RA Efficacy

An in-depth look at the data in RA

KINERET was studied in 899 patients with active RA1

This randomized, double-blind, placebo-controlled trial was conducted on 899 patients with active RA who had been on a stable dose of methotrexate (10-25 mg/week) for at least 8 weeks. Patients were randomized to KINERET (n=250) or placebo (n=251) in addition to their stable doses of methotrexate. The first 501 patients were evaluated for signs and symptoms of active RA.

An infographic with 4 people icons, with 3 in gray and 1 in teal. At month 6, about 1 in 4 patients achieved a minimum of ACR50 (23%) following treatment with KINERET® (anakinra) compared with placebo (10%)

*17% + 6% = 23%.

Two horizontal bars showing ACR response at 6 months for KINERET® (anakinra) + methotrexate compared to placebo + methotrexate
An infographic with 4 people icons, with 3 in gray and 1 in teal. At month 6, about 1 in 4 patients achieved a minimum of ACR50 (23%) following treatment with KINERET® (anakinra) compared with placebo (10%)

Patients using KINERET saw improvements in ACR component scores1

In addition to swollen, tender, or painful joints, elevated ESR and CRP levels can indicate systemic autoinflammation, which KINERET has been shown to control in refractory RA patients.

A 24-week study was conducted in 242 patients with active RA on background methotrexate who were randomized to receive either etanercept alone or the combination of KINERET and etanercept. The ACR50 response rate was 31% for patients treated with the combination of KINERET and etanercept and 41% for patients treated with etanercept alone, indicating no added clinical benefit of the combination over etanercept alone. Serious infections were increased with the combination compared to etanercept alone.

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At 6 months, KINERET DEMONSTRATED REDUCTION IN OBJECTIVE MEASURES like acute-phase reactant levels1:

  • ESR decreased by nearly half (47.2%) from baseline
  • CRP levels decreased by 77% from baseline
Median ACR component scores in patients treated with KINERET® (anakinra) 100 mg/day + methotrexate compared to placebo + methotrexate, measured at baseline and at month 6

aHealth Assessment Questionnaire (HAQ); 0 = best, 3 = worst; includes 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. bVisual analog scale; 0 = best, 100 = worst. cScale 0 to 68. dScale 0 to 66.

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At 6 months, KINERET DEMONSTRATED REDUCTION IN OBJECTIVE MEASURES like acute-phase reactant levels1:

  • ESR decreased by nearly half (47.2%) from baseline
  • CRP levels decreased by 77% from baseline

Radiographic changes improved over the course of 1 year with KINERET1

The effect of KINERET on the progression of structural damage was assessed by measuring the change from baseline at month 12 in the TMSS and its subcomponents, erosion score, and JSN score. Radiographs of hands/wrists and forefeet were obtained at baseline, 6 months, and 12 months and scored by readers who were unaware of treatment group. Differences between placebo and KINERET for change in TMSS, ES, and JSN score were observed at 12 months.

The disability index of the HAQ was administered monthly for the first 6 months and quarterly thereafter during the study.

Health outcomes were assessed by the Short Form-36 (SF-36) questionnaire. The 1-year data on HAQ in Study 1 showed more improvement with KINERET than placebo. The physical component summary score of the SF-36 also showed more improvement with KINERET than placebo but not the mental component summary.

Prescribe KINERET
Mean radiographic changes over 12 months in patients treated with KINERET® (anakinra) 100 mg/day + methotrexate compared to placebo + methotrexate. The first group of bars shows change in total modified sharp score. The second group of bars shows change in erosion score. The third group of bars shows change in joint space narrowing score

eDifferences and 95% confidence intervals for the differences in change scores between placebo/MTX and KINERET/MTX. fBased on Wilcoxon rank sum test. MTX, methotrexate.

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Following 1 year of treatment, TMSS CHANGES WERE 42% LESS IN KINERET PATIENTS compared with placebo.1

Prescribe KINERET
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Important Safety Information
INDICATION

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, and serious cutaneous reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) 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 and DRESS 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.
For more information about WAC pricing, click here.

Reference: 1. KINERET [Prescribing Information]. Stockholm, Sweden: Swedish Orphan Biovitrum AB (publ).