Long‐term safety of icatibant treatment of patients with angioedema in real‐world clinical practice

Abstract

The Icatibant Outcome Survey (IOS) is an observational study monitoring safety and effectiveness of icatibant in the real‐world setting. We analyzed safety data from 3025 icatibant‐treated attacks in 557 patients (enrolled between July 2009 and February 2015). Icatibant was generally well tolerated. Excluding off‐label use and pregnancy, 438 patients (78.6%) did not report adverse events (AEs). The remaining 119 (21.4%) patients reported 341 AEs, primarily gastrointestinal disorders (19.6%). Of these, 43 AEs in 17 patients (3.1%) were related to icatibant. Serious AEs (SAEs) occurred infrequently. A total of 143 SAEs occurred in 59 (10.6%) patients; only three events (drug inefficacy, gastritis, and reflux esophagitis) in two patients were considered related to icatibant. Notably, no SAEs related to icatibant occurred in patients with cardiovascular disease, nor in those using icatibant at a frequency above label guidelines. Additionally, no major differences were noted in AEs occurring in on‐label vs off‐label icatibant users.

Management of patients with hereditary angioedema in Germany: comparison with other countries in the Icatibant Outcome Survey

“…Data from the IOS have clearly shown that early icatibant treatment results in earlier resolution of attacks and that real‐world outcomes of icatibant are comparable with the aforementioned controlled studies . More recently, a range of IOS publications have further described icatibant use and disease characteristics for HAE‐C1‐INH patients in the real‐world setting across the IOS countries …”

“…9 More recently, a range of IOS publications have further described icatibant use and disease characteristics for HAE-C1-INH patients in the real-world setting across the IOS countries. [10][11][12][13][14][15] A recent country-specific IOS analysis, using 2015 data, clearly identified German patients with HAE-C1-INH who are enrolled in IOS administer icatibant to treat their attacks significantly earlier, following symptom onset, than similarly diagnosed IOS patients from Austria, France, Italy, Spain, and the United Kingdom. 14 Here, we report data from IOS that focus on icatibant treatment outcomes in patients with HAE-C1-INH from seven HAE specialist centres across Germany and compares outcomes with patients from 11 other IOS countries.…”

Multiple Doses of Icatibant used during Pregnancy

“…Icatibant use during pregnancy can be documented through publication and in the Icatibant Outcome Survey, an observational study for patients who received icatibant. 21 We recommend adhering to the guidelines, 1 which suggest the use of pdhC1INH during pregnancy for attacks and for short-term and long-term prophylaxis. Until further data are available for use of icatibant during pregnancy, the utilization of icatibant should be reserved for when the benefit outweighs the risk.…”

A hypothesized role for dysregulated bradykinin signaling in COVID‐19 respiratory complications

“…Icatibant has been shown to be safe and effective, with side effects and adverse reactions being rare when used in the context of angioedema 19 . A human study on the off‐label use of icatibant to treat allergic rhinitis showed that, the drug significantly reduced grass pollen antigen‐induced hyperresponsiveness to histamine, which was linked to icatibant inhibiting interleukin‐8 (IL‐8) release 20 .…”