JW Pharmaceutical's Hemlibra Proven to Prevent Bleeding During Exercise in Hemophilia A Patients

Only 2 Exercise-Related Bleeding Events Among 968 High-Intensity Activities

JW Pharmaceutical announced on August 11 that a study demonstrating the preventive effect against bleeding and various physical activity data in patients treated with Hemlibra (active ingredient: emicizumab), a treatment for hemophilia A, was recently published in the international journal Hemophilia.

'Hemlibra'. JW Pharmaceutical

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Hemlibra is an innovative new drug that mimics coagulation factor VIII, which is deficient in patients with hemophilia. Among treatments for hemophilia A, it is the only one that can be used by both patients with antibodies (who are resistant to existing factor VIII therapies) and those without antibodies. It also features sustained preventive effects with a subcutaneous injection administered once every four weeks at most. In May 2023, the scope of health insurance coverage was expanded to include severe non-inhibitor hemophilia A patients aged one year and older.

The research team, led by Kagehiro Amano of the Department of Laboratory Medicine at Tokyo Medical University, conducted a study from January 2019 to October 2021 involving 129 non-inhibitor hemophilia A patients with an average age of 29.7 years.

The team evaluated patients' exercise, intensity, bleeding events, and safety after Hemlibra administration using the electronic patient-reported outcome application 'ePRO' and a wearable activity tracker.

Among the patients treated with Hemlibra, 73 recorded their exercise activities in ePRO during 8-day periods at weeks 5, 25, 49, 73, and 97. A total of 968 exercise sessions were reported during these periods, of which 58 involved high-risk activities for bleeding, such as soccer, marathon running, and weightlifting.

Of the recorded activities, walking was the most common with 374 sessions (38.6%), followed by cycling with 112 sessions (11.6%), and full-body stretching with 84 sessions (8.7%). The median metabolic equivalent of task (MET), which quantifies exercise intensity, was 2.39 METs for all activities, and the median of the maximum MET recorded during exercise was 4.30 METs. The median daily exercise duration was 30 minutes, which is similar to the general guideline recommended for healthy individuals (60 minutes per day at 3 METs).

The median annualized bleeding rate (ABR) among the 129 patients was 0.5 events. Only two bleeding events were associated with exercise: one traumatic bleed caused by being hit by a ball while playing basketball, and one bleed that occurred during fishing. No adverse drug reactions related to Hemlibra were observed.

The researchers stated, "Through this study, we confirmed that hemophilia A patients treated with Hemlibra can safely participate in a variety of physical activities without worrying about bleeding," adding, "The results demonstrate that patients can safely enjoy the health benefits of exercise."

Based on these findings, JW Pharmaceutical plans to strengthen its marketing efforts to help improve the quality of life for hemophilia A patients. A representative from JW Pharmaceutical commented, "Since the level of physical activity performed by patients was similar to that recommended for the general population, we expect that with Hemlibra, patients can enjoy the same activities as healthy individuals without an increased risk of bleeding."

This content was produced with the assistance of AI translation services.