Long term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4 year extended study

Weinblatt, Michael E.; Keystone, Edward; Fürst, Daniel E.; Kavanaugh, Arthur; Chartash, Elliot; Segurado, Oscar G.

doi:10.1136/ard.2005.044404

Cited by 188 publications

(119 citation statements)

References 28 publications

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“…The results presented here are also consistent with published PRO data for adalimumab 27, 28, 29. In the Anti‐TNF Research Study Program of the Monoclonal Antibody Adalimumab trial, patients who had an inadequate response to MTX and were treated with adalimumab plus MTX demonstrated significant improvements in physical function from baseline to year 4 (mean Health Assessment Questionnaire disability index [HAQ DI] 0.7 and 1.5, respectively [ P < 0.001]) 27.…”

Section: Discussionsupporting

confidence: 92%

“…In the Anti‐TNF Research Study Program of the Monoclonal Antibody Adalimumab trial, patients who had an inadequate response to MTX and were treated with adalimumab plus MTX demonstrated significant improvements in physical function from baseline to year 4 (mean Health Assessment Questionnaire disability index [HAQ DI] 0.7 and 1.5, respectively [ P < 0.001]) 27. Similarly, in the DE019 adalimumab study, patients who had an inadequate response to MTX who received up to 10 years of adalimumab plus MTX therapy demonstrated a reduction in mean HAQ DI from 1.4 at baseline to 0.7 at year 10, while 42% of patients achieved HAQ DI <0.5 (normal functionality) at year 10 28.…”

Section: Discussionmentioning

confidence: 99%

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Patient‐Reported Outcomes From a Two‐Year Head‐to‐Head Comparison of Subcutaneous Abatacept and Adalimumab for Rheumatoid Arthritis

Fleischmann

Weinblatt

Schiff

et al. 2016

Arthritis Care & Research

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ObjectiveTo report 2‐year patient‐reported outcomes (PROs) from the head‐to‐head Abatacept versus Adalimumab Comparison in Biologic‐Naive RA Subjects with Background Methotrexate (MTX) (AMPLE) trial.MethodsAMPLE was a phase IIIb, randomized, investigator‐blinded trial. Biologic‐naive patients with rheumatoid arthritis (RA) and an inadequate response to MTX were randomized to subcutaneous (SC) abatacept (125 mg/week) or adalimumab (40 mg every 2 weeks) with background MTX. PROs (pain, fatigue, ability to perform work, and ability to perform daily activities) were compared up to year 2 for patients in each treatment group, as well as those who achieved low disease activity at both years 1 and 2 (responders) and those who did not (nonresponders).ResultsA total of 646 patients were randomized and treated with SC abatacept (n = 318) or adalimumab (n = 328). Baseline characteristics were balanced between the 2 treatment arms. Comparable improvements in PROs were observed in the abatacept and adalimumab groups over 2 years, with both groups achieving clinically meaningful improvements in PROs from baseline. At year 2, fatigue improved by 23.4 mm and 21.5 mm on a 100‐mm visual analog scale with abatacept and adalimumab, respectively. Clinical responders achieved greater improvements in PROs than nonresponders.ConclusionIn biologic‐naive patients with active RA, despite prior MTX, treatment with SC abatacept or adalimumab with background MTX resulted in comparable improvements in PROs, which were highly correlated with physician‐reported clinical response end points.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Patient‐Reported Outcomes From a Two‐Year Head‐to‐Head Comparison of Subcutaneous Abatacept and Adalimumab for Rheumatoid Arthritis

Fleischmann

Weinblatt

Schiff

et al. 2016

Arthritis Care & Research

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“…While those genes might still be critical to the pathogenesis of RA, they can be modulated or induced at a somatic level and do not necessarily have to be genetically controlled in humans to be important. For example, highly effective therapies that target TNFa, [88][89][90] IL-1, 91 IL-6, 92 CTLA-4 93 and CD20 94 emerged from functional studies and did not require any genetic association study in RA. The same may apply to some of the new rodent arthritis genes that will continue to be discovered and studied in the next few years.…”

Section: Targeting Susceptibility Versus Severitymentioning

confidence: 99%

Contribution of genetic studies in rodent models of autoimmune arthritis to understanding and treatment of rheumatoid arthritis

Gulko

2007

Genes Immun

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Rheumatoid arthritis (RA) is a chronic and potentially debilitating autoimmune disease. While novel therapies have emerged in recent years, disease remission is rarely achieved. RA is a complex trait, and the identifying of its susceptibility and severity genes has been anticipated to generate new targets for therapeutic intervention. However, finding those genes and understanding their function has been a challenging task. Studies in rodent intercrosses and congenics generated from inbred strains have been an important complementary strategy to identify arthritis genes, and understand how they operate to regulate disease. Furthermore, these new rodent arthritis genes will be new targets for therapeutic interventions, and will identify new candidate genes or candidate pathways for association studies in RA. In this review-opinion article I discuss RA genetics, difficulties involved in gene identification, and how rodent models can facilitate (1) the discovery of both arthritis susceptibility and severity genes, (2) studies of gene-environment interactions, (3) studies of gene-gender interactions, (4) epistasis, (5) functional characterization of the specific genes, (6) development of novel therapies and (7) how the information generated from rodent studies will be useful to understanding and potentially treating RA.

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“…Available treatments induce significant clinical improvement, but rarely achieve cure or remission (1). RA has a strong genetic component, with a heritability of 60% (2), and therefore the identification of genes contributing to disease susceptibility and severity is expected to generate novel and better therapeutic targets.…”

Section: Introductionmentioning

confidence: 99%

Genetic Regulation of T Regulatory, CD4, and CD8 Cell Numbers by the Arthritis Severity Loci Cia5a, Cia5d, and the MHC/Cia1 in the Rat

Laragione

Yarlett

Gulko

2007

Mol Med

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Long term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4 year extended study

Abstract: Adalimumab plus MTX sustained clinical response and remission in patients with RA during 4 years. The safety profile during the first 6 months was similar to that after 4 years' follow up. Reduction of corticosteroid and/or MTX dosages did not adversely affect long term efficacy.

Cited by 188 publications

References 28 publications

Patient‐Reported Outcomes From a Two‐Year Head‐to‐Head Comparison of Subcutaneous Abatacept and Adalimumab for Rheumatoid Arthritis

Patient‐Reported Outcomes From a Two‐Year Head‐to‐Head Comparison of Subcutaneous Abatacept and Adalimumab for Rheumatoid Arthritis

Contribution of genetic studies in rodent models of autoimmune arthritis to understanding and treatment of rheumatoid arthritis

Genetic Regulation of T Regulatory, CD4, and CD8 Cell Numbers by the Arthritis Severity Loci Cia5a, Cia5d, and the MHC/Cia1 in the Rat

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