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Clinical Trial
. 2014 Nov 15;98(9):960-8.
doi: 10.1097/TP.0000000000000159.

Beneficial effect of belatacept on health-related quality of life and perceived side effects: results from the BENEFIT and BENEFIT-EXT trials

Fabienne Dobbels  1 , Schiffon Wong, You Min, Joo Sam, Anupama Kalsekar
Affiliations
Clinical Trial

Beneficial effect of belatacept on health-related quality of life and perceived side effects: results from the BENEFIT and BENEFIT-EXT trials

Fabienne Dobbels et al. Transplantation. .

Abstract

Background: Patient-reported outcomes are increasingly incorporated in drug evaluation trials. Whether new immunosuppressive drugs result in an improved health-related quality of life (HRQoL) and a reduced side effect experiences remains unknown. Moreover, the relationship between HRQoL and kidney function has never been investigated in kidney transplant recipients.

Methods: Using the BENEFIT and BENEFIT-EXT trials, we investigated the following: (a) evolution of HRQoL, assessed by the Medical Outcomes Short Form Health Survey (SF-36) in the first 3 years (baseline, 12, 24, and 36 months) after kidney transplantation; (b) association among kidney function (chronic kidney disease stage), HRQoL, and patient-reported side effects (Modified Transplant Symptom Occurrence and Symptom Distress Scale-59R; BENEFIT trial only); and (c) impact of belatacept and cyclosporine on side effect experience and HRQoL.

Results: In the BENEFIT trial, all subjects reported clinically meaningful improvements compared with baseline and returned to general population scores, both for physical composite score (PCS) and mental composite score Short Form (36) Health Survey at 12 to 36 months after transplantation. In the BENEFIT-EXT trial, this was observed for PCS only. Belatacept-treated patients reported better absolute PCSs compared with cyclosporine-treated patients. The differences were small but statistically significant at all times. Belatacept-treated patients tended to experience less side effects compared with cyclosporine-treated patients, except for dry skin. Worsening kidney function was associated with a significant decrease in HRQoL.

Conclusion: Worsening in kidney function was associated with lower HRQoL. Compared with cyclosporine, belatacept was associated with improved HRQoL, suggesting that use of non-nephrotoxic immunosuppressants may affect the patient's side effect experience and improve their HRQoL.

Trial registration: ClinicalTrials.gov NCT00114777 NCT00256750.

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