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


CONCLUSIONS
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.
1 Health Services and Nursing Research, University of Leuven, Leuven, Belgium. 2 Health Services Research, Bristol-Myers Squibb, Plainsboro, NJ. 3 Global Health Economics and Outcomes Research, Bristol-Myers Squibb, Princeton, NJ. 4 Address correspondence to: Fabienne Dobbels, M.Sc., Ph.D., Department of Public Health and Primary Care, Health Services and Nursing Research, University of Leuven (KU Leuven), Kapucijnenvoer 35/4, B-3000 Leuven, Belgium.
Fabienne
F
Dobbels
Schiffon
S
Wong
You
Y
Min
Joo
J
Sam
Anupama
A
Kalsekar
D000069594:Abatacept; D000328:Adult; D016572:Cyclosporine / Q000627:therapeutic use; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007668:Kidney / Q000473:pathology; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D051437:Renal Insufficiency / Q000523:psychology* / Q000601:surgery*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D018796:Immunoconjugates; D007166:Immunosuppressive Agents; D000069594:Abatacept; D016572:Cyclosporine