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.