POS1331 CERTOLIZUMAB PEGOL IN UVEITIS. RETENTION PROBABILITY AND CAUSES OF DISCONTINUATION.

Abstract

BackgroundA personalized disease-specific treatment for non-infectious uveitis (NIU) is challenging. Around 50% of adults with NIU who required classic DMARDs or adalimumab in clinical trials, failed at 6 months during open label phase [1,2]. Therefore, to investigate treatment alternatives for NIU are most needed.ObjectivesTo study Certolizumab pegol (CZP) retention rate (RR) at 24 months in NIU and susceptibility factors for discontinuation.MethodsAdults with NIU who received CZP for this indication were included. Data were gathered from the BioÚvea Spanish registry, detailed elsewhere[3]. Demographics, clinical, and therapeutic data was recorded from Nov 2016 to Nov 2017. The primary endpoint assessed was CZP RR at 24 months. Causes and susceptibility factors for definitive discontinuation of CZP were analyzed as well. CZP RR was calculated with the Kaplan-Meier method, Log-rank test was used for the univariate, and the Cox proportional hazard model was implemented for the multivariate analysis.ResultsThirty patients with a median of 41 (IQR 16) years, 18 (60%) females, were included. NIUs were bilateral in 19 (63%) patients and were active at CZP onset in 20 (71%). Half of the patients suffered from non-anterior NIUs, and etiologically 2 (7%) were unclassifiable, 7 (23%) had ocular syndromes, and 21 (70%) were associated to systemic disorders. Seven (23%) patients were bio-naïve, whereas 23 (77%) started CZP as a 2nd (5, 17%) or ≥ 3rd (18, 60%) biologic. With a median follow-up of 21.2 (Range 0.2 to 54.8) months, 12 (40%) patients discontinued CZP, 6 (20%) due to adverse events and 6 (20%) due to lack of efficacy. The overall CZP RR at 24 months was 53.6%, with a median Retention Time (RT) of 27.1 months. In the multivariate analysis, CZP started as a first biologic (HR 0.053, 95%CI 0.003 to 0.809; p = 0.035), and male gender (HR 0.1, 95%CI 0.015 to 0.694; p = 0.02) were protective factors for discontinuation. CZP RR at 24 months as a 1st line biologic was 100% with a median RT of 27.1 months. Conversely, CZP RR at 24 months as a ≥2nd line was 41.1% with a median RT of 17.1 months. When given as a 1st biologic, one (14%) patient discontinued CZP due to loss of efficacy at 27.1 months. Conversely, discontinuation of CZP when administered in ≥2nd line was more frequent, either due to lack or loss of efficacy in 5 (22%) patients or adverse events (AEs) in 6 (26%) (Figure 1).Figure 1.Retention rate of Certolizumab pegol in bio-naïve and bio-experienced patients with non-infectious uveitis.Abbreviations: DRT, Drug Retention Time; LTFU, lost to follow-up; DRR, Drug Retention Rate; PAR, Patients at Risk; AE, adverse event.ConclusionCZP in NIU showed an excellent retention rate at 24 months in bio-naïve patients. However, it was more than halved when CZP was started as a ≥2nd biologic. Discontinuation of CZP in bio-experienced patients was due to lack or loss of efficacy in 22% and to adverse events in an additional 26% of patients.