Takeda Pharmaceutical Company Limited presents new data from an ad-hoc analysis of the Phase 3 HELP Study™, designed to evaluate the onset of action for TAKHZYRO (lanadelumab) during days 0-69 of treatment. The analysis suggests that TAKHZYRO starts to prevent HAE attacks during this early treatment phase, with patients experiencing an 80.1% decrease in mean monthly attack rate compared to placebo. The results were presented during the European Academy of Allergy and Clinical Immunology (EAACI) Congress in Lisbon, Portugal.
“The unpredictable nature of HAE attacks makes living with the disease physically and emotionally challenging for patients,” said Professor Marcus Maurer, M.D., Department of Dermatology and Allergy, Allergie-Centrum-Charité, Charité–Universitätsmedizin Berlin, Germany. “HAE requires an individualised approach to treatment, and it is important that a patient’s treatment plan helps reduce the frequency of attacks. These results are exciting as they suggest that lanadelumab begins to prevent HAE attacks during the initial phase of treatment.”
The ad-hoc analysis evaluated the efficacy of TAKHZYRO compared with placebo during days 0-69 of treatment using the same approach that was used to evaluate the primary and secondary endpoints during the complete study period (days 0-182). Results from the analysis showed that in patients receiving the recommended starting dose of TAKHZYRO 300 mg every two weeks, there was a significant reduction in mean monthly attack rate (80.1% decrease) compared to placebo (Adjusted P<0.001). During this initial treatment phase, patients treated with TAKHZYRO 300 mg every two weeks also experienced fewer severe attacks compared to placebo (7.4% vs. 22%) and were more likely to be HAE attack-free compared to those on placebo (48.1% vs. 7.3%).
“Original data from the HELP Study showed that TAKHZYRO was effective in preventing HAE attacks over the entire duration of the study and, according to an exploratory analysis, many patients remained attack-free during the 16-week steady state period,” said Donatello Crocetta, M.D., Franchise Global Medical Unit Head, Rare Immunology and HAE at Takeda. “This new analysis supports previous study findings and builds on our understanding of how quickly TAKHZYRO can begin to help prevent HAE attacks, further supporting its use for appropriate patients as a preventive therapy that can be administered subcutaneously and begins to work rapidly.”
Across all TAKHZYRO treatment arms, (300 mg every two weeks, 300 mg every four weeks, 150 mg every four weeks), there was an improvement in mean monthly attack rate, monthly rate of moderate to severe attacks, monthly rate of attacks requiring acute treatment and the number of attack-free days, versus placebo, during the entire study period.
The most commonly observed adverse reactions (52.4%) associated with TAKHZYRO were injection site reactions. Of these, 97% were of mild intensity. Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was observed (1.2%).1
TAKHZYRO 300 mg is approved in the European Union and Australia for the routine prevention of recurrent attacks of HAE in patients aged 12 years and older. TAKHZYRO 300 mg is approved as prophylaxis to prevent attacks of HAE in patients aged 12 years and older in the United States and for the routine prevention of attacks in patients aged 12 years and older in Canada.