Evidence map›Paper›PMID 35379598›Full record

Trial reportThe British journal of ophthalmology2023

Utilisation of composite endpoint outcome to assess efficacy of tocilizumab for non-infectious uveitis in the STOP-Uveitis Study.

Muhammad Hassan, Mohammad Ali Sadiq, Maria Soledad Ormaechea, Günay Uludağ, Muhammad Sohail Halim, Rubbia Afridi, Diana V Do, Yasir Jamal Sepah, Quan Dong Nguyen

Open access · greenAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The British journal of ophthalmology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.8field-weighted citation impact, top 16% 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

7 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Biosimilars in Adult and Pediatric Noninfectious Uveitis.Clinical ophthalmology (Auckland, N.Z.) · 2026
    Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. 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

9 authors at 3 institutions in 2 countries.

Muhammad HassanByers Eye Institute, Stanford University, Stanford, California, USA.
Mohammad Ali SadiqDepartment of Ophthalmology, Weill Cornell Medicine, New York, New York, USA.
Maria Soledad OrmaecheaByers Eye Institute, Stanford University, Stanford, California, USA.
Günay UludağByers Eye Institute, Stanford University, Stanford, California, USA.
Muhammad Sohail HalimByers Eye Institute, Stanford University, Stanford, California, USA.
Rubbia AfridiByers Eye Institute, Stanford University, Stanford, California, USA.
Diana V DoByers Eye Institute, Stanford University, Stanford, California, USA.ORCID 0000-0003-1935-1241
Yasir Jamal SepahByers Eye Institute, Stanford University, Stanford, California, USA.ORCID 0000-0002-0104-6284
Quan Dong NguyenByers Eye Institute, Stanford University, Stanford, California, USA ndquan@stanford.edu.ORCID 0000-0001-9033-8117
Stanford University · USCornell University · USHospital Universitario Austral · AR

Funding

Stanford Vision Research CoreP30EY026877 · NEI · STANFORD UNIVERSITY · PI Jeffrey L Goldberg · 2017 to 2026
$8.0M
NEI NIH HHS P30 EY026877
6 · The paper itself

Abstract

BACKGROUND/

aimsTo use a composite endpoint scoring system in assessing efficacy of two doses of intravenous tocilizumab (TCZ), in eyes with non-infectious uveitis.

methodsData from STOP-Uveitis Study (a phase 2 multicentre, randomised, interventional clinical trial), where monthly intravenous infusions of 4 mg/kg (Group 1) or 8 mg/kg (Group 2) TCZ until month 6 (M6) were administered, were used. Efficacy was ascertained by a composite endpoint scoring system consisting of: (1) visual acuity; (2) intraocular inflammation; (3) central retinal thickness; (4) posterior segment inflammation on fluorescein angiographic and (5) steroid taper. Each component of grading system was graded as ((+1) improvement, (-1) worsening or (0) no change) based on specific criteria. The clinical response was classified as positive (improvement in at least one parameter and worsening in none), negative (worsening of any parameter) or stable (neither improvement nor worsening of any parameter). The percentage achieving various clinical responses was compared between groups.

resultsThirty-seven patients were analysed. At M6, 31 (83.8%) subjects demonstrated a positive clinical response (Group 1=14 (77.8%) and Group 2=17 (89.5%)). Three (8.1%) subjects (all Group 1) met the criteria for treatment failure, whereas three (8.1%) subjects showed a stable clinical response (Group 1=1 and Group 2=2). The difference in clinical responses between study groups was not significant (p>0.05).

conclusionsBoth doses of intravenous TCZ were effective in either improving or maintaining stability in patients using the composite endpoint scoring system. A composite scoring system as used in this study may be a better measure to assess efficacy outcomes as compared with only vitreous haze or other single outcome measures.

Indexed as

UveitisAntibodies, Monoclonal, HumanizedHumansInflammationRetinaTreatment OutcomeAntibodies, Monoclonal, HumanizedtocilizumabClinical TrialDrugsImmunologyInflammation

Identifiers

PMID35379598
PMCPMC10863991
OpenAlexW4226048504

What OpenQuestion holds

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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.