What is Coming Down the Pipeline?
The following biologic therapies have recent or ongoing studies in UC. Some are more promising than others.
Basiliximab is an antibody which binds to the interleukin-2 (IL-2) receptor on activated white blood cells (T-lymphocytes). Antibody binding prevents IL-2 from binding to the receptor and activating the lymphocyte. This process impairs immune system responses. Basiliximab was initially studies in the late 1990s and approved for prevention of organ rejection after kidney transplant. A study of 20 patients with steroid resistant UC showed promising results after a single dose of Basiliximab. Thirteen of 20 patients were in remission after 24 weeks, while had undergone colectomy.
Visilizumab is an antibody to the CD3 antigen, a receptor intimately related to the immune response, with the ability to induce cell death (apoptosis) selectively in activated T cells. Preliminary studies were performed in bone marrow transplant. A single open label phase I (safety) study of 32 steroid refractory patients showed a possible benefit of therapy with an acceptable safety profile. Follow-up studies are currently underway.
Daclizumab is an antibody to the IL-2 receptor similar to basiliximab. It is also used for the prevention of acute rejection of transplanted kidneys. The only study in ulcerative colitis involved 159 patients with moderate disease and did not show a benefit over placebo.