Rare Disease Report

Sobi Randomizes First Patient with Still's Disease in Phase 3 of Anakinra

NOVEMBER 16, 2017
Mathew Shanley
This morning, Swedish Orphan Biovitrum AB (Sobi) announced that the first patient was randomized in a phase 3 evaluating the safety and efficacy of anakinra for the treatment of Still’s disease.

"We are very pleased with having initiated this confirmatory clinical study investigating the safety and efficacy of anakinra in people with Still's disease. This is a disease affecting both young people and adults and is associated with a significant morbidity and with a large unmet medical need," says Milan Zdravkovic, Senior Vice President, Chief Medical Officer and Head of Research & Development at Sobi in a press release.

The condition is characterized by symptoms like spiking fever, typical transient cutaneous rash, arthritis, lymphadenopathy, hepatosplenomegaly, and serositis.

In October, Rare Disease Report sat down with Len Walt, the Vice President and Head of Medical Affairs at Sobi in North America. In the video below, he explains the pathophysiology of Still’s disease, and also the mechanism of action and targets for anakinra.

Walt: So, Still’s disease is an autoinflammatory disease, and a defect in the innate immune system. Once again, what you get is you get an increased inflammatory state. Still’s disease occurs in both children and adults. In children, it’s known as SJIA, or Systemic Juvenile Idiopathic Arthritis. In the adult-onset (population), it’s known as AOSD, which is Adult Onset Still’s Disease. Essentially, it’s the same disease, but adult-onset, obviously, occurs later in life.

We currently don’t have an approved label for Still’s disease, but we have a clinical development program that is ongoing in Still’s disease. We are in the process of enrolling patients into a phase 3 trial where we’re looking at both SJIA and AOSD patients, and comparing (anakinra) to placebo. Endpoints we’re looking at are reduction in fever and associated morbidity.


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