September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Interim Analyses of Study of Safety and Bioactivity of TOcilizumab in Patients with Non-Infectious UVEITIS: STOP-UVEITIS
Author Affiliations & Notes
  • Yasir Jamal Sepah
    Ophthalmology, University of Nebraska Medical Center, Omaha, Massachusetts, United States
  • Mohammad Ali Sadiq
    Ophthalmology, University of Nebraska Medical Center, Omaha, Massachusetts, United States
  • Muhammad Hassan
    Ophthalmology, University of Nebraska Medical Center, Omaha, Massachusetts, United States
  • Rubbia Afridi
    Ophthalmology, University of Nebraska Medical Center, Omaha, Massachusetts, United States
  • Mark Dacey
    Ophthalmology, Colorado Retina Associates, Denver, Colorado, United States
  • David S Chu
    Ophthalmology, Metropolitan Eye Research and Surgery Institute , Palisades Park, New Jersey, United States
  • Ron P Gallemore
    Ophthalmology, Retina Macula Institute , Torrance, California, United States
  • Pouya Dayani
    Ophthalmology, Retina-Vitreous Associates Medical Group , Beverly Hills, California, United States
  • Diana V Do
    Ophthalmology, University of Nebraska Medical Center, Omaha, Massachusetts, United States
  • Quan Dong Nguyen
    Ophthalmology, University of Nebraska Medical Center, Omaha, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Yasir Sepah, None; Mohammad Sadiq, None; Muhammad Hassan, None; Rubbia Afridi, None; Mark Dacey, None; David Chu, None; Ron Gallemore, None; Pouya Dayani, None; Diana Do, Allergan (C), Genentech (F), Genentech (C), Regeneron (F), Regeneron (C), Santen (C); Quan Dong Nguyen, Bausch and Lomb (C), Genentech (F), L-path (F), MacuSight (F), Ophthotech (F), Regeneron (F), Santen (C), Santen (F)
  • Footnotes
    Support  Unrestricted educational grant from Research to prevent blindness (RPB) and research support from Genentech
Investigative Ophthalmology & Visual Science September 2016, Vol.57, No Pagination Specified. doi:
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      Yasir Jamal Sepah, Mohammad Ali Sadiq, Muhammad Hassan, Rubbia Afridi, Mark Dacey, David S Chu, Ron P Gallemore, Pouya Dayani, Diana V Do, Quan Dong Nguyen; Interim Analyses of Study of Safety and Bioactivity of TOcilizumab in Patients with Non-Infectious UVEITIS: STOP-UVEITIS. Invest. Ophthalmol. Vis. Sci. 201657(12):.

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

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Abstract

Purpose : To evaluate the safety and efficacy of tocilizumab (TZB) infusions for non-infectious posterior, intermediate, or panuveitis

Methods : STOP-Uveitis study is a randomized, open-label safety, efficacy and bioactivity clinical study evaluating the role of TCZ in patients with non-infectious uveitis (NIU). Patients with NIU were randomized into one of 2 treatment groups in a ratio of 1:1. Group 1 received intravenous (IV) infusions of 4mg/kg TZB and group 2 received IV infusions of 8mg/kg TZB. Infusions were given every 4 weeks in both groups until month 6 (primary endpoint). Treatment was given on an as needed basis from month 6 onwards until month 12. Primary outcome measures were mean change in visual acuity (VA), vitreous haze (VH) and foveal thickness (FTH) at month 6 in the two groups. Key study inclusion criteria were: 1) diagnosis of NIU; 2) have active uveitis, defined as having at least 1+ VH and/or at least 1+ Vitreous Cell Count (SUN scale); 3) best-corrected ETDRS VA of 20/400 or better in the study eye and 4) discontinuation of all systemic immunomodulatory therapies 30 days prior to the first administration of study drug.

Results : A total of 37 patients were randomized in the study. Baseline characteristics are shown in table 1. Repeated infusions of TZB were well tolerated. Two patients had low neutrophil counts secondary to margination that restored to normal with withholding of treatment. VH decreased by 1 step or more in 73.3% and 81.2% of patients in group 1 (low dose) and 2 (high dose), respectively, at month 6. VH decreased by 2 steps or more in 26.6% and 37.5% of patients in groups 1 and 2, respectively, at month 6. Mean change in FTH was -131.5 µm in group 1 and -38.91 µm in group 2 at month 6. The mean change in VA at month 6 was +10.9 and +5.5 ETDRS letters in group 1 and 2 respectively.

Conclusions : Repeated IV administrations of TZB are well tolerated. TZB (either 4 or 8 mg/kg) is effective in improving VA and reducing VH and FTH. Further monitoring of patients receiving TZB may be helpful to assess the long term safety and benefits of the drug.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

Table 1 - Baseline Characteristics

Table 1 - Baseline Characteristics

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