April 18, 2018
American College of Rheumatology White Paper on Biosimilars: The American College of Rheumatology (ACR) published a white paper that reviews the scientific, clinical, economic, and prescribing issues related to use of biosimilars. A "biosimilar" is a biologic product that is highly similar to an approved reference (or originator) biologic product and has no clinically meaningful differences in efficacy, adverse effects, or immunogenicity compared to the reference product. Based on the outcomes of rigorous regulatory requirements, the ACR white paper asserts that patients and healthcare providers should have confidence that an approved biosimilar should produce clinical outcomes comparable to those achieved with its reference product. The paper encourages healthcare providers to incorporate biosimilars into their practices where appropriate with the goal of continued delivery of high-quality health care at lower cost to individual patients.
September 1, 2017
Guselkumab (Tremfya®) Approved for Moderate to Severe Plaque Psoriasis: Guselkumab is a selective inhibitor of interleukin (IL) 23, a cytokine involved in development of psoriatic lesions. It was FDA approved in July 2017 for treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Three randomized, phase III clinical trials demonstrated efficacy superior to placebo and positive benefits compared to adalimumab and in patients who had inadequate responses to ustekinumab. Side effects are generally mild, but serious infectious have occurred rarely. Patients should be evaluated for tuberculosis infection prior to starting therapy and should avoid live vaccines while using guselkumab.
February 22, 2017
Brodalumab for Moderate to Severe Plaque Psoriasis: Brodalumab (Siliq) is a human interleukin-17 receptor A antagonist approved for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and who have failed to respond or have lost response to other systemic therapies. In three randomized, placebo-controlled trials, more patients treated with brodalumab compared with placebo had skin that was clear or almost clear of psoriatic lesions. Brodalumab carries a black box warning because of an observed risk of suicidal ideation and behavior, and the drug has restricted availability under a Risk Evaluation and Mitigation Strategy (REMS). At this time, the role of brodalumab in the treatment of psoriasis has not been established, and its cost is not yet available.
CHAPTER SUMMARY FROM THE PHARMACOTHERAPY HANDBOOK
For the chapter in the Wells Handbook, please go to Chapter 17. Psoriasis.
Patients with psoriasis have a lifelong illness that may be very visible and emotionally distressing. There is a strong need for empathy and a caring attitude in interactions with these patients.
Psoriasis is a progressive T-lymphocyte–mediated systemic inflammatory disease that results from a complex interplay between multiple genetic factors and environmental influences. Genetic predisposition and precipitating “trigger” factors play a role in the “march of psoriasis.” This ...