Guselkumab-Treated Patients with Plaque Psoriasis Who Achieved Complete Skin Clearance for ≥ 156 Consecutive Weeks: A Post-Hoc Analysis From the VOYAGE 1 Clinical Trial.

BACKGROUND: Treatment of moderate-to-severe plaque psoriasis with biologics, such as guselkumab, has demonstrated greater efficacy over traditional non-biologic treatments. However, given patient diversity, greater understanding of the relationship between patient characteristics, positive clinical outcomes, and long-term response to biologics is crucial for optimizing treatment choices. MATERIALS AND METHODS: This post-hoc analysis of the 5-year VOYAGE 1 clinical trial compares baseline characteristics of patients maintaining a Psoriasis Area and Severity Index (PASI) score of 0 at all visits for ≥ 156 consecutive weeks (PASI = 0 group) with those that never achieve PASI = 0 (comparator group), using descriptive statistics and a multiple logistic regression model. Guselkumab plasma trough concentrations in both response groups were assessed from Weeks 4-156. RESULTS: Of patients who started guselkumab treatment at Week 0 or at Week 16 after switching from placebo, 22.7% (112/494) maintained PASI = 0 for ≥ 156 consecutive weeks. Numerical differences in baseline characteristics, including age, obesity, diabetes, PASI score, disease duration, smoking status, and psoriatic arthritis comorbidity, were identified between the PASI = 0 group and comparator group. Plasma guselkumab levels were consistently higher in the PASI = 0 group. Multiple logistic regression analysis revealed absence of diabetes, lower Dermatology Life Quality Index score at baseline, and higher Week 4 guselkumab plasma concentration as significantly (p < 0.05) associated with the PASI = 0 group. CONCLUSION: A substantial (22.7%) number of guselkumab-treated patients in the VOYAGE 1 clinical trial maintained complete skin clearance for a consecutive period of ≥ 156 weeks. Factors associated with this outcome may suggest clinical benefits of holistic treatment approaches. TRIAL REGISTRATION: NCT02207231.

Apremilast for the treatment of psoriasis.

INTRODUCTION: Psoriasis is a chronic inflammatory skin disease characterized by dysregulation of the immune system and release of pro-inflammatory mediators. Drugs available for psoriasis show some limits as tolerability and route of administration. Apremilast , Otezla®, is an oral small molecule recently approved for the treatment of patients with moderate-to-severe plaque psoriasis. Compared to biologics that target a single cytokine, apremilast, degrading phosphodiesterase 4 (PDE4), interferes with cyclic anti-microbial peptides, which is involved in the transduction of intracellular signals, controlling the balance of pro-inflammatory and anti-inflammatory signals. AREAS COVERED: This review reported the latest data available from Phase I, II and III trials on apremilast for the treatment of plaque psoriasis. A focus on the clinical management of apremilast, safety and clinical efficacy based on two pivotal clinical trials (ESTEEM 1 and ESTEEM 2) currently ongoing was described. A systematic search was conducted using the PubMed Medline database for primary articles. EXPERT OPINION: Apremilast treatment was demonstrated effective and well tolerated in Phase II and III clinical trials. Several drug peculiarities, such as the low frequency of adverse events and the oral route of administration, make apremilast an innovative treatment for moderate-to-severe psoriasis.

Calcipotriene/betamethasone in the treatment of psoriasis: a review article.

Plaque-type psoriasis is a chronic and immune-mediated skin disease affecting approximately 1-3% of the Caucasian population. Most cases are of mild or moderate severity and benefit from local treatment that represents the mainstay therapy. Topical corticosteroids and vitamin D(3) analogues remain the option of choice. Optimization of these treatments is made by the combination of calcipotriene and betamethasone dipropionate. This formulation combines the keratinocyte differentiation and antiproliferative action of the vitamin D(3) analogues with the anti-inflammatory effect of steroids enhancing effectiveness while reducing the side-effect profile of the single topical agent. In this article, we highlight the advantages of the association of calcipotriene and betamethasone in the treatment of localized plaque-type, scalp and nail psoriasis.

Recent patents on melanoma with focus on genetic strategies.

Recent advances in molecular biology have enhanced the understanding of the pathology of melanocytic lesions. Several targetable pathways, responsible for survival and apoptosis resistance in melanoma cells, have been described and current research has focused on mechanism inactivating these pathways. However, the therapeutic resistance of malignant melanoma remains the main limit that cast the poor prognosis of cutaneous melanoma. Current advances in high-resolution genome-wide technologies, as well as gene-specific mutational analysis, in conjunction with genetic and phenotypic analyses, improved animal models, may ultimately help to better define the seminal molecular events contributing to disease pathogenesis and ultimately identify more effective therapeutic targets. The focus of this review is to summarize the emerging patents in the treatment and diagnosis of melanoma related to the latest genetic models and bio-molecular discoveries.