Flebogamma (IVIG) Effective in Treating Post-Polio Syndrome

Grifols announced positive results from its Phase II/III clinical trial (NCT02176863) evaluating the efficacy and safety of Flebogamma 5% DIF (intravenous immune globulin [IVIG]) to treat patients with post-polio syndrome (PPS), which demonstrated a significant improvement in distance walked compared to placebo.  

The trial, which evaluated whether Flebogamma 5% DIF dosed at 1g/kg improved the physical capabilities of PPS patients compared with the placebo group using changes in the 2MWD from baseline as the primary measure, found that in the majority (95 percent) of the 191 participants, the legs were the main part of the body impacted by PPS symptoms. Patients who received monthly IVIG infusions of 1g/kg showed a statistically significant improvement in 2MWD versus placebo. The least squares mean 2MWD change from baseline at week 52, after adjusting for differences between groups, was 12.75 meters, equating to a mean improvement of 6.07 meters over placebo. Treated patients with IVIG 1g/kg also showed greater numerical endurance as measured by the six-minute walk distance (6MWD). The least squares mean 6MWD change from baseline at week 52, after adjusting for differences between groups, was 29.16 meters, which equates to a mean improvement of 15.8 meters over placebo.

The treatment was found to be safe and well-tolerated with a similar safety profile to that of IVIG administration in other indications.

“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 Frans Nollet, MD, PhD, of the Department of Rehabilitation Medicine of the Academic Medical Center, University of Amsterdam, 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.”