Introduction: There remains a need for immunosuppressive agents which offer long-term preservation of renal function and an acceptable safety profile in the switch setting. Here we report the 3-year (yr) outcomes in a long-term extension (LTE) of a Phase II study in kidney transplant recipients (KTRs) switching from a CNI to belatacept (bela).
Methods and study cohort: This was a randomized, open-label trial in KTRs 6-36 months post-transplant, with stable graft function (MDRD GFR 35-75 mL/min), and receiving a CNI (tacrolimus or CsA). Pts were randomized to continue CNI treatment or switch to bela. Pts were eligible to enter the LTE after 1 yr. Of 173 randomized pts, 162 (n=81 bela; n=81 CNI) entered the LTE. After Yr 2, 16 pts in the CNI group converted to bela; the CNI population reported at Yr 3 (n=65) excludes these pts.
Results: At Yr 3, 79/81 bela pts and 64/65 CNI pts were alive with a functioning graft; 1 death of unknown etiology was reported in the bela group. Mean cGFR (SD) was 61.4 (20) mL/min in bela pts and 54.7 (20) mL/min in CNI pts. The mean change in cGFR (SD) from baseline was 8.2 (16) mL/min in bela pts and 0.1 (18) mL/min in CNI pts. AR occurred in 5 (6.2%) bela pts and 3 (4.6%) CNI pts up to Yr 3, of which 2 bela pts and 1 CNI pt subsequently experienced graft loss. From randomization to 3-yr database lock, serious AEs occurred in 37 (46%) bela pts and 34 (52%) CNI pts; serious infections occurred in 22 (27%) bela pts and 21 (32%) CNI pts. Viral infections occurred in 29 (36%) bela pts and 17 (26%) CNI pts. Fungal infections occurred in 20 (25%) bela pts and 4 (6%) CNI pts; none were serious (mostly mucocutaneous). Malignancies occurred in 10% of bela and 8% of CNI pts and no PTLD was reported in either treatment arm.
Conclusions: Renal function improvement was maintained at 3 yrs for KTRs who switched to belatacept from either CNI. Adherence remained high, and no new safety signals were identified through 3 yrs of follow-up. This exploratory trial indicates that switching pts from a CNI to belatacept may represent an effective clinical approach that should be validated in a large-scale trial.
Rial, M.: Grant/Research Support, Belatacept, Other, Tacrolimus, Honoraria for Lecture. Alberu, J.: Other, BMS, Honoraria (speaker), Sanofi (Mexico), Honoraria (speaker), Pfizer (CentroamÉrica), Honoraria (speaker). Steinberg, S.: Other, Bristol-Myers Squibb, Support for Travel. Vincenti, F.: Grant/Research Support, Bristol-Myers Squibb. Jones-Burton, C.: Employee, Bristol-Myers Squibb. Kamar, N.: Other, BMS, Honoraria for Lectures, Novartis, Honoraria for Lectures, Astellas, Honoraria for Lectures.
To cite this abstract in AMA style:Grinyo J, Rial M, Alberu J, Steinberg S, Manfro R, Nainan G, Vincenti F, Jones-Burton C, Kamar N. Outcomes of Switching to Belatacept from a Calcineurin Inhibitor in Kidney Transplant Recipients: 3 Year Results from the Long-Term Extension of a Phase II Study [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/outcomes-of-switching-to-belatacept-from-a-calcineurin-inhibitor-in-kidney-transplant-recipients-3-year-results-from-the-long-term-extension-of-a-phase-ii-study/. Accessed May 7, 2021.
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