Biologics registers in RA: methodological aspects, current role and future applications

Nikiphorou, Elena; Buch, Maya H; Hyrich, Kimme L

doi:10.1038/nrrheum.2017.81

Cited by 57 publications

(40 citation statements)

References 73 publications

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“…П р о г р е с с в р е в м а т о л о г и и в X X I в е к е Открытые исследования и регистры РПКИ занимают центральное место в медицине, основанной на доказательствах [96][97][98], однако использование «жестких» критериев «включения» и «исключения» затрудняет генерализацию полученных данных на всю популяцию пациентов, наблюдаемых в клинической практике. Эта проблема получила название «брешь эффективностирезультативности» (efficacy-effectiveness gap) [99], которая в определенной степени может быть преодолена материалами регистров пациентов, позволяющими составить более полное представление об истинном месте лекарственных препаратов [100][101][102][103][104], включая ТОФА [105], в реальной клинической практике.…”

Section: таблицаunclassified

Efficacy and safety of tofacitinib for immune-mediated inflammatory rheumatic diseases (Part I)

Насонов

Авдеева²,

Лила

2020

Naučno-praktičeskaâ revmatologiâ

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Расшифровка механизмов патогенеза иммуновоспалительных ревматических заболеваний (ИВРЗ), основными формами кото-рых являются ревматоидный артрит (РА), спондилоартриты (СпА), включающие анкилозирующий спондилит (АС) и псориатиче-П р о г р е с с в р е в м а т о л о г и и в X X I в е к е Насонов Е.Л.научный руководитель ФГБНУ «НИИР им. В.А. Насоновой», академик РАН, профессор, докт. мед. наук 1 ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой»,

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Section: таблицаunclassified

Efficacy and safety of tofacitinib for immune-mediated inflammatory rheumatic diseases (Part I)

Насонов

Авдеева²,

Лила

2020

Naučno-praktičeskaâ revmatologiâ

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“…По данным E. Nikiphorou и соавт. [7], в течение 5 лет от начала приема первого ГИБП лечение прекращают почти половина пациентов. У существенной доли больных РА заболевание остается активным, несмотря на продолжительное лечение самыми современными препаратами.…”

Section: Factors Influencing the Efficiency Of Therapy In Patients Wiunclassified

Factors Influencing the Efficiency of Therapy in Patients With Rheumatoid Arthritis: The Role of Comorbid Mental and Somatic Diseases

Абрамкин¹,

Лисицына²,

Veltishchev³

et al. 2018

rsp

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The response rate to therapy for rheumatoid arthritis (RA) rarely exceeds 60%. Mental disorders (MDs) of the anxiety-depressive spectrum (ADS) and cognitive impairment (CI) substantially affect the evaluation of the efficiency of RA therapy. Adequate psychopharmacotherapy is one of the possible approaches to optimizing the treatment of RA. The factors influencing the efficiency of RA therapy with standard disease-modifying antirheumatic drugs (DMARDs) and biological agents (BAs) in combination with adequate psychopharmacotherapy have not been previously identified. Objective: to determine the predictors of response to therapy in patients with RA receiving DMARDs and BAs with or without adequate psychopharmacotherapy for ADS disorders. Subjects and methods. The investigation included 128 patients (13% men and 87% women) with a reliable diagnosis of RA. At baseline, 75.1% of patients received DMARDs; 7.8% – BAs. ADS disorders were detected in 123 (96.1%) patients. Psychopharmacotherapy was offered to all the patients with MDs; 52 patients agreed to treatment and 71 refused. The following therapeutic groups were identified according to the performed therapy: 1) DMARDs (n = 39); 2) DMARDs + psychopharmacotherapy (n = 43); 3) DMARDs + BAs (n = 32); 4) DMARDs + BAs + psychopharmacotherapy (n = 9). The changes of MDs symptoms and the outcomes of RA were assessed in 83 (67.5%) patients at five-year follow-up. The efficiency of RA therapy was evaluated with DAS28 (EULAR criteria). Predictors of response to therapy were determined using linear regression modeling. Results and discussion. At 5 years, 22 (26.5%) and 37 (44.6%) patients were recorded to show good and moderate responses to therapy, respectively; 24 (28.9%) patients were non-respondents. The linear regression model included 14 factors (p<0.001). The high values of DAS28 (β=0.258) at the inclusion; belonging to therapeutic groups 2 (β=0.267), 3 (β=0.235), and 4 (β=0.210), the absence of diabetes mellitus (β=-0.230), and experience in using glucocorticoids (β=-0.230) were associated with a high likelihood of response to therapy; high body mass index (β=-0.200) and long RA duration (β=-0,181), a high level of rheumatoid factor (β=-0.176), a history of myocardial infarction (β=-0.153), schizotypic disorder (β=-0.132), and extra-articular manifestations of RA (β=-0.106), and older age (β=-0.102) were related to a low probability of response. The area under the ROC curve for the model was 0.99 (p><0.001). Conclusion. BA therapy and psychopharmacotherapy, along with younger age, shorter duration and high activity of RA, a low level of rheumatoid factor, lower body mass index, the absence of diabetes mellitus, myocardial infarction, and extra-articular manifestations of RA in the history, schizotypic disorder, and experience in using glucocorticoids are associated with a greater likelihood of a good and moderate treatment response. Keywords: rheumatoid arthritis; mental disorders; disease-modifying antirheumatic drugs; biological agents; efficiency of therapy; predictors; psychopharmacotherapy; therapy adherence><0.001). The high values of DAS28 (β=0.258) at the inclusion; belonging to therapeutic groups 2 (β=0.267), 3 (β=0.235), and 4 (β=0.210), the absence of diabetes mellitus (β=-0.230), and experience in using glucocorticoids (β=-0.230) were associated with a high likelihood of response to therapy; high body mass index (β=-0.200) and long RA duration (β=-0,181), a high level of rheumatoid factor (β=-0.176), a history of myocardial infarction (β=-0.153), schizotypic disorder (β=-0.132), and extra-articular manifestations of RA (β=-0.106), and older age (β=-0.102) were related to a low probability of response. The area under the ROC curve for the model was 0.99 (p<0.001). Conclusion. BA therapy and psychopharmacotherapy, along with younger age, shorter duration and high activity of RA, a low level of rheumatoid factor, lower body mass index, the absence of diabetes mellitus, myocardial infarction, and extra-articular manifestations of RA in the history, schizotypic disorder, and experience in using glucocorticoids are associated with a greater likelihood of a good and moderate treatment response. Keywords: rheumatoid arthritis; mental disorders; disease-modifying antirheumatic drugs; biological agents; efficiency of therapy; predictors; psychopharmacotherapy; therapy adherence><0.001). Conclusion. BA therapy and psychopharmacotherapy, along with younger age, shorter duration and high activity of RA, a low level of rheumatoid factor, lower body mass index, the absence of diabetes mellitus, myocardial infarction, and extra-articular manifestations of RA in the history, schizotypic disorder, and experience in using glucocorticoids are associated with a greater likelihood of a good and moderate treatment response.

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“…In particular, biologics registers have provided robust and reliable evidence for the effectiveness and safety of these therapies in real life setting, based on greater number of patients followed for longer periods of time than clinical trials [19]. The inflammatory rheumatic diseases' natural history distinguishes them from other diseases such as cancer, and their chronic nature and necessity for long term therapy has mandated the establishment of registries to Volume 9 Issue 2 -2017 monitor the long-term efficacy and safety in a real-life setting and provide data that cannot be obtained through clinical trials.…”

Section: Registries In Rheumatic Diseasesmentioning

confidence: 99%

“…However, registers still face many challenges such as longterm sustainability due to their significant cost, multiple biases -mainly confounding factors-due to the lack of randomization and international comparability due to different methodologies and the use of different variables [19,34].…”

Section: Registries In Rheumatic Diseasesmentioning

confidence: 99%

Registries in Spondyloarthritis: What have we Learned?

Ziadé

2017

MOJOR

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Biologics registers in RA: methodological aspects, current role and future applications

Cited by 57 publications

References 73 publications

Efficacy and safety of tofacitinib for immune-mediated inflammatory rheumatic diseases (Part I)

Efficacy and safety of tofacitinib for immune-mediated inflammatory rheumatic diseases (Part I)

Factors Influencing the Efficiency of Therapy in Patients With Rheumatoid Arthritis: The Role of Comorbid Mental and Somatic Diseases

Registries in Spondyloarthritis: What have we Learned?

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