For NOMID | The Data

In a long-term study, Kineret® (anakinra) was shown to reduce NOMID symptoms and inflammation.1,2

Kineret was studied in a prospective, long-term, open-label study of 43 NOMID patients, 0.7 to 46 years of age, treated for up to 60 months.1

Overall DSSS and each of its symptoms rapidly improved and was maintained over 60 months.1

  • The figure shows mean values for observed cases at all given time points. ITT observed cases (N=29)
    • Results for this endpoint were consistent across all subgroups including age, gender, presence of NLRP3/CIAS1 mutation, and disease phenotype
  • Treatment with Kineret also appeared to be associated with improvement of, or stability in, other NOMID disease manifestations, up to 60 months
    • CNS inflammation
    • Audiogram
    • Visual acuity
  • NOMID patients who were withdrawn from Kineret therapy responded again when treatment resumed
  • For the 11 patients who went through a withdrawal phase, disease symptoms and key biomarkers of inflammation worsened after withdrawal and promptly responded to reinstitution of Kineret therapy
Disease symptom scores chart
Study design: Clinical efficacy and safety were determined by a prospective, long-term, open-label, uncontrolled study in 43 NOMID patients 0.7 to 46 years of age. Primary endpoints included change in disease-specific Diary Symptom Sum Scores (DSSS), including fever, rash, joint pain, vomiting, and headache, as well as change in the levels of inflammatory biomarkers SAA, hsCRP, and ESR. Initial Kineret dose was 1 mg/kg to 2.4 mg/kg body weight, adjusted to 0.5 mg/kg to 1 mg/kg increments. The maximum dose actually studied was 7.6 mg/kg/day. The average maintenance dose was 3 to 4 mg/kg daily. The duration of treatment with Kineret was up to 60 months.

Systemic inflammatory markers were significantly reduced in all patients treated with Kineret.2–3

  • Systemic inflammatory remission was achieved in all patients; however, remission and relapse continued to occur in patients with infections or stress3
    • Inflammatory remission was defined as CRP level 0.5 mg/dL, ESR 25 mm/hour, and SAA 10 mg/liter3
  • Patients had significant reductions in inflammatory markers from baseline at 6, 12, and 36 months and results were stable from 36 to 602–3
Inflammatory markers chart
Study design: Clinical efficacy and safety were determined by a prospective, long-term, open-label, uncontrolled study in 43 NOMID patients 0.7 to 46 years of age. Primary endpoints included change in disease-specific Diary Symptom Sum Scores (DSSS), including fever, rash, joint pain, vomiting, and headache, as well as change in the levels of inflammatory biomarkers SAA, hsCRP, and ESR. Initial Kineret dose was 1 mg/kg to 2.4 mg/kg body weight, adjusted to 0.5 mg/kg to 1 mg/kg increments. The maximum dose actually studied was 7.6 mg/kg/day. The average maintenance dose was 3 to 4 mg/kg daily. The duration of treatment with Kineret was up to 60 months.

Kineret has a well-documented safety profile with > 13 years of clinical and patient experience in NOMID.1,3

  • The most common adverse event associated with Kineret was injection-site reaction (ISR)1
  • No patient permanently discontinued Kineret treatment due to injection site reactions, the majority of which were mild (76%) or moderate (24%)1
  • There were 24 serious adverse events (SAEs) reported in 14 of the 43 treated patients*

*The most common SAEs were infections (a total of 13 infections in 7 patients, with pneumonia and gastroenteritis occurring in 3 and 2 patients, respectively. Five SAEs were related to lumbar puncture, which was a study procedure.)

Percent of NOMID patients reporting adverse events1
Preferred Term N (%) Number of Events/Patient Year
Injection site reaction 7 (16.3%) 0.5
Headache 6 (14.0%) 0.7
Vomiting 6 (14.0%) 0.6
Arthralgia 5 (11.6%) 0.6
Pyrexia 5 (11.6%) 0.4
Nasopharyngitis 5 (11.6%) 0.3