Effects of Abatacept in Patients with Methotrexate-Resistant Active Rheumatoid Arthritis

Kremer, Joel M.; Genant, Harry K.; Moreland, Larry W.; Russell, Anthony S.; Emery, Paul; Abud-Mendoza, Carlos; Szechiński, Jacek; Li, Tracy; Ge, Zhiqiang; Becker, Jean‐Claude; Westhovens, René

doi:10.7326/0003-4819-144-12-200606200-00003

Cited by 659 publications

(470 citation statements)

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“…However, the remission rates of these non-TNF biologic agents in anti-TNF-naïve or -refractory populations differ. For abatacept, the remission rate in MTX-resistant patients (AIM study) was 14.8% [28], while that in anti-TNF therapy-refractory patients (ATTAIN study) was 10.0% [29]. In the case of rituximab, the American College of Rheumatology (ACR) 70% rate in MTX-resistant patients (DANCER study) was 20% [30], and that in anti-TNF therapy-refractory patients (REFLEX study) was 12% [31].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and tolerability of tocilizumab in rheumatoid arthritis patients seen in daily clinical practice in Japan: results from a retrospective study (REACTION study)

et al. 2010

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Tocilizumab, a humanized monoclonal antibody to the interleukin 6 (IL-6) receptor, was approved for use as rheumatoid arthritis (RA) therapy in Japan in 2008, but its efficacy and tolerability in daily practice has not yet been reported. We report the results of a multicenter retrospective study on the efficacy and safety of tocilizumab involving all patients (n = 229) who were started on tocilizumab therapy at three rheumatology institutes in Japan from April 2008 through to March 2009. Tocilizumab was infused every 4 weeks at a dose of 8 mg/kg according to the drug labeling. Among the 229 patients, 55% concomitantly received methotrexate (MTX) and 63% had previously received anti-tumor necrosis factor (TNF) therapy. Average disease activity score (DAS) 28 of all 229 patients significantly decreased from 5.70 to 3.25 after 24 weeks of therapy. A European League Against Rheumatism (EULAR) good response and DAS28 remission was achieved in 57.4 and 40.7% of the patients, respectively, at 24 weeks. White blood cell counts significantly decreased and liver enzymes and total cholesterol slightly but significantly increased; however, liver enzyme levels did not increase in patients without MTX. Tocilizumab was discontinued in 47 cases (20.5%) due to lack of efficacy (5.2%), adverse events (11.4%), and other reasons (3.9%). The overall retention rate at 24 weeks was 79.5%. Based on these results, we conclude that tocilizumab therapy in daily rheumatology practice appears to be highly efficacious and well tolerated among active RA patients, including the anti-TNF therapy-refractory population. Tocilizumab infusion is therefore applicable not only as an alternative approach for anti-TNF therapy-resistant patients, but also as primary biologic therapy for active RA patients.

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Section: Discussionmentioning

confidence: 99%

Efficacy and tolerability of tocilizumab in rheumatoid arthritis patients seen in daily clinical practice in Japan: results from a retrospective study (REACTION study)

et al. 2010

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“…Overall, the 30-min intravenous abatacept infusion was well tolerated by patients in this trial [29] and did not require premedication [37]. The incidence of infusion reactions was low, reported by only 5% of abatacept-treated patients compared with 3% of the placebo-treated patients ( p= 0.35), and no severe or very severe reactions were observed in either group during the double-blind period.…”

Section: Safety Of Abatacept In the Attain Trialmentioning

confidence: 70%

Abatacept: a T-cell co-stimulation modulator for the treatment of rheumatoid arthritis

Östör

2008

Clin Rheumatol

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“…As in AMPLE, these 3 abatacept studies included patients with an inadequate response to MTX who were biologics‐naive 5, 24, 25, 26.…”

Section: Discussionmentioning

confidence: 99%

“…Abatacept is a T‐cell costimulation modulator that has shown efficacy in patients with RA in a wide range of disease and treatment durations 4, 5, 6, 7, 8, 9, 10, 11. The AMPLE (Abatacept versus Adalimumab Comparison in Biologic‐Naive RA Subjects with Background MTX) trial, the first head‐to‐head trial comparing biologic DMARDs in patients with RA receiving MTX, demonstrated noninferiority for abatacept versus adalimumab by the ACR 20% improvement response (ACR20) at year 1 (64.8% subcutaneous [SC] abatacept versus 63.4% adalimumab; estimated difference between treatments 1.8% [95% confidence interval (95% CI) −5.6, 9.2] in an intent‐to‐treat analysis) 12.…”

Section: Introductionmentioning

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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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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Effects of Abatacept in Patients with Methotrexate-Resistant Active Rheumatoid Arthritis

Abstract: Abatacept statistically significantly reduced disease activity in patients with rheumatoid arthritis and an inadequate response to methotrexate. Longer treatment in different patient populations is needed to establish its appropriate role in rheumatoid arthritis.

Cited by 659 publications

References 24 publications

Efficacy and tolerability of tocilizumab in rheumatoid arthritis patients seen in daily clinical practice in Japan: results from a retrospective study (REACTION study)

Efficacy and tolerability of tocilizumab in rheumatoid arthritis patients seen in daily clinical practice in Japan: results from a retrospective study (REACTION study)

Abatacept: a T-cell co-stimulation modulator for the treatment of rheumatoid arthritis

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

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