by Danielle Bradshaw from In The Cloud Copy
Hereditary angioedema (HAE) is a rare condition in which a person has swelling beneath their skin (which can occur in any part of the body) as well as under the lining of their lungs and gut. Hereditary angioedema is a genetic disorder, but treatments exist to help manage its symptoms. There are different variations of HAE and they are each caused by a malfunction with the blood protein C1 inhibitor (C1-INH). In some cases, there is too little of the protein and in others it doesn’t function as intended.
It was found that a 300mg dosage of lanadelumab every two weeks greatly reduced the number of HAE attacks per month for the participants. The attack rates for patients that either did or did not use long-term prophylaxis were gathered on a historic three-month basis and compared against these positive test results.
There is an ongoing open-label extension (OLE) of the phase 3 HELP study that demonstrated the potential effectiveness of lanadelumab against HAE. Researchers have seen that because the use of long-term prophylaxis is possibly demonstrative of the severity of a patient’s HAE, they should check to see how useful lanadelumab might be in combating the disease according to whether the participant has a history of long-term prophylaxis.
Over the course of two weeks, 212 participants over 12 years of age (in a group of either type I or type II sufferers of HAE) were given 300mg of lanadelumab. The group was a combination of both rollover patients from the previous HELP study (a total of 109 people) and entirely new participants who could take lanadelumab for more than three weeks and still maintain their long-term prophylaxis. The frequency of their HAE attacks was used as a measurement for their monthly attack rate (recorded as the number of attacks/4 weeks) and was then measured against their historic three-month baseline for attacks before participating in the study.
The breakdown of the results of the OLE study was as follows:
- Participants who used long-term prophylaxis for C1-INH numbered up to 106 people (half of the study group) and they typically had an attack rate of around 2.9 attacks every four weeks. Using lanadelumab lowered that number to 0.3.
- There were 87 participants who didn’t use any long-term prophylaxis whose attack rate was around 3.0 every four weeks and lanadelumab reduced it to 0.2.
- Participants who used long-term prophylaxis of some other sort numbered up to 19 people (9% of the study group) and they all experienced a reduction in attack rates as well, while using lanadelumab.
The decrease in each group’s resultant attack rate due to taking lanadelumab was independent of whether they were rollover or non-rollover (new to the study). In conclusion, taking 300mg of lanadelumab as a long-term treatment was able to considerably reduce HAE attacks when correlated with a three-month baseline in patients both with and without previous C1-INH long-term prophylaxis.
Check out the original article here.