Does Icatibant work?
Yes, in large controlled trials: an 88-adult trial.
Approval rested on three randomised phase 3 trials (FAST-1, FAST-2 and FAST-3). The cited FAST-3 trial randomised 88 patients with moderate to very severe attacks to icatibant or placebo and found median time to symptom relief of 2 hours against 20 hours. 12
FAST-3 randomised 88 adults with moderate to very severe skin or abdominal attacks. They got a single subcutaneous injection of icatibant (43) or placebo (45). The median time to a 50% drop in symptom score was 2.0 hours with icatibant. With placebo it was 19.8 hours. The groups separated within the first hour. Ten patients had laryngeal attacks. Five had mild to moderate attacks and were randomised. Median time to 50% relief was 2.5 hours on icatibant and 3.2 on placebo. The other five had severe attacks and received icatibant open-label. The authors concluded that icatibant was effective and generally well tolerated. The result cleared the way for approval. 1
Evidence checklist
- Randomised controlled trial FAST-3 placebo-controlled
- Human study over 100 people FAST-3 had 88 patients
- More than one research group Three phase 3 trials, FAST-1 to FAST-3
- Clinical outcomes, not surrogate markers Time to symptom relief in attacks
- Human safety data beyond case reports Trial and label safety data
More on Icatibant
Citations
- Lumry 2011, Annals of Allergy, Asthma and Immunology: randomised placebo-controlled trial of icatibant for acute attacks of hereditary angioedema (FAST-3) doi.org
- NDC List: Firazyr (icatibant injection) label ndclist.com
Reference information only, not medical advice. Drawn from the Icatibant article, fact-checked against the cited sources. No dosing anywhere on this site.