For DIRA | The Data

In a long-term study, Kineret® (anakinra) was demonstrated to induce remission in patients with DIRA.1

Remission criteria:

C-reactive protein (CRP) ≤5 mg/L, no pustulosis, no inflammatory bone disease (no evidence of bone inflammation shown in imaging [bone scans, X-rays, or MRIs] such as osteomyelitis/periostitis, or no clinical evidence of bone pain or bone swelling [in which case no bone imaging was performed]), no concomitant glucocorticosteroid use.2

  • The median time to the first documented inflammatory remission was 15 months2
  • Almost all patients were able to discontinue glucocorticosteroid treatment2
Study Design: Clinical efficacy and safety were determined by a long-term natural history study including 9 DIRA patients (ages 1 month to 9 years at the start of Kineret treatment).1
  • Primary endpoints included the proportion of patients during the first Kineret treatment period who achieved inflammatory remission at 6 months, 12 months, and at the final National Institutes of Health (NIH) visit2
  • Initial Kineret dose was 1 to 2 mg/kg/day in the 6 patients for which the dose was reported. The dose was then individually adjusted to reach a stable efficacious dose1
  • The highest Kineret dose studied was 7.5 mg/kg/day. At the last visit during the first Kineret treatment period, the dose ranged between 2.2 and 6.1 mg/kg/day1
  • The duration of treatment with Kineret was up to 10 years1

The safety of Kineret was studied in patients with DIRA for more than 11 years.1

  • The most common adverse events were upper respiratory tract infections, rash, pyrexia, influenza-like illness, and gastroenteritis1
  • No patient permanently discontinued Kineret treatment due to adverse events1
  • There were 16 serious adverse events (SAEs) reported in 4 out of 9 treated patients1,2,*
  • Overall, the safety profile observed in patients with DIRA treated with Kineret was consistent with the safety profile in NOMID patients1
*The most common type of SAE reported (5 events in 2 patients) was infection.