Publications (71) View all
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Article: Efficacy and Safety of Efalizumab in Patients with Moderate-to-Severe Plaque Psoriasis Resistant to Previous Anti-Psoriatic Treatment: Results of a Multicentre, Open-label, Phase IIIb/IV Trial.
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ABSTRACT: OBJECTIVES: To evaluate the efficacy and safety of efalizumab in continuous or interrupted therapy of adults with moderate-to-severe plaque psoriasis who had failed to respond to or were intolerant of other systemic therapies, including methotrexate, ciclosporin and psoralen plus UVA phototherapy, or for whom such therapies were contraindicated. METHODS: Patients received a conditioning dose of efalizumab 0.7 mg/kg followed by once-weekly open-label efalizumab 1.0 mg/kg for 11 weeks. Responders (Physician Global Assessment [PGA] score of "good" or better at Week 12) could continue efalizumab for a further 8 weeks (continuous-treatment period). Nonresponders transitioned to alternative anti-psoriasis medication or stopped treatment. Responders who discontinued efalizumab could restart treatment if symptoms worsened. PGA response was evaluated at Weeks 12 (primary endpoint) and 20, as were the proportions of patients achieving an improvement from baseline of >/=50%, >/=75% and >/=90% in Psoriasis Area and Severity Index (PASI) (PASI 50, PASI 75 and PASI 90, respectively). RESULTS: A total of 1,255 patients were included in the intention-to-treat population. At Week 12, 68.0% of patients had a PGA rating of "good" or better. Of 688 patients who entered the continuous-treatment period, 79.5% had a PGA rating of "good" or better at Week 20. At Week 12, median improvement in PASI score was 68.4%. PASI 50/75/90 was achieved by 65.5%/35.9%/13.0% of patients at Week 12, and by 78.2%/52.9%/24.3% of responders at Week 20. Of the 127 responders at Week 12 who discontinued efalizumab, 11% experienced rebound and 56.7% relapsed within 8 weeks after stopping therapy. Efalizumab was well tolerated during the study. CONCLUSIONS: Efalizumab provided effective control of psoriasis in the majority of patients during the initial treatment period. The high response rates were maintained in initial responders when treatment was continued beyond 12 weeks.Archives of Drug Information 03/2010; 3(1):9-18. -
Article: Analysis of alterations adjacent to invasive squamous cell carcinoma of the penis and their relationship with associated carcinoma.
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ABSTRACT: In contrast to vulvar squamous cell carcinoma (SCC), the etiologic factors and precancerous lesions associated with penile carcinoma remain uncertain. To describe the morphologic features of lesions adjacent to invasive penile SCC and their relationship with the associated carcinoma and to compare these associations with vulvar carcinoma. This was a retrospective histologic analysis of 68 cases of penile SCC. Adjacent lesions were considered to be premalignant lesions. They were classified as penile intraepithelial neoplasia (PIN), squamous hyperplasia (SH), and lichen sclerosus (LS). PIN cases were divided into two subtypes depending on the extension of atypia throughout the epithelium and, by analogy, with the classification of the vulvar intraepithelial neoplasia (VIN). Thus they were designated as undifferentiated (or bowenoid) PIN, defined by full-thickness atypia throughout the epithelium, and differentiated PIN, characterized by atypia confined to the lower third of the epithelium. SCC subtypes were classified as usual, verrucous, warty (condylomatous), basaloid, and mixed. Undifferentiated PIN was observed in 22 cases; LS was observed in 26 cases. Differentiated PIN and SH (except for two cases) were associated with underlying LS. Undifferentiated PIN was always associated with warty (condylomatous) (4 cases), basaloid (16 cases) or mixed SCC (2 cases), and LS with usual (19 cases) or verrucous SCC (7 cases). This was a retrospective analysis This study suggests that, similarly to vulvar carcinoma, penile SCC occurs in association with two types of penile lesions: undifferentiated (or bowenoid) PIN and LS-linked differentiated PIN and/or SH. It appears that the subtype of these carcinomas is related to these adjacent lesions.Journal of the American Academy of Dermatology 02/2010; 62(2):284-90. · 3.99 Impact Factor -
Article: Large scale study of epidermal recovery after stratum corneum removal: dynamics of genomic response.
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ABSTRACT: The stratum corneum (SC) is a superficial skin compartment that protects the body from the outside environment. Any disturbance of this function induces cascading steps of molecular and cellular repair in the whole epidermis. The aim of this study was to investigate epidermal gene expression following SC removal by tape stripping. Twenty-nine healthy male volunteers were included (27 +/- 4 years old). Tape stripping was processed on one inner forearm, the other unstripped forearm served as a control. Epidermis samples were collected at 2, 6, 19, 30 and 72 h after tape stripping. Trans-epidermal water loss measurements were performed at each step to monitor barrier restoration. Total RNA was extracted from collected epidermis samples and analysed by using DermArray cDNA microarrays. Among 4000 genes under investigation, we found that the expression of 370 genes varied significantly at least once during the time following stripping. Using an original clustering method, the modulated genes were gathered into eight groups. A functional characterization of the clusters enabled us to get a dynamic and global view of the main molecular processes taking place during epidermal recovery.Experimental Dermatology 09/2009; 19(3):259-68. · 3.54 Impact Factor -
Article: Incidence, risk factors, and severity of herpesvirus infections in a cohort of 121 patients with primary dermatomyositis and dermatomyositis associated with a malignant neoplasm.
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ABSTRACT: Opportunistic infections have been reported in 15% to 21% of patients with inflammatory myositis. However, to our knowledge, no data are available regarding the incidence, risk factors, and severity of herpesvirus infections. Retrospective inception cohort study. Two departments in tertiary teaching hospitals. Patients All patients diagnosed as having dermatomyositis (DM) according to the criteria of Bohan and Peter seen during a 13-year period. Cumulative incidence rates of herpesvirus infections using the Kaplan-Meier method and risk factors for herpesvirus infections during the first year of DM using Cox proportional hazards models. A total of 121 patients met the inclusion criteria (mean [SD] age, 52 [15] years; 85 were women [70%]). Seventy-six percent had primary dermatomyositis, and 24% had dermatomyositis associated with a malignant neoplasm. The mean (SD) duration of follow-up was 42 (33) months. During follow-up, 20 patients developed a total of 22 herpesvirus infections (16 developed herpes zoster infections). The incidence rates for herpesvirus and for herpes zoster infections were 49 and 33 episodes per 1000 patient-years, respectively. In multivariate analysis, a positive association was noted between the risk of herpesvirus infection and use of systemic corticosteroid therapy (hazard ratio [HR], 3.71 [95% confidence interval {CI}, 1.02-13.41]; P = .04), lymphocyte count lower than 6000/microL (HR, 3.55 [95% CI, 1.00-12.65]; P = .05), and creatine phosphokinase level higher than 300 U/L (HR, 4.81 [95% CI, 1.28-18.06]; P = .02). Dermatomyositis associated with a malignant neoplasm tended to be negatively associated with the risk of herpesvirus infection (HR, 0.16 [95% CI, 0.02-1.29]; P = .08). The risk of serious herpesvirus infections in patients with DM is high. Educational strategies and studies evaluating the risk-to-benefit and the cost-to-benefit balances of a prophylaxis with valacyclovir hydrochloride in selected patients with DM are warranted.Archives of dermatology 09/2009; 145(8):889-93. · 4.76 Impact Factor -
Article: Psoriasis: characterization of six different clinical phenotypes.
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ABSTRACT: Until recently, psoriasis was considered as a single disease entity. However, the discovery of major differences between early- or late-onset psoriasis suggests the presence of distinct disease phenotypes which may differ in their pathophysiology and in their treatment responsiveness. The objective of this study was to use exploratory data analysis methods to identify potential clinical psoriasis phenotypes without a priori hypotheses. A prospective questionnaire-based survey collected comprehensive informations on the main clinical characteristics of 1484 psoriatic patients. Six statistically different clusters of clinical symptoms were observed, corresponding at least to six different clinical psoriasis phenotypes. Moreover, discriminant functions allow patients to be assigned to one or other of these phenotypes. Our findings open the way to focus genetic, pharmaco-genetic, pathophysiological and therapeutic studies on more homogenous group of patients.Experimental Dermatology 04/2009; 18(8):712-9. · 3.54 Impact Factor
