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IL-1β Monoclonal Antibody (Anti-Inflammatory CV Agent) Pregnancy: Avoid — insufficient data; IL-1β plays a role in fetal development and parturition.

Canakinumab (IL-1β Inhibitor — Post-MI CV Prevention)

Brand names: Ilaris

Adult dose

Dose: 150 mg SC every 3 months (post-ACS cardiovascular secondary prevention — off-label in most countries)
Route: Subcutaneous
Frequency: Every 3 months
Max: 150 mg per injection
Canakinumab is licensed in UK for rare inflammatory conditions (CAPS, SJIA, adult-onset Still's disease, gout, FMF). The CV secondary prevention indication (post-MI patients with CRP >2 mg/L) is based on CANTOS data but NOT currently licensed for this indication by MHRA/EMA. Use is investigational/specialist decision. High cost limits routine use.

Paediatric dose

Dose: 2–4 mg/kg
Route: SC
Frequency: Every 4–8 weeks (licensed inflammatory indications)
Max: 150 mg per dose
BNFc: licensed for CAPS (1 mg/kg), SJIA (4 mg/kg), FMF/TRAPS/HIDS (2–4 mg/kg). Not for CV secondary prevention in children.

Dose adjustments

Renal

No dose adjustment required.

Hepatic

No dose adjustment required.

Paediatric weight-based calculator

BNFc: licensed for CAPS (1 mg/kg), SJIA (4 mg/kg), FMF/TRAPS/HIDS (2–4 mg/kg). Not for CV secondary prevention in children.

Clinical pearls

  • CANTOS trial (Ridker et al. NEJM 2017): canakinumab 150 mg every 3 months vs placebo in post-MI patients with hsCRP ≥2 mg/L — 15% relative risk reduction in primary endpoint (CV death, MI, stroke); dose-dependent. First large RCT to validate the inflammation hypothesis of atherosclerosis without lipid lowering. Historical landmark
  • Why it's not in routine clinical use: CANTOS showed increased fatal infections (~50% more per year) that offset some CV benefit; canakinumab costs approximately $73,000–200,000 annually; no licensing approval for CV indication in UK/EU. Research focus has shifted to colchicine (proven CV benefit, dramatically lower cost) and ziltivekimab (smaller IL-6 pathway inhibitor, RESCUE trial 2022)
  • Gout indication (licensed): canakinumab 150 mg single SC dose for acute gout flares in adults who cannot tolerate or have contraindications to colchicine and NSAIDs — MHRA licensed indication. NICE recommends as last resort before biologics for gout

Contraindications

  • Active infection (especially serious infections — IL-1β is a key mediator of the innate immune response; blocking it impairs defence against bacterial infections)
  • Active TB (screen before starting — similar to anti-TNF biologics)
  • Live vaccines (during and for 3 months after)

Side effects

  • Serious infections (upper and lower respiratory tract infections — significant signal in CANTOS; fatal infections slightly increased)
  • Injection site reactions
  • Hypersensitivity
  • Neutropenia (mild)
  • Elevated LFTs
  • Increased infection mortality (fatal infection rate 0.31% vs 0.18% per 100 patient-years in CANTOS)

Interactions

  • Live vaccines (absolute — immunosuppression risk)
  • TNF inhibitors (avoid combination — increased infection risk)
  • Other immunosuppressants (additive immunosuppression)

Monitoring

  • CRP/hsCRP (anti-inflammatory response monitoring — target <2 mg/L)
  • WBC and neutrophil count (neutropenia and infection risk)
  • Signs of infection (fever, productive cough — threshold for treatment must be low)
  • LFTs
  • TB screening (QuantiFERON or Mantoux before starting)

Reference: BNFc; BNF 90; CANTOS Trial (Ridker et al. NEJM 2017); MHRA SPC Ilaris (gout/CAPS indications); BNFc; NICE TA395 (Canakinumab for CAPS). Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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