Evidence map›Paper›PMID 30899987›Full record

ArticleRheumatology international2019

Clinical relevance of monitoring serum adalimumab levels in axial spondyloarthritis.

José Miguel Senabre Gallego, Jose Rosas, Mariana Marco-Mingot, José Alberto García-Gómez, Gregorio Santos-Soler, Esteban Salas-Heredia, Ana Pons-Bas, Xavier Barber-Vallés, José Antonio Bernal-Vidal, Catalina Cano-Pérez and 3 more

Abstract read
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In one paragraph

Article in Rheumatology international, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
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  3. Observational
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
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

13 authors at 3 institutions in 2 countries.

José Miguel Senabre GallegoSección de Reumatología, Hospital Marina Baixa, Av. Alcalde En Jaume Botella Mayor 7, 03570, Villajoyosa, Alicante, Spain. josemisenabre@gmail.com.ORCID 0000-0002-8602-4198
Jose RosasSección de Reumatología, Hospital Marina Baixa, Av. Alcalde En Jaume Botella Mayor 7, 03570, Villajoyosa, Alicante, Spain.ORCID 0000-0001-5179-9674
Mariana Marco-MingotLaboratory Department, Hospital Marina Baixa, Villajoyosa, Alicante, Spain.
José Alberto García-GómezInfectious Disease Department, Hospital General Universitario de Elche, Elche, Alicante, Spain.ORCID 0000-0002-1203-7260
Gregorio Santos-SolerSección de Reumatología, Hospital Marina Baixa, Av. Alcalde En Jaume Botella Mayor 7, 03570, Villajoyosa, Alicante, Spain.
Esteban Salas-HerediaSección de Reumatología, Hospital Marina Baixa, Av. Alcalde En Jaume Botella Mayor 7, 03570, Villajoyosa, Alicante, Spain.
Ana Pons-BasSección de Reumatología, Hospital Marina Baixa, Av. Alcalde En Jaume Botella Mayor 7, 03570, Villajoyosa, Alicante, Spain.
Xavier Barber-VallésCenter of Operations Research, Universitas Miguel Hernández, Elche, Alicante, Spain.ORCID 0000-0003-3079-5855
José Antonio Bernal-VidalSección de Reumatología, Hospital Marina Baixa, Av. Alcalde En Jaume Botella Mayor 7, 03570, Villajoyosa, Alicante, Spain.ORCID 0000-0002-6955-5747
Catalina Cano-PérezSección de Reumatología, Hospital Marina Baixa, Av. Alcalde En Jaume Botella Mayor 7, 03570, Villajoyosa, Alicante, Spain.
Mario García-CarrascoSystemic Autoimmune Disease Research Unit, HGR-36-CIBIOR IMSS, Puebla, Mexico.ORCID 0000-0003-1696-9871
Emilio Flores-PardoClinical Medicine Department, Universitas Miguel Hernández, Elche, Alicante, Spain.ORCID 0000-0001-7524-0808
AIRE-MB Group
Hospital Marina Baixa · ESUniversitat de Miguel Hernández d'Elx · ESHospital General Universitario de Elche · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Our aim was to assess the relationship between serum adalimumab levels, anti-drug antibodies (ADA) and disease activity in patients with axial spondylarthritis (SpA). We have carried out a single-centre cross-sectional study. adalimumab and ADA levels were analysed with ELISA and correlated with SpA activity using BASDAI and ASDAS scores. Adalimumab cut-off value was calculated to discriminate inactive disease/low disease activity (BASDAI < 4; ASDAS < 2.1) from moderate/high disease activity (BASDAI ≥ 4; ASDAS ≥ 2.1), using a receiver operating characteristic (ROC) curve. Up to January 2016, 51 consecutive patients were included. The median (range) age was 46.6 (18-68) and 47.1% were women. ADA prevalence was 27.5%, with none detected in the 21.6% receiving concomitant disease-modifying antirheumatic drugs (DMARDs) (p = 0.021). Adalimumab level was normal (> 3 mg/l) in 36 patients (70.6%), all without ADA. Fifteen patients (29.4%) had subtherapeutic adalimumab levels (< 3 mg/l), with ADA in 14 (93%). Median adalimumab (mg/l) was significantly higher in patients with inactive disease/low disease activity: BASDAI < 4 vs ≥ 4: 9.5 vs 2.6 (p < 0.01); ASDAS-CRP < 2.1 vs ≥ 2.1: 9.3 vs 0.3 (p < 0.001); ASDAS-ESR < 2.1 vs ≥ 2.1: 9.9 vs 3.0 (p < 0.001), and this finding was consistent with the result of the multivariate model. Patients with inactive disease/low disease activity presented significantly lower ADA levels. The adalimumab level cut-offs and area under the curve (AUC) obtained in the ROC curves were: ASDAS-CRP (< 2.1) 4.6 mg/l (AUC 81.2%; 95% CI 67.5-94.9; p < 0.001); ASDAS-ESR (< 2.1) 7.7 mg/l (AUC 82.4%; 95% CI 69.3-95.5; p < 0.001); BASDAI (< 4) 6.4 mg/l (AUC 73.5%; 95% CI 58.6-88.3; p < 0.01). In conclusion, presence of ADA in axial SpA patients treated with adalimumab was associated with lower serum drug levels. ADA levels were lower and adalimumab levels were higher in patients with inactive disease/low disease activity based on BASDAI and ASDAS indices. Concomitant treatment with MTX reduces de likelihood of finding ADA. Serum adalimumab levels above 4.6 mg/l are recommended to avoid compromising efficacy.

Indexed as

AdalimumabAdolescentAdultAgedAntibodiesCross-Sectional StudiesFemaleHumansMaleMiddle AgedSeverity of Illness IndexSpondylarthropathiesTreatment OutcomeTumor Necrosis Factor InhibitorsYoung AdultAdalimumabAntibodiesTumor Necrosis Factor InhibitorsAdalimumabAntibody formationEnzyme-linked immunosorbent assayROC curveSpondylarthritisTreatment outcome

Identifiers

PMID30899987
OpenAlexW2924583065

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.