Hemlibra shows efficacy in bleeding prevention during exercise for hemophilia A

JW Pharmaceutical announced on Monday that research results demonstrating the various motor data and bleeding prevention effects of patients who took Hemlibra (emicizumab), a treatment for hemophilia A, were recently published in the international academic journal, “Hemophilia.”

Hemlibra is a new drug that mimics the missing blood clotting factor VIII in patients with hemophilia. It is the only treatment for hemophilia A that can be used by both patients with antibodies against existing treatments (factor VIII products) and those without antibodies. It also maintains its preventive effect with a single subcutaneous injection every four weeks. In May 2023, health insurance coverage was expanded to include non-antibody severe hemophilia A patients aged one year and older.

A research team led by Professor Kagehiro Amano of the Department of Diagnostic Medicine at Tokyo Medical University in Japan conducted a study from January 2019 to October 2021 on 129 non-antibody patients with hemophilia A, with an average age of 29.7 years.

The research team utilized the electronic patient reporting application “ePRO” and wearable activity trackers to assess patients' exercise, intensity, bleeding, and safety following Hemlibra administration.

Of the patients who received Hemlibra, 73 recorded their exercise for eight days at weeks 5, 25, 49, 73, and 97 in ePRO. During this period, 968 exercises were reported, of which 58 were high-risk exercises, including soccer, marathons, and weightlifting. Walking was the most common exercise, with 374 cases (38.6 percent), followed by cycling with 112 cases (11.6 percent) and full-body stretching with 84 cases (8.7 percent).

The metabolic equivalent (MET), which quantifies exercise intensity, had a median average of 2.39 MET for all exercises, with a median maximum MET of 4.30 MET recorded during exercise. The median daily exercise time was 30 minutes, similar to the recommended guideline for the general population (60 minutes per day at a 3 MET level).

The median annual bleeding rate (ABR) for the 129 patients was 0.5 episodes per year. Bleeding associated with exercise occurred in only two cases: traumatic bleeding from being hit by a basketball and bleeding during fishing. No drug-related adverse reactions were observed with Hemlibra.

“This study confirmed that patients with hemophilia A who received Hemlibra can engage in various physical activities without worrying about bleeding,” researchers said. “The study results demonstrate that patients can safely enjoy the health benefits of physical activity.”

JW Pharmaceutical plans to strengthen its marketing efforts based on these study results to help patients with hemophilia A improve their quality of life.

“Since the exercises performed by the patients were similar to those recommended for the general population, we expect that Hemlibra will allow patients to engage in the same activities as the general population without an increased risk of bleeding,” A JW Pharmaceutical official said.