Efficacy of abatacept and tocilizumab in patients with rheumatoid arthritis treated in clinical practice: results from the nationwide Danish DANBIO registry

Leffers, Henrik Christian Bidstrup; Østergaard, Mikkel; Glintborg, Bente; Krogh, Niels Steen; Foged, Heidi; Tarp, Ulrik; Lorenzen, Tove; Hansen, Annette; Hansen, Michael Sejer; Jacobsen, Martin Skov; Dreyer, Lene; Hetland, Merete Lund

doi:10.1136/ard.2010.140129

Cited by 123 publications

(80 citation statements)

References 30 publications

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“…We previously reported that the efficacy of abatacept in clinical practice was significantly poorer in patients with a prior history of biological DMARD use [2,9]. Results from the nationwide Danish DANBIO registry demonstrated the unfavorably low drug retention rate of abatacept: 72 % at 24 weeks and 54 % at 48 weeks in patients with RA treated in routine clinical practice, 97 % of whom had a prior history of biological DMARD use [10]. There is a high level of interest in identifying optimal drugs to use concomitantly with abatacept to augment its clinical response, particularly in patients with a prior history of biological DMARD use.…”

Section: Introductionmentioning

confidence: 95%

Concomitant methotrexate and tacrolimus augment the clinical response to abatacept in patients with rheumatoid arthritis with a prior history of biological DMARD use

et al. 2015

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This observational retrospective study examined whether abatacept efficacy could be augmented with concomitant methotrexate (MTX) or tacrolimus (TAC) in patients with rheumatoid arthritis (RA) who experienced failure with prior biological disease-modifying antirheumatic drugs (DMARDs) and in whom favorable therapeutic efficacy is difficult to achieve. All patients with a prior biological DMARD history who were treated with abatacept for 52 weeks and registered in a Japanese multicentre registry were included. Clinical efficacy and safety of abatacept according to the concomitant drug used, i.e., none (ABT-mono), MTX (ABT-MTX), and TAC (ABT-TAC), were compared. A greater mean percent change of DAS28-ESR was observed in the ABT-TAC group compared with the ABT-mono group at weeks 12 (-20.5 vs. -5.4 %, p = 0.035) and 24 (-25.0 vs. -11.0 %, p = 0.036). ABT-MTX and ABT-TAC groups had a significantly higher proportion of patients who achieved low disease activity (LDA) within 52 weeks compared with the respective baselines, while no significant change was observed in the ABT-mono group. A higher proportion of patients in the ABT-TAC group achieved EULAR moderate response compared with the ABT-mono group at week 52 (66.7 vs. 35.0 %, p = 0.025). Multivariate logistic regression analysis revealed that concomitant TAC use was independently associated with the achievement of LDA and EULAR response at 52 weeks, while concomitant MTX use was not. Concomitant TAC use may offer a suitable option for RA patients treated with abatacept after prior biological DMARD failure, likely because both abatacept and TAC affect T cell activation.

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Section: Introductionmentioning

confidence: 95%

Concomitant methotrexate and tacrolimus augment the clinical response to abatacept in patients with rheumatoid arthritis with a prior history of biological DMARD use

et al. 2015

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“…Multiple strategies targeted at the neutralization of proinflammatory cytokines using mAbs (e.g., anti-TNF-a, anti-IL-6R), soluble receptors (e.g., TNFR:Fc), or antagonists (e.g., IL-1Ra) have been shown to be efficacious for treatment of arthritis in some patients (8)(9)(10)(11)(12). However, considerable adverse effects such as increased risk of microbial infections, development of secondary diseases, and other drawbacks such as primary or secondary unresponsiveness remain (13).…”

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confidence: 99%

SB1578, a Novel Inhibitor of JAK2, FLT3, and c-Fms for the Treatment of Rheumatoid Arthritis

Madan¹,

Goh²,

Hart³

et al. 2012

The Journal of Immunology

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SB1578 is a novel, orally bioavailable JAK2 inhibitor with specificity for JAK2 within the JAK family and also potent activity against FLT3 and c-Fms. These three tyrosine kinases play a pivotal role in activation of pathways that underlie the pathogenesis of rheumatoid arthritis. SB1578 blocks the activation of these kinases and their downstream signaling in pertinent cells, leading to inhibition of pathological cellular responses. The biochemical and cellular activities of SB1578 translate into its high efficacy in two rodent models of arthritis. SB1578 not only prevents the onset of arthritis but is also potent in treating established disease in collagen-induced arthritis mice with beneficial effects on histopathological parameters of bone resorption and cartilage damage. SB1578 abrogates the inflammatory response and prevents the infiltration of macrophages and neutrophils into affected joints. It also leads to inhibition of Ag-presenting dendritic cells and inhibits the autoimmune component of the disease. In summary, SB1578 has a unique kinase spectrum, and its pharmacological profile provides a strong rationale for the ongoing clinical development in autoimmune diseases.

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“…As mentioned earlier, the RADIATE trial showed that RA patients who had previously discontinued TNF inhibitors achieved ACR20/50/70 responses of 50%, 28.8% and 12.4%, respectively, in response to TCZ [91]. In addition, the ACT-SURE [99], TAMARA [101,102], DANBIO [103] and REACTION [104,105] trials also showed that TCZ was efficacious for patients with RA who had been previously treated with TNF inhibitors. At present, TCZ is likely to be prescribed as a second-line biological therapy and will have to overcome significant competition from established anti-TNF therapies to be accepted as a first-line biologic.…”

Section: Place Of Tocilizumab In Biological Treatment Of Ramentioning

confidence: 97%

“…In the nationwide registry of biological therapies established in Denmark, DANBIO, 178 patients with RA treated with TCZ have been identified, 93% of whom had previously received one or more TNF inhibitors [103]. The disease activity in these patients decreased at all time points, with DAS28 remission rates of 39% for TCZ treatment after 24 weeks and 58% after 48 weeks.…”

Section: Phase Iiib and IV Clinical Trials And Clinical Practicementioning

confidence: 99%

Targeting of Interleukin-6 for the Treatment of Rheumatoid Arthritis: A Review and Update

Ogata¹

2014

Rheumatology (Sunnyvale)

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Tanaka et al., Rheumatol Curr Res 2013, S4 http://dx.doi.org/10.4172/2161-1149 Review ArticleOpen Access AbstractRheumatoid Arthritis (RA) is a chronic inflammatory disease, characterized by persistent joint inflammation, systemic inflammation and immunological abnormalities. Since IL-6 plays a major role in the development of these characteristics, its targeting could reasonably be expected to constitute a novel therapeutic strategy for the treatment of RA. Tocilizumab, a humanized anti-human IL-6 receptor monoclonal antibody, has demonstrated its outstanding clinical efficacy and tolerable safety profile in phase III clinical trials for RA patients, resulting in its worldwide approval for moderate-to-severe active RA. Post-marketing clinical trials have confirmed its efficacy. This success led to the development of various other IL-6 inhibitors. Further clinical studies including head-to-head comparative studies, and clarification of the mechanisms through which tocilizumab exerts its clinical effects can be expected to identify RA patients who should be treated with tocilizumab as a first-line biologic. In addition, recent case reports and pilot studies indicate that therapies targeting IL-6 will be widely applicable to the treatment of various intractable immune-mediated diseases.

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Efficacy of abatacept and tocilizumab in patients with rheumatoid arthritis treated in clinical practice: results from the nationwide Danish DANBIO registry

Cited by 123 publications

References 30 publications

Concomitant methotrexate and tacrolimus augment the clinical response to abatacept in patients with rheumatoid arthritis with a prior history of biological DMARD use

Concomitant methotrexate and tacrolimus augment the clinical response to abatacept in patients with rheumatoid arthritis with a prior history of biological DMARD use

SB1578, a Novel Inhibitor of JAK2, FLT3, and c-Fms for the Treatment of Rheumatoid Arthritis

Targeting of Interleukin-6 for the Treatment of Rheumatoid Arthritis: A Review and Update

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