Immunosuppressive therapy in cutaneous vasculitis.
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Clinical Trials as Topic↗
Biomedical subjects
N Cassano
Publications and source records attributed to N Cassano.
Infliximab monotherapy for refractory psoriasis: preliminary results.
Tumour necrosis factor (TNF)-alpha plays an important role in the pathogenesis of psoriasis. Infliximab is an anti-TNF-alpha chimeric monoclonal antibody, which is licensed for the treatment of rheumatoid arthritis and Crohn's disease. Some reports have shown the efficacy of infliximab, either in monotherapy or in combination with methotrexate, for the treatment of psoriatic arthropathy and psoriasis. The efficacy and tolerability of infliximab monotherapy was evaluated in 29 patients with moderate to severe psoriasis, unresponsive to conventional treatments. Fourteen patients suffered from concomitant arthropathy. Patients received intravenous infliximab, 5mg/kg, at weeks 0, 2, and 6. After this 3-dose-induction regimen, patients were followed-up at monthly intervals and retreated with a single-dose infusion in case of relapse of signs and symptoms. Clinical assessment was performed using the psoriasis area and severity index (PASI) to monitor psoriasis activity; pruritus and joint pain were assessed on a scale of 0 to 3. A marked improvement of skin lesions and subjective symptoms was noted in the majority of patients; an excellent reduction of PASI score (> or =75%) was observed in 13.8% of cases at week 2, 71.4% at week 6 and 78.6% at week 10. During the follow-up period, some patients maintained satisfactory clinical results without requiring any additional infusions. In general, skin lesions showed a trend towards a more prolonged and sustained improvement as compared with subjective symptoms. Treatment was well tolerated and no serious adverse events occurred.
Adult↗
Oral terbinafine in the treatment of multi-site seborrhoic dermatitis: a multicenter, double-blind placebo-controlled study.
Seborrheic dermatitis (SD) is a common disorder for which no satisfactory curative treatment exists. Preliminary studies suggest that terbinafine may be effective. The efficacy and tolerability of oral terbinafine was evaluated in multi-site SD in a randomized, double-blind, placebo-controlled study. For this purpose, 174 adult patients with SD lesions involving >or=3 skin areas, each causing >or=2 moderate/severe symptoms according to a pre-defined clinical score, were classified according to the localization of lesions: patients with lesions predominantly involving non-exposed skin areas, such as scalp and hairline and sternum and/or interscapular area (Population A, n=83) or patients with lesions in exposed sites, mainly the face (Population B, n=91). Patients were randomized to oral terbinafine (250 mg/day ) (n=86) or matching placebo (n=88), each given for 6 weeks. Primary efficacy variable was the response rate, defined as >or=50% decrease in baseline total clinical score without rescue medication intake after 6 weeks of treatment. The main secondary assessments were: subject's global assessment of relief and proportion of patients satisfied with treatment. Recurrence rate was assessed in responder patients during a 4-week treatment-free period. In Population A the response rate after 6 weeks of treatment was significantly higher with terbinafine (70% vs 45.4%; p=0.03) and so was the proportion of patients who reported relief (75% vs 41%; p=0.007) and who were satisfied (66% vs 40%; p=0.02). No significant differences were recorded in Population B. Adverse events occurred in 11.5% of terbinafine patients and 8% of placebo patients. One patient discontinued treatment with terbinafine because of adverse events (mild tachycardia and insomnia). In conclusion, our results show that terbinafine is significantly more effective than placebo in reducing the severity of SD lesions in nonexposed sites. Clinical trials comparing terbinafine to standard treatment regimens in different types of patients with SD are warranted.
Administration, Oral↗
Risk factors for sensitization to AnisakiS simplex: a multivariate statistical evaluation.
Anisakis simplex is a nematode belonging to the Anisakidae family. The ingestion of third stage larvae in uncooked or undercooked seafood may cause human diseases known as anisakiasis and anisakidosis. A total of 400 (159 atopic and 241 non-atopic) subjects living in an area of southern Italy (Bari district) were consecutively evaluated to identify the association of some factors (sex, age, atopy, consumption of uncooked seafood and sensitization to dust mites) with the risk of Anisakis simplex sensitization. Patients were investigated on history of atopy and allergic diseases and were skin prick tested with commercial allergen extracts of Anisakis simplex, Acarus siro, Lepidoglyphus destructor, Tyrophagus putrescentiae, Glycyphagus domesticus, Euroglyphus maynei, Dermatophagoides pteronyssinus and Dermatophagoides farinae. Our results suggest that atopic subjects have a lower risk of Anisakis allergy than non-atopic subjects and show the association of Anisakis simplex sensitization with the consumption of uncooked seafood (anchovies and squid), increasing age and sensitization to Glycyphagus domesticus.
Animals↗
Once-weekly administration of high-dosage Etanercept in patients with plaque psoriasis: results of a pilot experience (power study).
Etanercept is a soluble tumour necrosis factor receptor fusion protein which is approved for the treatment of plaque psoriasis at the dose of either 25mg twice weekly (BIW) or, for the initial 12 weeks, 50mg BIW. Alternative dosing regimens have not been evaluated in psoriasis. In this study, we compare the efficacy and tolerability of two etanercept dosing regimens--50mg BIW and 100mg once weekly (OW)--for 12 weeks in 108 patients with moderate-to-severe recalcitrant psoriasis. Efficacy measures included Psoriasis Area and Severity Index (PASI), severity of pruritus recorded on a visual analogue scale (VAS) and the influence on quality of life assessed by means of Dermatology Life Quality Index (DLQI). Both etanercept regimens caused a significant change in all the efficacy parameters after 4 weeks and 12 weeks, at a comparable rate. At week 12, a PASI improvement of at least 50% from baseline (PASI 50) was achieved by 74% of patients treated with 50mg BIW and 78% of patients treated with 100mg OW. A PASI 75 response was obtained in 54% and 50% of patients treated with 50mg BIW and 100mg OW, respectively. Treatment was well tolerated with similar type and frequency of adverse events between the two groups.
Adult↗
Infliximab in recalcitrant severe atopic eczema associated with contact allergy.
Infliximab is an anti-tumour necrosis factor (TNF)-alpha chimeric monoclonal antibody which is effective in diseases associated with a T-helper (Th) 1 response, such as rheumatoid arthritis, Crohn's disease and psoriasis. There are sporadic case reports of atopic dermatitis (AD) induced or precipitated by anti-TNF-alpha therapy, which have been attributed to the switch towards Th2-mediated reactions. We report the case of a 30-year-old man with long-standing severe AD associated with contact allergy and poorly responding to conventional treatments. The use of infliximab resulted in a dramatic amelioration of AD lesions and pruritus, persisting at follow-up examinations over a 3-year period. Probably, the unexpected response to infliximab therapy in this case might be due to some peculiar features of AD in our patient (i.e. chronic-continuous course and concomitant contact allergy) which could have been responsible for a more preponderant recruitment of Th1 cells as compared to common forms of AD.
Adult↗