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Adverse events increase with corticosteroid dose in noninfectious uveitis

Stephen Padilla
10 Jul 2017

Patients with noninfectious uveitis (NIU) receiving corticosteroids have significantly higher incidence rates of corticosteroid-related adverse events (AEs), according to a posthoc analysis of the VISUAL-1 and VISUAL-2 placebo-controlled clinical trials.

“Moreover, these incidence rates increase systematically and significantly with dose level, even after controlling for important patient characteristics and adverse event reporting time trends, reinforcing again the importance of developing steroid-sparing strategies in the treatment of patients with chronic NIU,” researchers said.

Placebo patients during the prednisone treatment period in VISUAL-1 had statistically higher incidence rates of corticosteroid-related AEs than after discontinuation (454.2 vs 36.1 per 100 patient-years [PY]; incident rate ratio [IRR], 12.6; p<0.001). In VISUAL-2, patients also showed similarly high incidence rates (317.5 vs 41.1 per 100 PY; IRR, 7.7; p<0.001). [Opthalmology 2017;doi:10.1016/j.ophtha.2017.06.017]

The most common corticosteroid-related AEs in VISUAL-1 patients were skin and subcutaneous tissue disorders, laboratory abnormalities/weight change, infections, musculoskeletal and connective tissue disorders, and psychiatric disorders. In VISUAL-2 participants, the most common AEs were infections, musculoskeletal and connective tissue disorders, injection site reactions, skin and subcutaneous tissue disorders, and ocular disorders.

The Poisson multivariate longitudinal Generalized Estimating Equation model revealed a dose-response relationship, with each 10 mg increase in prednisone dose correlating with a 1.5- and 2.6-fold increase (p<0.001 and p<0.001) in the rate of corticosteroid-related AEs in VISUAL-1 and VISUAL-2, respectively.

“This implies in turn that a patient with active uveitis taking 60 mg/day of prednisone will experience, on average, an additional 10.1 (95 percent CI, 6.3 to 14.5; p<0.001) corticosteroid-related AEs per year compared with a patient taking 10 mg/day, whereas a patient with inactive uveitis taking 35 mg/day of prednisone will experience, on average, an additional 23.5 (7.6 to 52.7; p=0.05) corticosteroid-related AEs per year compared with a patient taking 10 mg/day,” researchers said.

In this study, the participants were adults with active (VISUAL-1) and inactive (VISUAL-2) NIU who were randomized to receive adalimumab or placebo and underwent a protocol-defined mandatory taper to discontinue their oral corticosteroids.

Researchers collected AE data at each visit and assessed the corticosteroid relationship. They also estimated a longitudinal Poisson regression model, controlling for time-dependent corticosteroid dose, age, sex, prior oral corticosteroid dose, prior topical corticosteroid use and concomitant immunosuppressive drug use. Only patients assigned to placebo were considered.

This study has several limitations. First, analyses were performed on clinical trial populations, which may not be representative of the broader NIU population. Second, other formulations could have been chosen even though the formulation of the longitudinal model was both parsimonious and flexible. Finally, VISUAL-1 and VISUAL-2 had different patient populations and dose-tapering designs, which might have confounded the comparability of the results obtained with this model.

NIU refers to a group of inflammatory disorders characterized by inflammation inside the eye that can lead to structural ocular complications and visual morbidity, including partial or complete loss of vision, according to researchers. [Am J Ophthalmol 2005;140:509–516]

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