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Cristobal A Couto, Maria de las Mercedes Frick, Erika Miolet Hurtado Jallaza, Matilde Lopez, Bernardo Ariel Schlaen, ; Adalimumab treatment in patients with Vogt-Koyanagi-Harada Syndrome. Invest. Ophthalmol. Vis. Sci. 2014;55(13):5798.
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To evaluate the clinical outcome and safety of treatment with Adalimumab in patients with Vogt-Koyanagi-Harada (VKH) disease with refractory uveitis.
Patients with VKH disease treated with Adalimumab for at least 6 months, in whom conventional therapy had failed were identified from April 2006 to April 2013. Patients in chronic stage treated with corticosteroids and immunosuppressives with active anterior and / or posterior inflammation were included. Adalimumab was administered on a compassionate off-label use basis at the dose of 40 mg subcutaneously every other week . The main outcome measures were BCVA, anterior segment inflammation (SUN) , efficacy of treatment in anterior and posterior inflammation, steroid sparing effect and reduction in concomitant immunosuppressive therapy.
Fourteen patients , 4 male and 10 female , with a mean age of 23.07 ± 8.51 years ( r= 11-39 ) with a mean follow-up of 42.35 ± 37.55 months (r=8-132)and a mean duration of adalimumab treatment (AT) of 14.57 ± 11.54 months ( r=6-45) were included in this study. Regarding the systemic corticosteroid, the treatment with AT at 6 months was statistically significantly lower than the dose at baseline (Wilcoxon signed rank test, P= 0.0037). Furthermore, the dose at 12 months was statistically significantly lower than the dose at 6 months of AT( Wilcoxon signed rank test , P= 0.0157). Out of 14 patients,11 (78.57%) had IMT at baseline whereas 5 out of 14 (35.71%) had IMT at 6 months of AT (Mc Nemar's Chi square test = 4.50 ; P= 0.0339) , showing a trend toward statistical significance (p= 0.07). The comparison between anterior inflammation in OD previous to AT and the one observed at 6 months revealed a statistically significant difference with the binomial test for one sided (P=0.0001) and for two sided (P=0.0002) . The comparison between the anterior inflammation in OS previous to AT and the one observed at 6 months revealed a statistically significant difference with the binomial test for one sided(P=0.0002) and for two sided (P=0.0005). Four patients had recurrences within the first three months after the withdrawal of medication.
Our study showed the significant response to Adalimumab in 14 patients with diagnosis of VKH disease who were refractory to standard IMT. This anti-TNF agent seemed to be an effective and well-tolerated treatment for these patients.
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