Recent human trials of a new one-year-long immune-based treatment for post-polio syndrome, which can strike polio survivors years after the initial infection and be very debilitating, have produced positive results.
Caused by a highly contagious virus, polio primarily infects the brain and spinal cord. While many people infected with poliovirus remain asymptomatic or experience mild symptoms, in some cases it can lead to paralysis, difficulty breathing, and even death.
Post-polio syndrome (PPS) affects between 25% and 40% of polio survivors years after the initial infection. It’s characterized by new weakening in muscles previously affected by polio, as well as seemingly unaffected muscles. While there’s currently no treatment other than symptom management, a recent clinical trial evaluating the effectiveness of a novel treatment for PPS has produced positive results.
“This study is great news since it proves that the ongoing decline in physical functioning due to post-polio syndrome, which was so far considered inevitable, can be halted, and even be improved,” said Professor Dr Frans Nollet from the Department of Rehabilitative Medicine at the University of Amsterdam’s Academic Medical Center (AMC), and one of the study’s principal investigators. “That is positive for all polio survivors, who are confronted with increasing disabilities as they age and for whom no effective medication was yet available.”
Grifols, a global healthcare company and leading producer of plasma-based medicines, developed the novel intravenous immunoglobulin (IVIG) treatment called Flebogamma 5% DIF. IVIG involves injecting a concentrated solution of antibodies into a vein to boost the recipient’s immune system’s ability to fight infections and reduce inflammation.
The investigators recruited 191 participants for the clinical trial, the goal of which was to see if the treatment helped people with PPS improve their physical ability and if it was safe. In most (95%) of the participants, their legs were most impacted by PPS. The principal test used by the investigators was the two-minute walk distance (2MWD) test, which measures how far someone can walk in two minutes. It’s a good way to test strength, endurance, and mobility.
People who received Flebogamma 5% DIF injections once a month for 12 months walked an average of 12.75 m (41.8 ft) farther compared to how far they could walk before treatment. Compared to the placebo group, the IVIG walked an extra 6.07 m (20 ft) on average. The trial investigators also checked patients’ performance on the six-minute walk distance (6MWD). Those in the IVIG treatment group walked an extra 29.16 m (95.7 ft) compared to where they started, which was 15.8 m (51.8 ft) farther than the placebo group.
The treatment was found to be safe and well-tolerated. The most common adverse reactions to Flebogamma 5% DIF, reported in at least 5% of adult trial subjects, were headache, fever, pain, infusion site reactions, diarrhea, chills, and hives.
“These results show a meaningful physical accomplishment, providing patients with more freedom of movement and the ability to be more self-reliant,” said Dr Jörg Schüttrumpf, Grifols Chief Scientific Innovation Officer. “Grifols is committed to increasing the range of indications of its plasma-derived medicines and other biopharmaceuticals to benefit more patients globally and make a real positive difference in their lives.”
Note, the trial results have not yet been peer-reviewed or published in a scientific journal.
Source: Grifols