High-risk RA patients include those with complicating conditions, such as asthma, diabetes, chronic obstructive pulmonary disease, coronary artery disease, congestive heart failure, and pneumonia
In a large clinical trial, the well-established safety profile of Kineret was demonstrated in patients with RA with complicating conditions, many of whom were receiving concurrent RA medications (excluding anti-TNFs)3
IL-1 driven inflammatory symptoms of RA may include4-8:
Joint pain and swelling
In clinical trials, Kineret significantly reduced signs, symptoms, and joint damage associated with RA1
6% of patients with RA achieved ACR70 with Kineret at 6 months
Most clinical responses occurred within 12 weeks of enrollment, but some patients continued to experience improvement between month 3 and month 61
Patients treated with Kineret had significant reductions in Total Modified Sharp Score (TSS) and joint space narrowing (JSN) score vs. placebo at 12 months1
Change in TSS was 1.7 points in patients treated with Kineret + methotrexate, vs 2.6 in patients treated with placebo + methotrexate (P< 0.001, 95% CI=0.9 [0.3, 1.6])
Change in JSN score was 0.7 points in patients treated with Kineret + methotrexate, vs 1.1 in patients treated with placebo + methotrexate (P< 0.001, 95% CI=0.4 [0.1, 0.7])
Study design: In a randomized, double-blind, placebo-controlled trial of 899 patients with active RA who have 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. The total 899 patients were evaluated for progression of structural damage.1
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
Kineret [Prescribing Information]. Stockholm, Sweden: Biovitrum AB; 2016.
McGonagle D, McDermott MF. A proposed classification of the immunological diseases. PLoS Med. 2006;3(8):1242-1248.
Schiff MH, DiVittorio G, Tesser J, et al. The safety of anakinra in high-risk patients with active rheumatoid arthritis: six-month observations of patients with comorbid conditions. Arthritis Rheum. 2004;50(6):1752- 1760.
Dinarello CA. A clinical perspective of IL-1β as the gatekeeper of inflammation. Eur J Immunol. 2011;41(5):1203-1217.
Dinarello CA, Simon A, van der Meer JW. Treating inflammation by blocking interleukin-1 in a broad spectrum of diseases. Nat Rev Drug Discov. 2012;11(8):633-652.
Vela P. Extra-articular manifestations of rheumatoid arthritis, now. EMJ Rheumatol. 2014;1:103-112.
Sayah A, English JC. Rheumatoid arthritis: a review of the cutaneous manifestations. J Am Acad Dermatol. 2005; 53:191-209.
Rawlings CR, Fremlin GA, Nash J, Harding K. A rheumatology perspective on cutaneous vasculitis: assessment and investigation for the non-rheumatologist. Int Wound J. 2016; 13:17-21.