May 2004
Volume 45, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2004
A Prospective Trial of Infliximab Therapy for Patients with Refractory Uveitis: Interim Analysis of Safety and Efficacy Outcomes
Author Affiliations & Notes
  • E.B. Suhler
    Uveitis Clinic,
    Casey Eye Inst, Portland, OR
  • J.R. Smith
    Uveitis Clinic,
    Casey Eye Inst, Portland, OR
  • A.K. Lauer
    Retina Clinic,
    Casey Eye Inst, Portland, OR
  • D.E. Kurz
    Uveitis Clinic,
    Casey Eye Inst, Portland, OR
  • M.S. Wertheim
    Uveitis Clinic,
    Casey Eye Inst, Portland, OR
  • T.D. Pickard
    Uveitis Clinic,
    Casey Eye Inst, Portland, OR
  • J.T. Rosenbaum
    Uveitis Clinic,
    Casey Eye Inst, Portland, OR
  • Footnotes
    Commercial Relationships  E.B. Suhler, Centocor F, C; J.R. Smith, Centocor F; A.K. Lauer, Centocor F; D.E. Kurz, Centocor F; M.S. Wertheim, Centocor F; T.D. Pickard, Centocor F; J.T. Rosenbaum, Centocor F, C.
  • Footnotes
    Support  none
Investigative Ophthalmology & Visual Science May 2004, Vol.45, 3370. doi:
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      E.B. Suhler, J.R. Smith, A.K. Lauer, D.E. Kurz, M.S. Wertheim, T.D. Pickard, J.T. Rosenbaum; A Prospective Trial of Infliximab Therapy for Patients with Refractory Uveitis: Interim Analysis of Safety and Efficacy Outcomes . Invest. Ophthalmol. Vis. Sci. 2004;45(13):3370.

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

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Abstract

Abstract: : Purpose: Infliximab, a monoclonal antibody that neutralizes tumor necrosis factor alpha, has proven utility in the treatment of several immune–mediated diseases. We have previously presented preliminary data from a prospective, open–label clinical trial of infliximab for refractory uveitis. Additional safety and efficacy data from this ongoing trial are presented here. Methods: We have enrolled 17 patients whom have been treated for a minimum of 10 weeks, the a priori selected endpoint for initial assessment of efficacy. All enrolled patients had uveitis and were either refractory to standard immunosuppression with prednisone and at least one other immunosuppressive drug, or were intolerant to such treatment. Ages ranged between 20 – 74 years (mean 44); gender distribution was 11 female: 5 male. Seven patients were diagnosed with idiopathic uveitis, three each with Behcet's disease, birdshot retinochoroidopathy, and sarcoidosis, and one with pars planitis unrelated to MS. All patients were treated with three intravenous loading doses of 3 – 5 mg/kg of infliximab over six weeks followed by maintenance therapy every eight weeks. Dosage escalation up to 10mg/kg was allowed for breakthrough inflammation which had been initially controlled by loading therapy. Other therapy, especially prednisone, was tapered as tolerated and clinically appropriate. Successful treatment was measured using a composite endpoint comprised of visual acuity, intraocular inflammatory activity graded clinically and with fluoroscein angiography, and ability to taper other immunosuppressives. Results: Six patients have completed one year of therapy and ten others have been treated for a minimum of 10 weeks. At the 10 week endpoint, 15 of 17 patients were successfully treated as measured by our composite endpoint. Five patients have withdrawn from the study due to systemic side effects occuring between 4 and 70 weeks after starting therapy. One patient withdrew at 8 weeks due to worsening inflammation and two patients had recurrent vitreous hemorrhages associated with regressing neovascularization which had been present before enrollment. All six patients whom have completed one year have maintained or improved their 10 week outcomes. Conclusions: These preliminary results demonstrate promise for the use of infliximab in the management of patients with uveitis refractory to standard oral immunosuppression. Significant ocular and systemic side effects may occur and careful monitoring is necessary. Continued study is warranted.

Keywords: clinical (human) or epidemiologic studies: outcomes/complications • uveitis–clinical/animal model • immunomodulation/immunoregulation 
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