Real-Life Efficacy, Safety, and Use of Dexamethasone Intravitreal Implant in Posterior Segment Inflammation Due to Non-infectious Uveitis (LOUVRE 2 Study)

Bahram Bodaghi, Antoine P Brézin, Michel Weber, Cécile Delcourt, Laurent Kodjikian, Alexandra Provost, Marie-Ève Velard, Doris Barnier-Ripet, Sybil Pinchinat, Laure Dupont-Benjamin, Bahram Bodaghi, Antoine P Brézin, Michel Weber, Cécile Delcourt, Laurent Kodjikian, Alexandra Provost, Marie-Ève Velard, Doris Barnier-Ripet, Sybil Pinchinat, Laure Dupont-Benjamin

Abstract

Introduction: To evaluate real-life efficacy, safety, and treatment patterns with the dexamethasone intravitreal implant (DEX) in posterior segment inflammation due to non-infectious uveitis (treatment-naïve or not) in French clinics.

Methods: In this prospective, multicenter, observational, non-comparative, post-reimbursement study, consecutive patients with posterior segment inflammation due to non-infectious uveitis were enrolled and evaluated at baseline (day 0). Those who received DEX on day 0 were re-evaluated at months 2, 6, and 18. Retreatment with DEX and/or alternative therapies was allowed during follow-up.

Primary outcome: patients (%) with at least a 15-letter gain in best corrected visual acuity (BCVA) at 2 months. Secondary outcomes included patients (%) with at least 15-letter BCVA gains at 6 and 18 months; mean BCVA change from baseline at 2, 6, and 18 months; and patients (%) retreated, mean central retinal thickness (CRT), and adverse events (AEs) at all post-baseline visits.

Results: Ninety-seven of 245 enrolled patients with posterior segment inflammation due to non-infectious uveitis (80% previously treated) and disease duration of 5 years (average) received DEX on day 0 and were included in efficacy analyses. At month 2 (n = 91), 20.5% of patients (95% CI 12.0-28.9) gained at least 15 letters from a baseline mean of 60.9 letters; the mean gain was 6.2 letters (95% CI 3.5-8.9). At month 6, 50.0% (n = 38/76) of patients did not receive alternative treatment or DEX retreatment, mostly because inflammation had sufficiently subsided (n = 27/38, 71.1%). Although early study termination prevented efficacy analysis at 18 months (n = 12), CRT reductions persisted throughout follow-up. From baseline to month 18, 21/245 (8.6%) patients had DEX-related AEs; 17/245 (6.9%) had ocular hypertension (most common AE).

Conclusion: LOUVRE 2 confirms DEX efficacy on visual acuity and CRT in predominantly DEX-pretreated patients with relatively old/stabilized uveitis. DEX tolerability was consistent with known/published data, confirming treatment benefits in posterior segment inflammation due to non-infectious uveitis.

Gov identifier: NCT02951975.

Keywords: Dexamethasone; France; Intravitreal; Real-world evidence; Uveitis.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Patient disposition. Recall refers to a dexamethasone intravitreal implant (DEX) recall on 4 October 2018. aReasons for ineligibility included absence of inflammation of the posterior segment due to non-infectious uveitis, age or residency criteria not met, and participation in another clinical study. bThe total adds up to more than 65 as some patients were excluded for more than one reason
Fig. 2
Fig. 2
Reasons for not treating with the dexamethasone intravitreal implant (DEX) on day 0. N = 144. BCVA best corrected visual acuity
Fig. 3
Fig. 3
Intraocular pressure (IOP) evolution over time in patients treated with the dexamethasone intravitreal implant (DEX) on day 0. n = number of patients with the indicated IOP increase from baseline at the indicated time point. N = total number of patients with data available at the indicated time point. CI confidence interval, M month, NA not available

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