The use of adalimumab, etanercept, golimumab and infliximab in rheumatic pathologies: variation between label dosage and real-world use

Martínez-Cutillas, Julio; Alerany-Pardo, Carme; Borrás-Blasco, Joaquı́n; Broto-Sumalla, Antonio; Burgos-SanJosé, Amparo; Climent-Bolta, Consuelo; Escudero‐Vilaplana, Vicente; Fernández-Fuente, María Anunciación; Ferrit-Martin, Mónica; Gómez-Germá, Pilar; Martínez-Sesmero, José Manuel; Mayorga-Pérez, Jesús; Menchén-Viso, Belén; Alonso, Javier Merino; Polache-Vengud, Josefa; Sánchez-Guerrero, A

doi:10.1586/14737167.2015.1044514

Cited by 9 publications

(6 citation statements)

References 14 publications

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“…These results were consistent with a previous study that found that patients with AS often required dose increases of infliximab [27]. Although the reasons for the more frequent dose escalations with infliximab are not entirely understood, possible reasons include specific dosing instructions, caution in administering the initial dose(s), increased flexibility of iv.…”

Section: Add-on Medication N (%)supporting

confidence: 91%

Treatment patterns of biologics in US patients with ankylosing spondylitis: descriptive analyses from a claims database

et al. 2018

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Aim: Examine treatment patterns among patients with active ankylosing spondylitis (AS) treated with a TNF inhibitor (TNFi). Patients & methods: Patients with AS who initiated a TNFi between 1 January 2013, and 31 January 2015, were identified in the Optum Research Database. Outcomes included adherence, persistence, discontinuation and therapy modifications of the index TNFi during 12-month follow-up. Results: Of the 426 patients included, 40.6% persisted on the index TNFi for ≥12 months, 31.0% discontinued, 21.4% switched to a different TNFi, and 7.0% discontinued and then restarted. Of the 333 patients who persisted on their TNFi for >90 days, 44.7% received ≥1 add-on medication. Conclusion: A high proportion of patients with AS switched, discontinued or modified their TNFi therapy.

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Section: Add-on Medication N (%)supporting

confidence: 91%

Treatment patterns of biologics in US patients with ankylosing spondylitis: descriptive analyses from a claims database

et al. 2018

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“…Currently, an overview of the guidelines in individual European countries and the changes therein over time does not exist. Examples of differences between countries are different initial doses and/or step up strategies,20–22 comedication with csDMARDs23–25 and mandatory elevation of CRP or evidence of inflammation on MRI for patients with nr-axSpA 26. Those differences in access to therapy and treatment guidelines between countries probably account for some of the variation in both baseline variables and treatment outcomes observed in the present study.…”

Section: Discussionmentioning

confidence: 89%

“…Collaboration across registries may provide knowledge regarding prescription patterns, which has an interest in its own, but may also allow for investigation of heterogeneity across countries. The differences in prescription patterns and access to treatment imply that the results of pooling of data across countries should be interpreted with caution 20…”

Section: Discussionmentioning

confidence: 99%

Treatment response and drug retention rates in 24 195 biologic-naïve patients with axial spondyloarthritis initiating TNFi treatment: routine care data from 12 registries in the EuroSpA collaboration

Ørnbjerg¹,

Brahe²,

Askling

et al. 2019

Ann Rheum Dis

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ObjectiveTo study drug retention and response rates in patients with axial spondyloarthritis (axSpA) initiating a first tumour necrosis factor inhibitor (TNFi).MethodsData from 12 European registries, prospectively collected in routine care, were pooled. TNFi retention rates (Kaplan-Meier statistics), Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive disease (<1.3), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <40 mm and Assessment of SpondyloArthritis International Society responses (ASAS 20/40) were assessed at 6, 12 and 24 months.ResultsA first TNFi was initiated in 24 195 axSpA patients. Heterogeneity of baseline characteristics between registries was observed. Twelve-month retention was 80% (95% CI 79% to 80%), ranging from 71% to 94% across registries. At 6 months, ASDAS Inactive disease/BASDAI<40 rates were 33%/72% (LUNDEX-adjusted: 27%/59%), ASAS 20/40 response rates 64%/49% (LUNDEX-adjusted 52%/40%). In patients initiating first TNFi after 2009, 6097 patients was registered to fulfil ASAS criteria for axSpA, 2935 was registered to fulfil modified New York Criteria for Ankylosing Spondylitis and 1178 patients was registered as having non-radiographic axSpA. In nr-axSpA patients, we observed lower 12-month retention rates (73% (70%–76%)) and lower 6-month LUNDEX adjusted response rates (ASDAS Inactive disease/BASDAI40 20%/50%, ASAS 20/40 45%/33%). For patients initiating first TNFi after 2014, 12-month retention rate, but not 6-month response rate, was numerically higher compared with patients initiating TNFi in 2009–2014.ConclusionA large European database of patients with axSpA initiating a first TNFi treatment in routine care, demonstrated that 27% of patients achieved ASDAS inactive disease after 6 months, while 59% achieved BASDAI <40. Four of five patients continued treatment after 1 year.

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“…Recent studies have shown that optimizing bDMARD therapy via off-label dosage for patients with rheumatic diseases is becoming more routine [12–14]. Limited research has been conducted to support long-term health outcomes associated with patterns of bDMARD utilization in the symptom management of PsA [3, 4, 12, 15, 16].…”

Section: Introductionmentioning

confidence: 99%

“…Limited research has been conducted to support long-term health outcomes associated with patterns of bDMARD utilization in the symptom management of PsA [3, 4, 12, 15, 16]. Off-label dosages (i.e., dose escalation or reduction, interrupted treatment) have been shown to occur in clinical practice for the treatment of other inflammatory conditions, such as psoriasis (PsO) and rheumatoid arthritis (RA) [8, 13, 17–20].…”

Section: Introductionmentioning

confidence: 99%

Economic impact of biologic utilization patterns in patients with psoriatic arthritis

Schwartzman

Zhou

et al. 2017

Clin Rheumatol

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The aim of the study is to examine the frequency and costs associated with above-label dosing of biologics in patients with psoriatic arthritis (PsA). MarketScan identified adults with ≥1 International Classification of Diseases, Clinical Modification diagnosis for PsA and ≥1 pharmacy claim for biologics of interest between January 1, 2011 and December 31, 2013. The first biologic claim was the index date with a 1-year follow-up period and three additional months to confirm continuous biologic use. Exclusion criteria included switching to a different biologic or diagnosis with another autoimmune disease. During the follow-up period, duration was stratified into three groups: <30, 30–179, and ≥180 days of above-label dosing (>10% of the labeled dose). One-tailed t test was conducted to examine the impact of above-label duration on healthcare costs. We identified 4245 PsA patients receiving etanercept (n = 2342), adalimumab (n = 1788), and golimumab (n = 115). Above-label dosing of <30 days (85% adalimumab, 90.4% etanercept, and 95.7% golimumab) and ≥180 days (9.6% adalimumab, 4.1% etanercept, and 2.6% golimumab) was observed. All-cause total healthcare costs for <30 days of above-label use (etanercept $30,625, adalimumab $31,620, and golimumab $37,224), 30–179 days (etanercept $35,602, adalimumab $38,915, and golimumab $64,349), and ≥180 days (etanercept $55,349, adalimumab $54,176, and golimumab $47,993) were reported. Longer above-label duration (30–179 versus <30 days, ≥180 versus 30–179 and ≥180 days) with etanercept or adalimumab was significantly associated with higher mean increased total all-cause healthcare, PsA-specific healthcare, and biologic costs (p < 0.05). Above-label use of anti-TNF biologics does occur and is associated with significantly increased healthcare costs.

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The use of adalimumab, etanercept, golimumab and infliximab in rheumatic pathologies: variation between label dosage and real-world use

Cited by 9 publications

References 14 publications

Treatment patterns of biologics in US patients with ankylosing spondylitis: descriptive analyses from a claims database

Treatment patterns of biologics in US patients with ankylosing spondylitis: descriptive analyses from a claims database

Treatment response and drug retention rates in 24 195 biologic-naïve patients with axial spondyloarthritis initiating TNFi treatment: routine care data from 12 registries in the EuroSpA collaboration

Economic impact of biologic utilization patterns in patients with psoriatic arthritis

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