How to monitor the therapeutic drug of rheumatism patients?

*For medical professionals only, 6 principles and 13 points to consider Therapeutic Drug Monitoring (TDM) of biopharmaceuticals refers to the use of biopharmaceutical blood drug concentrations and optional drug resistance antibodies (ADAb) to guide treatment decisio.
An emerging branch of clinical pharma.
TDM may be helpful in clinical situations such as non-response to therapy, interpretation of side effects of therapy, and determination of dose adjustmen.
At present, most of the small-molecule drugs used in clinical treatment of epilepsy, mental disorders and infections require TDM, which is also increasingly used in biopharmaceutica.
In rheumatology, there is also growing interest in biopharmaceutical TD.
However, there is still little guidance on whether or how TDM should be applied in clinical practi.
 Recently, the latest guidelines issued by the European League Against Rheumatism (EULAR) provide guidance for TDM in patients with inflammatory rheumatic diseases and musculoskeletal diseases (RMDs), which contains a total of 6 general principles and 13 points to be consider.
 Screenshot of the literature 6 general principles The general principles refer to the application of pharmacokinetic and pharmacodynamic principles in TDM, involving all biopharmaceuticals, and comparing active and reactive T.
Most research in this area is related to rheumatoid arthritis (RA), but these principles can also be extrapolated to other diseases such as spondyloarthritis (SpA) and psoriatic arthritis (Ps.
Finally, the Working Group emphasized that the points to be considered should always be based on shared decision-making, in the context of national (international) and local guidelin.
The 6 overarching principles are as follows:Pharmacokinetic and pharmacodynamic principles provide the basis for the interpretation of TDM in biopharmaceuticals;TDM refers to the use of pharmacokinetic data (biopharmaceutical blood concentrations and optional ADAbs) The principle of optimizing individualized treatment of patients;TDM is divided into two main categories: active TDM refers to regular testing regardless of clinical situation, reactive TDM refers to testing for specific clinical scenarios;Most of the research in this field Related to tumor necrosis factor inhibitors, but its rationale can also be extended to other biopharmaceuticals;Treatment of patients with inflammatory RMDs should comply with relevant international and national disease management guidelines, and TDM should be considered in this case;TDM The patient's experience and preferences should be considered, and the patient should be involved in clinical decision-making in health ca.
Table 1: General Principles 13 Points to ConsiderTesting of biopharmaceutical blood drug concentrations should be performed in a validated laboratory The working group recommends that laboratories performing the assay should be familiar with biopharmaceutical blood drug concentration testing and specific test characteristics, Verification must be carried out according to (international) national standar.
Testing for ADAb should be performed in a validated laboratory, preferably using a method that is consistent over ti.
Testing should be interpreted in conjunction with contemporaneous biopharmaceutical plasma concentratio.
In clinical practice, due to the presence of ADAbs, it is usually only relevant when biopharmaceutical plasma concentrations are low or abse.
Therefore, the working group recommends testing biopharmaceutical blood concentrations first, and only when there is no drug concentration or very low drug concentration, ADAb testi.
Biopharmaceutical plasma concentrations depend on the dose administered, the dosing interval and the date of the last do.

Patient factors affecting pharmacokinetics, including body weight, methotrexate combination therapy, disease activity and treatment adherence task force recommendations, biopharmaceutical plasma concentrations (and ADAbs), should be considered when interpreting biopharmaceutical plasma concentrations Blood sampling for testing is best done before the next dose, when blood levels are at or near trou.
This is especially important and easier to do with intravenous administrati.

Several patient factors also affect pharmacokinetic parameters, such as body weight, methotrexate co-therapy, disease activity, and treatment complian.

Body weight: At biopharmaceutical fixed-dose and body-weight-adjusted doses, patients with higher body weight have lower plasma concentrations; Methotrexate combination therapy: Combined with methotrexate from the start of treatment, plasma levels will be higher; Disease Activity: Biopharmaceutical plasma concentrations were negatively correlated with baseline CRP or ESR leve.

Thus, patients with lower disease activity tend to have higher biopharmaceutical blood levels; treatment adherence: When patients delay biopharmaceutical use due to poor adherence or concomitant medical problems (such as infections), biopharmaceutical blood Concentrations will also be lower than expect.

The working group recommends combination therapy with methotrexate, taking into account the dose, dosing interval and route of administration, and the date of the last dose, especially in the case of a therapeutic m.

Despite the association with clinical response, the use of biopharmaceutical plasma concentrations to guide dosing is not recommended due to the lack of clear optimal ranges for most biopharmaceutical indicationsRoutine use is not recommended in the management of inflammatory RMDs Active TDM Measurement of biopharmaceutical blood levels within 3 months of treatment initiation may be considered to predict future efficacyReactive TDM may be considered for treatment of inflammatory RM.

For example, TDM may determine the cause of lack or non-response to treatment by detecting low biopharmaceutical blood levels associated with ADA.

Therefore, these data may also help to decide subsequent treatment optio.

On the other hand, in patients with low disease activity or in remission, TDM results may suggest dose reduction or discontinuation of biopharmaceutica.

In this way, reactive TDM can be associated with personalized patient care
Testing of biopharmaceutical blood levels can be considered to identify patients with high blood levels of biopharmaceuticals, who can reduce the use of biopharmaceutica.

When disease activity is high, the doses of biopharmaceuticals required to achieve a therapeutic response are likely to be higher than those required to maintain this response after inflammation has been suppress.

This point of consideration applies to patients already on biopharmaceuticals, but does not apply to the induction and early stages of thera.

And reducing biopharmaceuticals does not appear to affect disease activity in patients with high blood leve.

Therefore, the working group recommends testing biopharmaceutical plasma concentrations in patients with reduced biopharmaceutical consumpti.

Testing biopharmaceutical blood levels should be considered for clinical non-respon.

Testing biopharmaceutical plasma levels when non-responsive to clinical treatment can provide insight into the root cause of non-response,.


to differentiate between pharmacokinetics or pharmacodynamics fact.

Therefore, the working group recommends consideration of blood levels of biopharmaceuticals when there is no clinical respon.

1 In the case of immunogenic biopharmaceuticals and clinical non-response, it should be considered that the presence of ADAb ADAb detected at the same time as the biopharmaceutical plasma concentration may be associated with clinical non-response, including treatment failure, treatment interruption and shortened treatment surviv.

ADAbs can both interfere with biopharmaceutical target binding and reduce plasma concentrations by increasing clearance, both of which negate clinical respons.

The working group believes that the presence of ADAbs can provide insight into the reasons for non-response to clinical treatme.

1 In the event of anaphylaxis primarily related to infusion, testing for ADAb anaphylaxis should be considered, which refers to a variety of reactions that occur immediately or shortly after biopharmaceutical administration and can have multiple manifestations
Such a response is to the complex formed by the ADAb and the biopharmaceutic.

Most of the immune complexes formed are small (2-4 immunoglobulins) and do not cause infusion reactio.

During intravenous infusion of biopharmaceuticals, large amounts of immune globulin enter the patient's bloodstre.

If the patient has previously developed large amounts of ADAb, large immune complexes are formed, potentially triggering an infusion reacti.

1 Testing of ADAbs is not recommended in the case of injection site reactions There is currently no reliable evidence of a causal relationship between the presence of ADAbs and injection site reactions in biopharmaceutica.

The working group considered this link unlikely and recommended against testing ADAbs in the case of injection site reactio.

1 The cost-effectiveness of TDM should be considered in light of local circumstances and standards of care The working group recommends that the impact of TDM on these factors should be considered in the context of local circumstances and guidelin.

In contrast to the current practice of using biopharmaceuticals for the treatment of inflammatory RMDs, robust economic analysis based on published recommendations for relevant clinical situations is required, incorporating existing data into decision-analytics models to quantify the incremental costs of TDM and consequenc.

 Table 2: Summary of 13 points to consider In summary, this is the first EULAR-approved set of guidelines for TDM biopharmaceuticals in inflammatory RM.

Advise on if, when, where and how to perform and interpret TDM for biopharmaceuticals in inflammatory RMDs in clinical practi.

Given the rapid development of TDM and the broader field of personalized medicine, it is expected that some of the unanswered questions highlighted in these points for consideration will be answered as more data become available, which may prompt an update of these in the coming yea.

Points to consider
References [1] Krieckaert CL, van Tubergen A, Gehin JE, et .

EULAR points to consider for therapeutic drug monitoring of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases[.

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