Lanadelumab demonstrates sustained efficacy for HAE
19 Nov 2021
The monoclonal antibody lanadelumab demonstrated long-term efficacy for patients with hereditary angioedema (HAE) who had received prophylactic lanadelumab for ≥12 months, according to findings from the post hoc analysis of the phase III HELP OLE* study presented at ACAAI 2021.
“Most of our study participants were attack-free within fixed 6-month intervals from months 12–30,” said Dr Marc Riedl from the University of California San Diego, La Jolla, California, US, in his virtual poster presentation.
“HAE is a rare genetic condition characterized by recurrent and severe AE episodes that generally affect the skin, gastrointestinal tract, or the airway,” Riedl continued. The swelling of subcutaneous and submucosal tissues are unpredictable, may impair quality of life, and could lead to potentially life-threatening attacks if left untreated. [Am J Manag Care 2018;24:S292-S298]
The HELP OLE study comprised 212 patients (mean age 40.7 years, 68 percent female, 89 percent with HAE type 1). Half of the participants comprised the rollover arm, which included lanadelumab recipients in the placebo-controlled phase. The other half comprised the non-rollover arm, which included patients who had not been involved in the randomized study. In both arms, lanadelumab was administered at a dose of 300 mg Q2W. [ACAAI 2021, abstract P054]
Ninety-two percent of enrolees were treated for at least 12 months. Eighty-two percent either completed the study or transitioned to a commercial product. Mean duration of exposure to lanadelumab was about 29 months.
After a year of lanadelumab treatment, more than two-thirds of participants in both the rollover and non-rollover arms were attack-free between 12 and 18 months (65 percent and 74 percent, respectively). A similar trend was seen between 18 and 24 months (70 percent and 69 percent) and from 24 months to end-of-treatment (EOT; 74 percent and 69 percent).
When evaluating attack-free status from 12 months to EOT, half of participants in the rollover and non-rollover arms were attack-free (54 percent and 57 percent, respectively). Mean number of attack-free days/month was 27.6 days in both arms, while mean percentage of attack-free days was nearly 99 percent. Average durations of attack-free periods were 11.4 and 12.5 months in the respective rollover and non-rollover arms.
“[Taken together,] these results demonstrate the sustained efficacy of lanadelumab in the long-term prophylactic treatment of HAE for patients who were treated beyond 12 months and received up to >30 months of therapy,” concluded Riedl.
The current findings reinforce the previously reported findings of HELP OLE, wherein lanadelumab markedly reduced attack rates by 87 percent compared with baseline over a treatment period of up to 132 weeks. Attack-free periods at ≥6 and ≥12 months were achieved by 82 percent and 69 percent of participants, respectively. There were no new safety signals identified. [Allergy 2021;doi:10.1111/all.1501]
Lanadelumab is approved for the long-term preventative treatment of HAE attacks in patients aged ≥12 years in the US, Europe, and other countries and regions. [www.accessdata.fda.gov/drugsatfda_docs/label/2018/761090s000lbl.pdf; accessed November 18, 2021; www.ema.europa.eu/en/documents/product-information/takhzyro-epar-product-information_en.pdf, accessed November 18, 2021]