PMID- 30389343
OWN - NLM
STAT- MEDLINE
DCOM- 20191007
LR  - 20191007
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 40
IP  - 11
DP  - 2018 Nov
TI  - Persistence of Efficacy of 0.1% Cyclosporin A Cationic Emulsion in Subjects with 
      Severe Keratitis Due to Dry Eye Disease: A Nonrandomized, Open-label Extension of 
      the SANSIKA Study.
PG  - 1894-1906
LID - S0149-2918(18)30463-6 [pii]
LID - 10.1016/j.clinthera.2018.09.012 [doi]
AB  - PURPOSE: Results from a 6-month double-masked and a 6-month open-label study 
      (SANSIKA) established the efficacy and safety of once-daily 0.1% cyclosporin A 
      cationic emulsion (CsA CE) in severe keratitis due to dry eye disease (DED). This 
      article presents results from the Post-SANSIKA study, a 24-month extension of 
      SANSIKA assessing the sustained efficacy of CsA CE after treatment 
      discontinuation. METHODS: Time to relapse (corneal fluorescein staining [CFS] 
      score >/=4 [modified Oxford scale]) was assessed after treatment discontinuation in 
      patients from the SANSIKA study who had CFS improvement from a score of 4 to </=2 
      after 6 or 12 months of treatment with CsA CE. FINDINGS: Of 62 patients who 
      achieved a CFS score </=2 at the end of the SANSIKA study, 38 did not relapse and 
      24 (39%) relapsed during the 24-month period after CsA CE discontinuation; the 
      latter (relapse) group comprised 35% of patients initially treated with CsA CE 
      for 12 months in SANSIKA versus 47% of those treated for 6 months only. Patients 
      spent the most time during the extension study at CFS scores of 1 or 2 (median 
      duration of 8.5 weeks and 14.7 weeks per year, respectively), indicating marked 
      improvement, and less time at scores of 3, 4, or 5 (median time, 2.0 weeks, 0 
      weeks, and 0 weeks per year). Of 23 patients eligible for safety analysis (ie, 
      patients who received the study treatment at least once), 12 (52.2%) reported a 
      total of 26 ocular adverse events (AEs). Among these, 5 ocular AEs, reported in 5 
      patients (21.7%), were considered related to study treatment: 3 events of mild 
      instillation site pain in 3 patients (13.0%) and eye discharge and foreign body 
      sensation, each reported in 1 patient (4.3%). Only 1 systemic AE (nasal 
      congestion), reported in 1 patient (4.3%), was considered related to study 
      treatment. None of the AEs led to treatment discontinuation. IMPLICATIONS: The 
      majority of patients who discontinued CsA CE after experiencing DED improvement 
      in the SANSIKA study did not experience a relapse in this 24-month follow-up 
      study; these patients spent the most time at CFS scores consistent with marked 
      improvement. CsA CE had a favorable safety/tolerability profile over 2 years. 
      Treatment for up to 12 months with CsA CE provides sustained improvements in 
      patients with severe keratitis due to DED. EudraCT registration no. 
      2012-002066-12.
CI  - Copyright (c) 2018 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Labetoulle, Marc
AU  - Labetoulle M
AD  - Department of Ophthalmology, Bicetre Hospital, AP-HP, Paris-Sud University, Le 
      Kremlin-Bicetre, France. Electronic address: marc.labetoulle@bct.aphp.fr.
FAU - Leonardi, Andrea
AU  - Leonardi A
AD  - Department of Neuroscience, Ophthalmology Unit, University of Padua, Padua, 
      Italy.
FAU - Amrane, Mourad
AU  - Amrane M
AD  - Santen SAS, Evry, France.
FAU - Ismail, Dahlia
AU  - Ismail D
AD  - Santen SAS, Evry, France.
FAU - Garrigue, Jean-Sebastien
AU  - Garrigue JS
AD  - Santen SAS, Evry, France.
FAU - Garhofer, Gerhard
AU  - Garhofer G
AD  - Department of Clinical Pharmacology, Medical University of Vienna, Vienna, 
      Austria.
FAU - de la Maza, Maite Sainz
AU  - de la Maza MS
AD  - Institute Clinic of Ophthalmology, Hospital Clinic of Barcelona, University of 
      Barcelona, Barcelona, Spain.
FAU - Baudouin, Christophe
AU  - Baudouin C
AD  - Quinze-Vingts National Ophthalmology Hospital, Paris, France; UPMC University, 
      Paris 6, Vision Institute, INSERM UMRS968, CNRS UMR7210, Paris, France; 
      University of Versailles Saint-Quentin en Yvelines, Versailles, France.
LA  - eng
SI  - EudraCT/2012-002066-12
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20181030
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Emulsions)
RN  - 0 (Ophthalmic Solutions)
RN  - 83HN0GTJ6D (Cyclosporine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Cyclosporine/*administration & dosage
MH  - Double-Blind Method
MH  - Dry Eye Syndromes/*drug therapy
MH  - Emulsions
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Keratitis/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Ophthalmic Solutions
MH  - Tears
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - cationic emulsion
OT  - cyclosporin A
OT  - dry eye disease
OT  - inflammation
OT  - keratoconjunctivitis sicca
OT  - severe keratitis
EDAT- 2018/11/06 06:00
MHDA- 2019/10/08 06:00
CRDT- 2018/11/04 06:00
PHST- 2018/02/28 00:00 [received]
PHST- 2018/07/06 00:00 [revised]
PHST- 2018/09/20 00:00 [accepted]
PHST- 2018/11/06 06:00 [pubmed]
PHST- 2019/10/08 06:00 [medline]
PHST- 2018/11/04 06:00 [entrez]
AID - S0149-2918(18)30463-6 [pii]
AID - 10.1016/j.clinthera.2018.09.012 [doi]
PST - ppublish
SO  - Clin Ther. 2018 Nov;40(11):1894-1906. doi: 10.1016/j.clinthera.2018.09.012. Epub 
      2018 Oct 30.