STEROID AVOIDANCE WITH LOW-DOSE TACROLIMUS IS SAFE AND EFFECTIVE FOR KIDNEY TRANSPLANT RECIPIENTS WITH LOW IMMUNOLOGIC RISK IN THE LONG-TERM: SAILOR II FOLLOW-UP STUDY

8 Feb 2025 12 a.m. 12 a.m.
WCN25-AB-3638, Poster Board= SAT-430

Introduction:

In our previous randomized controlled open-label multicenter trial, the SAILOR study, we reported good feasibility, safety, and efficacy of steroid avoidance at 2-years in immunologically low-risk kidney transplant recipients. A total of 222 participants were randomized to the following two treatment arms: Steroid avoidance arm with ATG induction + low-dose tacrolimus + mycophenolate mofetil (MMF) or the standard of care steroid maintenance arm with basiliximab induction + low-dose tacrolimus + MMF + prednisolone. Long-term results are needed to prove the safety and efficacy of the steroid avoidance protocol.

Methods:

In SAILOR II, a non-interventional observational study, we collected clinical data of all original SAILOR study participants at 1-, 2-, 5-years and the last follow-up, unless they withdrew the consent for participation. 

Efficacy endpoints were: 1) patient survival, 2) death-censored graft survival, 3) overall graft survival, 4) incidence of biopsy-proven rejection, 5) incidence of post-transplantation diabetes mellitus (PTDM), and 6) estimated glomerular filtration rate (eGFR). Safety endpoints were incidence of: 1) severe infection (including opportunistic infections) requiring hospitalization, 2) opportunistic infections not requiring hospitalization, 3) malignancies (including non-melanoma skin cancer), 4) MACE (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, stroke, heart failure requiring hospitalization or cardiovascular death), and 5) donor-specific antibodies (DSA).  

Results:

A total of 111 patients were included in the steroid avoidance arm and 104 in the steroid maintenance arm (Figure 1). The mean follow-up time post-randomization was 7.3 ± 1.8 years. Death-censored graft survival (91.8 vs. 93.1%, p=0.88), patient survival (88 vs. 93%, p=0.32), cumulative incidence of biopsy-proven rejection (19.8% vs. 16.3% (p=0.6), kidney function (50.8 vs. 54 ml/min/1.73m2, p=0.27), and donor-specific antibodies (13.5 vs. 15,4%, p=0.70), respectively, were similar in both arms (Table 1, Figures 2 and 3). Incidence of PTDM, serious infections requiring hospitalization, malignancies and chronic rejection did not differ significantly. Two thirds of participants in steroid avoidance arm remained steroid-free at the end of follow-up.

Table 1: Efficacy endpoints

 

Steroid avoidance

        + ATG

        (n=111)

Steroid maintenance

    + basiliximab

         (n=104)

p-value

 

Follow-up time (years)

    7.3 ± 1.76

      7.3 ± 2.03

0.99

Patient survival 7-years

0.877 (0.791-0.929)

0.931 (0.860-0.966)

0.32

Age at death

      62.0 ± 9.6

      62.6 ± 9.6

0.88

Time from transplant to death (months)

    74.2 ± 23.1

      54.7 ± 38

<0.0001

Deaths, all causes

      17 (15.3)

        10 (9.6)

0.22

       Cardiovascular

        6 (5.4)

            0

0.03

       Malignancy

      10 (9.0)

        2 (1.9)

0.1

      Infection-related

        1 (0.9)

            0

1.0

       Other

        2 (1.8)

        1 (1.0)

1.0

Death-censored graft survival 7-years

0.918 (0.841-0.959)

0.931 (0.860-0.966)

0.88

Graft loss, all causes

        7 (6.3)

        5 (4.8)

0.77

       Rejection

        3 (2.7)

        3 (2.9)

1.0

       Recurrence of glomerular   

       disease

      1 (0.9)

        1 (1.0)

1.0

       Primary non-function

      1 (0.9)

          0

1.0

       Other

      2 (1.8)

        1 (1.0)

1.0

Overall graft survival at 7-years

0.813 (0.721-0.877)

0.893 (0.815-0.939)

0.19

Any biopsy-proven rejection

      22 (19.8)

      17 (16.3)

0.60

DSA

      15 (13.5)

      16 (15.4)

0.70

Results presented as mean ±SD; survival (CI); n (%)

Figure 1. Flow-chart of patient population

Figure 1. Flow-chart of patient population

Figure 2: Death-censored graft survival

Figure 2. Death-censored graft survival

Figure 3. Rejection-free survival

Conclusions:

Steroid avoidance in patients with low immunological risk was safe and effective at 7 years after kidney transplantation. Two-thirds of the patients could be maintained steroid-free. This study provides further evidence for long-term safety of the steroid-free protocol after kidney transplantation even with the current regimen using low-dose tacrolimus + MMF with antibody induction.

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I have no potential conflict of interest to disclose.

I did not use generative AI and AI-assisted technologies in the writing process.