CLINICAL IMMUNOSUPPRESSION - KIDNEY EARLY

B. Kiberd¹, K. Budde², W. Arns³, M. Zeier³, A. Shoker⁴, D. Del castillo⁵, G. Grandaliano⁶, D.M. Kuypers⁷, R. Walker⁸, F.T. Kawakami⁹, H. Tedesco-silva^10
1Medicine, Dalhousie University, Halifax/NS/CANADA, ²Medizinische Klinik, Universitätsklinik Charité, Berlin/GERMANY, ³Department Of Nephrology, Medical Clinic Ko¨ln-Merheim, Cologne/GERMANY, ⁴, University of Saskatchewan, saskatoon/CANADA, ⁵, hospital Reina Sofia, Córdoba/SPAIN, ⁶Dept. Of Emergency And Transplantation, University of Bari, Bari/ITALY, ⁷, University Hospitals of Leuven, Leuven/BELGIUM, ⁸, Royal Melbourne Hospital, Melbourne/AUSTRALIA, ⁹, Novartis Pharma AG, Basel/SWITZERLAND, ¹⁰, Hospital do Rim e Hipertensao, Sao Paulo/BRAZIL

Body: Introduction: Early adequate mycophenolic acid (MPA) exposure has been associated with effective rejection prophylaxis in de novo renal transplant recipients (RTs). An intensified EC-MPS dosing regimen early post-transplant (Tx) may improve efficacy while maintaining a comparable tolerability profile. The study compared gastrointestinal (GI)symptom burden using the validated GI Symptom Rating Scale (GSRS) questionnaire in RTs receiving initially intensified vs. standard EC-MPS dosing regimens.
Methods: In two 6-month studies run in parallel (ERLDE12 and ERL2419), RTs were randomized (1:1) to Intensified EC-MPS group (2880 mg/d for 2 wks; subsequently 2160 mg/d for 4 wks; 1440 mg/d thereafter) or Standard EC-MPS group (1440mg/d) with CsA and steroids +/- anti-IL2R induction. The GSRS questionnaire was completed by the patients at baseline (prior to Tx, only ERL2419), Days 10, 21, 56, and 84 post-Tx. Analyses of the pooled population are presented here. Lower GSRS scores indicate better GI status. Results: N=213 and N=219 (Intensified vs. Standard) RTs were included in the GSRS analyses. Mean GSRS total scores were comparable at all time points, 2.06 in both groups at Day 10 and 1.53 vs. 1.56, Intensified vs. Standard, at Day 84. The overall mean GSRS change did not differ significantly between the treatment groups (p=0.993). Similarly for all five GI subgroups (diarrhea, indigestion, constipation, abdominal pain, and reflux scores) no significant differences were observed between treatments. Changes from Day 10 to Days 21, 56 and 84 were statistically significant in both groups (p<0.001). Conclusion: The intensified and standard EC-MPS dosing regimens had comparable GI symptom burden profiles supporting the potential role of the intensified EC-MPS regimen in the treatment of de novo renal transplant recipients.

Disclosure: All authors have declared no conflicts of interest.