FDA核准Canakinumab(Ilaris)用於治療成人痛風發作

美國食品和藥物管理局(FDA)已核准Canakinumab(Ilaris)用於治療無法使用 NSAIDs, colchicine或repeated courses of corticosteroids的成人痛風發作。 該藥還適用於不能耐受NSAIDs or colchicine或對 NSAIDs or colchicine反應不佳的病人。

Canakinumab是一種humanized anti-interleukin-1β monoclonal antibody，是美國第一個也是唯一一個被核准用於治療痛風發作的生物製劑。 單次皮下注射 150 mg。

Canakinumab於 2009 年在美國首次核准用於治療cryopyrin-associated periodic syndrome (CAPS)的兒童和成人。此後，Canakinumab已被核准用於治療其他autoinflammatory diseases，包括Still's disease和recurrent fever syndromes (TNF receptor-associated periodic fever syndrome (TRAPS))。

Canakinumab 機轉：

Canakinumab is a recombinant, human anti-human interleukin-1 beta (IL-1B) monoclonal antibody of the IgG1/kappa isotype. By binding to human IL-1B, canakinumab blocks the IL-1 receptor interaction and neutralizes overactive IL-1B activity which is present in disorders such as Cryopyrin-Associated Periodic Syndromes (CAPS) and systemic juvenile idiopathic arthritis (SJIA). Canakinumab does not bind IL-1 alpha or IL-1 receptor antagonist (IL-ra)

Precautions：

• Concomitant use: Use with tissue necrosis factor (TNF) inhibitors not recommended 
• Concomitant use: Use with live vaccines not recommended 
• Immunologic: Hypersensitivity reactions have been reported; symptoms of underlying disease may mimic symptoms of hypersensitivity. Discontinuation may be required 
• Immunologic: Infections, including serious and opportunistic infections, have been reported. Use not recommended with active infection requiring medical intervention; use caution with recurring infection or predisposition to infection. Monitoring recommended; discontinue if serious infection develops 
• Immunologic: Macrophage activation syndrome, potentially life-threatening, may occur; increased risk in patients with rheumatic conditions, including Still's disease 
• Immunologic: Increased risk for developing new TB infection or reactivation of latent infection. Screen all patients for TB prior to initiation and treat latent TB before starting therapy 
• Immunologic: Risk of malignancy may increase with use. 

Canakinumab indications and dosage：

Adult onset Still's disease

• Usual dosage: 4 mg/kg subQ every 4 weeks (MAX 300mg/dose)

Cryopyrin associated periodic syndrome：

• Usual dosage, weight greater than 40 kg: 150 mg subQ every 8 weeks.
• Usual dosage, weight 15 to 40 kg: 2 mg/kg subQ every 8 weeks

Deficiency of mevalonate kinase

• Usual dosage, weight greater than 40 kg: 150 mg subQ every 4 weeks; may increase to 300 mg every 4 weeks if inadequate response
• Usual dosage, weight 40 kg or less: 2 mg/kg subQ every 4 weeks; may increase to 4 mg/kg every 4 weeks if inadequate response

Hyper-IgD periodic fever syndrome (HIDS)

• Usual dosage, weight greater than 40 kg: 150 mg subQ every 4 weeks; may increase to 300 mg every 4 weeks if inadequate response.
• Usual dosage, weight 40 kg or less: 2 mg/kg subQ every 4 weeks; may increase to 4 mg/kg every 4 weeks if inadequate response

TRAPS：

• Usual dosage, weight greater than 40 kg: 150 mg subQ every 4 weeks; may increase to 300 mg every 4 weeks if inadequate response
• Usual dosage, weight 40 kg or less: 2 mg/kg subQ every 4 weeks; may increase to 4 mg/kg every 4 weeks if inadequate response

Muckle-Wells syndrome：

• Usual dosage, weight greater than 40 kg: 150 mg subQ every 8 weeks 
• Usual dosage, weight 15 to 40 kg: 2 mg/kg subQ every 8 weeks

Familial cold urticaria

• Usual dosage, weight greater than 40 kg: 150 mg subQ every 8 weeks. 
• Usual dosage, weight 15 to 40 kg: 2 mg/kg subQ every 8 weeks

Familial Mediterranean fever

• Usual dosage, weight greater than 40 kg: 150 mg subQ every 4 weeks; may increase to 300 mg every 4 weeks if inadequate response.
• Usual dosage, weight 40 kg or less: 2 mg/kg subQ every 4 weeks; may increase to 4 mg/kg every 4 weeks if inadequate response