POS1340\u2005MULTICENTER STUDY OF 71 PATIENTS WITH REFRACTORY UVEITIS RELATED TO IMMUNE-MEDIATED INFLAMMATORY DISEASES ON CERTOLIZUMAB PEGOL TREATMENT

Abstract

Prognosis of non-infectious refractory uveitis has improved markedly with biologic therapy (BT) (1-5). Most data are with monoclonal anti-TNF drugs, especially Adalimumab (ADA) and Infliximab (IFX). However, there is not enough evidence for the use of Certolizumab Pegol (CZP).To evaluate the efficacy and safety of CZP in refractory uveitis secondary to Immune-Mediated Inflammatory Diseases (IMID).Multicenter study of 71 patients with uveitis due to IMID refractory to glucocorticoids and conventional immunosuppressants. Efficacy was assessed with the following ocular parameters: best corrected visual acuity (BCVA), anterior chamber cells, vitritis, macular thickness and presence of retinal vasculitis. These outcomes were compared between baseline, 1st week, 1st and 6th month, and 1st and 2nd year. Statistical analysis was performed with IBM SPSS Statistics v.23.71 patients/100 affected eyes (29 men/42 women) with mean age of 40.0±11.3 years were studied. Underlying IMIDs were: spondyloarthritis (n=38), Behçet (10), psoriatic arthritis (8), Crohn disease (3), sarcoidosis (2), JIA (1), reactive arthritis (1), rheumatoid arthritis (1), relapsing polychondritis (1), TINU (1), pars planitis (1), Birdshot (1) and idiopathic uveitis (3). Uveitis pattern was anterior (n=55), posterior (6), panuveitis (6) and intermediate (4).Prior to CZP, patients had received: methotrexate (37), sulfasalazine (26), azathioprine (14), cyclosporine (10), leflunomide (3), mycophenolate mofetil (3) and cyclophosphamide (1). Previous BT was administered in 48 (67.6%) patients, with a mean of 1.4±1.3 drugs per patient as follows: ADA (n=56), IFX (27), golimumab (14), tocilizumab (5) and etanercept (3). Pregnancy was the reason for prescribing CZP in 19 patients. CZP was administered in monotherapy (n=39) or combined with conventional immunosuppressants (n=32).After a mean follow-up of 27.1±21.1 months, most of the ocular variables showed a rapid and significantly improvement (Table 1). A decrease in the median number [IQR] of flares of uveitis before and after CZP, (3 [1-4] vs. 0 [0-1], p<0.001) was observed. CZP was discontinued in 15 patients due to remission (n=2), ocular insufficient response (2) and incomplete response of extraocular manifestations (11). No serious adverse events were reported.CZP seems to be effective and safe in patients with refractory uveitis due to IMID.[1]Martín-Varillas JL, et al. Ophthalmology 2018; 125:1444-1451. doi: 10.1016/j.ophtha.2018.02.020.[2]Atienza-Mateo B, et al. Arthritis Rheumatol 2019; 71:2081-2089. doi: 10.1002/art.41026.[3]Santos-Gómez M, et al. Clin Exp Rheumatol 2016; 34(6 Suppl 102):S34-S40. PMID: 27054359[4]Vegas-Revenga N, et al. Am J Ophthalmol 2019; 200:85-94. doi: 10.1016/j.ajo.2018.12.019[5]Calvo-Río V, et al. Clin Exp Rheumatol. 2014; 32 (4 Suppl 84):S54-7. PMID: 25005576Table 1.Baseline1stweek1stMonth6thMonth1styear2ndyearBCVA (mean±SD)0.68±0.270.72±0.27*0.79±0.25*0.84±0.24*0.85±0.25*0.87±0.22*Improvement in AC Cells, n (%)Patients with AC cells at baseline (n=48)-21 (43.7)30 (62.5)*41 (85.4)*48 (100)*48 (100)*Improvement in Vitritis, n (%)Patients with vitritis at baseline (n=13)-3 (23.1)8 (61.5)*11 (84.6)*13 (100)*13 (100)*OCT (µ) (mean±SD)292.5±47.7294±47.4286.7±41.9*274.7±38.7*272.8±38.9*266.31±36.2*Choroiditis; affected eyes, n, (%)3 (4.2)3 (4.2)2 (2.8)2 (2.8)1 (1.4)0 (0)Retinal Vasculitis; affected eyes, n, (%)2 (2.8)0 (0)1 (1.4)0 (0)0 (0)0 (0)*p<0.001None declared