Systemic glucocorticoid-free therapy with adalimumab plus immunosuppressants versus conventional therapy in treatment-naïve Vogt-Koyanagi-Harada disease patients

Abstract

Background: High dose systemic glucocorticoid is the main therapy of treatment-naïve Vogt-Koyanagi-Harada (VKH) disease. However, series side effects induced by high dose systemic glucocorticoid frequently occur, which makes alternative therapy necessary for certain patients. This study sought to compare the efficacy and safety of systemic glucocorticoid-free (SGF) therapy with conventional therapy (CT) as an initial treatment for VKH patients. Methods: VKH patients who had not been systemically treated were enrolled. Patients were allocated into 2 therapeutic groups depending on their treatments. In CT group, patients received systemic glucocorticoid plus immunosuppressants (IS), and in SGF group, patients received adalimumab (ADA) plus IS. Patients received approximately 12 months treatment and visit monthly. The outcome parameters included the changes of best-corrected visual acuity (BCVA), intraocular inflammation (including anterior chamber cell grade and vitritis grade) and central macular thickness (CMT) (the change values define as the finalvisit values subtracted from baseline counterparts). Other outcomes included the relapses times of ocular inflammation, adverse events (AEs), changes of optic nerve inflammation (ONI) and intraocular/extraocular manifestations.Results: A total of 30 patients (60 eyes) were included. with 19 patients (38 eyes) in CT group and 11 patients (22 eyes) in SGF group. After approximately 1 year of treatment, the improvements of BCVA were slight better in the SGF group (0.57±0.23) than in the CT group (0.40±0.26), (P=0.014). In both groups, the ocular inflammatory improvements in both groups were similar, with an improvement of AC cell grade of −1.5 (−2, −0.5) in CT group versus −1 (−2, −1) in SGF group (P=0.367); improvement of vitritis grade was 0 (−1.25, 0) in CT group and −1 (−1, −1) in SGF group (P=0.050). The improvement in CMT was similar in both groups, with −523.47±412.09 μm in CT group and −362.73±375.73 μm in SGF group (P=0.572). The mean number of relapses was 1 (0, 2) in the CT group and 0 (0, 2) in the SGF group (P=0.372).No severe AEs were observed in this study.Conclusions: SGF therapy is effective, safe, and well-tolerated in treatment-naïve VKH patients. SGF therapy seems to be a feasible option in patients with existing systemic diseases intolerant to glucocorticoid.

Adalimumab plus Conventional Therapy versus Conventional Therapy in Refractory Non-Infectious Scleritis

“…As for Vogt-Koyanagi-Harada, a retrospective study showed that additional adalimumab was effective and safe in patients refractory to CT alone [50]. Even adalimumab plus immunosuppressants could be considered as a systemic GC-free therapy in treatment-naïve Vogt-Koyanagi-Harada patients [51]. For scleritis, there are several case reports and case series of non-infectious scleritis successfully treated with adalimumab [21,22,52,53].…”

Immunosuppressive therapy for Vogt-Koyanagi-Harada disease: a retrospective study and review of literature

“…A single centre large cohort study from China evaluated the use Ada and IMT alone without the use of systemic corticosteroid (“systemic glucocorticoid free”, or SGF) [ 68 ]. Thirty patients naïve to systemic therapy were recruited.…”