Adalimumab (Humira) for the Treatment of Refractory Uveitis: Preliminary Results of a Multicenter Prospective Phase II Clinical Trial

Abstract

Purpose: : to ascertain the safety and effectiveness of adalimumab (Humira, Abbott), a fully human monoclonal antibody against TNF-alpha, for the treatment of refractory non-infectious uveitis.

Methods: : Three centers received IRB approval to participate in an open-label, prospective clinical trial utilizing 40 mg injections of subcutaneous adalimumab administered every two weeks for the treatment of non-infectious uveitis refractory to corticosteroids and at least one standard immunosuppressive. Treatment outcome was ascertained at 10 weeks after study initiation by a composite clinical endpoint comprised of improvement in visual acuity, intraocular inflammation, ability to taper corticosteroids or immunosuppressives, and fluorescein angiography or ocular coherence tomography. Patients who meet criteria for clinical success at 10 week will be allowed to complete one year of therapy, after which outcome assessment will be repeated.

Results: : Three of six patients met the composite endpoint for clinical success at week 10 in the study. Two had improvement in both visual acuity of at least 10 ETDRS letters in one or both eyes and in control of bilateral intraocular inflammation which had been active at study outset. The third patient had unchanged vision and continued quiescent intraocular inflammation, but had improvement in fluorescein angiographic signs of inflammation. Three patients did not meet criteria for clinical success, either due to failure to taper corticosteroids or continued active inflammation.

Conclusions: : Adalimumab is safe and effective for the treatment of refractory uveitis in approximately half of enrolled patients based on our preliminary results. No major side effects were noted with this therapy. Enrollment is ongoing at three sites. Further study is required to define patient populations who will derive benefit from adalimumab therapy.

Clinical Trial: : www.clinicaltrials.gov NCT00525902

Keywords: uveitis-clinical/animal model • immunomodulation/immunoregulation • clinical (human) or epidemiologic studies: outcomes/complications