Background/Purpose: To evaluate the clinical response and safety of Tocilizumab (TCZ) in a series of patients with non-infectious uveitis refractory to other biologic drugs.

Methods: Multicenter study of patients studied in the Uveitis Units of 14 hospitals from Spain. All patients had experienced inadequate response to at least one biologic agent. Intraocular inflammation, macular thickness, visual acuity, steroid sparing effect and immunosuppression load score were the outcome variables. Comparisons were made between baseline and 1^st week, 1^st month, 6^th month and 1^st year.

Results: We studied 31 patients/58 affected eyes (7 men/24 women) with a mean age of 31.7±17.2 years (range 8-70). Uveitis was bilateral (n=27 cases) or unilateral (n=4). The pattern of ocular involvement was anterior uveitis (n=11 cases), panuveitis (n=6), posterior (n=4), intermediate (n=3), panuveitis+ retinal vasculitis (n=3), retinal vasculitis without uveitis (n=2) and panuveitis+retinal vasculitis+papillitis (n=1). Uveitis was acute (n=1), chronic (n=26) or recurrent (n=4).

The main underlying diseases were: Juvenile Idiopathic Arthritis (n=13), Behçet disease (n=5), idiopathic uveitis (n=5), Birdshot retinopathy (n=3), idiopathic retinal vasculitis (n=2), spondyloarthritis (n=2) and rheumatoid arthritis (n=1).

Besides oral steroids and before TCZ onset they had received: intraocular corticosteroids (n=21), intravenous. methylprednisolone pulses (n=9), methotrexate (n=25), cyclosporine A (n=20), azathioprine (n=3), other synthetic immunosuppressive drugs (n=9), adalimumab (n=25), infliximab (n=12), etanercept (n=7), abatacept (n=6), rituximab (n=2), golimumab (n=2) and anakinra (n=1). TCZ was started because of inefficacy (n=28) and/or toxicity (n=3) to other biologics. TCZ was used as monotherapy (n=10) or in combination with methotrexate (n=12), leflunomide (n=4), cyclosporine A (n=4) and mycophenolate (n=1). After one year of TCZ therapy all the following variable improved statistically (p<0.05) (TABLE): a) mean best corrected visual acuity (from 0.46±0.3 at baseline to 0.58±0.3); b) anterior chamber cells and vitreous inflammation (from 58% and 60% of eyes, to 15.3% and 34%, respectively); c) cystoid macular edema (OCT>300 μm) (from 66.6% to 21%); d) the mean OCT (from 389.1±197.2 to 261.8±46.1 μm); and e) the median [IQR] dose of prednisone (from 30 [10-90] to 5 [0-5] mg/day). A non-statistically reduction in the mean of the immunosuppression load score (from 6.3±5.1 to 4.2±3.3, p=0.6) was also observed.

After a mean follow-up of 13.4±9.5 months the more important side-effects observed were bullous impetigo (n=1), mild thrombocytopenia (n=1), pneumonia (n=1) and infusional reaction (n=1).

Conclusion: Our results indicate that TCZ is an effective and safe therapy for patients with non-infectious uveitis refractory to other biologic agents.

TABLE.

*p<0.05 compare with baseline