Clinical Consequences of Delayed Addition of Adalimumab to Methotrexate Therapy Over 5 Years in Patients with Rheumatoid Arthritis

Keystone, Edward; Kavanaugh, Arthur; Weinblatt, Michael E.; Patra, Kaushik; Pangan, Aileen L.

doi:10.3899/jrheum.100752

Cited by 25 publications

(13 citation statements)

References 32 publications

(33 reference statements)

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“…The proportions of patients who remained in the trials – and consequently were persistent to golimumab treatment – after 256 weeks were 65.8% in GO-BEFORE and 70.5% in GO-FORWARD. For etanercept, adalimumab, and certolizumab pegol, the five-year persistence rates from extension studies of RCTs in TNFi-naive RA patients were 56%,46 49%,47 and 55%,48 respectively. The persistence estimate with the longest follow-up (36 months) from clinical practice in biologic-naive RA patients was 60% 35.…”

Section: Resultsmentioning

confidence: 99%

Persistence with golimumab in immune-mediated rheumatic diseases: a systematic review of real-world evidence in rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis

Svedbom¹,

Storck²,

Kachroo³

et al. 2017

PPA

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PurposeIn immune-mediated rheumatic diseases (IMRDs), persistence to treatment may be used as a surrogate marker for long-term treatment success. In previous comparisons of persistence to tumor necrosis factor α inhibitors (TNFis), a paucity of data for subcutaneous (SC) golimumab was identified. The aim of this study was to conduct a systematic review of persistence to SC golimumab in clinical practice and contextualize these data with five-year persistence estimates from long-term open-label extension (OLE) trials of SC TNFis in IMRDs.Patients and methodsPubMed, Embase, MEDLINE, and conference proceedings from European League Against Rheumatism (EULAR), American College of Rheumatology (ACR), and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) were searched. All studies on patients treated with SC golimumab for IMRD were included if they reported data on the persistence to golimumab.ResultsOf 376 available references identified through the searches, 12 studies with a total of 4,910 patients met the inclusion criteria. Furthermore, nine OLE trials were available. Among the included studies from clinical practice, at six months, one year, two years, and three years, the proportion of patients persistent to treatment ranged from 63% to 91%, 47% to 80%, 40% to 77%, and 32% to 67%, respectively. In the four studies that included comparisons to other biologics, golimumab was either statistically noninferior or statistically superior to other treatments, an observation that was supported by indirect comparisons of unadjusted point estimates of OLE trials.ConclusionThe data reviewed in this study indicate that golimumab may have higher persistence than other TNFis, a notion that is supported by indirect comparisons of persistence data from OLEs of randomized controlled trials (RCTs). Furthermore, the study suggests that persistence may be lower in biologic-experienced compared with biologic-naive patients and higher in axial spondyloarthritis compared with rheumatoid arthritis and psoriatic arthritis.

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Section: Resultsmentioning

confidence: 99%

Persistence with golimumab in immune-mediated rheumatic diseases: a systematic review of real-world evidence in rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis

Svedbom¹,

Storck²,

Kachroo³

et al. 2017

PPA

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“…The methodology and primary results for the 1-year, double-blind phase of DE019, a randomized, placebo-controlled trial of adalimumab in patients with moderate to severe RA who demonstrated an inadequate response to MTX, have been published 6 , as have results from the first 4 years of the open-label extension 17 . The study protocol and informed consent forms were approved by the local institutional review boards (USA) or research committees (Canada) at each participating site.…”

Section: Methodsmentioning

confidence: 99%

“…They had accrued significant amounts of radiographic damage (mean mTSS was 51), with low function (mean HAQ-DI was 1.4; Table 1). Baseline characteristics for all randomized patients (n = 619) and patients who received at least 1 injection of adalimumab during blinded or open-label therapy (n = 553; safety population) have been described 6,17 . Characteristics were generally similar between the 10-year radiographic completers and the overall intent-to-treat population, with the exception that the radiographic completers appeared to represent a younger subset of the overall randomized population.…”

Section: Patientsmentioning

confidence: 99%

Clinical, Functional, and Radiographic Benefits of Longterm Adalimumab Plus Methotrexate: Final 10-year Data in Longstanding Rheumatoid Arthritis

Keystone

Heijde²,

Kavanaugh³

et al. 2013

J Rheumatol

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Objective.To examine the longterm effectiveness and safety of adalimumab in patients with longstanding rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX), and to assess the effect of a 1-year delay in initiation of combination therapy.Methods.DE019 was a 1-year randomized controlled trial (RCT) in which patients received adalimumab 20 mg weekly, adalimumab 40 mg every other week (eow), or placebo; all received concomitant MTX. Patients completing the RCT could receive open-label adalimumab 40 mg eow + MTX for an additional 9 years. Clinical, functional, and radiographic outcomes were assessed using composite measures of disease activity (e.g., American College of Rheumatology responses, 28-joint Disease Activity Score with C-reactive protein, Simplified Disease Activity Index), Health Assessment Questionnaire-Disability Index, and the modified total Sharp score (mTSS), respectively.Results.Of the 619 patients randomized, 457 entered the open-label extension; 202 completed 10 years. At Year 10, patients demonstrated effective disease control and inhibition of radiographic progression. Differences in clinical and functional responses between adalimumab + MTX and placebo + MTX observed during the RCT became less apparent at Year 10. Still, patients who initially received adalimumab + MTX had significantly lower mean ΔmTSS at Year 10 compared with patients who initially received placebo + MTX. No new safety signals arose following up to 10 years of adalimumab + MTX exposure.Conclusion.During up to 10 years of treatment with adalimumab + MTX, patients with longstanding RA experienced effective disease control with no change to the expected safety profile. A 1-year delay in receipt of adalimumab + MTX was associated with reduced effectiveness, suggesting that a window of opportunity to prevent irreversible damage exists even in a population with established RA.

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“…Two studies were included in this post hoc analysis; details of the methods, primary results, and 5‐ and 10‐year findings have been previously described (). DE019 was a 1‐year, double‐blind, multicenter, randomized placebo‐controlled trial in patients with longstanding RA, followed by a 9‐year, open‐label extension period.…”

Section: Methodsmentioning

confidence: 99%

Analysis of Integrated Radiographic Data From Two Long‐Term, Open‐Label Extension Studies of Adalimumab for the Treatment of Rheumatoid Arthritis

Landewé

Østergaard

Keystone

et al. 2015

Arthritis Care & Research

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Objective. A longitudinal integration approach evaluated all radiographic scores assessed over 10 years, rather than only completer data, from 2 studies of adalimumab (ADA) for rheumatoid arthritis (RA). Results. Data from patients with baseline and >1 postbaseline radiograph were included (n ‫؍‬ 327 for DE019; n ‫؍‬ 452 for PREMIER). Integrated and 10-year completer ⌬mTSS progression curves differed slightly. In DE019, for patients originally assigned PBO ؉ MTX, accrued ⌬mTSS at year 10 was 6.6 units (integrated model) and 6.2 units (completers). For patients originally assigned ADA ؉ MTX, accrued ⌬mTSS was 0.9 units by integrated analysis and 0.7 units in completers. In PREMIER, for patients originally assigned PBO ؉ MTX, accrued ⌬mTSS at year 10 was 11.2 units (integrated analysis) and 11.0 units (completers). For patients originally assigned ADA ؉ MTX, accrued ⌬mTSS was 5.1 units (integrated analysis) and 4.0 units (completers). A higher radiographic progression rate was observed in patients who received delayed versus immediate ADA ؉ MTX treatment. Conclusions. Longitudinal integrated analysis provided robust estimates of radiographic progression that only slightly differed from completers-only scores and confirmed the effects.

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Clinical Consequences of Delayed Addition of Adalimumab to Methotrexate Therapy Over 5 Years in Patients with Rheumatoid Arthritis

Cited by 25 publications

References 32 publications

Persistence with golimumab in immune-mediated rheumatic diseases: a systematic review of real-world evidence in rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis

Persistence with golimumab in immune-mediated rheumatic diseases: a systematic review of real-world evidence in rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis

Clinical, Functional, and Radiographic Benefits of Longterm Adalimumab Plus Methotrexate: Final 10-year Data in Longstanding Rheumatoid Arthritis

Analysis of Integrated Radiographic Data From Two Long‐Term, Open‐Label Extension Studies of Adalimumab for the Treatment of Rheumatoid Arthritis

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