Muristek
Therapeutic Drug Monitoring vs Standard Therapy During Maintenance Infliximab Therapy and Control of Immune-Mediated Inflammatory Diseases
To the Editor The results of the NOR-DRUM B study confirmed previous findings of the TAXIT trial, the first randomized clinical trial to evaluate the benefit of proactive TDM for biologics, which enrolled patients with Crohn disease or ulcerative colitis who were receiving maintenance infliximab therapy. Although the TAXIT trial showed that the proportion of patients in the standard care group who had a disease flare was higher than in the proactive TDM group, the primary end point of achieving combined clinical and biochemical remission 52 weeks after randomization was similar between the proactive TDM (69%) and standard care (60%) groups. The NOR-DRUM B study also found that remission rates did not differ between groups at 52-week follow-up. In this study, there was a clinically meaningful difference in sustained disease control despite median trough concentrations being similar in both groups, which may indicate that TDM is not required for all patients but may greatly benefit some. In the proactive TDM group, only 30% of patients had drug concentrations in the optimal range vs 17% in the standard therapy group throughout the trial. Two recent advancements that could further increase the proportion of patients with optimal exposure were not available when the NOR-DRUM B trial was conceptualized. First, rapid assays for TDM at the point of care are now available, with results available in minutes instead of weeks, thereby avoiding delay in treatment decisions. Second, model-informed precision dosing algorithms allow for precise dose adjustments in individual patients to reach a target exposure level. Use of these novel tools may have increased the delta between the proactive TDM and standard therapy groups.
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