Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed

Putte, L.B.A. van de; Atkins, Christopher J.; Malaise, Michel; Sany, J; Russell, Anthony S.; Riel, P.L.C.M. van; Settas, L.; Bijlsma, J. W. J.; Todesco, S; Dougados, Maxime; Nash, Peter; Emery, Paul; Walter, Norman; Kaul, Martin; Fischkoff, Steven A.; Küpper, H.

doi:10.1136/ard.2003.013052

Cited by 563 publications

(339 citation statements)

References 24 publications

(14 reference statements)

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“…The incidences of adverse events, serious adverse events, and infections were similar between treatment groups. Overall, the safety of adalimumab was similar to that reported in studies of adalimumab in RA (25)(26)(27) and to that reported in previous studies of other therapies in PsA (11,20,50,51).…”

Section: Discussionsupporting

confidence: 86%

“…Adalimumab (Humira; Abbott, Abbott Park, IL) is a fully human, anti-TNF monoclonal antibody that has been shown to have efficacy, when used alone or in combination with MTX, in patients with moderate-tosevere RA (24)(25)(26). Since adalimumab has the potential to be an effective treatment for PsA, the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT) (Appendix A), a double-blind, randomized, placebocontrolled trial, was carried out to evaluate the safety and efficacy of adalimumab.…”

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confidence: 99%

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Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: Results of a double‐blind, randomized, placebo‐controlled trial

Mease

Gladman

Ritchlin

et al. 2005

Arthritis & Rheumatism

837

629

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Objective. Adalimumab, a fully human, antitumor necrosis factor monoclonal antibody, was evaluated for its safety and efficacy compared with placebo in the treatment of active psoriatic arthritis (PsA).Methods. Patients with moderately to severely active PsA and a history of inadequate response to nonsteroidal antiinflammatory drugs were randomized to receive 40 mg adalimumab or placebo subcutaneously every other week for 24 weeks. Study visits were at baseline, weeks 2 and 4, and every 4 weeks thereafter. The primary efficacy end points were the American College of Rheumatology 20% improvement (ACR20) response at week 12 and the change in the modified total Sharp score of structural damage at week 24. Secondary end points were measures of joint disease, disability, and quality of life in all patients, as well as the severity of skin disease in those patients with psoriasis involving at least 3% of body surface area.Results. At week 12, 58% of the adalimumabtreated patients (87 of 151) achieved an ACR20 response, compared with 14% of the placebo-treated patients (23 of 162) (P < 0.001). At week 24, similar ACR20 response rates were maintained and the mean change in the modified total Sharp score was ؊0.2 in patients receiving adalimumab and 1.0 in those receiving placebo (P < 0.001). Among the 69 adalimumabtreated patients evaluated with the Psoriasis Area and Severity Index (PASI), 59% achieved a 75% PASI improvement response at 24 weeks, compared with 1% of the 69 placebo-treated patients evaluated (P < 0.001). Disability and quality of life measures were also significantly improved with adalimumab treatment compared with placebo. Adalimumab was generally safe and welltolerated.Conclusion. Adalimumab significantly improved joint and skin manifestations, inhibited structural changes on radiographs, lessened disability due to joint damage, and improved quality of life in patients with moderately to severely active PsA.Psoriatic arthritis (PsA) is a chronic, inflammatory arthritis occurring in individuals with psoriasis. Psoriasis occurs in 2-3% of the US population (1). The reported range of prevalence of PsA in patients with psoriasis is 6-39%, depending on the population studied

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Section: Discussionsupporting

confidence: 86%

mentioning

confidence: 99%

Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: Results of a double‐blind, randomized, placebo‐controlled trial

Mease

Gladman

Ritchlin

et al. 2005

Arthritis & Rheumatism

837

629

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“…The efficacy confirmed in the CHANGE study should be seen as such [18], since all the ADA-treated patients received ADA monotherapy. The results compared well to those of the DE011 monotherapy study conducted overseas [8]. The present HARMONY study is the first study to demonstrate the efficacy and safety of ADA therapy in combination with MTX in Japanese RA patients.…”

Section: Discussionsupporting

confidence: 74%

Effectiveness and safety of adalimumab in Japanese patients with rheumatoid arthritis: retrospective analyses of data collected during the first year of adalimumab treatment in routine clinical practice (HARMONY study)

et al. 2011

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We retrospectively investigated the ability of adalimumab (ADA) to reduce disease activity, improve physical function, and retard the progression of structural damage in 167 patients with rheumatoid arthritis. Clinical and functional outcomes were compared between patients with or without prior biologic treatment and those with or without concomitant methotrexate (MTX) treatment. At week 52, 38.3% achieved clinical remission: 42.4 and 28.6% of patients achieved remission in those without and with previous biologics, respectively, while 42.7 and 12.5% of patients achieved remission in those with and without concomitant MTX, respectively. ADA treatment significantly reduced the rate of radiographic progression from 27.1 ± 46.0 (median 13.6; 25th–75th percentiles 8.3 to 28.9) at baseline to 0.8 ± 5.0 (median 0.0; 25th–75th percentiles −0.9 to 2.0) at week 52 (P < 0.0001). Radiographic progression was absent in 59.8% of patients. Sixty adverse events (34.21/100 patient-years) were reported, 16 of which were serious (9.12/100 patient-years). ADA therapy is highly effective for reducing disease activity, improving physical function, and limiting radiographic progression. It is generally safe and well tolerated by Japanese RA patients in routine clinical practice.

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“…A recent meta-analysis on the effects of anti-TNF␣ therapy (12) excluded etanercept and included 2 studies (32,33) that compared adalimumab monotherapy with placebo (RR 6.3 and RR 15.3). Such an increase in the rate of serious infections is not unexpected when comparing an immunosuppressive agent with placebo; however, "no treatment" is an unrealistic strategy in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Anti–tumor necrosis factor α therapy and the risk of serious bacterial infections in elderly patients with rheumatoid arthritis

Schneeweiß¹,

Setoguchi²,

Weinblatt³

et al. 2007

Arthritis & Rheumatism

280

169

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Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed

Cited by 563 publications

References 24 publications

Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: Results of a double‐blind, randomized, placebo‐controlled trial

Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: Results of a double‐blind, randomized, placebo‐controlled trial

Effectiveness and safety of adalimumab in Japanese patients with rheumatoid arthritis: retrospective analyses of data collected during the first year of adalimumab treatment in routine clinical practice (HARMONY study)

Anti–tumor necrosis factor α therapy and the risk of serious bacterial infections in elderly patients with rheumatoid arthritis

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