Abstract

AbstractPurposeTo assess the relationship between adalimumab (ADA) trough levels and clinical efficacy and to evaluate the importance of quantification of ADA serum in combination with clinical data of the patient.MethodsA retrospective study of patients with non‐infectious uveitis (NIU) treated with ADA for at least 6months who had ADA trough and antibody levels measured during maintenance therapy. Disease activity was evaluated by changes in best‐corrected visual acuity (BCVA), degree of anterior chamber cells, central macular thickness and imaging findings.ResultsTwenty‐four patients were included. The median age was 36 years and 50% were women. The most common diagnosis was idiopathic uveitis (50%), followed by sarcoidosis (17%) and Birdshot (8%). All patients received 40 mg adalimumab every other week and showed an initial clinical benefit. Mean follow‐up was 39.5 months. The median trough level of adalimumab was higher in patients in clinical remission (11.02 μg/mL) than in patients with active disease (4.22 μg/mL). Adalimumab cut‐off value was calculated to discriminate clinical remission from disease activity. A cut‐off drug level of 7.95 μg/mL yielded optimal sensitivity and specificity. Only 2 of 25 patients (8%) had undetectable adalimumab trough levels with antibodies against adalimumab which correlated with loss of clinical response. None of the responders had antibodies.ConclusionDespite the limited number of cases, our data suggest that in NIU clinical efficacy improves with increasing adalimumab serum levels. Clinical remission is more likely to occur in those patients who achieve an adalimumab trough level of at least 7.95 μg/mL The development of anti‐adalimumab‐antibodies was associated with undetectable trough adalimumab levels and worse uveitis outcome. Since there is variability in the range for its clinical applicability, controlled prospective studies are required to determine the optimal therapeutic window of ADA serum levels.

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