No major adverse events and minimal use of escape medication
during treatment were reported
Administration of rhC1-INH in patients with normal C1-INH levels did not
lead to any severe adverse events, including thrombotic events. Three
patients reported episodes of headache during the treatment. One patient
reported an uncomplicated herpes labialis flare-up in treatment week 7.
Escape medication used by patient 1 in the first observation period was
one dose of 50mg prednisolone and one-time use of the adrenaline
auto-injector (0.3mg). No escape medication was used during the
treatment period. In the second observation period (after 8 weeks of
treatment) seven doses of prednisolone were used ranging from 20 to 60
mg and four adrenaline auto-injector over two episodes were used by
patient 1. Patient 3 used one dose of 20mg prednisolone during the
treatment period and one during the second observation period. Patient 4
used one dose of 60mg prednisolone during the first observation period.
The other patients did not use escape medication during the study
period.