The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial

Schiff, Michael; Pritchard, Charles; Huffstutter, J. Eugene; Rodríguez‐Valverde, V.; Durez, Patrick; Zhou, Xianhuang; Li, T; Bahrt, K; Kelly, Sheila; Bars, Manuela Le; Genovese, Mark C.

doi:10.1136/ard.2008.099218

Cited by 139 publications

(137 citation statements)

References 13 publications

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“…Data were pooled from 8 clinical trials of IV abatacept in adult patients with active, established RA with inadequate response to DMARD or anti-TNF therapy (Table 1). All studies consisted of short-term periods of ≤ 12 months' duration and subsequent open-label longterm extensions (LTE), and included 2 phase II (NCT00162266 and NCT00162279) 1,14 and 4 phase III (NCT00048568, NCT00048581, NCT00048932, and NCT00095147) 2,4,5,15 RCT, and 2 open-label trials (NCT00162201 and NCT00162201) 16,17 . Data are reported for the pooled short-term period according to abatacept or placebo treatment arm, and for the cumulative trial periods, which included data from both the short-term and open-label LTE of the studies.…”

Section: Methodsmentioning

confidence: 99%

Safety of Abatacept Administered Intravenously in Treatment of Rheumatoid Arthritis: Integrated Analyses of up to 8 Years of Treatment from the Abatacept Clinical Trial Program

Weinblatt

Moreland²,

Westhovens³

et al. 2013

J Rheumatol

119

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Objective.To assess the overall safety, including rare events, of intravenous (IV) abatacept treatment in rheumatoid arthritis (RA).Methods.Data from 8 clinical trials of IV abatacept in RA were pooled. Safety events were assessed during the short-term (duration ≤ 12 months) and cumulative (short-term plus longterm extensions) abatacept treatment periods. Incidence rates per 100 patient-years were calculated. Standardized incidence ratios (SIR) for hospitalized infections and malignancies were compared with external RA cohorts and, for malignancies, with the US general population.Results.There were 3173 IV abatacept-treated patients with 2331 patient-years of exposure in the short-term periods, and 4149 IV abatacept-treated patients with 12,132 patient-years of exposure in the cumulative period. Incidence rates for serious infections were low and consistent over time (3.68 for abatacept vs 2.60 for placebo during the short-term, and 2.87 for abatacept during the cumulative period). Hospitalized infections were generally similar to external RA patient cohorts and were consistent over time. Incidence rates of malignancies were similar for abatacept- and placebo-treated patients during the short-term period (0.73 vs 0.59) and remained low during the abatacept cumulative period (0.73). SIR of some tissue-specific malignancies (e.g., colorectal and breast) in the cumulative period tended to be lower, while others (lymphoma and lung) tended to be higher, compared with the general population; however, incidence rates were comparable with RA cohorts. Autoimmune events were rare and infusion reactions uncommon.Conclusion.Longterm safety of IV abatacept was consistent with the short-term, with no unexpected events and low incidence rates of serious infections, malignancies, and autoimmune events.

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Section: Methodsmentioning

confidence: 99%

Safety of Abatacept Administered Intravenously in Treatment of Rheumatoid Arthritis: Integrated Analyses of up to 8 Years of Treatment from the Abatacept Clinical Trial Program

Weinblatt

Moreland²,

Westhovens³

et al. 2013

J Rheumatol

119

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“…Schiff et al 10 observed that the safety and tolerability profiles of abatacept are more acceptable than those of infliximab, with fewer serious adverse events, including severe infections and acute infusion events. In another study with 1,286 patients with rheumatoid arthritis, followed for over a one-year period, Schiff et al 11 observed that only one patient had a serious infection, but no cases of opportunistic infections, including tuberculosis, occurred. In conclusion, this study demonstrated acceptable safety and tolerability of abatacept in patients with inadequate response to anti-TNF therapy.…”

Section: Discussionmentioning

confidence: 99%

“…Some studies 10,11 have shown that this medication has a lower risk of adverse events and it has been used in the treatment of RA unresponsive to MTX and anti-TNFα agents. This biological agent has shown favorable results in the treatment of psoriasis, although the studies are still in the experimental phase.…”

Section: Discussionmentioning

confidence: 99%

Uso do abatacepte em uma paciente com artrite psoriásica

Rodrigues¹,

Vieira²,

Callado³

et al. 2010

Rev. Bras. Reumatol.

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Psoriatic arthritis (PA) is an inflammatory seronegative arthritis of unknown origin. Classically, PA has five clinical forms, and asymmetric oligoarthritis is the most common type. We describe the case of a patient with PA refractory to disease-modifying drugs, who developed drug-induced hepatitis after chemoprophylaxis with isoniazid, administered prior to the treatment with an anti-TNFα agent. Due to the risk of activating latent tuberculosis with the administration of anti-TNFα and hepatotoxicity onset caused by the TB treatment and based on the fact that the treatment of PA is similar to the treatment of rheumatoid arthritis, a decision was made to use the empirical treatment with abatacept. Approximately twenty days after the second infusion of the drug, the patient showed clinical improvement, resolution of the arthritis, almost complete disappearance of the skin lesions and improvement of anemia and inflammatory tests.

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“…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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The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial

Cited by 139 publications

References 13 publications

Safety of Abatacept Administered Intravenously in Treatment of Rheumatoid Arthritis: Integrated Analyses of up to 8 Years of Treatment from the Abatacept Clinical Trial Program

Safety of Abatacept Administered Intravenously in Treatment of Rheumatoid Arthritis: Integrated Analyses of up to 8 Years of Treatment from the Abatacept Clinical Trial Program

Uso do abatacepte em uma paciente com artrite psoriásica

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

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