ORLADEYO® helps to prevent hereditary angioedema (HAE) attacks1
ORLADEYO® was studied in one of the largest clinical studies for a prophylactic therapy in hereditary angioedema (HAE)1,2
APeX-2 is a 3-part, double-blind, placebo-controlled study. The APeX-2 part 1 primary efficacy endpoint was HAE attack rate at 24 weeks.1,2
aPatients were allowed to use rescue medications to treat attacks but had to discontinue all prophylactic HAE medications prior to the start of the study.2
bIn part 2 of the study, patients on active drug in part 1 continued on the same dose and patients on placebo in part 1 were rerandomized to a blinded active dose.3
Patients in APeX-2 had considerable disease burden and a history of past prophylactic treatment use5
aBaseline investigator-confirmed attack rate was defined as (total number of investigator-confirmed HAE attacks experienced in the period between screening and first date/time of study drug) x 28/(date of first dose – date of screening + 1).5
bBased on 120 subjects. One subject was randomized but did not receive study drug. As this subject did not receive drug, the subject had no baseline calculations.5
cResponses for individual drugs may not be mutually exclusive. Percentages were based on the number of responses per category and may not sum to 100%.5
dIncludes plasma-derived C1-INH replacement, recombinant C1-INH replacement, and fresh frozen plasma.5
eIncludes unspecified androgens, oxandrolone, methyl-testosterone, danazol, and stanozolol.5
APeX-2 part 1 (0-24 weeks) data
Primary endpoint: HAE attack rate reduction over 24 weeks
- ORLADEYO demonstrated a significant attack rate reduction over 24 weeks from 3.06 to 1.31 attacks per month compared with a reduction of 2.91 to 2.35 attacks per month with placebo (44% reduction vs placebo, P<0.001)1,2,a
- The effect of ORLADEYO in reducing attacks was seen within the first 4 weeks and maintained over 24 weeks1
aThe percent reduction in attack rate was greater with ORLADEYO 150 mg (n=40) relative to placebo (n=39) regardless of attack rate during the run-in period.1
Reduced need for rescue therapy
- In an ad hoc analysis of the first 24 weeks of treatment, patients treated with ORLADEYO 150 mg experienced a reduction in rescue medication use per 28 days vs placebo (nominal P<0.001)2
Relative attack rate reductions
b Ad hoc analysis; nominal P=0.002.1,5
APeX-2 Parts 1-3 (0-96 weeks) data
Sustained HAE attack rate reduction
- Twenty-one patients who were randomized to ORLADEYO 150 mg at the beginning of APeX-2 and completed 96 weeks of treatment demonstrated a decline in mean attack rate per 4 weeks from baseline to 96 weeks of treatment4,c
cThis reflects an ad hoc analysis of interim data.5
d86% attack rate reduction from baseline to week 96 was seen for patients who completed 96 weeks of treatment with ORLADEYO 150 mg (n=21).4,5
ORLADEYO provides sustained HAE attack rate reduction
HAE attack rate reduction was seen within 4 weeks of starting ORLADEYO and was maintained over 96 weeks1,4,a
- Twenty-one patients who were randomized to ORLADEYO 150 mg at the beginning of APeX-2 and completed 96 weeks of treatment demonstrated a decline in mean attack rate per 4 weeks from baseline to 96 weeks of treatment4,a
Median attack rate
Every individual with HAE responds differently to treatment. The clinical phenotype is variable and does not predict response to prophylactic therapy.6,7 See if ORLADEYO could be right for your patients.