Health >> JAMA Current Issue

Therapeutic Drug Monitoring vs Standard Therapy During Maintenance Infliximab Therapy and Control of Immune-Mediated Inflammatory Diseases—Reply

Link [2022-04-23 10:52:27]

In Reply In response to our study on TDM during maintenance infliximab therapy, Mr Javor and colleagues comment on the study design and believe that reactive TDM should have been allowed in the standard therapy group. Proactive TDM, the treatment strategy addressed in the NOR-DRUM trials, refers to scheduled assessments of serum drug levels and antidrug antibodies to guide dose adaptions in order to optimize therapy and prevent treatment failure. Reactive TDM refers to assessments of serum drug levels and antidrug antibodies in a particular clinical situation, ie, to guide therapy if a treatment failure is suspected. Our aim when designing the NOR-DRUM B trial in 2016 was to assess whether proactive TDM was better than standard clinical care in maintaining disease control and preventing loss of response during maintenance therapy with infliximab. Based on clinical guidelines and clinical practice at that time, the natural choice was to compare proactive TDM with therapy without TDM. We are aware that reactive TDM has emerged as a possible new standard of care for optimizing biological therapy in IBD in recent years. As pointed out by Javor and colleagues, reactive TDM is recommended by the American Gastroenterological Association, though as a conditional recommendation with a very low quality of evidence. However, according to the European Crohn’s and Colitis Organisation guidelines published in 2020, neither proactive nor reactive TDM is recommended. Furthermore, reactive and proactive TDM are not recommended in any guidelines in the fields of rheumatology and dermatology.