DIRA Efficacy

KINERET efficacy in DIRA patients

In a long-term study, KINERET was demonstrated to induce remission in patients with DIRA1

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Remission criteria:

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 use1,2

  • The median time to the first documented inflammatory remission was 15 months2
  • 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 (aged 1 month-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 visit1
  • 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 dose2
  • 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/day2
  • The duration of treatment with KINERET was up to 10 years2
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Important Safety Information
INDICATIONS

KINERET® (anakinra) 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)

Deficiency of Interleukin-1 Receptor Antagonist (DIRA). Treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

CONTRAINDICATION

KINERET is contraindicated in patients with known hypersensitivity to E. coli–derived proteins, KINERET, or to any components of the product

IMPORTANT SAFETY INFORMATION

Serious Infections. In RA, discontinue use if serious infection develops. In KINERET-treated NOMID or DIRA patients, the risk of a disease 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. Patients with DIRA may have an increased risk of allergic reactions, particularly in the first several weeks after starting KINERET treatment

Immunosuppression. The impact of treatment with KINERET on active and/or chronic infections and the development of malignancies is not known

Immunizations. 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

Serious Adverse Reactions

RA: The most serious adverse reactions were: Serious Infections and Neutropenia, particularly when used in combination with TNF blocking agents.

NOMID and DIRA: The most serious adverse events were infections.

Most Common Adverse Reactions

RA: The 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

DIRA: The most common AEs are upper respiratory tract infections, rash, pyrexia, influenza-like illness, and gastroenteritis

Post-marketing Experience

Hepato-biliary disorders (elevations of transaminases; non-infectious hepatitis) and thrombocytopenia, including severe thrombocytopenia have been identified during postapproval use of KINERET. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

These are not all the possible risks associated with KINERET. Please see Full Prescribing Information for KINERET at https://www.KineretRxHCP.com/home.php
To report suspected adverse reactions, contact Sobi North America at 1-866-773-5274 or FDA at 1-800-FDA-1088
Click here for full Prescribing Information for KINERET.

References: 1. KINERET [Prescribing Information]. Stockholm, Sweden: Swedish Orphan Biovitrum AB (publ). 2. Data on file. Sobi, Inc.