Tacrolimus for the Treatment of Refractory Biopsy-Proven Acute Cellular Rejection in Patients on Belatacept-Based, CNI- and Steroid-Free Immunosuppression Regimens

K. Trobaugh,¹ A. Shields,^1,2 S. Tremblay,¹ R. Alloway,¹ M. Cardi,² D. Witte,¹ F. Paterno,¹ M. Cuffy,¹ E. Woodle.¹

¹Univ of Cincinnati, Cincinnati
²The Christ Hospital, Cincinnati.

Meeting: 2015 American Transplant Congress

Abstract number: D160

Keywords: Biopsy, FK506, Multicenter studies, Rejection

Session Information

Session Name: Poster Session D: Kidney: Acute Rejection

Session Type: Poster Session

Date: Tuesday, May 5, 2015

Session Time: 5:30pm-6:30pm

Presentation Time: 5:30pm-6:30pm

Location: Exhibit Hall E

Background: Tacrolimus (TAC) is effective as rescue treatment (tx) in renal transplant patients (pts) on cyclosporine-based immunosuppression (IS) who have recurrent or resistant acute rejection (AR) episodes. Clinical experience has suggested that pts on a belatacept (BELA)-based regimen may experience AR that is refractory to standard tx with corticosteroids (CS) or rabbit antithymocyte globulin (ATG). In these pts, TAC may be required to resolve the AR.

Methods: This study describes a subset of pts enrolled in a prospective, randomized, multicenter study who were on BELA and experienced refractory biopsy-proven acute cellular rejection (BPACR). Per protocol, recommended first-line tx for BPACR Banff IA or IB is pulse doses of CS followed by a CS taper; for BPACR ≥ Banff IIA, ATG for 7-14 days of CD3 suppression is recommended. Rescue tx with TAC may be used for refractory AR with a planned duration of 28 days (initial goal trough: 12-15 ng/mL). Data analysis was performed using descriptive statistics.

Results: 102/155 pts enrolled as of November 6, 2014, were randomized to a BELA-based regimen. 18 pts have had BPACR, with 6 (33%) experiencing refractory AR.


	Pt 1	Pt 2	Pt 3	Pt 4	Pt 5	Pt 6
Age, yrs	56	60	54	55	35	72
Gender	M	M	F	M	M	M
Race	W	W	AA	W	W	W
Donor type	LD	LD	LD	LD	DD	DD
cPRA, %	0	0	64	0	8	0
IS at time of AR	anti-CD52; BELA; MMF; 5-d CS taper	anti-CD52; BELA; MMF; 5-d CS taper	ATG; BELA; MMF; 5-d CS taper	anti-CD52; BELA; MMF; daily CS	ATG; BELA; MMF; 5-d CS taper	anti-CD52; BELA; MMF; 5-d CS taper
Overview – AR Episode
Baseline SCr, mg/dL	1.6	1.6	1.4	1.3	N/A	1.4
Time to AR, days	486	72	55	101	15	292
SCr at time of biopsy, mg/dL	1.7	3.3	2.1	1.7	1.7	1.7
BANFF Grade	IB	IIB	IIA	IIA	IB	IIA
Summary of AR tx	1) ATG x10d CD3 supp; 2) Banff IA: CS; 3) ongoing IA: +TAC; 4) Banff IB: ↑MMF, ↑TAC trough	1) ATG x14d CD3 supp, CS; 2) Banff IB: cont CS, +TAC	1) ATG x14d CD3 supp, ↑MMF; 2) ongoing IIA: CS, +TAC	1) ATG x14d CD3 supp; 2) ongoing IIA: CS, ↑MMF, +TAC	1) CS; 2) +TAC for ongoing AR; 3) developed BKVN, now on TAC monotherapy	CS and TAC first-line
Time to AR resolution, days	105	37	23	26	N/A	11

Patient and graft survival is 100%.

Conclusion: TAC seems effective as rescue tx for refractory BPACR in pts on BELA. More data are needed to evaluate the optimal goal TAC trough and tx duration in these pts.

To cite this abstract in AMA style:

Trobaugh K, Shields A, Tremblay S, Alloway R, Cardi M, Witte D, Paterno F, Cuffy M, Woodle E. Tacrolimus for the Treatment of Refractory Biopsy-Proven Acute Cellular Rejection in Patients on Belatacept-Based, CNI- and Steroid-Free Immunosuppression Regimens [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/tacrolimus-for-the-treatment-of-refractory-biopsy-proven-acute-cellular-rejection-in-patients-on-belatacept-based-cni-and-steroid-free-immunosuppression-regimens/. Accessed May 13, 2025.

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