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The young child was hospitalized for an episode of adenovirus gastroenteritis, which resolved within 2 weeks. Four days later, after receiving the third dose of canakinumab, he was rehospitalized for the macrophage activation syndrome; serious pulmonary hypertension developed, and he died 3 weeks later. In addition, two deaths occurred outside the studies. A 9-year-old girl died from disease progression around 3 months after trial discontinuation due to an unsatisfactory therapeutic impact. A 19-year-old woman died more than 2 years after receiving the last dosage of canakinumab in the phase 2 trial18; the patient’s cerebrospinal-fluid and bloodstream cultures were positive for Streptococcus pneumoniae.