PMID- 35802252
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220907
IS  - 2193-8245 (Print)
IS  - 2193-6528 (Electronic)
VI  - 11
IP  - 5
DP  - 2022 Oct
TI  - Real-Life Efficacy, Safety, and Use of Dexamethasone Intravitreal Implant in 
      Posterior Segment Inflammation Due to Non-infectious Uveitis (LOUVRE 2 Study).
PG  - 1775-1792
LID - 10.1007/s40123-022-00525-8 [doi]
AB  - 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-naive 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.
CI  - (c) 2022. The Author(s).
FAU - Bodaghi, Bahram
AU  - Bodaghi B
AUID- ORCID: 0000-0002-0962-5301
AD  - APHP Department of Ophthalmology, IHU FOReSIGHT, Pitie-Salpetriere Hospital, 
      Sorbonne University, 47-83 Boul. de l'Hopital, 75013, Paris, France. 
      bahram.bodaghi@aphp.fr.
FAU - Brezin, Antoine P
AU  - Brezin AP
AUID- ORCID: 0000-0001-8461-3119
AD  - Centre d'ophtalmologie de l'Assistance Publique, Hopitaux de Paris, Hopital 
      Cochin, Universite de Paris, Paris, France.
FAU - Weber, Michel
AU  - Weber M
AD  - Centre Hospitalier Universitaire de Nantes, Nantes, France.
FAU - Delcourt, Cecile
AU  - Delcourt C
AUID- ORCID: 0000-0002-2099-0481
AD  - INSERM, Bordeaux Population Health Research Center, UMR 1219, Universite de 
      Bordeaux, Bordeaux, France.
FAU - Kodjikian, Laurent
AU  - Kodjikian L
AUID- ORCID: 0000-0002-3908-6716
AD  - La Croix-Rousse Hospital, University Hospital of Lyon, Lyon, France.
AD  - UMR CNRS 5510 MATEIS INSA Lyon, Universite de Lyon Claude Bernard, Lyon, France.
FAU - Provost, Alexandra
AU  - Provost A
AUID- ORCID: 0000-0001-7103-234X
AD  - Allergan, an AbbVie company, Courbevoie, France.
FAU - Velard, Marie-Eve
AU  - Velard ME
AD  - Allergan, an AbbVie company, Courbevoie, France.
FAU - Barnier-Ripet, Doris
AU  - Barnier-Ripet D
AD  - Axonal-Biostatem, Castries, France.
FAU - Pinchinat, Sybil
AU  - Pinchinat S
AD  - Axonal-Biostatem, Castries, France.
FAU - Dupont-Benjamin, Laure
AU  - Dupont-Benjamin L
AUID- ORCID: 0000-0001-7748-0768
AD  - Allergan, an AbbVie company, Courbevoie, France.
LA  - eng
SI  - ClinicalTrials.gov/NCT02951975
PT  - Journal Article
DEP - 20220708
PL  - England
TA  - Ophthalmol Ther
JT  - Ophthalmology and therapy
JID - 101634502
PMC - PMC9437191
OTO - NOTNLM
OT  - Dexamethasone
OT  - France
OT  - Intravitreal
OT  - Real-world evidence
OT  - Uveitis
EDAT- 2022/07/09 06:00
MHDA- 2022/07/09 06:01
PMCR- 2022/07/08
CRDT- 2022/07/08 11:17
PHST- 2021/11/22 00:00 [received]
PHST- 2022/05/06 00:00 [accepted]
PHST- 2022/07/09 06:00 [pubmed]
PHST- 2022/07/09 06:01 [medline]
PHST- 2022/07/08 11:17 [entrez]
PHST- 2022/07/08 00:00 [pmc-release]
AID - 10.1007/s40123-022-00525-8 [pii]
AID - 525 [pii]
AID - 10.1007/s40123-022-00525-8 [doi]
PST - ppublish
SO  - Ophthalmol Ther. 2022 Oct;11(5):1775-1792. doi: 10.1007/s40123-022-00525-8. Epub 
      2022 Jul 8.