About KINERET® (anakinra)

KINERET is a very specific treatment for a very specific RA patient.

RA that is primarily autoinflammatory may be mediated by interleukin-1 (IL-1), cytokines produced by cells in the innate immune system. KINERET is an IL-1 receptor antagonist, blocking an underlying cause of inflammation in difficult-to-treat RA.1

The effects of IL-1

Elevated levels of IL-1 may be responsible for some of the hallmarks of RA, such as1:

  • Cartilage degradation
  • Bone resorption
  • Other autoinflammatory symptoms
An illustrated diagram of how the KINERET® (anakinra) molecule blocks the receptor from receiving IL-1 signaling

KINERET is the only FDA-approved RA treatment that blocks both IL-1α and IL-1β.1

Watch the video to see KINERET in action.

An in-depth look at the data.

In a 2004 study, 6% of KINERET-treated patients achieved ACR70.1

In a randomized, double-blind, placebo-controlled trial of 899 patients with active RA who had been on a stable dose of methotrexate (10 to 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.

Two horizontal bar charts showing ACR response at 6 months. The top bar, KINERET + methotrexate, shows a 6% ACR response and the lower bar, placebo + methotrexate, shows a 2% ACR response

Today, patients who may benefit from KINERET are better understood and may be more readily identified.

See Who They Are

Patients using KINERET saw improvements in ACR component scores.1

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 [see Warnings and Precautions (5.1) in the full Prescribing Information].

PLACEBO / MTX(n=251) KINERET (anakinra) / MTX 100 mg/day ( n=250 )
parameter (median) baseline month 6 baseline month 6
patient-reported outcomes
Disability indexa 1.38 1.13 1.38 1.00
Patient global assessmentb 51.0 41.0 51.0 29.0
Painb 56.0 44.0 63.0 34.0
ESR (mm/hr) 35.0 32.0 36.0 19.0
CRP (mg/dL) 2.2 1.6 2.2 0.5
Tender/painful jointsc 20.0 11.0 23.0 9.0
Physician global assessmentb 59.0 31.0 59.0 26.0
Swollen jointsd 18.0 10.5 17.0 9.0

a Health Assessment Questionnaire; 0 = best, 3 = worst; includes eight categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. b Visual analog scale; 0 = best, 100 = worst c Scale 0 to 68

Over the course of the year, radiographic changes also improved.1

The effect of KINERET on the progression of structural damage was assessed by measuring the change from baseline at month 12 in the Total Modified Sharp Score (TSS) and its subcomponents, erosion score, and joint space narrowing (JSN) score.a 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. A difference between placebo and KINERET for change in TSS, erosion score (ES), and JSN score was observed at 12 months.

The disability index of the Health Assessment Questionnaire (HAQ) was administered monthly for the first six 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 (PCS) score of the SF-36 also showed more improvement with KINERET than placebo but not the mental component summary (MCS).

Prescribe KINERET
A chart labeled mean radiographic changes over 12 months. The first group of bars measures total sharp score with placebo + MTX vs KINERET 100 mg + MTX with the KINERET arm lower by 0.9. The second group of bars measures erosion with placebo vs KINERET with the KINERET arm lower by  0.5. The final group of bars shows joint space narrowing with placebo vs KINERET and the KINERET arm is lower by 0.4
aSharp JT, Young DY, Bluhm GB, et al. How many joints in the hands and wrists should be included in a score of radiologic abnormalities used to assess rheumatoid arthritis? Arthritis Rheum. 1985;28:1326-1335.
*Differences and 95% confidence intervals for the differences in change scores between Placebo/MTX and KINERET/MTX
**Based on Wilcoxon rank sum test

Consider KINERET for patients with complicating conditions.

The safety profile of KINERET was demonstrated in a high-risk RA patient population and shown to be well-tolerated among those with1:

  • Varying degrees of disease activity
  • Concurrent medications
  • History of complicating conditions, including:
  • Asthma
  • Diabetes
  • Chronic obstructive pulmonary disease
  • Pneumonia

Flexible, for better control.

Flexible icon

KINERET’s 4-6 hour half-life gives doctors the flexibility to stop and restart treatment as necessary.1

Adverse Events1

PREFERRED TERM PLACEBO(n=733) KINERET 100 mg/day ( n=1565 )
Injection site reaction 29% 71%
Worsening of RA 29% 19%
Upper respiratory tract infections 17% 14%
Headache 9% 12%
Nausea 7% 8%
Diarrhea 5% 7%
Sinusitis 7% 7%
Arthralgia 6% 6%
Flu-like symptoms 6% 6%
Abdominal pains 5% 5%
  • The most commonly reported adverse event was an injection site reaction (ISR)
  • Most ISRs were mild (72.6% mild, 24.1% moderate, 3.2% severe)
  • ISRs were typically reported within the first 4 weeks of therapy and usually stop about 14 to 28 days after starting treatment