EULAR: Routine, proactive therapeutic drug monitoring unnecessary in RMDs
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Routine, proactive therapeutic drug monitoring for patients receiving biopharmaceuticals for rheumatic and musculoskeletal diseases is not recommended, according to new points-to-consider published by EULAR.
“Understanding whether [therapeutic drug monitoring (TDM)] would improve ownership of patient health decisions is important,” Charlotte L.M. Krieckaert, MD, of the Amsterdam Rheumatology and Immunology Center, and co-authors wrote in the Annals of the Rheumatic Diseases. “Equally, many rheumatologists are unaware of the pharmacokinetic properties of biopharmaceuticals and whether TDM-informed dosing may improve outcomes.”
To develop the new points to consider on TDM of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases (RMDs), Krieckaert and colleagues created a steering committee that included a convenor, a methodologist, a junior-methodologist, four fellows and four rheumatologists. Additionally, seven more rheumatologists were included, along with a bioanalytical scientist, a health economist, a health professional, one Emerging EULAR Network (EMEUNET) representative and three patient representatives. In all, the task force included representation from 18 European countries.
The committee met twice. The first meeting saw members gather face-to-face in September 2019, during which the group constructed 13 research questions to guide the recommendation process. The researchers then conducted a systematic literature review of articles published through July 2020, using PubMed, Embase and Cochrane as sources. American College of Rheumatology abstracts from 2018 and 2019, and EULAR abstracts from 2020, were also included in the review.
For their second meeting, the task force members gathered virtually in October 2020 to review results from the literature review and discussed preliminary recommendations. The final recommendations were approved by each member and later formally approved by the EULAR Executive Committee.
In all, the task force approved six overarching principles and 13 points-to-consider for therapeutic drug monitoring in rheumatic and musculoskeletal diseases.
Among the overarching principles are definitions of the two kinds of drug monitoring — proactive and reactive. Additionally, the principles point out that most research relates to TNF inhibitors, but the underlying principles can be used in other drug classes. Finally, they state that therapeutic approaches for patients with inflammatory diseases should be “in line” with international and national guidelines, and that drug monitoring should be part of a shared decision-making process between patient and physician.
According to the new points-to-consider, proactive drug monitoring is not recommended for inflammatory rheumatic and musculoskeletal diseases. It is similarly not recommended to use blood concentrations as a dosing guide. The new points also state that drug concentration measurements up to 3 months after treatment initiation could be used to predict future efficacy. Drug concentration measurements additionally may be useful to identify patients with high concentrations and for whom tapering may be used. They should also be used to measure therapy non-response, according to EULAR.
Other points to consider include:
Drug blood concentration measurements should only be performed by a “validated” laboratory;
Antidrug antibody measurements should be conducted by a validated laboratory and measurements should be analyzed with drug concentrations of a similar time;
Blood concentrations are dependent on several factors including dose, time since last dose and the regular time interval before doses;
Reactive drug monitoring could be used for inflammatory rheumatic and musculoskeletal disease management;
Antidrug antibodies should be used with immunogenic drugs alongside drug concentrations when non-response is identified;
Antidrug antibodies should be considered in cases of hypersensitivity reactions;
Antidrug antibody measurement should not be used in the case of injection-site reactions; and
Drug monitoring cost-effectiveness should be considered alongside local “context.”
“Although targeted toward enhancing personalized care for patients with inflammatory RMDs, these points-to-consider are derived from population-based data,” Krieckaert and colleagues wrote. “In addition, their generalizability depends on (inter)national guidelines on patient management and on local context. Even within Europe, and despite the existence of EULAR recommendations, there remain differences regarding the use of biopharmaceuticals, which impact generalizability of these points-to-consider.”
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