Ilaris (Canakinumab) 150mg/ml — Comprehensive Drug Information
Ilaris (canakinumab) by Novartis is a fully human monoclonal antibody that selectively targets and neutralizes interleukin-1 beta (IL-1β), a master pro-inflammatory cytokine driving autoinflammatory diseases. As the only anti-IL-1β biologic with FDA approval across multiple autoinflammatory indications, Ilaris represents a paradigm shift in treating rare inflammatory conditions.
FDA-approved indications include Cryopyrin-Associated Periodic Syndromes (CAPS) — including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), Systemic Juvenile Idiopathic Arthritis (SJIA), Adult-Onset Still's Disease (AOSD), and Periodic Fever Syndromes including Familial Mediterranean Fever (FMF), TNF Receptor-Associated Periodic Syndrome (TRAPS), and Hyperimmunoglobulin D Syndrome (HIDS/MKD).
The landmark CANTOS trial (Canakinumab Anti-inflammatory Thrombosis Outcomes Study, 10,061 patients) demonstrated that canakinumab 150mg every 3 months significantly reduced major adverse cardiovascular events by 15%, validating the inflammatory hypothesis of atherosclerosis and opening new therapeutic frontiers.
Ilaris vs Kineret vs Arcalyst — IL-1 Inhibitor Comparison 2026
| Feature | Ilaris (Canakinumab) | Kineret (Anakinra) | Arcalyst (Rilonacept) |
|---|---|---|---|
| Mechanism | Anti-IL-1β mAb | IL-1 receptor antagonist | IL-1 Trap (soluble decoy) |
| Target | IL-1β only | IL-1α + IL-1β | IL-1α + IL-1β + IL-1ra |
| Dosing Frequency | Every 4-8 weeks | Daily | Weekly |
| Half-life | 26 days | 4-6 hours | 6.3 days |
| FDA Indications | CAPS, SJIA, AOSD, FMF, TRAPS, HIDS | RA, CAPS, DIRA | CAPS |
| Self-injection | Yes (SC) | Yes (SC) | Yes (SC) |
| Pediatric Use | ≥2 years (CAPS), ≥2 years (SJIA) | ≥8 months (CAPS) | ≥12 years (CAPS) |
| US Price/Dose | ~$16,000-$20,000 | ~$100-200/day | ~$3,500/week |
Clinical Evidence — Key Trials
CANTOS (2017)
10,061 patients — canakinumab 150mg Q3M reduced MACE by 15% and CV death/MI/stroke by 17% vs placebo (p=0.005)
CAPS Phase III
Complete response in 71% of FCAS/MWS patients at 48 weeks — rapid normalization of CRP and SAA
SJIA Phase III
84% ACR30 response at Day 15 vs 10% placebo; 80% maintained flare-free at 2 years with Q4W dosing
CLUSTER (FMF/TRAPS/HIDS)
Complete response in 61% FMF, 45% TRAPS, 35% HIDS patients at Week 16 — controlling previously refractory disease
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