Yasir Jamal Sepah1, Mohammad Ali Sadiq2, David S Chu3, Mark Dacey4, Ron Gallemore5, Pouya Dayani6, Mostafa Hanout7, Muhammad Hassan8, Rubbia Afridi8, Aniruddha Agarwal7, Muhammad Sohail Halim8, Diana V Do1, Quan Dong Nguyen9. 1. Byers Eye Institute, Stanford University, Palo Alto, California; Ocular Imaging Research and Reading Center, Menlo Park, California. 2. Byers Eye Institute, Stanford University, Palo Alto, California; West Virginia University, Morgantown, West Virginia. 3. Metropolitan Eye Research and Surgery Institute, Palisades Park, New Jersey. 4. Colorado Retina Associates, Denver, Colorado. 5. Retina Macula Institute, Torrance, California. 6. Retina-Vitreous Associates Medical Group, Beverly Hills, California. 7. Ocular Imaging Research and Reading Center, Menlo Park, California. 8. Byers Eye Institute, Stanford University, Palo Alto, California. 9. Byers Eye Institute, Stanford University, Palo Alto, California; Ocular Imaging Research and Reading Center, Menlo Park, California. Electronic address: ndquan@stanford.edu.
Abstract
PURPOSE: To report the primary endpoint analyses of the safety and efficacy of 2 different doses of intravenous (IV) infusions of tocilizumab (TCZ), an IL-6 inhibitor, in eyes with noninfectious intermediate uveitis, posterior uveitis, or panuveitis. DESIGN: Randomized, controlled, multicenter clinical trial. METHODS: STOP-Uveitis is a randomized, open-label safety, efficacy, and bioactivity clinical trial conducted at 5 clinical centers across the United States. The study evaluated the role of TCZ in patients with noninfectious uveitis (NIU). Thirty-seven patients with NIU were randomized into one of 2 treatment groups in a ratio of 1:1. Group 1 received IV infusions of 4 mg/kg TCZ and group 2 received IV infusions of 8 mg/kg TCZ. Infusions were given every 4 weeks in both groups until month 6 (primary endpoint). Primary outcome measure was incidence and severity of systemic and ocular adverse events through month 6. Secondary outcome measures included mean change in visual acuity (VA), vitreous haze (VH), and central macular thickness (CMT) at month 6. RESULTS: A total of 37 patients were randomized in the study. At month 6, 43.5% of patients who had the potential for a 2-step decrease in VH demonstrated a 2-step decrease (40% in Group 1 and 46.1% in Group 2). Mean change in CMT was -83.88 ± 136.1 μm at month 6 (-131.5 ± 41.56 μm in Group 1 and -38.92 ± 13.7 μm in Group 2). Mean change in VA was +8.22 ± 11.83 ETDRS letters at month 6 (10.9 ± 14.6 in Group 1 and 5.5 ± 7.8 in Group 2). Repeated infusions of TCZ were well tolerated. CONCLUSIONS: Repeated IV administrations of TCZ are well tolerated. TCZ (both 4 and 8 mg/kg) is effective in improving VA and reducing VH and CMT in eyes with noninfectious intermediate uveitis, posterior uveitis, and panuveitis.
RCT Entities:
PURPOSE: To report the primary endpoint analyses of the safety and efficacy of 2 different doses of intravenous (IV) infusions of tocilizumab (TCZ), an IL-6 inhibitor, in eyes with noninfectious intermediate uveitis, posterior uveitis, or panuveitis. DESIGN: Randomized, controlled, multicenter clinical trial. METHODS: STOP-Uveitis is a randomized, open-label safety, efficacy, and bioactivity clinical trial conducted at 5 clinical centers across the United States. The study evaluated the role of TCZ in patients with noninfectious uveitis (NIU). Thirty-seven patients with NIU were randomized into one of 2 treatment groups in a ratio of 1:1. Group 1 received IV infusions of 4 mg/kg TCZ and group 2 received IV infusions of 8 mg/kg TCZ. Infusions were given every 4 weeks in both groups until month 6 (primary endpoint). Primary outcome measure was incidence and severity of systemic and ocular adverse events through month 6. Secondary outcome measures included mean change in visual acuity (VA), vitreous haze (VH), and central macular thickness (CMT) at month 6. RESULTS: A total of 37 patients were randomized in the study. At month 6, 43.5% of patients who had the potential for a 2-step decrease in VH demonstrated a 2-step decrease (40% in Group 1 and 46.1% in Group 2). Mean change in CMT was -83.88 ± 136.1 μm at month 6 (-131.5 ± 41.56 μm in Group 1 and -38.92 ± 13.7 μm in Group 2). Mean change in VA was +8.22 ± 11.83 ETDRS letters at month 6 (10.9 ± 14.6 in Group 1 and 5.5 ± 7.8 in Group 2). Repeated infusions of TCZ were well tolerated. CONCLUSIONS: Repeated IV administrations of TCZ are well tolerated. TCZ (both 4 and 8 mg/kg) is effective in improving VA and reducing VH and CMT in eyes with noninfectious intermediate uveitis, posterior uveitis, and panuveitis.
Authors: Mathilde Leclercq; M Le Besnerais; V Langlois; N Girszyn; Y Benhamou; C Ngo; H Levesque; M Muraine; J Gueudry Journal: Clin Rheumatol Date: 2018-02-03 Impact factor: 2.980
Authors: Mohammad Ali Sadiq; Muhammad Sohail Halim; Muhammad Hassan; Neil Onghanseng; Irmak Karaca; Aniruddha Agarwal; Rubbia Afridi; Yasir J Sepah; Diana V Do; Quan Dong Nguyen Journal: Int J Retina Vitreous Date: 2020-07-08
Authors: Samendra Karkhur; Murat Hasanreisoglu; Erin Vigil; Muhammad Sohail Halim; Muhammad Hassan; Carlos Plaza; Nam V Nguyen; Rubbia Afridi; Anh T Tran; Diana V Do; Yasir J Sepah; Quan Dong Nguyen Journal: J Ophthalmic Inflamm Infect Date: 2019-09-16