July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Composite Endpoint Outcomes of the STOP-Uveitis Study: Evaluating the Safety, Tolerability, and Efficacy of Tocilizumab in Patients with Noninfectious Uveitis.
Author Affiliations & Notes
  • Muhammad Hassan
    Byers Eye Institute, Palo Alto, California, United States
  • Maria Soledad Ormaechea
    Byers Eye Institute, Palo Alto, California, United States
    Ophthalmology, Hospital Universitario Austral, Pilar, Buenos Aires, Argentina
  • Mohammad Ali Sadiq
    Ophthalmology, University of Louisville, Louisville, Kentucky, United States
  • Günay Uludağ
    Byers Eye Institute, Palo Alto, California, United States
  • Sarakshi Mahajan
    Byers Eye Institute, Palo Alto, California, United States
  • Muhammad Sohail Halim
    Byers Eye Institute, Palo Alto, California, United States
  • Khalid Yusuf Yaseen Al-Kirwi
    Byers Eye Institute, Palo Alto, California, United States
    Ophthalmology, Imamein Khadhimein Medical City University Hospital, Baghdad, Iraq
  • Jeong Hun Bae
    Byers Eye Institute, Palo Alto, California, United States
    Ophthalmology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Sungkyunkwan, Korea (the Republic of)
  • Rubbia Afridi
    Byers Eye Institute, Palo Alto, California, United States
  • Murat Hasanreisoglu
    Ophthalmology, Ankara University, School of Medicine, Ankara, Turkey
    Byers Eye Institute, Palo Alto, California, United States
  • Carlos Plaza
    Ophthalmology, Hospital Universitario de León, Leon, Spain
    Byers Eye Institute, Palo Alto, California, United States
  • Mohamed A Ibrahim
    Ocular Imaging Research and Reading Center, Menlo Park, California, United States
  • Diana V Do
    Byers Eye Institute, Palo Alto, California, United States
  • Yasir Jamal Sepah
    Byers Eye Institute, Palo Alto, California, United States
  • Quan Dong Nguyen
    Byers Eye Institute, Palo Alto, California, United States
  • Footnotes
    Commercial Relationships   Muhammad Hassan, None; Maria Ormaechea, None; Mohammad Sadiq, None; Günay Uludağ, None; Sarakshi Mahajan, None; Muhammad Sohail Halim, None; Khalid Al-Kirwi, None; Jeong Hun Bae, None; Rubbia Afridi, None; Murat Hasanreisoglu, None; Carlos Plaza, None; Mohamed Ibrahim, None; Diana Do, Allergan (C), Genentech (C), Genentech (F), Regeneron (C), Regeneron (F), Santen (C), Santen (F); Yasir Jamal Sepah, Astellas (F), Genentech (F), Genentech (S), Optos (S), Optovue (F), Regeneron (S); Quan Nguyen, AbbVie (S), Bayer (S), Genentech (S), Genentech (F), NEI P30-EY026877 (F), Regeneron (S), Regeneron (F), Research to Prevent Blindness, Inc (F), Santen (S)
  • Footnotes
    Support  NEI P30-EY026877, Research to Prevent Blindness, Inc
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 3857. doi:https://doi.org/
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      Muhammad Hassan, Maria Soledad Ormaechea, Mohammad Ali Sadiq, Günay Uludağ, Sarakshi Mahajan, Muhammad Sohail Halim, Khalid Yusuf Yaseen Al-Kirwi, Jeong Hun Bae, Rubbia Afridi, Murat Hasanreisoglu, Carlos Plaza, Mohamed A Ibrahim, Diana V Do, Yasir Jamal Sepah, Quan Dong Nguyen; Composite Endpoint Outcomes of the STOP-Uveitis Study: Evaluating the Safety, Tolerability, and Efficacy of Tocilizumab in Patients with Noninfectious Uveitis.. Invest. Ophthalmol. Vis. Sci. 2019;60(9):3857. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To report the efficacy of two different doses of intravenous (IV) infusions of Tocilizumab (TCZ), in eyes with non-infectious intermediate, posterior or pan-uveitis using a composite endpoint scoring system.

Methods : STOP-Uveitis is a randomized, multi-center clinical trial evaluating the role of intravenous infusions of TCZ in patients with non-infectious uveitis. Patients were randomized (1:1) into one of 2 treatment groups (Group 1:4mg/kg and Group 2:8mg/kg). Infusions were given every 4 weeks in both groups until month 6 (primary endpoint). Efficacy outcome was ascertained by a composite endpoint scoring system consisting of: 1) visual acuity; 2) intraocular inflammation as assessed by vitreous haze; 3) central retinal thickness; 4) posterior segment inflammatory outcome assessed by fluorescein angiography, and 5) tapering of steroid dose. Each component of the grading system was assigned one of three possible outcomes: (+1) improvement, (-1) worsening, or (0) no-change based on specific criteria (Table 1). A positive clinical response was defined by improvement in at least one parameter and worsening in none. A negative clinical response was defined as worsening of any parameter. A stable clinical response was defined as neither improvement nor worsening in any of the parameters. Number of patients achieving successful clinical response was calculated and compared between the study groups. Statistical significance was set at p<0.05.

Results : Thirty-seven patients were enrolled in STOP-Uveitis. At month 6, 31 (83.8%) subjects demonstrated a positive clinical response (Group-1=14 (77.8%) and Group-2=17 (89.5%)). Three (8.1%) subjects (Only in Group-1) met the criteria for treatment failure. Three (8.1%) subjects showed a stable clinical response (Group-1=1 and Group-2=2). The difference in clinical response between the two groups was not significant (p>0.05). Figure 1 demonstrates the percentage of patients showing outcomes of various components of the composite endpoint scoring system.

Conclusions : Both high and low dose IV TCZ were effective in either improving or maintaining stability in various components of the composite end point scoring system. A composite scoring system as used in this study may be a better measure to assess efficacy outcomes as compared to only vitreous haze score.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

 

 

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