Full Prescribing Information and Instructions for Use
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Kineret and IL-1 Patient Insights Kineret RA Data Kineret NOMID Data KINERET® On TRACK Resources

Kineret® (anakinra) is the first and only approved treatment for NOMID1

  • NOMID is the most severe form of cryopyrin-associated Periodic Syndromes (CAPS), a group of rare autoinflammatory disorders2
  • In the treatment of NOMID, early diagnosis and control of inflammation is critical to preventing the long-term, irreversible damage and disability that can occur2-4
  • 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 months1

NOMID is a challenging diagnosis, derived from inflammatory markers, clinical symptoms, severity, and age of onset2,3

  • Symptoms of NOMID include aseptic meningitis, urticaria-like rash, fever, vomiting, joint pain, headache, and conjunctivitis1,3
  • Over time, chronic inflammation can lead to developmental delay, sensorineural hearing loss, physical disability, and intellectual disability2,3
  • Although NOMID is often associated with mutations in the CIAS1/NLRP3 gene, approximately 40% of NOMID patients test negative using conventional genetic analyses5
    • 2016 clinical diagnostic criteria for CAPS do not "mandate evidence of a disease-causing NLRP3 mutation"3

diagnostic criteria for nomid3

Must have raised inflammatory markers (CRP/SAA)

AND

≥2 of the following symptoms

  • Urticaria-like rash
  • Cold-stress triggered episodes
  • Sensorineural hearing loss
  • Musculoskeletal symptom (arthralgia/arthritis/myalgia)
  • Chronic aseptic meningitis
  • Skeletal abnormalities (epiphyseal overgrowth/frontal bossing)

Kineret reduced NOMID symptoms and inflammation with results maintained through 60 months1,4

Overall DSSS and each of its key symptoms rapidly improved and was maintained over 60 months1

  • 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 phenotype1
  • Treatment with Kineret also appeared to be associated with improvement of, or stability in, other NOMID disease manifestations, up to 60 months1
    • CNS inflammation
    • Audiogram
    • Visual acuity
  • NOMID patients who were withdrawn from Kineret therapy responded again when treatment resumed1
    • 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 therapy1

Individual disease symptoms scores comprising the DSSS by visit
(baseline to 60 months)1

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 Kineret4,6

  • Systemic inflammatory remission was achieved in all patients; however, remission and relapse continued to occur in patients with infections or stress6
    • Inflammatory remission was defined as CRP level ≤0.5 mg/dl, ESR ≤25 mm/hour, and SAA ≤10 mg/liter6
  • Patients had significant reductions in inflammatory markers from baseline at 6, 12, and 36 months and results were stable from 36 to 604,6

Inflammatory markers (baseline to 6 months)4

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 NOMID1,6

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 patients with NOMID reporting adverse events1

Kineret dosing must be adjusted to manage active inflammation and to account for changes in patient weight

  • The starting dose of Kineret is 1-2 mg/kg injected subcutaneously each day1
  • The dose should be individually adjusted in 0.5 mg/kg to 1.0 mg/kg increments to a maximum of 8 mg/kg daily to control active inflammation

WEIGHT

KG

DOSE STRENGTH


## mg

1 syringe = 100 mg. Doses greater than 100 mg will require more than one syringe

KINERET® On TRACK and KINERET On TRACK Guidance can help you educate and support your patients as they learn to inject Kineret and manage ISRs

Learn more here

INDICATION

Kineret® is an interleukin-1 receptor antagonist indicated for:

Rheumatoid Arthritis (RA)

  • Reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease-modifying antirheumatic drugs (DMARDs)

Cryopyrin-Associated Periodic Syndromes (CAPS)

  • Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

IMPORTANT SAFETY INFORMATION

  • Kineret is contraindicated in patient with known hypersensitivity to E. coli-derived proteins, Kineret, or to any components of the product
  • In RA, discontinue use if serious infection develops. In Kineret-treated NOMID patients, the risk of a NOMID flare when discontinuing Kineret treatment should be weighed against the potential risk of continued treatment. Do not initiate Kineret in patients with active infections
  • Use in combination with Tumor Necrosis Factor (TNF) blocking agents is not recommended
  • Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported
  • The impact of treatment with Kineret on active and/or chronic infections and the development of malignancies is not known
  • Live vaccines should not be given concurrently with Kineret
  • Neutrophil counts should be assessed prior to initiating Kineret treatment, and while receiving Kineret, monthly for 3 months, and thereafter quarterly for a period up to 1 year
  • RA: Most common adverse reactions (incidence ≥ 5%) are injection site reaction, worsening of rheumatoid arthritis, upper respiratory tract infection, headache, nausea, diarrhea, sinusitis, arthralgia, flu-like symptoms, and abdominal pain
  • NOMID: The most common AEs during the first 6 months of treatment (incidence > 10%) are injection site reaction, headache, vomiting, arthralgia, pyrexia, and nasopharyngitis
  • A higher rate of serious infections has been observed in RA patients treated with concurrent Kineret and etanercept therapy than in patients treated with etanercept alone. Use of Kineret in combination with TNF blocking agents is not recommended
  • Because there is a higher rate of infections in the elderly population in general, caution should be used in treating the elderly
  • Kineret is substantially excreted by the kidney, and the risk of toxic reactions to Kineret may be greater in patients with impaired renal function

Please see full Prescribing Information.