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To compare the efficacy of proactive TDM during the introduction of infliximab (a chimeric monoclonal antibody) therapy and standard infliximab therapy without TDM.
The results of this randomized controlled study do not
encourage the regular use of therapeutic drug monitoring (TDM) during the
initiation of infliximab therapy for improving disease remission rates in cases
of chronic immune-mediated inflammatory diseases.
To compare the efficacy of proactive TDM during the
introduction of infliximab (a chimeric monoclonal antibody) therapy and
standard infliximab therapy without TDM.
This randomized clinical study comprised of 411 adults (51% women) with spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, Crohn's disease, ulcerative colitis, or psoriasis starting with infliximab therapy. The patients were randomized to:
Clinical remission of the disease at week 30 was
the primary outcome.
All in all, the full analysis set comprised 398 patients out
of the total study population (198 patients in the TDM group and 200 patients
in the standard therapy group) who got their randomized intervention. At week
30, 100 (50.5%) of 198 patients in the TDM group and 106 (53.0%) of 200
patients in the standard therapy group achieved clinical remission. About 68%
and 70% of patients in the TDM and standard therapy group reported as having
adverse events.
Proactive TDM when
used for over a period of 30 weeks did not considerably improve the clinical
remission rates in immune-mediated inflammatory disease patients initiating
infliximab therapy.
JAMA
Effect of Therapeutic Drug Monitoring vs Standard Therapy During Infliximab Induction on Disease Remission in Patients With Chronic Immune-Mediated Inflammatory Diseases: A Randomized Clinical Trial
Silje Watterdal Syversen et al.
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