New therapeutic approaches in the treatment of anogenital lichen sclerosus: does photodynamic therapy represent a novel option?

BACKGROUND: Lichen sclerosus et atrophicus (LSA) is an inflammatory, mucocutaneous disorder that affects male and especially female with a debilitating impact on the quality of life. Common localization is the anogenital area. If not treated LSA can leave scars, functional impairment and can evolve in squamous cell carcinoma. The first line of treatment is represented by topical, ultra-potent corticosteroids, but often patients are unresponsive; moreover this therapy is frequently associated to relapses of the disease after discontinuation. METHODS: In this prospective observational study, the efficacy of three different treatments - topical calcineurin inhibitors, avocado and soya beans extracts, and methyl aminolevulinate photodynamic therapy (MAL-PDT) - was evaluated, and an effort has been made to define a therapeutic algorithm according to the severity of the disease. RESULTS: Of the 150 patients who were referred to the outpatient clinic for a dermatological and gynecological visit, 33 met the inclusion criteria. Sixteen (88%) patients showed an improvement of the lesion and a reduction of the itch; 3 (16.7%) patients with sever itch and fissurated lesions were evaluated for the MAL-PDT therapy. A total of 9 patients, after accurate examination of the lesions, were treated with MAL-PDT. The totality of the patients experienced a resolution of the lesions. CONCLUSIONS: In the early stages the use of ASE can represent a valid alternative that is well tolerated by the patients reducing the itching, dryness and improving the mucosal texture. The use of MAL-PDT represents a valid treatment in the moderate-severe stages of LSA.

From patients' needs to treatment outcomes in psoriasis: Results from the 'pSORRIDI' experience.

OBJECTIVE: To evaluate results of the 'pSORRIDI' experience (which is a prevention campaign to evaluate the prevalence of comorbidities, multidisciplinary needs and appropriateness of the therapeutic approach for comorbidities) in patients already being treated for psoriasis. METHODS: Telephone interviews were conducted in patients with psoriasis, who then underwent comprehensive evaluation and investigation of comorbidities. If necessary, patients were referred to specialist cardiology, endocrinology and/or rheumatology services. RESULTS: Overall, 72.0% (54/75) of patients required a multidisciplinary consultation. Among patients referred to cardiology, therapeutic adjustment was needed in 33.3% (five of 15) patients and a redefined diagnosis in 26.7% (four of 15) cases. Among patients undergoing endocrinology evaluations, therapeutic adjustment and a redefined diagnosis were needed in 61.1% (11/18) and 33.3% (six of 18) patients, respectively; for rheumatology evaluations, therapeutic adjustment and a redefined diagnosis were needed in 76.2% (16/21) and 19.0% (four of 21) of patients, respectively. CONCLUSIONS: Among patients with psoriasis, there may be a need for an improvement in the diagnosis of underlying comorbid conditions, and in disease management of both psoriasis and any comorbid conditions.

Vitiligo treatment with monochromatic excimer light and tacrolimus: results of an open randomized controlled study.

BACKGROUND DATA: Narrow band ultraviolet B (UVB) is an effective and safe option for the treatment of vitiligo. However, a complete and long-lasting repigmention of vitiligo patches is difficult to achieve. Combined treatments with novel sources of phototherapy and topical agents represent possible new strategies. OBJECTIVE: The purpose of this study was to compare the efficacy of combined tacrolimus and 308-nm excimer light (MEL) vs 308-nm MEL monotherapy in treating vitiligo in a controlled study. METHODS: Fifty-three patients affected by vitiligo were enrolled in this open prospective study. Patients were divided into three groups: Group I included 20 patients treated with MEL 308 nm twice weekly and oral vitamin E; Group II included 20 patients treated with MEL 308 nm twice weekly combined with 0.1% tacrolimus once a day and oral vitamin E; and Group III included 13 patients treated only with oral vitamin E. Efficacy was assessed at the end of 12 weeks based on the percentage of repigmentation. RESULTS: Fifty-two patients completed 12 weeks of treatment. Group I (MEL + vitamin E) showed a moderate repigmentation in 35% of patients, good repigmentation in 30%, excellent repigmentation in 25%, and poor repigmentation in 10%; Group II (MEL + tacrolimus 0.1%+ vitamin E) presented moderate repigmentation in 25% of patients, good repigmentation in 40%, excellent repigmentation in 30%, and poor repigmentation in 5%; Group III (vitamin E) showed moderate repigmentation in 16% and 84% did not show signs of repigmentation. CONCLUSIONS: Our results demonstrate that the combination treatment of 0.1% tacrolimus ointment plus 308-nm MEL and 308-nm MEL monotherapy are effective, safe, and well tolerated for the treatment of vitiligo compared to treatment with vitamin E. Furthermore, this study suggests that an association with topical immunomodulators could enhance the clinical response in vitiligo, especially in more resistant anatomical sites.

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.

Long-term experience with etanercept in psoriatic arthritis patients: a 3-year observational study.

OBJECTIVE: To evaluate the clinical efficacy and tolerability of etanercept in the treatment of active and progressive psoriatic arthritis (PsA) in patients who have previously demonstrated an inadequate response to standard treatments, such as disease-modifying anti-rheumatic drugs (DMARDs) and non-steroidal anti-inflammatory drugs (NSAIDs). METHODS: An open-label, non-controlled, prospective study was conducted including 32 patients affected by PsA with variable skin involvement who had responded inadequately to at least two DMARDs. Patients received etanercept subcutaneously administered as monotherapy at the dosage of 50 mg twice weekly for 12 weeks followed by 25 mg twice weekly. Clinical response was evaluated using the EULAR (European League Against Rheumatism) disease activity score (DAS) in 28 joints (DAS-28) and the Psoriasis Area and Severity Index (PASI). The percentage improvement in DAS-28 and the proportion of patients achieving a PASI improvement from baseline of between 50% and 75% (PASI 50), > 75% (PASI 75) and > 90% (PASI 90) were analysed as primary endpoints. RESULTS: Twenty-seven (27/32) patients (84.3%) completed 3 years (144 weeks) of continuous treatment, while 5/32 (15.6%) patients were withdrawn from the study. At week 144, a significant improvement in DAS-28 was registered with a reduction in mean DAS-28 from 5.3 at baseline to 1.8, while 25/27 patients (92.5%) achieved PASI 75 with a mean PASI score of 0.7; the mean pain visual analogue scale (pain-VAS) score decreased from 64.2 at baseline to 2 at week 144, corresponding to an improvement of 94.7%. CONCLUSIONS: Etanercept is a safe and effective agent in the long-term management of PsA patients. After 3 years of continuous treatment, symptoms were under control in the majority of patients and there was a low level of disease activity.

Different applications of monochromatic excimer light in skin diseases.

BACKGROUND: Ultraviolet radiation has been used for curative purposes in dermatologic conditions, especially in the last 30 years. OBJECTIVES: We analyzed the efficacy of monochromatic excimer light in psoriasis, palmoplantar pustulosis, vitiligo, mycosis fungoides and alopecia areata, and to examine potential new indications. METHODS: Two hundred seventy-nine patients with common and persistent skin diseases were enrolled in an open prospective study: 152 patients with stable and localized plaque psoriasis, 47 with palmoplantar psoriasis, 7 with palmoplantar pustulosis, 32 with vitiligo, 11 with prurigo nodularis, 9 with mycosis fungoides stage Ia, 8 with alopecia, 5 with localized scleroderma, 5 with genital lichen sclerosus, and 3 with granuloma annulare. The 308 nm excimer light was used at a power density of 48 mW/cm(2). An average of 12 sessions (range, 6-18), one session per week, was performed and yielded a total dose range of 4-12.5 J/cm(2). Clinical response was assessed using photos, biopsies, and specific clinical scores. Patients were monitorized for 6 and 12 months for psoriasis, 12 months for mycosis fungoides, and 4 months for the remaining conditions. RESULTS: We observed complete remission in more than 50% of patients with plaque psoriasis and palmoplantar dermatoses, respectively, complete remission in all patients affected by mycosis fungoides, excellent repigmentation in one third of vitiligo patients, hair regrowth in three patients with alopecia areata, an overall improvement in prurigo nodularis, a partial remission in patients affected by localized scleroderma, and a complete remission in most of the patients with genital lichen sclerosus and granuloma annulare. CONCLUSIONS: Our study confirms the use of monochromatic excimer light as a valid choice for the treatment of psoriasis, vitiligo, and mycosis fungoides; we also observed and report for the first time that monochromatic excimer light produces a therapeutic response in prurigo nodularis, localized scleroderma, genital lichen sclerosus, and granuloma annulare.

Effect of anti-tumor necrosis factor-alpha therapies on body mass index in patients with psoriasis.

Psoriasis is a lifelong, chronic and immune-mediated skin disease affecting approximately 1-3% of the Caucasian population. Pathogenesis of psoriasis is associated with an increased expression of tumor necrosis factor-alpha (TNF-alpha). TNF-alpha is a pro-inflammatory cytokine and important mediator of cachexia. Anti-TNF-alpha therapies are effective in the treatment of psoriasis. The primary end-point was to investigate retrospectively the effect of anti-TNF-therapies on body weight and body mass index (BMI) in patients with psoriasis under treatment with infliximab, etanercept, adalimumab (anti-TNF-alpha group), efalizumab or methotrexate (control group). The patients were treated for 48 weeks. BMI, weight and disease activity were measured at baseline (week 0), weeks 12, 24 and 48. At week 24 a significant increase in body weight and BMI in the anti-TNF-alpha treatment group compared to the control was observed. BMI and body weight did not interfere with the drugs' efficacy. We report a significant weight-gain associated with three different anti-TNF-alpha therapies in a large number of patients affected with psoriasis.

Clobetasol propionate foam 0.05% as a novel topical formulation for plaque-type and scalp psoriasis.

OBJECTIVES: To establish the efficacy of clobetasol propionate foam 0.05% in patients with plaque-type psoriasis and scalp psoriasis. METHODS: We conducted an open-label study on 24 patients. Twelve patients affected by plaque-type psoriasis (group 1) and 12 patients with scalp psoriasis (group 2) applied clobetasol propionate foam 0.05% twice daily for 4 weeks. RESULTS: Clobetasol propionate foam 0.05% led to a reduction of the disease severity. After 2 weeks the PASI score decreased from 7.5 at baseline to 2.5 (range: 0.8-4.6, SD: 1.1) in group 1 and from 5.7 to 1.7 (range: 0.2-4.8, SD: 1.1) in group 2. At week 4, the mean PASI was 2 (range: 0.6-4, SD: 1) and 1.1 (range: 0.2-2.2, SD: 0.6) in groups 1 and 2, respectively. In particular, at week 2, 83.3% of patients with plaque psoriasis and 75% with scalp psoriasis achieved an improvement of the PASI score from baseline> or =50% (PASI-50). At week 4, 91.6% of patients from group 1 and 100% from group 2 achieved or maintained PASI-50, while 41.6% in group 1 and 58.3% in group 2 demonstrated a further improvement, reaching PASI-75. CONCLUSION: The rapidity of effect and the good safety profile suggest a role for clobetasol propionate foam 0.05% in the management of both plaque-type and scalp psoriasis.