Home > Dermatology > Support for therapeutic drug monitoring with infliximab maintenance therapy

Support for therapeutic drug monitoring with infliximab maintenance therapy

Journal
JAMA
Reuters Health - 21/12/2021 - Proactive monitoring of antidrug antibody and drug concentrations improves outcomes in patients with immune-mediated inflammatory diseases receiving maintenance therapy with infliximab, new research indicates.

The findings, from the NOR-DRUM B study, are based on 454 patients with stable immune-mediated inflammatory diseases treated with maintenance infliximab; half were randomly assigned to proactive therapeutic-drug monitoring (TDM) in which infliximab doses and intervals of administration were chosen based on scheduled monitoring of serum drug levels and antidrug antibodies and half to standard infliximab therapy without TDM.

During the 52-week study period, significantly more patients in the TDM group than standard care group met the primary endpoint of sustained disease control without disease worsening (73.6% vs. 55.9%; P<0.001), report Dr. Silje Syversen with Diakonhjemmet Hospital, in Oslo, Norway, and colleagues in JAMA.

Standard care was associated with a two-fold higher risk of disease worsening than TDM over the study period (hazard ratio, 2.1; 95% CI, 1.5 to 2.9) and more frequent formation of antidrug antibodies at concentrations considered clinically significant (15.0% vs. 9.2%), the researchers say.

"The greater efficacy of TDM was maintained in sensitivity analyses of variable definitions of disease worsening, which was particularly important given the open-label design of the trial," note the authors of a JAMA editorial.

"The relatively large sample size and rigorous study design of this study helped to overcome some limitations of previous observational studies and small clinical trials that yielded conflicting results regarding TDM," write Dr. Zachary Wallace and Dr. Jeffrey Sparks of Harvard Medical School in Boston.

"Results of the current report by Syversen et al support a proactive treat-to-target approach using TDM to guide infliximab treatment - and perhaps other biologic disease-modifying antirheumatic drugs (bDMARDs) - for patients receiving maintenance therapy for immune-mediated inflammatory diseases. Maintaining disease control in nearly three of four patients represents a meaningful improvement over standard care," the editorial writers say.

"Addressing barriers to implementing proactive TDM may help introduce a new era in treatment approach to maintenance therapy for patients with immune-mediated inflammatory diseases. Further study is needed to determine whether TDM may be effective for patients with other conditions and for other bDMARDs," they add.

The study had no commercial funding.

SOURCE: https://bit.ly/3EulKeR and https://bit.ly/3snF8aN JAMA, online December 21, 2021.

By Reuters Staff



Posted on