Adalimumab for Ocular Inflammation

Abstract

Purpose: : To evaluate clinical outcomes of adalimumab for non-infectious ocular inflammatory diseases.

Methods: : Characteristics of patients with non-infectious ocular inflammation treated with adalimumab at 4 subspecialty clinics prior to October, 2007 participating in the Systemic Immunosuppressive Therapy for Eye Diseases (SITE) retrospective cohort study were abstracted by expert reviewers in a standardized chart review of every eye at every visit. The primary outcomes measured were control of inflammation, corticosteroid-sparing effect, and changes in visual acuity. The rate of occurrence of each outcome was calculated, adjusting for correlation between eyes of the same patient using Generalized Estimating Equations. Only eyes at risk of each event were considered. 95% confidence intervals are given in brackets. Rates greater than 1 event/year may be more easily interpreted by dividing by 2 (events/6 months) or 4 (events/3 months).

Results: : Thirty-two patients (57 eyes) were treated with adalimumab for anterior uveitis (47%), scleritis (28%), intermediate uveitis (9%), posterior or panuveitis (9%), or other inflammatory conditions (6.3%). The rate of improvement in anterior chamber cells by ≥2 grades was 1.84/eye-year (eyr) [0.77-4.35], whereas the rate of worsening by ≥2 grades was 0.23/eyr [0.10-0.54]. Initially ‘active’ cases became ‘inactive’ at a rate of 2.12/eyr [1.29-3.49] whereas "inactive" cases became "active" at a rate of 0.46/eyr [0.20-1.05]. Visual acuity improved an average of 1.3 lines (SD=3.1) during the first six months of therapy. Intraocular pressure elevation above 24 mmHg was not observed. Resolution of macular edema occurred at a rate of 2.48/eyr [1.57-3.91] whereas incidence of macular edema occurred in 0.22/eyr [0.07-0.63]. Discontinuation of topical corticosteroid occurred at a relatively low rate (0.39/person-yr (pyr) [0.18-0.85]; reduction in oral prednisone to ≤10 mg/day was more common (2.04/pyr [0.42-5.96]) but imprecisely estimated with the available data. Adalimumab was discontinued in 13 patients, due to lack of effectiveness in 4 patients, for possible toxicity in 4 (angina, fatigue, skin rash, injection site reaction), and for other reasons in 5.

Conclusions: : Adalimumab was moderately effective as an immunosuppressive drug in a heterogenous group of ocular inflammatory disease cases managed in a tertiary setting, generally after failing treatment with other immunosuppressive agents. Discontinuation of adalimumab for toxicity was infrequent.

Keywords: immunomodulation/immunoregulation • autoimmune disease • uvea