PDSA e-News: September 27, 2018



argenx logoArgenx releases Phase 2 trial results on efgartigimod (ARGX-113) as a possible alternative therapy for ITP management

In a Phase 2 clinical trial, ITP patients treated with efgartigimod (ARGX-113) exhibited clinically meaningful platelet count increases across doses and a wide range of patients, including those newly diagnosed with ITP. Efgartigimod blocks antibody recycling through FcRn binding and leads to fast depletion of autoimmune disease-causing IgG autoantibodies. In patients with ITP, pathogenic IgGs drive disease progression by accelerating platelet clearance, inhibiting the production of platelets, and inducing platelet destruction, all leading to the severe hindrance of a patient’s blood to clot and heal.

The Phase 2 proof-of-concept clinical trial (double-blind, randomized, placebo-controlled) involving 38 diagnosed ITP patients undergoing standard treatment has been completed. The topline results from this trial also showed that efgartigimod was well tolerated by patients, only presenting patients with mild adverse effects. The full data from this Phase 2 trial on ITP patients will be released in early December.

Based on their positive findings, Argenx plans to begin a Phase 3 trial on efgartigimod (IV) in treating ITP.

Argenx. “argenx reports positive topline results from Phase 2 proof-of-concept trial of efgartigimod in primary immune thrombocytopenia.” September 17, 2018. https://bit.ly/2QD7F6P


Impact of ITP – Increasing risk of complications in pregnancy

Pregnant womanPast studies have found that all women suffer a significant decrease in platelet count over the course of a pregnancy. However, this study also discovered a correlation between platelet count and the risk of pregnancy-related complications. Amassing data from over 7,000 patients displayed that the lower a patient’s platelet count at the third trimester, the higher the risk of a complication occurring. Two percent more pregnancy-related complications were seen in patients with platelet counts below 150,000 (11.9% vs. 9.9%). Patients suffering from additional causes of thrombocytopenia, such as ITP, have been found to have a platelet count of roughly 100,000.

Reese, J. A.; Peck, J. D.; Deschamps, D. R.; McIntosh, J. J.; Knudtson, E. J.; Terrell, D. R.; Vesely, S. K.; George, J. N. Platelet Counts during Pregnancy. N. Engl. J. Med. 2018, 379 (1), 32–43. https://bit.ly/2wZJwPI




 

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