scholarly journals Long‐term efficacy and safety results from an open‐label phase III study ( UNCOVER ‐J) in Japanese plaque psoriasis patients: impact of treatment withdrawal and retreatment of ixekizumab

2018 ◽  
Vol 33 (3) ◽  
pp. 568-576 ◽  
Author(s):  
Y. Umezawa ◽  
H. Torisu‐Itakura ◽  
Y. Morisaki ◽  
H. ElMaraghy ◽  
K. Nakajo ◽  
...  
Keyword(s):  
Plaque Psoriasis ◽  
Treatment Withdrawal ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Open Label ◽  
Term Efficacy ◽  
Open Label Phase ◽  
Phase Iii Study

scholarly journals Long-term Efficacy and Safety of Mepolizumab in Patients With Severe Eosinophilic Asthma: A Multi-center, Open-label, Phase IIIb Study

2016 ◽  
Vol 38 (9) ◽  
pp. 2058-2070.e1 ◽  
Author(s):  
Njira Lugogo ◽  
Christian Domingo ◽  
Pascal Chanez ◽  
Richard Leigh ◽  
Martyn J. Gilson ◽  
...  
Keyword(s):  
Efficacy And Safety ◽  
Open Label ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma ◽  
Term Efficacy ◽  
Phase Iiib ◽  
Open Label Phase

scholarly journals Long-Term Efficacy and Safety of Liquid Abobotulinumtoxina Formulation for Moderate-To-Severe Glabellar Lines: A Phase III, Double-Blind, Randomized, Placebo-Controlled and Open-Label Study

2021 ◽  
Author(s):  
Philippe Kestemont ◽  
Said Hilton ◽  
Bill Andriopoulos ◽  
Inna Prygova ◽  
Catherine Thompson ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Neutralizing Antibodies ◽  
Well Being ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Term Efficacy ◽  
Patient Reported

Abstract Background A ready-to-use liquid formulation of abobotulinumtoxinA (aboBoNT-A solution) has been developed. Objectives To assess long-term efficacy and safety of aboBoNT-A solution for glabellar lines (GL) treatment. Methods Multicenter, multinational, Phase III study (NCT02493946), with randomized double-blind placebo-controlled (DBPC; 2:1 aboBoNT-A solution 50 U: placebo) and open-label (OL; 4 cycles aboBoNT-A solution) periods; additional patients were recruited into the OL period. Patients were 18-65 years old; BoNT-naïve; dissatisfied/very dissatisfied with moderate/severe GLs at maximum frown. Investigator’s live assessment (ILA; primary endpoint)/subject’s self-assessment (SSA) of GL severity at maximum frown, patient satisfaction with GL appearance, and FACE-Q patient-reported scales (facial appearance overall, psychological well-being, aging) were assessed. Adverse events (AEs) were monitored. Analyses were performed on DBPC and long-term analysis (LTA; all patients receiving ≥ aboBoNT-A solution injection) populations. Results Mean ages of patients were 46.6–47.8 years, and 89.1–91.3% were female, across DBPC (N=190 [n=126 aboBoNT-A solution, n=64 placebo]) and LTA (N=595) populations. Responder rates for ILA, SSA and patient satisfaction were consistent at Day 29 post-injection across repeat LTA cycles (82.2–87.8%, 62.8–80.6% and 72.2–87.8%, respectively), with statistically significantly higher responder rates versus placebo (DBPC cycle; 81.6% versus 0.8%, 68.1% versus 2.3% and 83.1% versus 5.7%, respectively; all p<0.0001). Consistent improvements on FACE-Q scales occurred with repeat cycles (aboBoNT-A solution versus placebo, p<0.0001 [DBPC cycle]). No new or unexpected AEs, or neutralizing antibodies were observed. Conclusions Results support long-term efficacy and safety of aboBoNT-A solution, and its superiority over placebo, for GL treatment in adults.

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