Evidence map›Paper›PMID 27940624›Full record

ArticleBMJ open2016

Anti-adalimumab antibodies in psoriasis: lack of clinical utility and laboratory evidence.

G Lombardi, S Perego, V Sansoni, M Diani, G Banfi, G Altomare

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 29% 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

4 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. 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

6 authors at 3 institutions in 1 country.

G LombardiLaboratory of Experimental Biochemistry and Molecular Biology, I.R.C.C.S. Istituto Ortopedico Galeazzi, Milano, Italia.ORCID 0000-0002-8365-985X
S PeregoLaboratory of Experimental Biochemistry and Molecular Biology, I.R.C.C.S. Istituto Ortopedico Galeazzi, Milano, Italia.
V SansoniLaboratory of Experimental Biochemistry and Molecular Biology, I.R.C.C.S. Istituto Ortopedico Galeazzi, Milano, Italia.
M DianiDepartment of Dermatology and Venereology, I.R.C.C.S. Istituto Ortopedico Galeazzi, Milano, Italia.
G BanfiLaboratory of Experimental Biochemistry and Molecular Biology, I.R.C.C.S. Istituto Ortopedico Galeazzi, Milano, Italia.
G AltomareDepartment of Dermatology and Venereology, I.R.C.C.S. Istituto Ortopedico Galeazzi, Milano, Italia.
Istituto Ortopedico Galeazzi · ITUniversity of Milan · ITVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAdalimumab has proven effective in psoriasis; however, secondary failure may result from the drug's immunogenicity. Prevalence data on the immunogenicity of biologicals, and of adalimumab in particular, are highly variable. We investigated the prevalence of anti-adalimumab antibodies and the association with clinical indexes and tumour necrosis factor α (TNFα) serum levels in psoriatic patients.

designCase-control, longitudinal.

settingSingle centre.

participantsPatient groups: I (n=20) receiving biological therapies after switching from adalimumab; II (n=30) ongoing adalimumab therapy; III (n=30) novel adalimumab therapy; IV (n=15) biological therapies other than adalimumab.Healthy subjects: (group V; n=15) never treated with immunosuppressants or biologicals.

interventionsAll groups were tested at enrolment. Group II was also tested at 12 months, and group III at 1, 3, and 6 months. PRIMARY AND SECONDARY OUTCOME MEASURES: Standard clinical evaluations (Psoriasis Area Severity Index (PASI)), blood samples and two-site ELISA-based measurement of serum adalimumab trough levels, anti-adalimumab antibodies and TNFα.

resultsThe false-positive rate was 23% for adalimumab detection and 22% for anti-adalimumab antibodies in patients naïve to adalimumab. Spurious positivity for anti-adalimumab antibodies (one-time-point positivity in group III during follow-up) accounted for 33% of the total. The prevalence of anti-drug antibodies was highest (87%) in group I patients. No correlations were found between the presence of anti-adalimumab antibodies or adalimumab levels and changes in PASI scores.

conclusionsHigh variability of results, high prevalence of false-positives and lack of association between anti-adalimumab antibodies and TNFα level/PASI score limit this assay's usefulness. Accurate clinical evaluation is key to early identification of treatment failures.

Indexed as

AdalimumabAdultAntibodiesAnti-Inflammatory AgentsBiomarkersCase-Control StudiesFemaleHumansMaleMiddle AgedPsoriasisSeverity of Illness IndexTreatment FailureTumor Necrosis Factor-alphaAdalimumabAntibodiesAnti-Inflammatory AgentsBiomarkersTumor Necrosis Factor-alphaadalimumabanti-drug antibodiesELISA

Identifiers

PMID27940624
PMCPMC5168630
OpenAlexW2560260758

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.