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Guselkumab

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Information about Guselkumab

Guselkumab is human monoclonal antibody to interleukin-23 and is used to treat severe psoriasis. 

Liver toxicity

Guselkumab is associated with a low rate of transient and asymptomatic serum enzyme elevations during therapy, but has not been linked to cases of idiosyncratic, clinically apparent liver injury.

Mechanism of action of Guselkumab

Guselkumab (gue" sel koo' mab) is a human monoclonal immunoglobulin G1 antibody to interleukin (IL)-23, a cytokine that is an important mediator of autoimmune reactions.  IL-23 is found in the skin lesions of psoriasis and in the affected gastrointestinal mucosa of patients with inflammatory bowel disease.  Although similar, guselkumab is directed to the p19 subunit of IL-23 whereas ustekinumab is directed at the p40 subunit which is a component shared by both IL-23 and IL-12.  As a consequence, guselkumab has a more restricted activity in the Th17 immune pathways which are considered to play a major role in autoimmune reactions. 

FDA approval information for Guselkumab

Guselkumab was approved for use in United States in 2017, and current indications are limited to moderate-to-severe plaque psoriasis, although it is under active investigation as therapy of several other autoimmune diseases.  Guselkumab is available in liquid solution in single use prefilled syringes of 100 mg/mL under the brand name Tremfya. 

Dosage and administration for Guselkumab

The typical regimen is 100 mg subcutaneously initially, 4 weeks later and then every 8 weeks. 

Side effects of Guselkumab

Side effects are uncommon and are usually mild, but may include injection site reactions, headache, arthralgias, diarrhea, gastroenteritis, and minor infections such as upper respiratory infections and those due to tinea and herpes simplex.  Less common, but potentially severe side effects include serious infections and reactivation of tuberculosis.

Antipsoriasis agents

Monoclonal Antibodies IL-17A Antagonists

Tumor Necrosis Factor Antagonists

Other

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