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Adherence with Immunosuppressive Therapy: Results to 4 Years after Kidney Transplantation in the Mycophenolic Acid Observational Renal Transplant (MORE) Study

D. Tsapepas, A. Langone, L. Chan, A. Wiland, K. McCague, M. Chisholm-Burns

NY-Presbyterian Hospital-Columbia University Medical Center, New York, NY
Vanderbilt University Medical Center, Nashville, TN
University of Colorado School of Medicine, Aurora, CO
Novartis Pharmaceuticals, East Hanover, NJ
University of Tennessee Health Science Center, Memphis, TN

Meeting: 2013 American Transplant Congress

Abstract number: B1030

Related Abstracts
  • Mycophenolic Acid (MPA) Dosing: Effect on Efficacy to 4 Years after Kidney Transplantation in the Mycophenolic Acid Observational Renal Transplant (MORE) Study
  • Does African American (AA) Ethnicity Affect Kidney Transplant Outcomes at Four Years? An Analysis of the Mycophenolic Acid Observational Renal Transplant (MORE) Study

Introduction: Provider knowledge of factors influencing adherence with immunosuppression may help identify at-risk patients to allow for intervention.

Methods: MORE was a prospective, 4-year, observational study of de novo adult kidney transplant patients receiving mycophenolic acid (MPA) as enteric-coated mycophenolate sodium (EC-MPS) or mycophenolate mofetil (MMF) at 40 US sites. Adherence was assessed using the Immunosuppressant Therapy Adherence Scale (ITAS), a validated, self-reported, 4-item questionnaire: total score 0-12 (12=adherence; <12=non-adherence).

Results: ITAS data were available in 803/946 patients (84.9%); 49.7% (399/803) were non-adherent at some point. Mean(SD) total ITAS score at months 3, 6, 12, 24, 36 and 48 was 11.5(1.0), 11.4(1.2), 11.3(1.2), 11.2(1.2), 11.3(1.1) and 11.4(1.1), respectively, with non-adherence in 24.8%, 31.5%, 33.0%, 39.8%, 35.4% and 26.4% of patients. Patients receiving EC-MPS had a higher mean total score vs MMF at months 24 (11.3[1.0] vs 10.9 [1.4], p<0.01) and 36 (11.4[1.0] vs 11.1[11.3], p=0.02), and were more likely to take the prescribed dose of MPA at months 12 (94.6% vs 91.5%, p=0.04) and 24 (92.8% vs 87.7%, p=0.03). The odds ratio for non-adherence was 1.53 (95% CI 1.11, 2.12; p<0.01) in African Americans (AAs) vs non-AAs and 1.31 (95% CI 0.98, 1.75; p=0.06) for living vs deceased donation. Age, gender, and delayed graft function did not predict non-adherence. In non-adherent vs adherent patients, the incidence of biopsy-proven acute rejection was 12.8% (51/398) vs 11.1% (45/404) (log rank p=0.17); graft survival was 4.8% (19/399) vs 2.7% (11/404) (p=0.09); death was 1.5% (6/399) vs 4.5% (18/404) (p<0.01).

Conclusion: Adherence to immunosuppression decreases over time to month 24 post-transplant. Due to declining numbers of patients with follow-up data, limited conclusions could be not drawn thereafter. Demographic factors have limited predictive value other than African-American ethnicity, but choice of immunosuppressive regimen may be influential. Non-adherence was associated with a non-significant trend to greater graft loss, but reduced mortality.

Chan, L.: Grant/Research Support, Novartis, Other, Novartis, Consultant. Wiland, A.: Employee, Novartis. McCague, K.: Employee, Novartis.

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To cite this abstract in AMA style:

Tsapepas D, Langone A, Chan L, Wiland A, McCague K, Chisholm-Burns M. Adherence with Immunosuppressive Therapy: Results to 4 Years after Kidney Transplantation in the Mycophenolic Acid Observational Renal Transplant (MORE) Study [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/adherence-with-immunosuppressive-therapy-results-to-4-years-after-kidney-transplantation-in-the-mycophenolic-acid-observational-renal-transplant-more-study/. Accessed January 22, 2021.

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