New immunotherapy could replace daily pills after kidney transplantation

A new study offers hope that kidney transplant patients could one day have a monthly treatment instead of multiple pills every day. The new treatment also may reduce side effects and increase the lifespan of the donor organ. 

Currently, patients who have had a kidney transplant must take a cocktail of pills every day for the rest of their lives. These standard immunosuppressants prevent the immune system from attacking the new organ, but over time may damage kidney function and become less effective. 

Standard immunosuppressants also are associated with diabetes, hypertension, high cholesterol, and cause side effects that lead most transplant patients to skip doses, noted the study's first author Flavio Vincenti, MD, professor of medicine and surgery in the Division of Nephrology at UC San Francisco. Other side effects include fatigue, muscle weakness, sexual dysfunction, hair loss, and sleeplessness. 

In the Phase 2 pilot study, 23 patients received infusions of belatacept and dazodalibep, proteins that disrupt the immune system's attack on the new organ but do not affect non-immune cells the way standard treatment does. 

Kidney functioning improved in all patients who completed the study and was similar for those who experienced organ rejection. No patient experienced rejection due to antibodies produced by the immune system, which is a major cause of transplant failure. Results were published February 3 in the American Journal of Transplantation. 

We would hope to see better medication compliance with the new regimen since it does not involve taking multiple medications every day."

Flavio Vincenti, MD, professor of medicine and surgery, Division of Nephrology, UC San Francisco

Study patients received standard immunosuppressants at first, but these were discontinued by day 28 in favor of the infusions for the remainder of the 48-week study. 

Two of the first three patients experienced organ rejection, which was effectively treated and the rejection reversed. Drug frequency and dosing were revised in response for the remaining patients, 13 of whom completed the study. Seven patients withdrew due to acute kidney rejection, side effects, or for unspecified reasons. 

The next phase of the study will determine if these early findings are replicated in a large patient pool, said senior author Allan D. Kirk, MD, PhD, professor of surgery at Duke University School of Medicine. 

"We hope that most patients can be spared the toxic effects of immunosuppressants, which would be reserved for those with certain high-risk factors," said Kirk.