KLINICKÉ ZKOUŠKY ZENAPAXU/ZINBRYTY PŘED REGISTRACÍ
Daclizumab is an engineered human antibody that blocks the IL-2 receptor on immune cells. IL-2 is a potent immune stimulator and thus by blocking it, this therapy putatively dampens immune responses (including autoimmune responses).
The clinical benefit derived from daclizumab has been linked to the expansion of immunoregulatory CD56 natural killer cells, and the resulting downregulation of adaptive T-cell responses [Bielekova et al. 2006]. A recent open-label phase II trial using subcutaneous daclizumab at 2 mg/kg in patients with MS whose condition showed an inadequate response to IFN-β therapy demonstrated a 72% reduction in the number of new or enlarged contrast-enhancing lesions at week 24 compared with patients receiving IFN-β alone [Wynn et al. 2011]. A phase III trial of daclizumab versus IFN-β1a is ongoing (DECIDE study). Daclizumab is currently FDA approved for use in organ transplant patients.