Evidence mapPaperPMID 25435923Full record

ArticleTherapeutic advances in musculoskeletal disease2014

Biological drugs for the treatment of rheumatoid arthritis by the subcutaneous route: interpreting efficacy data to assess statistical equivalence.

Andrea Messori, Valeria Fadda, Dario Maratea, Sabrina Trippoli, Roberta Gatto, Mauro De Rosa, Claudio Marinai

Open access · bronzeAbstract read
In one paragraph

Article in Therapeutic advances in musculoskeletal disease, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 42% 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

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
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

7 authors at 1 institution in 1 country.

Andrea MessoriHTA Unit, Area Vasta Centro Toscana, Regional Health System, Via San Salvi 12, 50100 Firenze, Italy.
Valeria FaddaHTA Unit, ESTAV Toscana Centro, Regional Health Service, Firenze, Italy.
Dario MarateaHTA Unit, ESTAV Toscana Centro, Regional Health Service, Firenze, Italy.
Sabrina TrippoliHTA Unit, ESTAV Toscana Centro, Regional Health Service, Firenze, Italy.
Roberta GattoHTA Unit, ESTAV Toscana Centro, Regional Health Service, Firenze, Italy.
Mauro De RosaPresident, SIFACT, Italian Society for Clinical Pharmacy and Therapeutics, Milano, Italy.
Claudio MarinaiDepartment of Pharmaceutical Logistics, ESTAV Toscana Centro, Regional Health Service, Firenze, Italy.
Agenzia Regionale di Sanità della Toscana · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNo equivalence analysis has yet been conducted on the effectiveness of biologics in rheumatoid arthritis. Equivalence testing has a specific scientific interest, but can also be useful for deciding whether acquisition tenders are feasible for the pharmacological agents being compared.

methodsOur search covered the literature up to August 2014. Our methodology was a combination of standard pairwise meta-analysis, Bayesian network meta-analysis and equivalence testing. The agents examined for their potential equivalence were etanercept, adalimumab, golimumab, certolizumab, and tocilizumab, each in combination with methotrexate (MTX). The reference treatment was MTX monotherapy. The endpoint was ACR50 achievement at 12 months. Odds ratio was the outcome measure. The equivalence margins were established by analyzing the statistical power data of the trials.

resultsOur search identified seven randomized controlled trials (2846 patients). No study was retrieved for tocilizumab, and so only four biologics were evaluable. The equivalence range was set at odds ratio from 0.56 to 1.78. There were 10 head-to-head comparisons (4 direct, 6 indirect). Bayesian network meta-analysis estimated the odds ratio (with 90% credible intervals) for each of these comparisons. Between-trial heterogeneity was marked. According to our results, all credible intervals of the 10 comparisons were wide and none of them satisfied the equivalence criterion. A superiority finding was confirmed for the treatment with MTX plus adalimumab or certolizumab in comparison with MTX monotherapy, but not for the other two biologics.

conclusionOur results indicate that these four biologics improved the rates of ACR50 achievement, but there was an evident between-study heterogeneity. The head-to-head indirect comparisons between individual biologics showed no significant difference, but failed to demonstrate the proof of no difference (i.e. equivalence). This body of evidence presently precludes any option of undertaking competitive tenderings for the procurement of these agents.

Indexed as

adalimumabbiologicscertolizumabequivalenceetanerceptgolimumabmeta-analysisrheumatoid arthritistocilizumab

Identifiers

PMID25435923
PMCPMC4239151
OpenAlexW1966561776

What Socratic holds

Textmetadata
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 Socratic graph.