Is there potential for therapeutic drug monitoring of biologic agents in rheumatoid arthritis?

Bastida, Carla; Ruiz, Virginia Pajares; Pascal, Mariona; Yagüe, Jordi; Sanmartí, Raimón; Soy, Dolors

doi:10.1111/bcp.13192

Cited by 17 publications

(16 citation statements)

References 57 publications

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“…In accordance with previous studies, we showed that serum tocilizumab concentrations around 0.9 μg/mL are sufficient to normalize baseline CRP and ESR values. This normalization occurs rapidly from the initiation of treatment, with an estimated half‐life of approximately 2 weeks, as seen in the principal tocilizumab clinical trials . On the other hand, TJC, SJC, PGA and EGA formed the second group of variables.…”

Section: Discussionmentioning

confidence: 94%

“…Currently, there is still debate on which continuous composite measure should be chosen to evaluate disease activity in RA patients under tocilizumab treatment as there is concern about the impact of the steep reduction in CRP and ESR values within the first 4 weeks of tocilizumab treatment on disease activity . Nishimoto et al investigated the correlation between DAS28 and other disease activity measures in RA patients treated with tocilizumab.…”

Section: Discussionmentioning

confidence: 99%

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Exposure‐response modeling of tocilizumab in rheumatoid arthritis using continuous composite measures and their individual components

Bastida

Soy

Ruíz-Esquide

et al. 2019

Brit J Clinical Pharma

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Aims: Tocilizumab has a direct effect on inflammatory markers. Therefore, composite measures for disease activity assessment in rheumatoid arthritis (RA) using these inflammatory markers may not be suitable for tocilizumab treatment. We used a modelling approach to describe the tocilizumab exposure-response relationship and to investigate the different dynamics of the individual components of the routinely used continuous composite measures.Methods: Pharmacokinetic (PK), clinical and laboratory data were obtained from a prospective, observational, single-centre study involving 35 subjects with RA treated with intravenous tocilizumab. A population PK/pharmacodynamic analysis was performed using nonlinear mixed effects models. Results: The population for model development comprised 1086, 1083 and 1082 observations calculated with the disease activity score based on 28 joint (DAS28) and the simplified and clinical disease activity scores (SDAI, CDAI). The tocilizumab exposure-response relationship was described with an indirect-response model. Two main groups of individual components were identified based on their different dynamics under tocilizumab treatment: (i) tender and swollen joint counts and patient and evaluator global assessment showed a slower decrease of their baseline value (half-life: 4.6 weeks, RSE: 24%) and the need for higher serum drug concentration (EC 50 : 4.60 μg/mL, RSE: 103%, IIV: 359%) than (ii) C-reactive protein and erythrocyte sedimentation rate (half-life: 2.3 weeks, RSE 19%; EC 50 : 0.878 μg/mL, RSE: 41%, IIV: 238%). Conclusion: Our study confirms a different dynamics of the individual components of the most frequently used continuous composite measures under tocilizumab treatment which should be taken into account to avoid misassessment of disease activity.

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Section: Discussionmentioning

confidence: 94%

Section: Discussionmentioning

confidence: 99%

Exposure‐response modeling of tocilizumab in rheumatoid arthritis using continuous composite measures and their individual components

Bastida

Soy

Ruíz-Esquide

et al. 2019

Brit J Clinical Pharma

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“…A definitive treatment for all RA patients has not been discovered [ 23 , 161 – 164 ]. A multitarget approach is required to better control the disease, and several pathways must be considered to completely treat RA.…”

Section: Therapeutic Implicationsmentioning

confidence: 99%

The Role of High-Mobility Group Box-1 and Its Crosstalk with Microbiome in Rheumatoid Arthritis

Biscetti

Flex

Alivernini

et al. 2017

Mediators of Inflammation

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Rheumatoid arthritis (RA) is a chronic, definitely disabling, and potentially severe autoimmune disease. Although an increasing number of patients are affected, a key treatment for all patients has not been discovered. High-mobility group box-1 (HMGB1) is a nuclear protein passively and actively released by almost all cell types after several stimuli. HMGB1 is involved in RA pathogenesis, but a convincing explanation about its role and possible modulation in RA is still lacking. Microbiome and its homeostasis are altered in patients with RA, and the microbiota restoration has been proposed to patients with RA. The purpose of the present review is to analyze the available evidences regarding HMGB1 and microbiome roles in RA and the possible implications of the crosstalk between the nuclear protein and microbiome in understanding and possibly treating patients affected by this harmful condition.

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“…To date, several reviews have summarized the studies assessing the exposure-response relationships and optimal concentration thresholds for mAbs in inflammatory diseases [ 22 , 23 , 24 , 25 , 26 ]. It seems the consensus and guidelines for TDM and target mAb concentrations are best established in the field of Gastroenterology, but the advances are continuously made in the management of rheumatic and dermatologic conditions, as well ( Table 1 ) [ 23 , 27 , 28 , 29 , 30 , 31 , 32 , 33 ].…”

Section: Therapeutic Drug Monitoring Of Monoclonal Antibodiesmentioning

confidence: 99%

The Evolving Role of Microsampling in Therapeutic Drug Monitoring of Monoclonal Antibodies in Inflammatory Diseases

et al. 2021

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Monoclonal antibodies (mAbs) have been extensively developed over the past few years, for the treatment of various inflammatory diseases. They are large molecules characterized by complex pharmacokinetic and pharmacodynamic properties. Therapeutic drug monitoring (TDM) is routinely implemented in the therapy with mAbs, to monitor patients’ treatment response and to further guide dose adjustments. Serum has been the matrix of choice in the TDM of mAbs and its sampling requires the visit of the patients to laboratories that are not always easily accessible. Therefore, dried blood spots (DBS) and various microsampling techniques have been suggested as an alternative. DBS is a sampling technique in which capillary blood is deposited on a special filter paper. It is a relatively simple procedure, and the patients can perform the home-sampling. The convenience it offers has enabled its use in the quantification of small-molecule drugs, whilst in the recent years, studies aimed to develop microsampling methods that will facilitate the TDM of mAbs. Nevertheless, hematocrit still remains an obstacle that hinders a more widespread implementation of DBS in clinical practice. The introduction of novel analytical techniques and contemporary microsampling devices can be considered the steppingstone to the attempts made addressing this issue.

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Is there potential for therapeutic drug monitoring of biologic agents in rheumatoid arthritis?

Cited by 17 publications

References 57 publications

Exposure‐response modeling of tocilizumab in rheumatoid arthritis using continuous composite measures and their individual components

Exposure‐response modeling of tocilizumab in rheumatoid arthritis using continuous composite measures and their individual components

The Role of High-Mobility Group Box-1 and Its Crosstalk with Microbiome in Rheumatoid Arthritis

The Evolving Role of Microsampling in Therapeutic Drug Monitoring of Monoclonal Antibodies in Inflammatory Diseases

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