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

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Clinical science
Utilisation of composite endpoint outcome to assess efficacy of tocilizumab for non-infectious uveitis in the STOP-Uveitis Study
  1. Muhammad Hassan1,
  2. Mohammad Ali Sadiq2,
  3. Maria Soledad Ormaechea1,3,
  4. Günay Uludağ1,
  5. Muhammad Sohail Halim1,
  6. Rubbia Afridi1,
  7. Diana V Do1,
  8. Yasir Jamal Sepah1,
  9. Quan Dong Nguyen1
  1. 1 Byers Eye Institute, Stanford University, Stanford, California, USA
  2. 2 Department of Ophthalmology, Weill Cornell Medicine, New York, New York, USA
  3. 3 Department of Ophthalmology, Hospital Universitario Austral, Pilar, Argentina
  1. Correspondence to Dr Quan Dong Nguyen, Stanford University, Stanford, USA; ndquan{at}stanford.edu

Abstract

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

Methods Data 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.

Results Thirty-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).

Conclusions Both 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.

  • Inflammation
  • Clinical Trial
  • Drugs
  • Immunology

Data availability statement

Data are available upon reasonable request. Not applicable.

http://dx.doi.org/10.1136/bjophthalmol-2021-320604

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    Data availability statement

    Data are available upon reasonable request. Not applicable.

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    Footnotes

    • Presented at The manuscript was presented as e-poster at: (1) 2019 American Academy of Ophthalmology Meeting, San Francisco, California, USA, and (2) 2019 Association for Research in Vision and Ophthalmology Meeting, Vancouver, Canada.

    • Contributors MH: research design, data acquisition, data analysis, manuscript preparation, final approval and agreed with all aspects of work. MAS, MSH and QDN: research design, data acquisition, manuscript preparation, final approval and agreed with all aspects of work. MSO and GU: data acquisition, data analysis, manuscript preparation, final approval and agreed with all aspects of work. DVD and YJS: research design, manuscript preparation, final approval and agreed with all aspects of work. RA: data acquisition, data analysis, manuscript preparation, final approval and agreed with all aspects of work. QDN and MH will act as guarantors of the study.

    • Funding The STOP-Uveitis Clinical trial was a Investigator Sponsored Clinical trial chaired by QDN.

    • Competing interests YJS has received research support from Astellas, Genentech and Optovue, and serves on the Scientific Advisory Board for Genentech/Roche, Optos and Regeneron. QDN serves on the Scientific Advisory Board for AbbVie, Bayer, Genentech, Regeneron and Santen, among others, also chaired the Steering Committee for the STOP-Uveitis study and was on the Steering Committee for other studies sponsored by Genentech and Regeneron. DVD serves on the Scientific Advisory Board for Allergan, Genentech, Kodiak, Regeneron and Santen and has received research support from Genentech and Regeneron. No other authors have received any financial funding or support.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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