Adalimumab Demonstrated Superior Efficacy Over Standard of Care in Refractory Uveitis

Treatment with adalimumab demonstrated superior efficacy over combined use of a single immunosuppressive drug with low-dose systemic corticosteroids in patients with severe ocular inflammation, including anterior uveitis, according to a prospective, randomized, controlled study published in Ocular Immunology and Inflammation.¹ Acute anterior uveitis is often associated with inflammatory rheumatic diseases, in particular with spondyloarthritis.

Tumor necrosis factor alpha inhibitors have transformed the treatment of vision-threatening uveitis; however, there is a need for data from randomized controlled trials.¹ Researchers in Germany sought to address this need by recruiting from 2 tertiary care uveitis centers 25 patients with active uveitis despite combined oral low-dose prednisolone and immunosuppression treatment. 

All patients continued their previous immunosuppressive therapy and were randomly assigned to receive either additional adalimumab 40 mg subcutaneously every other week with corticosteroids in a fixed tapering schedule (n=10) or corticosteroids only (n=15). Demographics between the 2 groups were similar at baseline, including uveitis duration, current inflammatory activity, and visual acuity.

Of those in the adalimumab group, 60% demonstrated improvement in visual acuity compared with only 13% of patients in the control group (P =.00221). In addition, patients receiving adalimumab experienced a decrease in anterior chamber cell grade and vitreous haze, and central foveal thickness was reduced.

The number of adverse events was higher in the control group when calculated per exposure day; however, systemic infections and gastrointestinal events occurred more often with adalimumab.  

Although the results from this study were similar to those of previously conducted prospective case studies,^2-6 caution should be used because the sample group was small and the study population results are heterogeneous with regard to type of uveitis and associated disease.¹

The researchers concluded that, “the results of the current prospective randomized trial indicate superiority of adalimumab [vs] standard of care in the treatment of severe uveitis cases.”

References

1. Mackensen F, Heinz C, Jakob E, et al. Randomized controlled study to evaluate the efficacy of adalimumab in patients with different forms of refractory uveitis [published online December 29, 2017]. Ocular Immunol Inflamm. doi:10.1080/09273948.2017.1411518
2. Nguyen QD, Merrill PT, Jaffe GJ, et al. Adalimumab for prevention of uveitic flare in patients with inactive non-infectious uveitis controlled by corticosteroids (VISUAL II): a multicentre, double-masked, randomised, placebo-controlled phase 3 trial. The Lancet. 2016;388(10050):1183-1192.
3. Díaz-Llopis M, Salom D, Garcia-de-Vicuña C, et al. Treatment of refractory uveitis with adalimumab: a prospective multicenter study of 131 patients. Ophthalmology. 2012;119(8):1575-1581.
4. Suhler EB, Lowder CY, Goldstein DA, et al. Adalimumab therapy for refractory uveitis: results of a multicentre, open-label, prospective trial. Br J Ophthalmol. 2013;97(4):481-486.
5. Diaz-Llopis M, Garcia-Delpech S, Salom D, et al. Adalimumab therapy for refractory uveitis: a pilot study. J Ocul Pharmacol Ther. 2008;24(3):351-361.
6. Martel JN, Esterberg E, Nagpal A, Acharya NR. Infliximab and adalimumab for uveitis. Ocul Immunol Inflamm. 2012;20(1):18-26.