TY - JOUR
T1 - Therapeutic drug monitoring is more cost-effective than a clinically-based approach in the management of loss of response to infliximab in inflammatory bowel disease: an observational multi-centre study.
AU - Guidi, Luisa
AU - Pugliese, Daniela
AU - Berrino, Alexandra Maura
AU - Tolusso, Barbara
AU - Basile, Michele
AU - Cantoro, Laura
AU - Balestrieri, Paola
AU - Civitelli, Fortunata
AU - Bertani, Lorenzo
AU - Marzo, Manuela
AU - Felice, Carla
AU - Gremese, Elisa
AU - Costa, Francesco
AU - Viola, Franca
AU - Cicala, Michele
AU - Kohn, Anna
AU - Gasbarrini, Antonio
AU - Rapaccini, Gian Lodovico
AU - Ruggeri, Matteo
AU - Armuzzi, Alessandro
PY - 2018
Y1 - 2018
N2 - BACKGROUND:
Empirical dose intensification and therapeutic drug monitoring (TDM) of infliximab (IFX) trough levels (ITL) and antibody (ATI) assays are recognised approaches for managing the loss of response (LoR) in inflammatory bowel disease (IBD) patients.
AIM:
To compare these two interventions in a clinical setting, in terms of effectiveness and cost savings.
METHODS:
Consecutive IBD patients, experiencing LoR, were clinically managed according to a TDM algorithm. A historical group of empirically treated patients, for whom sera for ITL and ATI assays were collected, served as the control group. Clinical outcomes 12 weeks after the therapeutic interventions were compared between the two groups. A cost-minimization analysis was performed to compare the economic impact of these two approaches.
RESULTS:
Ninety-six patients were enrolled prospectively and compared with 52 controls. The two cohorts were similar in characteristics and the distribution of TDM results. In the prospective cohort, however, we observed less IFX dose escalations compared with controls (45% versus 71%, p=0.003). Also, more patients were switched to a different anti-TNF in the prospective cohort than in the control one (25% versus 4%, p=0.001). The percentages of patients achieving a clinical response at 12 weeks were 52% and 54% for the prospective and control groups, respectively. By cost analysis, we estimated a savings of 15% if the TDM algorithm was applied.
CONCLUSIONS:
In our population, applying a TDM algorithm for LoR to IFX resulted in less dose escalations, without loss of efficacy, compared with empirical adjustment. In addition, the TDM approach was cost-effective.
AB - BACKGROUND:
Empirical dose intensification and therapeutic drug monitoring (TDM) of infliximab (IFX) trough levels (ITL) and antibody (ATI) assays are recognised approaches for managing the loss of response (LoR) in inflammatory bowel disease (IBD) patients.
AIM:
To compare these two interventions in a clinical setting, in terms of effectiveness and cost savings.
METHODS:
Consecutive IBD patients, experiencing LoR, were clinically managed according to a TDM algorithm. A historical group of empirically treated patients, for whom sera for ITL and ATI assays were collected, served as the control group. Clinical outcomes 12 weeks after the therapeutic interventions were compared between the two groups. A cost-minimization analysis was performed to compare the economic impact of these two approaches.
RESULTS:
Ninety-six patients were enrolled prospectively and compared with 52 controls. The two cohorts were similar in characteristics and the distribution of TDM results. In the prospective cohort, however, we observed less IFX dose escalations compared with controls (45% versus 71%, p=0.003). Also, more patients were switched to a different anti-TNF in the prospective cohort than in the control one (25% versus 4%, p=0.001). The percentages of patients achieving a clinical response at 12 weeks were 52% and 54% for the prospective and control groups, respectively. By cost analysis, we estimated a savings of 15% if the TDM algorithm was applied.
CONCLUSIONS:
In our population, applying a TDM algorithm for LoR to IFX resulted in less dose escalations, without loss of efficacy, compared with empirical adjustment. In addition, the TDM approach was cost-effective.
KW - Inflammatory bowel diseas
KW - Infliximab
KW - drug monitoring
KW - Inflammatory bowel diseas
KW - Infliximab
KW - drug monitoring
UR - http://hdl.handle.net/10807/122404
U2 - 10.1093/ecco-jcc/jjy076
DO - 10.1093/ecco-jcc/jjy076
M3 - Article
SP - N/A-N/A
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
SN - 1873-9946
ER -