Abstract
Purpose: :
To provide preliminary data regarding the safety and efficacy of high-dose humanized anti-IL-2 receptor (daclizumab) therapy for the treatment of active uveitis associated with juvenile idiopathic arthritis (JIA).
Methods: :
Six patients were recruited into this non-randomized, prospective pilot study (trial#: 05-EI-0208) of high-dose iv induction daclizumab therapy (8mg/kg at day 0, 4mg/kg at day 14, 2mg/kg every 4 weeks thereafter) between June 2005 and July 2008. Primary safety outcome was assessed at day 14 and 28 and primary efficacy outcome, which was a 2 step reduction in ocular inflammation, was assessed at 12 weeks. The ocular inflammation was assessed according to the SUN criteria.
Results: :
Four of the 6 patients achieved 2 step reduction in the anterior chamber inflammation grade (or down to 0) within 12 weeks into the study. Two patients showed no decrease in inflammatory grade at 12 weeks and thus were re-induced at weeks 16 and 12 respectively. Only 1 of the 6 participants was considered an ocular treatment failure. One patient had a systemic disease flare without any ocular disease activity. All participants either maintained vision or mostly experienced visual acuity improvement in at least one eye (1-5 lines) with 4 participants with bilateral improvement. Side effects attributable to daclizumab included palpitations in one patient and eczematous rash in another.
Conclusions: :
Daclizumab appears to be a safe alternative for the treatment of JIA-associated active uveitis in children. This is the first demonstration that high-dose daclizumab can reduce inflammation in active JIA-associated anterior uveitis. Participants experienced improvement in both visual acuity and a reduction in inflammation.
Clinical Trial: :
www.clinicaltrials.gov NCT00130637
Keywords: uveitis-clinical/animal model • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • immunomodulation/immunoregulation