Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor ? monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis

Maini, R. N.; Breedveld, Ferdinand C.; Kalden, Joachim R.; Smolen, Josef S.; Davis, D. R.; Macfarlane, J. D.; Antoni, Christian; Leeb, Burkhard F.; Elliott, Michael J.; Woody, James N.; Schaible, T; Feldmann, Marc

doi:10.1002/1529-0131(199809)41:9<1552::aid-art5>3.0.co;2-w

Cited by 1,508 publications

(836 citation statements)

References 32 publications

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“…All patients had longstanding RA fulfilling the 1987 revised criteria of the American College of Rheumatology (ACR; formerly, the American Rheumatism Association) (7). Initially, these patients were included in multicenter, double-blind, placebocontrolled, randomized anti-TNF antibody studies (8,9). From those studies, clinical data and patient samples were available in order to retrospectively study aspects of the endocrine system.…”

Section: Methodsmentioning

confidence: 99%

“…Clinical improvement was calculated according to the following formula: improvement (%) ϭ 100 ϫ (1 -[DAS28 followup /DAS28 baseline ]), where DAS28 ϭ Disease Activity Score in 28 joints (10). For both types of anti-TNF antibodies, detailed efficacy assessments including ACR and European League Against Rheumatism response criteria have been reported elsewhere, and they are not reported here (8,9).…”

Section: Methodsmentioning

confidence: 99%

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Increased cortisol relative to adrenocorticotropic hormone predicts improvement during anti–tumor necrosis factor therapy in rheumatoid arthritis

Straub¹,

Pongratz²,

Cutolo³

et al. 2008

Arthritis & Rheumatism

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Objective. Some patients with chronic inflammatory diseases such as rheumatoid arthritis (RA) improve rapidly from anti-tumor necrosis factor (anti-TNF) therapy. No sensitive markers are available that might predict outcome of anti-TNF therapy. We undertook this study to investigate the predictive value of hypothalamic-pituitary-adrenal (HPA) axis hormones for clinical improvement during anti-TNF therapy.Methods. An observational study in 23 RA patients was followed by a validation study in 38 RA patients. The patients receiving anti-TNF antibodies had no glucocorticoid treatment, and we measured baseline serum levels of adrenocorticotropic hormone (ACTH) and cortisol. Improvement during anti-TNF antibody treatment was judged by the Disease Activity Score in 28 joints (DAS28), and serum levels of cortisol were measured at followup.Results. The observational study demonstrated that improvement in the DAS28 correlated negatively with baseline serum levels of cortisol (R ‫؍‬ ؊0.520, P ‫؍‬ 0.011) and the cortisol:ACTH ratio (R ‫؍‬ ؊0.700, P ‫؍‬ 0.0002). In the longitudinal part of the study at followup, those patients with good improvement and initially low serum levels of cortisol demonstrated an increase of serum cortisol, in contrast to patients with little or no improvement. Findings in the observational study were supported by those in the validation study in a group of RA patients with less inflammation (correlation of improvement in the DAS28 with cortisol:ACTH ratio: R ‫؍‬ -0.320, P ‫؍‬ 0.025).Conclusion. This is the first study in a human ISRCTN 68762628. FDA: BL 125057 (adalimumab portion of the studies).This publication reflects only the authors' views. The European Community is not liable for any use that may be made of the information herein.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Increased cortisol relative to adrenocorticotropic hormone predicts improvement during anti–tumor necrosis factor therapy in rheumatoid arthritis

Straub¹,

Pongratz²,

Cutolo³

et al. 2008

Arthritis & Rheumatism

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“…Another approach to addressing the need for MTX in the combination would be to gradually withdraw the MTX in a blinded manner once an optimal response of the DMARD combination has been achieved. Unfortunately, no studies of MTX withdrawal have been published to date, with the exception of a trial with a biologic agent (37). Taken together, the efficacy of the combination of cyclosporine or leflunomide with MTX or with SSZ may reflect the efficacy of the DMARD add-on alone, as supported by the remarkably similar efficacy of monotherapy and combination strategies with cyclosporine or leflunomide ( Table 1).…”

Section: Study Design Issuesmentioning

confidence: 99%

“…As mentioned above, although the results have uniformly demonstrated substantial benefit of the combination arm, the failure of most trials to include an arm with the biologic alone calls into question the utility of the combination. In a trial of infliximab in patients with active disease despite MTX therapy, in which MTX was partly withdrawn, there was a clear trend toward better efficacy of the combination compared with the biologic monotherapy, which was partly interpreted as being due to increased immunogenicity of the biologic in the absence of MTX (37). The effect of MTX in combination with monoclonal anti-TNF antibodies has been interpreted as a reduction in the immunogenicity of the monoclonal agent.…”

Section: Study Design Issuesmentioning

confidence: 99%

Superior efficacy of combination therapy for rheumatoid arthritis: Fact or fiction?

Smolen

Aletaha

Keystone

2005

Arthritis & Rheumatism

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“…Because initial safety studies suggested no increase in adverse hematologic events, current guidelines do not recommend regular complete blood cell count (CBC) monitoring for anti-TNF therapy (2)(3)(4)(5). However, significant hematologic reactions, in particular neu-tropenia, have been reported in patients treated with all 3 TNF inhibitor agents (5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15).…”

Section: Introductionmentioning

confidence: 99%

Neutropenia in patients receiving anti–tumor necrosis factor therapy

Hastings¹,

Ding²,

Butt³

et al. 2010

Arthritis Care & Research

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Objective. To examine the rates of and risk factors for neutropenia together with the dynamics of neutrophil and other white cell subset counts in a cohort of patients treated with a tumor necrosis factor (TNF) inhibitor for inflammatory arthritis. Methods. We performed a retrospective cohort study examining the association between baseline demographics, clinical features, medications used, and development of neutropenia, and behavior of neutrophil and other white cell subset counts during TNF inhibitor therapy. Results. In 367 patients (298 [81.2%] with rheumatoid arthritis, 38 [10.4%] with ankylosing spondylitis, and 31 [8.4%] with psoriatic arthritis), 69 (18.8%) had at least one episode of neutropenia (<2.0 ؋ 10 9 /liter) during TNF inhibitor therapy, and of these, 6% developed serious infections secondary to neutropenia. There was no significant difference in disease, demographic, or drug variables between patients with and without neutropenia. However, patients with neutropenia had significantly lower baseline neutrophil counts (4.2 ؋ 10 9 /liter; 95% confidence interval [95% CI] 3.8, 4.6 versus 6.2 ؋ 10 9 /liter; 95% CI 6.0, 6.5), and a previous history of neutropenia while receiving disease-modifying antirheumatic drugs increased the risk while receiving TNF inhibitors (hazard ratio 2.97; 95% CI 1.69, 5.25). A significant drop in mean neutrophil count (1.12 ؋ 10 9 /liter; 95% CI 0.92, 1.32) was observed after 2 weeks of TNF inhibitor therapy. Other white cell subsets tended to significantly increase. Conclusion. TNF inhibitor therapy is associated with a significant reduction in peripheral blood neutrophil count, leading to 19% of patients becoming neutropenic. Risk of neutropenia is significantly higher in patients with a low baseline neutrophil count or previous history of neutropenia. We suggest that patients receiving TNF inhibitor therapy would benefit from regular complete blood cell count monitoring.

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Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor ? monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis

Cited by 1,508 publications

References 32 publications

Increased cortisol relative to adrenocorticotropic hormone predicts improvement during anti–tumor necrosis factor therapy in rheumatoid arthritis

Increased cortisol relative to adrenocorticotropic hormone predicts improvement during anti–tumor necrosis factor therapy in rheumatoid arthritis

Superior efficacy of combination therapy for rheumatoid arthritis: Fact or fiction?

Neutropenia in patients receiving anti–tumor necrosis factor therapy

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