This post is by Keven Fowler, fresh off his win of NephJC MVP in the recent NephJC Kidneys
Here is my patient perspective on the HARMONY trial:
- I am 12 years and 3 months post-transplant with stable SCR.
- I had a pre-emptive kidney transplant (living donation) and thus considered low immunologic risk patient.
- My induction therapy was rATG, and I have been on triple maintenance therapy: low dose Prograf, CellCept, and low dose steroid.
In my opinion, I have done well long-term because my acute rejection riskhas been well managed with Prograf and rATG. When BMS launched belatacept, some members of the transplant community downplayed the risks ofacute rejection. This was significant oversight, and disservice to patients. The clinical trials with belatacept underscored the importance of managing acute rejection. Acute rejection episodes do effect long-term graft function. I suggest reviewing the work of Peter Nickerson, MD.
The risk of new onset diabetes after transplant (NODAT) with Prograf is a real risk. Although I have normal BMI and exercise on average 5-6 days per week, it is a constant fight to maintain my HbA1C under 6.0. With my lifestyle changes, I believe that my induction therapy and maintenance therapy have contributed to my long-term success.
While I believe the HARMONY study is well intended, I believe the path to longer term outcomes will be achieved by persuading patients to embrace a post-transplant lifestyle. The benefits of exercise extend beyond reducing the metabolic risk. One of the greatest benefits of exercise is the improvement of mental health and building discipline to face the uncertainty of a chronic disease.
In summary, the transplant community has reevaluated the importance of acute rejection correctly. The launch of belatacept underscored the importance of acute rejection. I can see why many transplant centers have emrbaced steroid free protocols. It is my hope these transplant centers do not diminish the importance acute rejection.