Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial

Gabay, Cem; Emery, Paul; Vollenhoven, Ronald van; Dikranian, Ara; Alten, Rieke; Pavelka, Karel; Klearman, Micki; Musselman, David; Agarwal, Sunil; Green, Jennifer; Kavanaugh, Arthur

doi:10.1016/s0140-6736(13)60250-0

Cited by 603 publications

(462 citation statements)

References 31 publications

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“…The significantly higher prevalence of monotherapy bDMARD prescription in the TCZ group confirmed by our study reflects the available evidence supporting the comparable efficacy of TCZ when prescribed with or without concomitant MTX [6,7,32,33]. However, a critical look at this approach was risen by Gabay et al [34] recently reporting that despite comparable clinical response, TCZ retention was shorter when prescribed as monotherapy.…”

Section: Discussionsupporting

confidence: 77%

“…The only exception being probably represented by TCZ monotherapy [6]. International recommendations [7] do not provide a preference on the mechanism of action (MoA) to be chosen as first bDMARD therapy.…”

Section: Introductionmentioning

confidence: 99%

“…TNFis, ABA or TCZ, and, under certain circumstances such as history of lymphoma or demyelinating disease, RTX are recommended as first-line biologic agents. Switching among bDMARDs is also mainly left to the clinician's decision between a second TNFi or a different MoA [6,7]. However, it is generally accepted that switching from a second to a third TNFi is associated with significantly lower response to treatment and a different MoA should be considered in these patients [8].…”

Section: Introductionmentioning

confidence: 99%

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Factors influencing the choice of first- and second-line biologic therapy for the treatment of rheumatoid arthritis: real-life data from the Italian LORHEN Registry

et al. 2017

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According to international recommendations, the selection of the biologic disease modifying anti-rheumatic drug (bDMARD) for rheumatoid arthritis (RA) is mainly left to the clinician's preference. We analyzed the real-life factors influencing the first-line choice or the switching strategy, focusing on the prescription of abatacept (ABA) or tocilizumab (TCZ) compared to TNFα inhibitors (TNFi). Patients enrolled in the Lombardy Rheumatology Network (LORHEN) Registry after January 1, 2010, when all considered bDMARD agents were available, were included. The population was divided into Bfirst-^and Bsecond-line^bDMARD. We included 1910 patients (first line n = 1264, second line n = 646). Age was higher in ABA or TCZ vs TNFi treated patients (p < 0.0001). Positive latent tuberculosis screening was associated with first-line ABA (p = 0.002). Methotrexate (MTX) combination therapy was lower in the TCZ group (p = 0.02). The type (dyslipidemia, hypertension, pulmonary disease) and the number of comorbidities influenced the choice towards ABA (p = 0.01). Multinomial logistic regression demonstrated that a second-line treatment, higher age, dyslipidemia, pulmonary disease, other comorbidities, and extraarticular RA manifestations were associated with ABA compared to TNFi. TCZ was associated with a second-line treatment, higher age, and more severe disease activity. Stopping the first bDMARD due to adverse events (AE) influenced the choice towards ABA. In real life, higher age and comorbidities influence the choice towards ABA and TCZ compared to TNFi. ABA was preferred in case of suspension of previous treatments due to AE. After failing a first-line TNFi, swapping to a different mechanism of action is more common.

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Section: Discussionsupporting

confidence: 77%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Factors influencing the choice of first- and second-line biologic therapy for the treatment of rheumatoid arthritis: real-life data from the Italian LORHEN Registry

et al. 2017

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“…For example, a 50% reduction in American College of Rheumatology parameters (ACR50) has been documented in 35% and 40% of RA patients treated with adalimumab and tocilizumab, respectively (3,5,6). Indeed, cytokine-blocking antibodies and antibody-based fusion proteins represent one of the largest sectors of modern pharmaceutical biotechnology.…”

mentioning

confidence: 99%

Antibody-based delivery of IL4 to the neovasculature cures mice with arthritis

Hemmerle

Doll

Neri

2014

Proc. Natl. Acad. Sci. U.S.A.

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Antibody-cytokine fusion proteins (immunocytokines) are innovative biopharmaceutical agents, which are being considered for the therapy of cancer and chronic inflammatory conditions. Immunomodulatory fusion proteins capable of selective localization at the sites of rheumatoid arthritis (RA) are of particular interest, as they may increase the therapeutic index of the cytokine payload. The F8 antibody recognizes the alternatively spliced extra domain A of fibronectin, a marker of angiogenesis, which is strongly overexpressed at sites of arthritis. In this study, we investigated the targeting and therapeutic activity of the immunocytokine F8-IL4 in the mouse model of collagen-induced arthritis. Different combination regimes were tested and evaluated by the analysis of serum and tissue cytokine levels. We show that F8-IL4 selectively localizes to neovascular structures at sites of rheumatoid arthritis in the mouse, leading to high local concentrations of IL4. When used in combination with dexamethasone, F8-IL4 was able to cure mice with established collagen-induced arthritis. Response to treatment was associated with an elevation of IL13 levels and decreased IL6 plasma concentrations. A fully human version of F8-IL4 is currently being developed for clinical investigations.

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“…В подтверждение вышеизложенному можно привести исследование ADACTA, в ходе которого не выявлено раз-личий по частоте СКИ среди больных РА, получавших ТЦЗ или АДА в рамках монотерапии (по 4% в каждой группе) [46]. В ходе 2-летнего исследования AMPLE сравнивали эффективность и переносимость п/к введения АБЦ и АДА.…”

Section: сравнительные исследованияunclassified

Biological Therapy and Infection in Rheumatoid Arthritis Patients: Modern Aspects

Белов¹,

Наумцева²,

Тарасова³

et al. 2016

Med. sov.

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В последние десятилетия в ревматологии отмечается явный прогресс, связанный с внедрением в практику генно-инже-нерных биологических препаратов (ГИБП). В то же время применение этих препаратов ассоциируется с нарастающим риском развития инфекций разнообразной природы и локализации, включая оппортунистические (инвазивные микозы, пневмоцистная пневмония и др.), а также повышенный риск реактивации латентной инфекции, в первую очередь тубер-кулеза (ТБ). Помимо этого, регистрируются случаи тяжелых инфекций (пневмония, сепсис, бактериальный артрит, пораже-ние кожи и мягких тканей и др.), в т. ч. с летальным исходом. В настоящем обзоре проанализированы данные литературы, преимущественно последних 5 лет, касающиеся частоты и локализации инфекций у больных ревматоидным артритом при лечении различными ГИБП. Охарактеризована значимость различных инфекций (ТБ, пневмонии, хронические вирусные гепатиты, герпес-вирусные инфекции и др.) в тактике курации указанных больных. Подчеркнута необходимость более широкого применения иммунизации различными вакцинами (в первую очередь пневмококковой и противогриппозной) пациентов с аутоиммунными воспалительными ревматическими заболеваниями.

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Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial

Cited by 603 publications

References 31 publications

Factors influencing the choice of first- and second-line biologic therapy for the treatment of rheumatoid arthritis: real-life data from the Italian LORHEN Registry

Factors influencing the choice of first- and second-line biologic therapy for the treatment of rheumatoid arthritis: real-life data from the Italian LORHEN Registry

Antibody-based delivery of IL4 to the neovasculature cures mice with arthritis

Biological Therapy and Infection in Rheumatoid Arthritis Patients: Modern Aspects

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