Abstract
Purpose: :
Infliximab is a monoclonal IgG1 chimeric monoclonal antibody, active against soluble and membrane bound TNF–α. The objectives of this prospective non randomized study were to: (1) determine the response to infliximab in patients with intermediate and/or posterior uveitis intolerant or unresponsive to standard therapy; (2) determine the incidence of side effects; (3) determine if long term remission is possible after 46 weeks of treatment. The current report will address the first two objectives.
Methods: :
Uveitis patients from ten European centers were recruited to receive infliximab 5 mg/kg at weeks 0, 2, 6, and every 8 weeks through week 46. At week 6, and over a 6 week period, concomittant medications were tapered when in the view of the treating physician such a taper was warranted. Patients were allowed to remain on low dose prednisone (PRED) (range 0–7.5 mg/day), methotrexate (MTX) (range 0–7.5 mg/week) or azathioprine. Patients reached an exit criterion (EC) and were withdrawn from the study if their vision was reduced by ≥2 ETDRS lines, gained ≥ 2 vitreous haze grades, developed a retinal infarction, or if they were reinitiated on immunosuppressive therapy.
Results: :
Fourty nine patients were included in the study, 6 patients were withdrawn (W) and, 7 patients reached an EC. The diagnostic groups included: Behçet’s disease (n=9, EC=1), sarcoidosis (n=5, W=1), intermediate uveitis (n=11, W=1, EC=1), birdshot retinochoroiditis (n=10)/idiopathic vasculitis (n=7) (combined group W=1, EC=4), and sympathetic ophthalmia/Vogt Koyanagi Harada (n=7, W=3, EC=1). Patients were withdrawn for the following reasons: tuberculosis (1) inclusion criteria violations (2), consent withdrawn(1), and drug reaction (2). Mean visual acuity (ETDRS letters) improved significantly as compared to baseline (OD: 9, standard deviation (sd) 14, p<0.001; OS: 7 sd 9, p<0.001). Fifty percent of all patients achieved a 10–letter improvement by week 22 in at least one eye. Compared to baseline, at week 46, vitreous haze grade decreased in 58% (OD) and 65% (OS) of patients (OD mean –0.75, sd 0.91 p<0.001; OS mean –0.76, sd 0.65, p<0.001). At week 46, eight patients were able to taper concomitant medications according to the guidelines in the protocol. PRED was reduced on average by 16 mg/day. Seventy–two percent (n=28) of patients were treated with low dose PRED with or without 1 other immunosuppressive.
Conclusions: :
Infliximab was generally well tolerated and was effective in the treatment of patients with Uveitis.
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • uveitis-clinical/animal model