scholarly journals Real-world data for golimumab treatment in patients with ulcerative colitis in Japan: interim analysis in post-marketing surveillance

2021 ◽  
Author(s):  
Shiro Nakamura ◽  
Teita Asano ◽  
Hiroaki Tsuchiya ◽  
Kanami Sugimoto ◽  
Yuya Imai ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Real World ◽  
Interim Analysis ◽  
Real World Data ◽  
World Data ◽  
Post Marketing Surveillance ◽  
Post Marketing

scholarly journals The Safety Profile of Vedolizumab in Ulcerative Colitis and Crohn’s Disease: 4 Years of Global Post-marketing Data

2019 ◽  
Vol 14 (2) ◽  
pp. 192-204 ◽  
Author(s):  
Russell D Cohen ◽  
Fatima Bhayat ◽  
Aimee Blake ◽  
Simon Travis
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Event ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Safety Profile ◽  
Safety Data ◽  
Real World Data ◽  
Safety Database ◽  
Post Marketing

Abstract Background and Aims Vedolizumab is a gut-selective antibody to α 4  β 7 integrin, approved to treat moderate-to-severe ulcerative colitis and Crohn’s disease in adults. Clinical trial data on patients meeting protocol-specified criteria may not reflect real-world clinical practice. This is a descriptive analysis of 4 years of post-marketing safety data on vedolizumab. Methods The Vedolizumab Global Safety Database contains all adverse event reports collated by Takeda Pharmaceutical Company Ltd since vedolizumab approval [May 20, 2014]. Adverse event reports received between approval and May 19, 2018 were identified using Medical Dictionary for Regulatory Activities version 21.0 Preferred Terms. Adverse event frequencies were calculated and categorised. Results In approximately 208 050 patient-years of vedolizumab exposure, 32 752 patients reported 80 218 events. In patients with Crohn’s disease or ulcerative colitis, 37 662 and 34 259 events occurred in 14 191 and 14 042 patients, respectively, and 8297 events occurred in 4519 individuals with other [off-label] or unreported indications. Overall, 5230 [14%; Crohn’s disease] and 3580 [10%; ulcerative colitis] events were serious. Most frequently reported were gastrointestinal events (Crohn’s disease, 6156 [16%]; ulcerative colitis, 5701 [17%]). Patients with Crohn’s disease or ulcerative colitis reported 251 malignancies [<1%], 402 hepatobiliary events [<1%], and 5876 infections (1137 serious [19%], 301 opportunistic [5%]). Patients aged ≥70 years [2326 patients] reported <10% of events. Conclusions Adverse event patterns were consistent with clinical trials, with no new safety concerns. Most reported events were non-serious and event frequency was low, considering patient-years of exposure. Although limitations of post-marketing safety reports require acknowledgement, these real-world data support a favourable safety profile of vedolizumab.

scholarly journals P416 Real world data on the effectiveness and safety of vedolizumab in the treatment of Crohn's disease and ulcerative colitis: the Edinburgh experience

2017 ◽  
Vol 11 (suppl_1) ◽  
pp. S288-S289 ◽  
Author(s):  
N. Plevris ◽  
T.A. Manship ◽  
A. Deekae ◽  
G.R. Jones ◽  
C.L. Noble ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Real World Data ◽  
World Data

scholarly journals AB0817 DOES SMOKING AFFECT SECUKINUMAB TREATMENT OUTCOMES AND SAFETY IN PATIENTS WITH PSORIATIC ARTHRITIS? - REAL WORLD DATA FROM THE GERMAN AQUILA STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1711.1-1711
Author(s):  
E. Riechers ◽  
U. Kiltz ◽  
J. Brandt-Juergens ◽  
P. Kästner ◽  
D. Peterlik ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Real World ◽  
Interim Analysis ◽  
Smoking Status ◽  
Depressive Mood ◽  
Research Support ◽  
Real World Data ◽  
World Data ◽  
Number Of Patients

Background:Several studies have shown a negative association between smoking status and psoriatic arthritis (PsA) clinical outcomes.1,2The German non-interventional study AQUILA provides real-world data on the influence of smoking on therapeutic effectiveness and safety issues under secukinumab (SEC), a fully human monoclonal antibody that selectively inhibits interleukin-17A.Objectives:The aim of this interim analysis is to describe selected baseline (BL) demographics, to evaluate SEC effectiveness on disease activity and depressive mood and to report the safety profile depending on smoking status of PsA patients.Methods:AQUILA is an ongoing, multi-center study including up to 2700 patients with active PsA or ankylosing spondylitis. Patients were observed from BL up to week (w) 52. Real-world data was assessed prospectively and analyzed as observed. In addition to the assessment of C-reactive protein (CRP), data was collected on patient´s disease activity (tender/swollen joint counts, TJC/SJC), skin disease activity (Psoriasis Area and Severity Index, PASI) and depressive mood (Beck´s Depression Inventory version II, BDI-II). For calculation of the proportion of patients who experienced (serious) adverse events ((S)AEs), all PsA patients were included who received at least one dose of SEC irrespective of further documentation of any study visit. This interim analysis focuses on subgroups non-smoker (NS) and smoker (S).Results:At BL, 641 PsA patients were included: 49.8% (n=319) non-smokers (NS) and 24.3% (n=156) smokers (S). 17.5% (n=112) were ex-smoker and 8.4% (n=54) of unknown smoking status. In both, NS and S, the proportion of women was higher (58.0% in NS and 67.3% in S). NS were slightly older than S (mean age: 53.8/49.7 years). There were no significant differences between NS and S in mean CRP within the 52 weeks (Fig. 1A). Both TJC and SJC improved over time and were similar between NS and S (Fig. 1B). Although mean absolute PASI value was worse in S at BL, a similar temporal improvement was seen in both groups (NS: 7.0 at BL to 1.0 at w52; S: 9.2 at BL to 1.0 at w52). BDI-II scores decreased in both groups with overall higher values in S (NS: 10.9 at BL to 9.1 at w52; S: 12.8 at BL and 10.8 at w52). Regarding the occurrence of AEs and SAEs with or without suspected relationship to SEC, NS had percentagewise less events than S (Table 1). In addition, percentage of PsA patients who discontinued SEC treatment due to an AE was lower for NS compared to S.Table 1.Overview of AEs (and SAEs) under SEC treatment depending on smoking status in PsA patientsNumber of patients withNS (N=333), n (%)S (N=161),n (%)P valueAE233 (70.0)118 (73.3)0.11AE with suspected relationship to SEC129 (38.7)72 (44.7)0.10SAE74 (22.2)45 (28.0)0.06SAE with suspected relationship to SEC29 (8.7)18 (11.2)0.37Figure 1.Disease activity in PsA patients treated with SEC depending on the smoking status**CRP data/ACR joint counts were documented not for all PsA patients at BL and subsequent visits.Conclusion:In a real-world setting, SEC improved disease activity and depressive mood of PsA patients with no obvious differences between NS and S. Overall, this interim analysis shows that SEC is an effective and reliable treatment, irrespective of the PsA patients’ smoking status. Further progress of the AQUILA study as well as long-term data from other real-world observational studies with SEC, such as SERENA, will reveal whether this trend will continue.References:[1]Hojgaard P et al, Ann Rheum Dis 2015; 74:2130-6; 2. Eder L et al, Arthritis Care Res 2011 Aug; 63:1091-7Disclosure of Interests:Elke Riechers Grant/research support from: AbbVie, Chugai, Lilly, Janssen, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Chugai, Novartis, UCB, Uta Kiltz Grant/research support from: AbbVie, Amgen, Biogen, Novartis, Pfizer, Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer, Roche, UCB, Jan Brandt-Juergens: None declared, Peter Kästner Consultant of: Chugai, Novartis, Daniel Peterlik Employee of: Novartis Pharma GmbH, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi

scholarly journals 4．Utilization of Real World Data for Post-marketing Pharmacovigilance Activity

2019 ◽  
Vol 24 (1) ◽  
pp. 31-39
Author(s):  
Makoto MIYAZAKI ◽  
Akihito SHITO ◽  
Eiji FURUTA ◽  
Minoru SHIMODERA
Keyword(s):  
Real World ◽  
Pharmacovigilance Activity ◽  
Real World Data ◽  
World Data ◽  
Post Marketing
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