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The clinical performance of biological therapies is affected by their manufacturing processes. The advent of biosimilars increases the need to understand the clinical impact of potential differences versus originator products. We review important recently published technical data on adalimumab consistency and manufacturing experience from a clinical perspective, including the implications for immunogenicity when there are changes to a tightly controlled manufacturing process that may lead to variations in the epitopes of biological therapies. ispartof: GaBI - Generics and Biosimilars Initiative Journal vol:5 issue:2 pages:70-73 status: published

This review delivers a commentary on the first decade of biologics’ use in psoriasis and provides a glimpse of the pipeline of therapies currently in development for psoriasis that will enhance the therapeutic armamentarium available to the dermatologist. In addition, the authors revisit the rationale for the development of biological therapies, inventory the available therapies of today, and retrospectively assess their impact on the dermatology practice as it relates to the management of patients with psoriasis.

Therapeutic agents with a putative anti-inflammatory mode of action are increasingly being pilot tested in psoriasis, a chronic inflammatory systemic disease. This is because the psoriasis patient contributes a number of advantages to trial design and execution (e.g., high disease prevalence, homogenous patient characteristics, skin manifestation that supports quick and easy quantification and viable placebo controls). Trial design for psoriasis is relatively standardized. Chronic plaque-type psoriasis usually follows a stable clinical course and also has well-accepted inclusion and exclusion criteria. Since psoriasis disease activity is characterized by lesions and percentage of the body area affected, there are multiple acceptable study end points that afford quantification of therapeutic impact, including quality of life, in the absence of a need for surrogate or biomarkers. Limitations of the psoriasis clinical trial framework are also apparent (e.g., multiple psoriasis phenotypes or capacity to evalu...

The International Psoriasis Council (IPC) is a global nonprofit organization dedicated to advancing psoriasis research and treatment by providing a forum for education, collaboration, and innovation among physicians, researchers, and other professionals interested in psoriasis. Each year, the IPC identifies the top papers in the field of psoriasis. Those selected from the second half of 2010 are reviewed here.

The International Psoriasis Council (IPC) is a global nonprofit organization dedicated to advancing psoriasis research and treatment by providing a forum for education, collaboration, and innovation among physicians, researchers, and other professionals interested in psoriasis. Each year, the IPC identifies the top papers in the field of psoriasis. They are reviewed here.

β–Defensin-2 Protein Is a Serum Biomarker for Disease Activity in Psoriasis and Reaches Biologically Relevant Concentrations in Lesional Skin

The entry of biosimilar forms of biopharmaceutical therapies for the treatment of psoriasis and other immune-mediated disorders has provoked considerable interest. Although dermatologists are accustomed to the use of a wide range of generic topical agents, recognition of key differences between original agent (ie, the name brand) and the generic or biosimilar agent is necessary to support optimal therapy management and patient care. In this review we have summarized the current state of the art related to the impending introduction of biosimilars into dermatology. Biosimilars represent important interventions that are less expensive and hence offer the potential to deliver benefit to large numbers of patients who may not currently be able to access these therapies. But the development of biosimilars is not equivalent to that of small molecule generic therapies because of differences in molecular structure and processes of manufacture. The planned regulatory guidelines and path to approval may not encompass all of these potentially important differences and this may have clinical relevance to the prescriber and patient. Consequently, we have identified a series of key issues that should be considered to support the full potential of biosimilars for the treatment of psoriasis; ie, that of increased access to appropriate therapy for the psoriasis population worldwide.

This study correlated assessment tools for evaluating the severity of skin, nail, and joint symptoms in patients with psoriasis (Pso) and psoriatic arthritis (PsA). Adults with plaque Pso (with or without PsA) were enrolled from four U.S. institutions. Patients were evaluated using a novel 10-area Linear Psoriasis Area and Severity Index (XL-PASI), Psoriatic Arthritis Assessment (PsAA), Psoriatic Arthritis Screening and Evaluation Questionnaire (PASE), Nail Assessment (NA) and Joint Assessment (JA) tools, Psoriasis Weighted Extent and Severity Index (PWESI), and Lattice Physician Global Assessment (LS-PGA). Correlations between assessment tools and individual items in the assessment tools were performed. Data from 180 patients (55 with PsA) were analyzed. Highest correlations between tools (r = 0.77-0.88) were between the XL-PASI, PWESI and LS-PGA. Individual items in the XL-PASI correlated with items in the PWESI for extent skin symptoms, but not for all body areas. Overall, correlations were seen between hands and feet, between face and scalp, and between buttocks, chest, and back. Only low correlation was seen between items assessing joint symptoms with items assessing skin symptoms. These data support the notion that the complex phenotype of psoriatic disease requires instruments that assess the severity of skin, nails, and joints separately.