scholarly journals P522. A multicentre open-label study assessing pharmacokinetics, efficacy, and safety of subcutaneous golimumab in paediatric patients with moderately to severely active ulcerative colitis

2016 ◽  
Vol 10 (suppl 1) ◽  
pp. S364.2-S365
Keyword(s):  
Ulcerative Colitis ◽  
Active Ulcerative Colitis ◽  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Paediatric Patients

scholarly journals P732 The clinical efficacy and safety of indigo naturalis in induction & maintenance therapy for moderate-to-severe ulcerative colitis: A single-centre prospective uncontrolled open-label study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S588-S588
Author(s):  
Y Matsuno ◽  
A Hirano ◽  
T Torisu ◽  
Y Fuyuno ◽  
Y Okamoto ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Maintenance Therapy ◽  
Mucosal Healing ◽  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Indigo Naturalis

Abstract Background Recently, several studies have shown the high efficacy of Indigo naturalis (IN) in the induction therapy for ulcerative colitis (UC). However, the efficacy and safety in the maintenance therapy remain unclear. Thus, we performed this prospective study to investigate the efficacy and safety of IN for induction and maintenance therapy in patients with moderate to severe active UC. Methods We conducted a prospective uncontrolled open-label study at Kyushu university hospital. A total of 33 patients with moderate to severe active UC (clinical activity index (CAI) ≥8) received 2 g per day of IN for 52 weeks. We assessed CAI at week 0, 4, 8, 52, and Mayo endoscopic score (MES) was evaluated at weeks 0, 4, 52. We calculated the clinical remission (CAI ≤4) rate and mucosal healing (MES ≤1) rate at each point. Overall adverse events (AEs) during the follow-up were also estimated. Results Clinical remission rates at weeks 4, 8, and 52 were 67%, 76%, and 73%, respectively. Mucosal healing rates at weeks 4 and 52 were 48% and 70%. Seventeen patients experienced adverse events (AEs) during the follow-up. Seven severe AEs, including intussusceptions, acute severe colitis, infectious colitis, portal thrombosis, appendicitis, were observed in 4 patients. Conclusion Our prospective study indicated that IN was a promising option for induction and maintenance therapy in UC. However, possible AEs of IN should be paid attention.

scholarly journals Efficacy and Safety of Calcipotriol/Betamethasone Dipropionate Ointment for the Treatment of Trachyonychia: An Open-Label Study

2015 ◽  
Vol 27 (4) ◽  
pp. 371 ◽  
Author(s):  
Jung-Min Park ◽  
Hyun-Ho Cho ◽  
Won-Jeong Kim ◽  
Je-Ho Mun ◽  
Margaret Song ◽  
...  
Keyword(s):  
Betamethasone Dipropionate ◽  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Calcipotriol Betamethasone

scholarly journals Efficacy and Safety of Thirst-Quenching Lozenges for Xerostomia in Patients Undergoing Hemodialysis: A Prospective, Single-Arm, Open-Label Study

2020 ◽  
Vol 6 (2) ◽  
Author(s):  
Sahay Manisha ◽  
Almeida Alan ◽  
Naqvi Syed Mujtaba Hussain ◽  
Venugopal Hariharan ◽  
Kale Ravindra Machhindra ◽  
...  
Keyword(s):  
Efficacy And Safety ◽  
Open Label ◽  
Open Label Study ◽  
Label Study
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