Efficacy and Safety of Canakinumab in Schnitzler Syndrome
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
Schnitzler syndrome is a disabling inflammatory disease, characterized by chronic urticaria,
fever, arthralgia, bone pain and gammopathy, which can so far only be effectively treated
with anakinra, an interleukin-1 receptor antagonist. However, this drug is not registered for
use in Schnitzler syndrome, and it needs to be injected daily, which is uncomfortable and
unpractical. Therefore other treatments targeting IL-1 are needed. Canakinumab is a
long-acting monoclonal antibody against IL-1β that has been registered for bimonthly use in
the rare autoinflammatory disease Cryopyrin-associated periodic syndrome (CAPS). We
hypothesize that it will be effective in Schnitzler syndrome too in view of clinical
similarities to CAPS and the targeting of IL-1B, which is also blocked by anakinra (which
blocks both IL-1B and IL-1A).
This is a 6-month open-label, single treatment arm study of canakinumab 150 or 300 mg (in
case of insufficient response to 150 mg) subcutaneous injection once per month in patients
with active Schnitzler syndrome, in which efficacy and safety will be assessed.