Evidence map›Paper›PMID 34278555›Full record

ArticleRheumatology and therapy2021

Cost-Effectiveness of Therapeutic Drug Monitoring-Guided Adalimumab Therapy in Rheumatic Diseases: A Prospective, Pragmatic Trial.

Catalina Gómez-Arango, Inigo Gorostiza, Eduardo Úcar, Maria Luz García-Vivar, Clara Eugenia Pérez, Juan Ramon De Dios, Belen Alvarez, Ana Ruibal-Escribano, Claudia Stoye, Margarida Vasques and 9 more

Open access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 6 institutions in 1 country.

Catalina Gómez-ArangoDepartment of Rheumatology, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.
Inigo GorostizaResearch Unit, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.
Eduardo ÚcarDepartment of Rheumatology, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.
Maria Luz García-VivarDepartment of Rheumatology, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.
Clara Eugenia PérezDepartment of Rheumatology, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.
Juan Ramon De DiosDepartment of Rheumatology, Osakidetza Basque Health Service, Araba University Hospital, Vitoria, Spain.
Belen AlvarezDepartment of Rheumatology, Osakidetza Basque Health Service, Araba University Hospital, Vitoria, Spain.
Ana Ruibal-EscribanoDepartment of Rheumatology, Osakidetza Basque Health Service, Araba University Hospital, Vitoria, Spain.
Claudia StoyeDepartment of Rheumatology, Osakidetza Basque Health Service, Araba University Hospital, Vitoria, Spain.
Margarida VasquesDepartment of Rheumatology, Osakidetza Basque Health Service, Araba University Hospital, Vitoria, Spain.
Joaquin BelzuneguiDepartment of Rheumatology, Osakidetza Basque Health Service, Donostia University Hospital, San Sebastian, Spain.
Antonio EscobarResearch Unit, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.
Ziortza TranchoResearch Unit, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.
Ainhoa Ruiz Del AguaR&D Department, Progenika Biopharma S.A., A Grifols Company, 504 Parque Tecnológico Bizkaia, 48160, Derio, Spain.
Lorena Del RioR&D Department, Progenika Biopharma S.A., A Grifols Company, 504 Parque Tecnológico Bizkaia, 48160, Derio, Spain.
Cristina JorqueraResearch Unit, Osakidetza Basque Health Service, Basurto University Hospital, Bilbao, Spain.
Eli DiezR&D Department, Progenika Biopharma S.A., A Grifols Company, 504 Parque Tecnológico Bizkaia, 48160, Derio, Spain.
Antonio MartínezR&D Department, Progenika Biopharma S.A., A Grifols Company, 504 Parque Tecnológico Bizkaia, 48160, Derio, Spain.
Daniel NagoreR&D Department, Progenika Biopharma S.A., A Grifols Company, 504 Parque Tecnológico Bizkaia, 48160, Derio, Spain. daniel.nagore@progenika.grifols.com.
Osakidetza · ESGrifols (Spain) · ESHospital Universitario Araba · ESOsasun Sistemen Ikerketa Institutua · ESBiogipuzkoa Health Research Institute · ESHospital de Basurto · ES

Funding

Ministerio de Economía y Competitividad INNPACTO program [IPT-2012-0062-010000].
6 · The paper itself

Abstract

introductionTo assess the clinical and cost-effectiveness of therapeutic drug monitoring (TDM) based on serum adalimumab levels compared to standard of care in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

methodsThis was a non-inferiority, multicentric, non-randomized, pragmatic trial including adult patients diagnosed with moderate-to-severe, clinically stable rheumatic diseases treated with adalimumab. Consecutive patients were assigned 1:2 to the control (CG) or the intervention group (IG), based on the site of inclusion, and followed up for 18 months. Adalimumab serum levels were measured at each study visit and released to the IG only to modify dosing strategy. Data on disease activity, healthcare resource utilization and health-related quality of life (HRQoL) measured through the EQ-5D-5L were collected. Number of persistent and overall flares, time to first flare, days experiencing high disease activity, total direct costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER) were calculated.

resultsOf the 169 recruited patients, 150 were included in the analysis (52 and 98 patients in the CG and IG, respectively). The primary endpoint was not met as persistent flares were not significantly lower in the IG, although mean (SD) number of flares was numerically lower in the IG (0.67 [0.70] versus 0.90 [0.82], P = 0.073), respectively. Based on EQ-5D-5L utilities, HRQoL was significantly higher in the IG at 3 (P = 0.001) and 6 months (P = 0.035), which overall translated into 0.075 QALYs gained per patient for the IG at month 18. Overall, direct costs were significantly lower for the IG patients (€15,311.59 [4,870.04] versus €17,378.46 [6,556.51], P = 0.030), resulting in the intervention being dominant, leading to increased QALY at a lower overall cost

conclusionAdalimumab dose tapering based on TDM for rheumatic patients led to an increased quality of life and QALY gain and entailed lower costs, being a more cost-effective alternative than clinically guided management.

Indexed as

AdalimumabCost-effectivenessRheumatic diseasesTherapeutic drug monitoring

Identifiers

PMID34278555
PMCPMC8380594
OpenAlexW3185556671

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.