Biosimilars: potential implications for clinicians

With the expiration of patent protection for several biologics looming, the production of highly similar therapeutic agents has begun to emerge on the pharmaceutical market. These alternative drugs are referred to as biosimilars. Many anticipate that the introduction of these agents will result in a reduction in health care costs, which may create a more affordable biopharmaceutical market and also improve patient access. In contrast to generics, which are exact copies of their original products, biosimilars are not identical to their reference products. Due to concern about the safety and efficacy of biosimilars, separate regulatory approval pathways have been developed and implemented by several countries, including the US and Europe. Europe has led the way in acceptance of biosimilars into mainstream clinical practice. Biosimilars are not generic products and require extensive clinical and nonclinical bioequivalence studies before receiving marketing approval. Not only is there a lengthy developmental process, but also they will likely be required to have postmarketing surveillance and ongoing safety monitoring to keep track of issues that may arise, such as immunogenicity. Although US Food and Drug Administration approved the first biosimilar product in March 2015, physicians remain unfamiliar about their indications

A case-control study to evaluate the prevalence of nonalcoholic fatty liver disease among patients with moderate-to-severe psoriasis

© 2018 Matrix Medical Communications. All rights reserved. Objective: International case-control studies have demonstrated that psoriasis is associated with an increased prevalence of nonalcoholic fatty liver disease (NAFLD). The purpose of the present study was to establish an association of psoriasis and NAFLD in patients attending a dermatology clinic center in the United States. Design: This was an observational, case-control study. Setting: The study setting was an outpatient dermatology clinic of the George Washington Medical Faculty Associates in Washington DC. Participants: One hundred fifty-one adult patients with psoriasis and 51 control subjects were recruited. Measurements: NAFLD was diagnosed by ultrasonography after excluding secondary causes of liver disease. Regression analysis was used to assess the associations between: 1) NAFLD and psoriasis and 2) metabolic syndrome components and NAFLD among psoriasis patients. Results: NAFLD was more prevalent in patients with psoriasis (21.2% vs. 7.8%, p\u3c0.04). However, psoriasis was not associated with NAFLD when matching for age, sex, and body mass index (BMI) (odds ratio: 2.63, 95% confidence interval [CI]: 0.51-13.6; p=0.25). As compared to patients with psoriasis but without NAFLD, those with NAFLD were more likely to have obesity (BMI: 34.9 vs. 27.2, 95% CI: 32.4-37.5 vs. 25.9-28.5; p\u3c0.01). NAFLD in patients with psoriasis was also associated with select components of metabolic syndrome, including hyperglycemia and hyperlipidemia. Conclusion: Our findings show there is an association of psoriasis with NAFLD. Our findings also suggest an increased presence of metabolic syndrome components in patients with psoriasis and NAFLD. Trial registry: NCT00930384

A Case–Control Study to Evaluate Serum Lipoprotein Levels and Other Biomarkers of Cardiovascular Disease in Patients With Psoriasis

© The Author(s) 2018. Background: Studies investigating lipid abnormalities associated with psoriasis have reported conflicting results. The purpose of this study is to evaluate differences in serum lipoprotein levels among patients with psoriasis compared to controls via the use of the Vertical Auto Profile (VAP) test, which directly measures the cholesterol concentrations of all 5 lipoprotein classes and their subclasses. We also assess other cardiovascular biomarkers, including highly sensitive C-reactive protein (hs-CRP), lipoprotein-associated phospholipase A2 (Lp-PLA2), and homocysteine. Methods: In this 6-year case–control study, 210 patients (110 patients with psoriasis and 100 controls) elected to participate in VAP testing between November 2009 and April 2016 at The George Washington Medical Faculty Associates dermatology clinic. All psoriatic cases were age-, sex-, and body mass index–matched to control patients. Data were analyzed in June 2016. We evaluated cardiovascular biomarkers in patients with psoriasis versus control patients and whether an association exists between the presence of psoriasis and the level of cardiovascular dysfunction. Results: Compared to the control group, patients with psoriasis had significantly lower high-density lipoprotein (HDL) (P =.007), HDL2 (P =.013), and HDL3 cholesterol (P =.015) as well as higher low-density lipoprotein (LDL) pattern B (P=.032), LDL3 (P =.030), and LDL4 cholesterol (P =.003). Patients with psoriasis also had lower apolipoprotein A1 (P =.011), lower Lp-PLA2 (P =.037), and higher hs-CRP (P =.048). Conclusion: Our findings suggest an increased risk of cardiovascular biomarker dysfunction in patients with psoriasis compared to their matched controls. Serum biomarkers such as high LDL pattern B, LDL3, and LDL4 as well as lower HDL2, HDL3, and total HDL were found to have a higher association with psoriatic disease