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Gabay and colleagues have reported the results of a novel new recombinant human IL-18 binding protein, tadekinig alfa, demonstrating its effectiveness in an open-label dose escalating study in patients with adult-onset Still's disease (AOSD).
The treatment of Still's disease has been revolutionized by the observation that this inflammasomopathy can be more effectively managed by inhibitors of IL-1 and IL-6. But the same mechanisms driving excess IL-1 production and excessive caspase activity are mirrored by IL-18.
They enrolled 21 adults with AOSD plus fever or or elevated C-reactive protein (CRP) levels and were treated with tadekinig alfa 80 mg (10 patients) or 160 mg (13 patients) subcutaneously three times per week for 12 weeks.
By week 3, half of those treated with either 80 mg or 160 mg achieved the predefined response criteria.
They found 155 treatment-emerging AEs were recorded, most of which were mild, resolved and one-third were were considered related to the study drug. There were 3 serious AEs occurred, one possibly related to treatment (toxic optic neuropathy).
These early results suggest and acceptable safety profile and good efficacy and warrants further controlled trial investigation in AOSD.