Evidence map›Paper›PMID 25243173›Full record

ArticleBioMed research international2014

Health technology assessment of belimumab: a new monoclonal antibody for the treatment of systemic lupus erythematosus.

Maria Lucia Specchia, Chiara de Waure, Maria Rosaria Gualano, Andrea Doria, Giuseppe Turchetti, Lara Pippo, Francesco Di Nardo, Silvio Capizzi, Chiara Cadeddu, Flavia Kheiraoui and 11 more

Open access · hybridAbstract read
In one paragraph

Article in BioMed research international, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
3.6field-weighted citation impact, top 8% 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, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Global & regional health technology assessment
    Article
  11. Belimumab in Systemic Lupus Erythematosus.Indian journal of dermatology
    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

21 authors at 5 institutions in 1 country.

Maria Lucia SpecchiaInstitute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.ORCID 0000-0002-3859-4591
Chiara de WaureInstitute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.ORCID 0000-0002-4346-1494
Maria Rosaria GualanoDepartment of Public Health, University of Turin, 10126 Turin, Italy.ORCID 0000-0001-7357-2892
Andrea DoriaRheumatology Department, Padua Hospital, 35128 Padua, Italy.
Giuseppe TurchettiInstitute of Management, Scuola Superiore Sant'Anna, 56127 Pisa, Italy.ORCID 0000-0002-1877-5459
Lara PippoGSK, 37135 Verona, Italy.ORCID 0000-0001-6414-3500
Francesco Di NardoInstitute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.ORCID 0000-0003-3655-0904
Silvio CapizziInstitute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
Chiara CadedduInstitute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.ORCID 0000-0003-0149-1078
Flavia KheiraouiInstitute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.ORCID 0000-0002-5756-0776
Luca IaccarinoRheumatology Department, Padua Hospital, 35128 Padua, Italy.
Francesca PierottiInstitute of Management, Scuola Superiore Sant'Anna, 56127 Pisa, Italy.
Ilaria PallaInstitute of Management, Scuola Superiore Sant'Anna, 56127 Pisa, Italy.
Maria Assunta VenezianoInstitute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
Daniela GliubizziInstitute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
Antonella SferrazzaInstitute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
Nicola NicolottiInstitute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
Rolando PorcasiGSK, 37135 Verona, Italy.ORCID 0000-0002-5430-8727
Giuseppe La TorreDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.
Maria Luisa Di PietroInstitute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.
Walter RicciardiInstitute of Public Health, Catholic University of the Sacred Heart, 00168 Rome, Italy.ORCID 0000-0002-5655-688X
Università Cattolica del Sacro Cuore · ITScuola Superiore Sant'Anna · ITGlaxoSmithKline (Italy) · ITSapienza University of Rome · ITUniversity of Turin · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveSystemic lupus erythematosus (SLE) is treated with anti-inflammatory and immunosuppressive drugs and off-label biologics. Belimumab is the first biologic approved after 50 years as an add-on therapy for active disease. This paper summarizes a health technology assessment performed in Italy.

methodsSLE epidemiology and burden were assessed using the best published international and national evidences and efficacy and safety of belimumab were synthesized using clinical data. A cost-effectiveness analysis was performed by a lifetime microsimulation model comparing belimumab to standard of care (SoC). Organizational and ethical implications were discussed.

resultsLiterature review showed that SLE affects 47 per 100,000 people for a total of 28,500 patients in Italy, 50% of whom are affected by active form of the disease despite SoC. These patients, if autoantibodies and anti-dsDNA positive with low complement, are eligible for belimumab. SLE determines work disability and a 2-5-fold increase in mortality. Belimumab with SoC may prevent 4,742 flares in three years being cost-effective with an incremental cost-effectiveness ratio of €32,859 per quality adjusted life year gained. From the organizational perspective, the development of clear and comprehensive clinical pathways is crucial.

conclusionsThe assessment supports the use of belimumab into the SLE treatment paradigm in Italy.

Indexed as

Antibodies, Monoclonal, HumanizedImmunosuppressive AgentsLupus Erythematosus, SystemicAdultCost-Benefit AnalysisFemaleHumansItalyMaleQuality of LifeAntibodies, Monoclonal, HumanizedbelimumabImmunosuppressive Agents

Identifiers

PMID25243173
PMCPMC4150460
OpenAlexW2079469575

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.