 41% considered CSU as a challenge to overcome, while 22% experienced CSU as a big commitment. The number of professional involved was evaluated as insufficient in 11 hospitals. Seventy-five percent of the 190 Italian patients had visited 3 or more physicians before receiving a final diagnosis, with a perceived waste of time and resources. The therapeutic pathways were described as unsatisfactory in 83% of cases. As a result, anger and frustration were life-dominant emotions in 92% of patients. The critical points of the care pathway are related to organizational issues and lack of awareness.

Serum Protein Profile Changes in Psoriatic Patients Undergoing Treatment With Infliximab.

UNLABELLED: The therapeutic paradigm in psoriasis includes antitumor necrosis alpha agents that have been proved effective and safe as long-term therapy. Recently, it has been described a correlation between the use of biologic agents and the occurrence of monoclonal gammopathies, which are haematological conditions characterized by clonal plasma cells proliferation producing a monoclonal immunoglobulin that accumulates in the blood. OBJECTIVE: The aim of this study is to detect electrophoretic abnormalities in psoriatic patients undergoing treatment with infliximab. RESEARCH DESIGN AND METHODS: A retrospective study evaluating all charts from the clinic database of all patients treated with infliximab. The evaluation of serum protein profile is routinely performed in the clinical setting during biologic therapies. We reported the occurrence MGUS in infliximab-treated patients. RESULTS: The study analysis included 141 charts. Overall, 23 patients showed a MGUS in their electrophoretic profile, though in 6 cases MGUS was detected at the baseline. Thereby, 17 cases (12.06% of the study population) developed MGUS during infliximab therapy. CONCLUSIONS: Serum protein electrophoresis test represents a useful tool to detect and monitor any potentially harmful condition that could occur during treatment with a biologic agent. Particularly, it could be crucial for the detection of MGUS, which does not affect clinical response, and it does not represent a criteria to withdraw the treatment.

Randomized, within-patient, clinical trial comparing fluorine-synthetic fiber socks with standard cotton socks in improving plantar pustulosis.

BACKGROUND/AIMS: Rubbing the skin may influence the persistence of pustulosis over time. The aim of this study was to assess the impact of a new fabric made with fluorine-synthetic fiber in improving plantar pustulosis. METHODS: A total of 17 patients were randomized to receive on one side a sock made of fluorine-synthetic fiber and on the other a sock made of cotton fabric for 4 weeks. The main outcome was the percentage reduction of lesional area at week 4. RESULTS: The median lesion reduction at week 4 was 42.6% in the fluorine-synthetic fiber arm and 2.7% in the cotton arm (p = 0.148). Among secondary outcomes, the overall reduction over time in the treated areas was significantly in favor of the fluorine-synthetic fiber arm (p = 0.045) as well as the perception of the disease by the patient (p = 0.025). CONCLUSION: Despite the fact that the primary outcome was not reached, there was a tangible reduction in the extension of the treated areas and in the perception of the disease by the patient.

Emergence of antinuclear antibodies in psoriatic patients treated with infliximab: personal experience and literature review.

Psoriasis is a chronic inflammatory skin disease affecting up to 2.5% of the population, with joint involvement in approximately 30% of patients. Given the role of tumor necrosis factor (TNF) in the pathogenesis of psoriasis, anti-TNF therapies have been developed; several studies have demonstrated the efficacy of infliximab (IFX) as induction and maintenance therapy in the treatment of moderate to severe plaque psoriasis. The development of antinuclear antibodies (ANA) in anti-TNF-treated patients has been frequently reported. The aim of this study was to investigate the incidence of ANA and anti-double stranded DNA (anti-dsDNA) antibodies in psoriatic patients receiving IFX. Incidence of new ANA and anti-ds-DNA was 16.2% and 8.1% respectively. No case of anti-TNF induced Lupus was observed during the follow-up.

Golimumab in patients affected by moderate to severe psoriatic arthritis: an open-label study in thirty-two patients previously treated with other biologics.

BACKGROUND: Clinical trials have demonstrated the efficacy of golimumab (GLB) in improving the signs and symptoms of psoriatic arthritis (PsA). OBJECTIVE: The aim of this study was to evaluate the efficacy of GLB in monotherapy in patients affected by PsA with cutaneous involvement unresponsive to other anti-tumor necrosis factor-α (TNF-α) agents. METHODS: This study included 32 patients treated with GLB as monotherapy, at a dosage of 50 mg, subcutaneously, every 4 weeks. Patients were divided into 3 groups (A, B, and C) according to their number of previous anti-TNF-α treatments (1, 2, or 3). Clinical and laboratory evaluations were performed at weeks 0, 12, and 24. RESULTS: All patients showed significant improvement of their clinical, inflammatory, and quality of life indexes. CONCLUSION: Data suggest that GLB can be successful and safe in patients affected by PsA with skin involvement previously treated with other anti-TNF-α agents.

Emerging applications of nanomedicine in dermatology.

BACKGROUND: Nanotechnology is a new branch of engineering consisting of the usage of nanoscale particles (100 nm and smaller). Nanomedicine is the application of nanoscale technologies for diagnostic and therapeutic purposes in medicine. Nanodermatology, nanotechnology applied to dermatology, represents one of the most advanced field for which an increasing interest, both economic and scientific, is rising. The skin is the first point of contact for a whole host of nanomaterials, ranging from topical preparations, articles of clothing and household products, to sporting goods and industrial manufactured goods. Applications of nanomedicine in dermatology include new direction in medical diagnosis, monitoring and treatment. Gold nanoparticle, quantum dots and magnetic nanoparticles are used in non-invasive nanoimaging of high-resolution dermoscopy, microscopy, nanopunch, and spectroscopy, offering advanced diagnostic and therapeutic modalities. Nanotherapeutics has been considered in immunotherapy, genetherapy, and drug therapy. In drug therapy, because of size reduction or encapsulation of drug particles, the therapeutic potential of water insoluble and unstable drugs improve, and also facilitate the delivery of small molecules across blood, skin, nails, and pilosebaceous unit. AIMS: To review therapeutic applications and benefits of nanomedicine in esthetic dermatology, treatment of malignancies, and inflammatory skin diseases.

-174G/C IL-6 gene promoter polymorphism predicts therapeutic response to TNF-α blockers.

BACKGROUND: Although TNF-α blockade is a very effective therapy for psoriasis, not all patients achieve a favorable outcome. The association between IL-6 and psoriasis has been investigated but no papers have focused on the pharmacogenetics of IL-6. OBJECTIVE: To examine whether the G or the C allele, at position -174 in the promoter of IL-6, influences the relationships between body weight, body composition, and therapeutic response to TNF-α blockers in psoriasis. METHODS: Sixty patients with psoriasis were studied, at baseline and 6-month follow-up after therapy. Assessment of the -174G/C IL-6 polymorphism, Psoriasis Area and Severity Index and Disease Activity Score-28 scores, body weight (kg), BMI, body composition by Dual-energy X-ray absorptiometry, and systemic inflammation was performed. RESULTS: Relevant body composition changes occurred after therapy. Normal weight participants showed a greater increase in fat mass than lean mass, compared with obese participants. According to their genotypes, C(+) carriers showed a greater increase in lean mass and fat mass, at the abdominal region, with respect to C(-) carriers. C(+) carriers outweighed C(-) carriers in the group of treatment responders. A higher number of responders were present among normal weight participants, with respect to obese participants. Obesity and the -174G/C IL-6 polymorphism predicted poor response to TNF-α blockers [odds ratio for C(-) carriers, obese: 2.00 (confidence interval: 1.19-3.38; P≤0.05)]. CONCLUSION: Our data show that the G allele of the -174G/C IL-6 polymorphism and obesity can be considered as risk factors for the prognosis and management of psoriasis. This is the first study to suggest the -174G/C IL-6 polymorphism as a novel genetic marker of responsiveness to TNF-α blockers in psoriasis.

Complete resolution of erythrodermic psoriasis in an HIV and HCV patient unresponsive to antipsoriatic treatments after highly active antiretroviral therapy (Ritonavir, Atazanavir, Emtricitabine, Tenofovir).

BACKGROUND: Psoriasis is a chronic, inflammatory disease affecting 2-3% of the worldwide population, and it may worsen with HIV or be detected as HIV cutaneous manifestation. HIV-related psoriasis shows a severe and prolonged clinical course with more frequent exacerbations. The management of this condition is challenging because immunomodulating and immunosuppressant agents may have variable and partial efficacy, and therefore, antiretroviral treatment represents a potential adjunctive therapeutic option. RESULTS: In the case we report, the HIV test was shown to be crucial for driving the therapeutic approach. Indeed, antiretroviral agents have been proven to be effective in the treatment of HIV+ psoriasis as first-line therapy. CONCLUSION: The HIV test should be considered in high-risk patients affected by severe psoriasis and resistant to conventional and biological treatments.

Prospective assessment of body weight and body composition changes in patients with psoriasis receiving anti-TNF-α treatment.

Tumor necrosis factor (TNF)-α is a pro-inflammatory cytokine associated with psoriasis pathogenesis. Anti-TNF-α therapies are effective in psoriasis. A significant weight gain has been reported in patients treated with anti-TNF-α agents. The aim of the present study was to evaluate the body composition changes in psoriatic patients receiving anti-TNF-α therapies according with disease phenotype. Forty patients affected with psoriasis were followed up for 24 weeks and divided into two groups: psoriasis vulgaris (PsO) and psoriatic arthritis (PsA). Anthropometric, blood biochemical, body composition parameters, resting metabolic rate, and disease activity indexes were measured at baseline and at week 24. After 24 weeks of anti-TNF-α administration, the disease activity indexes and concentration of inflammatory markers were significantly decreased. Seventy-five percent of PsO and 60% of PsA patients had an increase in body weight. Weight changes correlated with fat mass gain in the PsO group, and with fat and lean mass gain in the PsA group. In the present study, we demonstrated that a blockage of TNF-α bioactivity is related with fat and lean mass gain in both PsO and PsA subjects. The anti-TNF-α therapies could play a key role in the cross talk between adipose tissue and skeletal muscle, mediated by the reduction of TNF-α and interleukin-6 production.

Monochromatic excimer light 308 nm in monotherapy and combined with topical khellin 4% in the treatment of vitiligo: a controlled study.

Vitiligo is an acquired depigmentation disorder affecting 1-4% of the world's population. Conventional therapies include steroids, photosensitive topical agents, surgical treatments, and phototherapy. The aim of the study was to evaluate the efficacy of monochromatic excimer light 308 nm (MEL), both as a monotherapy and in combination with khellin 4% ointment in vitiligo. Forty-height patients (36 male and 12 female) affected with vitiligo were enrolled in this open prospective study. Patients were selected and divided into three groups: group I included 16 patients treated with MEL 308 nm once-weekly and oral vitamin E; group II included 16 patients treated with MEL 308 nm once-weekly combined with khellin 4% ointment (MEL-K) and oral vitamin E; group III (control group) included 16 patients treated only with oral vitamin E. Efficacy was assessed at the end of 12 weeks based on the percentage of repigmentation. Group I (MEL-group) showed a moderate repigmentation in 2/16 (12.5%) patients, good repigmentation in 10/16 (62.5%), and excellent repigmentation in 4/16 (25%) patients. Group II (MEL-K group) presented moderate repigmentation in 2/16 (12.5%) patients, good repigmentation in 5/16 (31.25%), and excellent repigmentation in 9/16 (56.25%). Group III (control group) showed a moderate repigmentation in 3/16 patients (18.75%), a good repigmentation in 1/16 (6.25%) patient, while 10/16 (62.5%) patients did not show signs of repigmentation. The clinical response achieved in group I and II was higher compared with group III (control group) without showing significant differences. MEL 308 nm, alone and/or combined with khellin 4% offered encouraging results and it may be considered a valid therapeutic option worthy of consideration in the treatment of vitiligo.

Treatment of folliculitis with monochromatic excimer light (308 nm).

BACKGROUND/AIMS: 308-nm excimer light has been reported to be safe and effective in the treatment of chronic skin diseases. The aim of the study was to prove the efficacy of 308-nm monochromatic excimer light in the treatment of recalcitrant and antibiotic-resistant folliculitis. METHODS: Eight patients affected with folliculitis were enrolled and treated twice weekly with the 308-nm excimer light. The follow-up was 12 weeks from the end of the treatment. RESULTS: A mean number of 13 sessions (range 10-20) was performed with increasing dosage according to the patient's photo-type and response. Remission, in terms of number and infiltration of papulopustular elements, was achieved in all patients after 4-16 therapeutic sessions. At the end of the follow-up period, recurrence of folliculitis was observed in 2 patients. CONCLUSIONS: These results suggest that the 308-nm excimer light is a valid therapeutic option for the treatment of resistant forms of folliculitis especially in difficult-to-treat areas.

Methyl aminolaevulinate photodynamic therapy for the treatment of hidradenitis suppurativa and pilonidal cysts.

Hidradenitis suppurativa (HS) and pilonidal cysts are chronic, inflammatory skin conditions involving apocrine gland-bearing skin. Treatment is limited and unsatisfactory. Photodynamic therapy (PDT) has been reported to be safe and effective in the treatment of several off-label skin conditions. We report the case of a 29-year-old man affected by HS and pilonidal cysts since the age of 21. In the past, the patient was treated with antibiotics, corticosteroids and retinoids, without significant clinical improvement. Treatment with methyl aminolaevulinate (MAL)-PDT was started. A topical MAL cream (Metvix) was applied to the affected areas with an occlusive dressing for 3 h and irradiated with a red light source. Therapy was repeated every 15 days for a total of nine applications. The patient completed a 6-month follow-up and achieved an almost complete clinical remission of the skin lesions (80%) and complete resolution of the itching and discomfort. This is the first case of HS associated with pilonidal cysts treated with MAL-PDT. MAL-PDT was effective and well tolerated in our patient. The costs of this therapy represent an important limitation, taking into account the high number of sessions that were performed compared with non-melanoma skin cancers.

Hydroxyurea associated with concomitant occurrence of diffuse longitudinal melanonychia and multiple squamous cell carcinomas in an elderly subject.

BACKGROUND: Hydroxyurea is a cytostatic agent used to treat myeloproliferative disorders and long-term treatment is associated with mucocutaneous adverse events and nail hyperpigmentation. OBJECTIVE: The purpose of this study was to report the concomitant occurrence of multiple squamous cell carcinomas and diffuse nail hyperpigmentation associated with hydroxyurea treatment, and to describe a successful therapeutic approach using imiquimod 5%. CASE SUMMARY: We report the case of an 81-year-old white man (weight, 82 kg; height, 173 cm; photodamaged type II skin) affected with cirrhosis of the liver, chronic idiopathic myelofibrosis, and a 3-year history of longitudinal melanonychia and periungual hyperpigmentation. His current medication regimen was hydroxyurea (500 mg BID), iron (525 mg QD), and folic acid (15 mg QD) for the myeloproliferative disease and the associated anemia; spironolactone (25 mg BID) and furosemide (20 mg BID) for the complications of cirrhosis; allopurinol (100 mg QD) to treat gout; and theophylline (250 mg QD) for chronic bronchitis. The patient presented with several actinic keratoses, squamous cell carcinomas, and multiple keratoacanthomas, one of which was pigmented. Both the longitudinal melanonychia and the multiple skin cancers first appeared after approximately 6 months of hydroxyurea treatment. A correlation between dose and manifestation was investigated but none was found. Based on the Naranjo algorithm, the adverse reaction observed was probably related to the hydroxyurea treatment (score = 6); however, the hydroxyurea chemotherapy could not be discontinued because of the myeloproliferative disorder. Complete remission was observed after 6 to 10 weeks of imiquimod 5% (10 mg/cm of skin cancer) treatment. The patient completed a 10-month follow-up, maintaining a complete resolution of the treated skin lesions; however, the development of a painful hand ulcer, possibly associated with the hydroxyurea, and new skin cancers were observed at the last follow-up visit. CONCLUSIONS: We report this case of the concomitant appearance of multiple skin cancers and nail changes associated with hydroxyurea use. The progressive appearance of squamous epitheliomas and other cutaneous adverse events, such as the ulcer, suggests that alternative chemotherapies should be considered for the treatment of myeloproliferative diseases.

How to manage infections in the era of biologics?

Biologic agents are immunosuppressants that target cytokines or specific immune cell subpopulations. Many therapies interfere with the normal inflammatory cascade and with the immune system, causing an increase in the incidence of infections. In particular, treatment with tumor necrosis factor (TNF)-alpha antagonists in psoriasis patients is associated with an increased risk of infection caused by intracellular microorganisms. TNF-alpha plays an important role in host resistance against infectious and several cases of Mycobacterium tuberculosis, Listeria monocytogenes, and Pneumocystis carinii have been reported with anti-TNF-alpha agents. Furthermore, B and T cells are essential to the immune response; thus, their specific reduction or inhibition by targeting molecules in T-cell cutaneous lymphomas and psoriasis could increase the risk for viral, fungal, and bacterial infections. A prompt and appropriate management of infections with the emergence of biologics is essential in clinical practice.

Efficacy of monochromatic excimer light (308 nm) in the treatment of atopic dermatitis in adults and children.

OBJECTIVE: To demonstrate the efficacy of light produced by a 308 nm xenon-chloride monochromatic excimer light (MEL) in the treatment of localized lesions of atopic dermatitis (AD) in adults and in children. BACKGROUND DATA: The 308-nm excimer light has been reported to be safe and effective in the treatment of chronic skin diseases, although the range of potential applications has not been fully explored. METHODS: Twelve adults and six children affected by localized lesions of AD were enrolled in this pilot study and treated with a weekly session of MEL. A range of 6-12 sessions was performed with an increasing dosage according to the patient's phototype and response. Follow-up was for 16 wk. RESULTS: All patients completed the protocol. At the end of treatment complete remission was observed in 12/18 patients (66.7%), a partial remission in 3/18 (16.7%) and no remission in 3/18 (16.7%). A mean total dose of 21.89 minimal erythemal dose (MED) was performed. Forty-four percent of patients maintained the results achieved at a 16-week follow-up. Treatment was well tolerated overall. CONCLUSIONS: MEL can be considered as a valid and safe therapeutic option for the treatment of localized AD in adults and children.

Oral lichen planus: therapy and phenotype.

BACKGROUND: Lichen planus (LP) is a mucocutaneous disease of chronic inflammatory nature. Although many therapeutic options are available, none are curative. The aim of this article was to describe a therapeutic algorithm that take into consideration the clinical futures of oral LP (OLP). METHODS: Patients affected by symptomatic OLP were enrolled into three groups to receive cyclosporine mouthwash, retinoic acid lotion 0.05%, and autologous platelet-rich plasma (PRP) gel in the treatment of reticular, plaque-like, and erosive-type respectively. The products were applied as follows: retinoic acid BID for 8 weeks, cyclosporine mouthwash OD for 8 weeks, PRP once a week for 8 weeks. Patients were assessed at 2, 4, 8, and 12 weeks. Improvement was evaluated as complete response, partial response and no response. RESULTS: A total of 20 Caucasian patients, 8 male and 12 female, mean age 56 years (range 40-74) concluded the study. Seven patients showed a complete response, 7 patients a partial response, and 6 patients no response. CONCLUSIONS: We propose a therapeutic algorithm that take into consideration the clinical features and symptoms of OLP. Long-term experience on larger series of cases are necessary to confirm our data.