Evidence map›Paper›PMID 36450407›Full record

Observational studyLupus science & medicine2022

Evaluating disease control following belimumab treatment in patients with SLE enrolled in the US OBSErve study.

Jacob N Hunnicutt, Jolyon Fairburn-Beech, Mary Elizabeth Georgiou, Anna Richards, Yun Irene Gregan, Holly Quasny, Deven Chauhan

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in Lupus science & medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 37% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Review
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 2 institutions in 2 countries.

Jacob N HunnicuttValue Evidence and Outcomes, GSK, Collegeville, Pennsylvania, USA jacob.n.hunnicutt@gsk.com.ORCID 0000-0003-2768-0272
Jolyon Fairburn-BeechValue Evidence and Outcomes, GSK, Brentford, UK.
Mary Elizabeth GeorgiouValue Evidence and Outcomes, GSK, Brentford, UK.
Anna RichardsValue Evidence and Outcomes, GSK, Brentford, UK.
Yun Irene GreganClinical Science Immunology, GSK, Collegeville, Pennsylvania, USA.
Holly QuasnyResearch and Development, GSK, Durham, North Carolina, USA.ORCID 0000-0002-1659-0004
Deven ChauhanValue Evidence and Outcomes, GSK, Brentford, UK.
Health Economics and Outcomes Research (United Kingdom) · GBGlaxoSmithKline (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo characterise disease control and remission in patients with SLE receiving belimumab for up to 12 months in the real world.

methodsThis post hoc analysis (GSK Study 213502) used data from the US evaluation Of use of Belimumab in clinical practice SEttings (OBSErve) study (GSK Study 117295), an observational cohort study of adults with SLE initiating and continuing belimumab for ≥6 months. Data were collected every 6 months by physician chart review; details of disease activity using the Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score were collected if routinely used by physicians. Disease control definitions evaluated were SELENA-SLEDAI score of ≤2 at 12 months, SELENA-SLEDAI score of ≤2 and glucocorticoid (prednisone equivalent) dose of ≤5 mg/day at 12 months, SELENA-SLEDAI score of ≤2 and glucocorticoid dose of ≤5 mg/day at both 6 and 12 months. Disease remission definition was SELENA-SLEDAI score=0 at 12 months. Glucocorticoid dose during follow-up was quantified.

resultsUS OBSErve enrolled 501 patients, 90 of whom had eligible SELENA-SLEDAI scores for inclusion in this analysis. Mean (SD) SELENA-SLEDAI scores were 13.1 (3.0) at baseline and 4.9 (3.4) at 12 months. Disease control at 12 months was achieved by 31.1% of patients when defined as a SELENA-SLEDAI score of ≤2 (95% CI 21.8 to 41.7); this decreased to 25.6% when requiring a SELENA-SLEDAI score of ≤2 and glucocorticoid dose of ≤5 mg/day (95% CI 16.9 to 35.8) and 17.8% when requiring a SELENA-SLEDAI score of ≤2 and glucocorticoid dose of ≤5 mg/day at both 6 and 12 months (95% CI 10.5 to 27.3). No patient achieved remission at 12 months. Glucocorticoids decreased from a baseline median of 20.0 mg/day (IQR 15.0-30.0) to 5.0 mg/day (IQR 0-10.0) at 12 months.

conclusionImproved disease control and reduced glucocorticoid use was achieved for a proportion of patients following up to 12 months of belimumab treatment in a US real-world setting.

Indexed as

GlucocorticoidsLupus Erythematosus, SystemicAdultAntibodies, Monoclonal, HumanizedHumansPrednisoneAntibodies, Monoclonal, HumanizedbelimumabGlucocorticoidsPrednisoneautoimmune diseasesbiological productslupus erythematosus, systemic

Identifiers

PMID36450407
PMCPMC9716789
OpenAlexW4310580569

What OpenQuestion holds

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LicenceCC BY-NC
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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.