ABSTRACT
Purpose: SUPREME, a phase IIIb study conducted in Italy, demonstrated safety and high efficacy of secukinumab for up to 72 weeks in patients with moderate-to-severe plaque-type psoriasis. SUPREME 2.0 study aimed to provide real-world data on the long-term drug survival and effectiveness of secukinumab beyond 72 weeks. Patients and Methods: SUPREME 2.0 is a retrospective observational chart review study conducted in patients previously enrolled in SUPREME study. After the end of the SUPREME study, eligible patients continued treatment as per clinical practice, and their effectiveness and drug survival data were retrieved from medical charts. Results: Of the 415 patients enrolled in the SUPREME study, 297 were included in SUPREME 2.0; of which, 210 (70.7%) continued secukinumab treatment throughout the 42-month observation period. Patients in the biologic-naïve cohort had higher drug survival than those in the biologic-experienced cohort (74.9% vs 61.7%), while HLA-Cw6-positive and HLA-Cw6-negative patients showed similar drug survival (69.3% and 71.9%). After 42 months, Psoriasis Area and Severity Index (PASI) 90 was achieved by 79.6% of patients overall; with a similar proportion of biologic-naïve and biologic-experienced patients achieving PASI90 (79.8% and 79.1%). The mean absolute PASI score reduced from 21.94 to 1.38 in the overall population, 21.90 to 1.24 in biologic-naïve and 22.03 to 1.77 in biologic-experienced patients after 42 months. The decrease in the absolute PASI score was comparable between HLA-Cw6-positive and HLA-Cw6-negative patients. The baseline Dermatology Life Quality Index scores also decreased in the overall patients (10.5 to 2.32) and across all study sub-groups after 42 months. Safety was consistent with the known profile of secukinumab, with no new findings. Conclusion: In this real-world cohort study, secukinumab showed consistently high long-term drug survival and effectiveness with a favourable safety profile.
Subject(s)
Granuloma/pathology , Immunoglobulin A/blood , Multiple Myeloma/pathology , Pyoderma/pathology , Skin Diseases, Vesiculobullous/pathology , Aftercare , Aged , Anti-Infective Agents/administration & dosage , Anti-Infective Agents/therapeutic use , Antineoplastic Agents, Alkylating/administration & dosage , Antineoplastic Agents, Alkylating/therapeutic use , Biopsy/methods , Bone Marrow/pathology , Cyclophosphamide/administration & dosage , Cyclophosphamide/therapeutic use , Dapsone/administration & dosage , Dapsone/therapeutic use , Drug Therapy, Combination , Granuloma/complications , Humans , Hyperpigmentation/pathology , Male , Multiple Myeloma/complications , Multiple Myeloma/diagnosis , Skin Diseases, Vesiculobullous/complications , Skin Diseases, Vesiculobullous/diagnosis , Treatment OutcomeABSTRACT
On January 30, 2020, World Health Organization (WHO) stated that a new coronavirus disease outbreak [COronaVIrus Disease - 19 (COVID-19)] was an international public health emergency. Many news, often fake ones, about the derived pandemic rapidly spread along the media, thus leading many dermatological patients to identify as "risk category" and sometimes discontinue treatments by themselves. The Dermatology Units in Grosseto and Pordenone simultaneously carried out a data collection by remote-conducted visits, evaluating the incidence of COVID-19 in psoriatic patients. Only 1 patient (close contact of a case) as part of the psoriasis analyzed group was tested and turned out to be positive for SARS-CoV-2, developing no symptoms during the observation period. The collected information may suggest that psoriasis, biotechnologically treated or not, cannot promote or aggravate the clinical trend of the SARS-CoV-2 infection, hence stopping systemic therapy in negative or clinically free SARS-CoV-2 patients is not recommended in general.
Subject(s)
Immunosuppressive Agents/adverse effects , Polyradiculoneuropathy, Chronic Inflammatory Demyelinating/drug therapy , Psoriasis/chemically induced , Rituximab/adverse effects , Adult , Combined Modality Therapy , Humans , Immunocompromised Host , Immunoglobulins, Intravenous/therapeutic use , Immunosuppressive Agents/therapeutic use , Male , Plasma Exchange , Prednisone/therapeutic use , Psoriasis/immunology , Rituximab/therapeutic useABSTRACT
Psoriasis (PSO) is traditionally defined as an immune-mediated, inflammatory dermatological disease characterized by a chronic-relapsing course and associated with multifactorial inheritance (genetic predisposition and influence of various environmental factors). Considered until recently a dermatological disease only, today PSO is correctly known as a systemic one because of the involvement of multiple organs with important impact on social life and relationships. PSO is found in the 0.3-4.6% of the world's population, while its prevalence in the Italian population is estimated at 2.8%. Therefore, if we consider that in Tuscany more than 100,000 people out of 3,672,202 suffer of psoriasis, it is of paramount importance to focus on a shared clinical and therapeutic protocol to manage the disease. With the aim of ensuring diagnostic-therapeutic suitability, high levels of care and standardization of treatment, a unique clinical-therapeutic management model has been developed and validated in Tuscany, involving all accredited regional dermatological centers. Among the possible alternatives to be implemented in the treatment of patients with mild, moderate-severe psoriasis, UVBnb phototherapy is widely used alone or in association with other systemic and non-systemic devices. Despite this, there is still no universally shared therapeutic protocol. In this context the CO.FO.TO working group (Consensus Fototerapia Toscana) is born with the aim of defining and validating the main guidelines in the use of phototherapy with UVBnb in psoriasis; the guidelines are based both on the real-life experience of the different centers of reference in the region and on the revision of the recent literature.