Efficacy and safety of combination etanercept and methotrexate versus etanercept alone in patients with rheumatoid arthritis with an inadequate response to methotrexate: the ADORE study

Riel, P.L.C.M. van; Taggart, A J; Sany, J; Gaubitz, M.; Nab, Henk; Pedersen, Ron; Freundlich, Bruce; MacPeek, D

doi:10.1136/ard.2005.043299

Cited by 130 publications

(89 citation statements)

References 23 publications

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“…Most AE observed during this study were not serious, and the incidence of serious AE (7.54%) was similar to that observed in clinical trials involving ETN (5% 16 , 7% 17 , and 11% 18 ). This surveillance showed that the most commonly observed AE was injection site reactions (5.3%), and the most frequently observed serious AE was pneumonia (0.8%).…”

Section: Discussionsupporting

confidence: 51%

Postmarketing Surveillance of the Safety and Effectiveness of Etanercept in Japan

Koike¹,

Harigai²,

Inokuma³

et al. 2009

J Rheumatol

171

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Objective.Postmarketing surveillance (PMS) was conducted evaluating safety and effectiveness of etanercept (ETN; Enbrel®) in Japan, following all patients with rheumatoid arthritis (RA) during the conditional approval period of ETN.Methods.Registration of patients from 1,334 medical sites was conducted between March 2005 and April 2007. Patients were followed for 24 weeks; data regarding patients’ background, safety, and effectiveness was recorded centrally. Adverse events (AE) and adverse drug reactions (ADR) were coded using the Medical Dictionary for Regulatory Activities. Effectiveness was measured using the Disease Activity Score 28 (DAS28).Results.Of 14,369 patients registered, data collection and evaluation for 7,091 patients by March 2006 is reported. At least 1 AE was observed for 2,173 patients (30.6%); 60% of AE occurred within 8 weeks of starting ETN. Most frequent AE were injection site reaction (n = 377, 5.3%) and rash (n = 228, 3.2%). Serious AE occurred in 403 patients (5.7%); most frequent were pneumonia (n = 59, 0.8%) and interstitial lung disease (n = 42, 0.6%). Pneumonia was the most common specifically important ADR (n = 102, 1.4%). Mean baseline DAS28 was 6.0, which reduced to 4.4 within 4 weeks, and to 3.9 within 24 weeks. The proportion of patients having good or moderate EULAR response measured by DAS28 was 84.1% at Week 24. Effectiveness rates were more favorable in patients concomitantly using methotrexate. Good or moderate EULAR response rate among patients switched from infliximab was 84.9%.Conclusion.This extensive observational trial, including all patients with RA in Japan taking ETN, found ETN to be both effective and well tolerated by Japanese patients with RA. Trial registration: clinicaltrials.gov identifier NCT00503503.

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Section: Discussionsupporting

confidence: 51%

Postmarketing Surveillance of the Safety and Effectiveness of Etanercept in Japan

Koike¹,

Harigai²,

Inokuma³

et al. 2009

J Rheumatol

171

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“…As in other studies [13,14,15] parameters of disease activity such as ESR and disease activity score (DAS28) decreased after three months therapy with etanercept. Subsequent drug administrations caused further decrease of these parameters of disease activity (data not shown).…”

Section: Discussionmentioning

confidence: 54%

“…Several studies have shown that anti-TNF-α treatment with infliximab, a chimeric antitumour necrosis factor α antibody [11,12] and etanercept, a soluble tumour necrosis factor receptor (sTNFr) [13,14,15] diminish clinical activity of RA. In our previous report, we demonstrated that infusions of infliximab reduce serum chemokines concentrations in RA patients [16].…”

Section: Introductionmentioning

confidence: 99%

Serum chemokines in patients with rheumatoid arthritis treated with etanercept

et al. 2009

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“…The trial failed to demonstrate the superiority of continuing MTX rather than discontinuing it upon starting ETN therapy 5 . Because the ADORE trial was only 16 weeks, with a regimen of MTX tapering over the initial 4 weeks, there could be no marked difference between continuation versus discontinuation of MTX, if any difference at all.…”

mentioning

confidence: 99%

Continuation of Methotrexate Resulted in Better Clinical and Radiographic Outcomes Than Discontinuation upon Starting Etanercept in Patients with Rheumatoid Arthritis: 52-week Results from the JESMR Study

et al. 2011

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Objective.The aim of the Efficacy and Safety of Etanercept on Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan (JESMR) study is to compare the efficacy of continuation versus discontinuation of methotrexate (MTX) when starting etanercept (ETN) in patients with active rheumatoid arthritis (RA).Methods.In total, 151 patients with active RA who had been taking MTX were randomized to either ETN 25 mg twice a week with 6–8 mg/week MTX (the E+M group), or ETN alone (the E group). The primary endpoint at Week 52 was the radiographic progression assessed by van der Heijde-modified Sharp score.Results.The mean progression in total score at Week 52 was not significantly different, statistically, between the E+M group and the E group (0.8 vs 3.6, respectively; p = 0.06). However, a significant difference was observed in radiographic progression between Weeks 24 and 52 (0.3 vs 2.5; p = 0.03), and the mean progression of the erosion score was negative in the E+M group, which was significantly better than the E group at Week 52 (–0.2 vs 1.8; p = 0.02). Clinically, the cumulative probability plot of the American College of Rheumatology (ACR)-N values at Week 52 clearly demonstrated a superior response in the E+M group than in the E group. ACR20, 50, and 70 response rates at Week 52 in the E+M group (86.3%, 76.7%, and 50.7%) were significantly greater than those in the E group (63.8%; p = 0.003, 43.5%; p < 0.0001 and 29.0%; p = 0.01, respectively).Conclusion.MTX should be continued when starting ETN in patients with active RA. (ClinicalTrials.gov: NCT00688103)

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Efficacy and safety of combination etanercept and methotrexate versus etanercept alone in patients with rheumatoid arthritis with an inadequate response to methotrexate: the ADORE study

Cited by 130 publications

References 23 publications

Postmarketing Surveillance of the Safety and Effectiveness of Etanercept in Japan

Postmarketing Surveillance of the Safety and Effectiveness of Etanercept in Japan

Serum chemokines in patients with rheumatoid arthritis treated with etanercept

Continuation of Methotrexate Resulted in Better Clinical and Radiographic Outcomes Than Discontinuation upon Starting Etanercept in Patients with Rheumatoid Arthritis: 52-week Results from the JESMR Study

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