One-year real life data of our patients with moderate-severe Crohn’s disease who underwent ustekinumab therapy

2021 ◽  
pp. 003693302110085
Author(s):  
Ferhat Bacaksız ◽  
Derya Arı ◽  
Volkan Gökbulut ◽  
Ömer Öztürk ◽  
Ertuğrul Kayaçetin
Keyword(s):  
Clinical Remission ◽  
Disease Duration ◽  
Real Life ◽  
Biological Agents ◽  
Induction Treatment ◽  
Life Data ◽  
Early Access ◽  
Real Life Data ◽  
One Year ◽  
Access Program

Aim The aim of this study was to present one-year real-life data of our patients with CD who showed unresponsiveness and/or intolerance to biological agents and then received ustekinumab treatment through an early access program. Materials and methods The retrospective study reviewed the 52-week clinical data of 10 patients with moderate or severe CD who underwent ustekinumab therapy. Results The 10 patients comprised 7 (70%) men and 3 (30%) women with a mean age of 38 ± 11.3 years. Mean disease duration was 13.5 ± 8.5 years. Mean pretreatment CDAI score was 273.5 ± 92 and mean pretreatment HBI score was 11.6 ± 3.8. At the end of the 8-week intravenous induction treatment, 5 (55%) patients showed clinical remission according to the CDAI and HBI scores. Additionally, 62.5% of the patients were in clinical remission at the end of week 52 according to the CDAI and HBI scores. No drug-related side effects were observed in any patient throughout the treatment. Conclusion Ustekinumab appears to be effective and safe in the treatment of moderate and severe CD, particularly in cases of unresponsiveness and intolerance to biological agents such as anti-TNF, and in the achievement of clinical remission.

scholarly journals Real-life data – a characteristic of RA in patients with cardiovascular diseases on the background of treatment with biological agents

2019 ◽  
pp. 10-17
Keyword(s):  
Cardiovascular Diseases ◽  
Real Life ◽  
Biological Agents ◽  
Mean Values ◽  
Average Value ◽  
Life Data ◽  
Real Life Data ◽  
Significant Difference ◽  
Time Average ◽  
Therapeutic Behavior

The purpose of this study is to analyze real-life data in order to characterize patients with RA and cardiovascular diseases that are treated with biological agents. Material and Methods: In a retrospective study, data from real clinical practice were analyzed in 195 patients with seropositive RA, which are being treated with biological agents. Results: In patients with existing CVD, significantly higher mean ESR values ​​(23.95 vs. 19.31, p = 0.031) and CRP (6.41 vs. 3.36, p = 0.004) were detected over the period of the study period of treatment. In contrast to the laboratory parameters, mean values of clinical parameters of RA - TJC, SJC and VAS clinical sings did not show a significant difference in patients with and without CVD. The time average value of DAS28 (ESR) during the study period was significantly higher in patients with CVD (3.7 vs. 3.39, p = 0.002) compared to those without CVD. DAS28 (CRP) shows the same trend. In patients with CVD, the time average value of the follow-up indicator was 3.21, and in patients without CVD, 2.88 (p <0.001). Conclusion: The results of this study, in PA patients conducting treatment with biological agents in the real life, outside of the clinical study conditions, demonstrate that independently of treatment, patients with CVD continue to maintain higher background inflammation. An optimization of therapeutic behavior in real life is necessary to improve the long-term prognosis of these patients.

One year experience with erenumab: real-life data in 30 consecutive patients

2020 ◽  
Vol 41 (S2) ◽  
pp. 505-506
Author(s):  
Angelo Ranieri ◽  
Gennaro Alfieri ◽  
Massimo Napolitano ◽  
Giovanna Servillo ◽  
Paolo Candelaresi ◽  
...  
Keyword(s):  
Real Life ◽  
Life Data ◽  
Real Life Data ◽  
One Year

scholarly journals Real-life data in 115 chronic migraine patients treated with Onabotulinumtoxin A during more than one year

2016 ◽  
Vol 17 (1) ◽  
Author(s):  
I. Aicua-Rapun ◽  
E. Martínez-Velasco ◽  
A. Rojo ◽  
A. Hernando ◽  
M. Ruiz ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Real Life ◽  
Life Data ◽  
Onabotulinumtoxin A ◽  
Real Life Data ◽  
One Year

scholarly journals Long-term outcome and predictors of long-term disease activity in natalizumab-treated patients with multiple sclerosis: real life data from the Austrian MS Treatment Registry

2021 ◽  
Author(s):  
Michael Guger ◽  
◽  
Christian Enzinger ◽  
Fritz Leutmezer ◽  
Franziska Di Pauli ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Activity ◽  
Rate Ratio ◽  
Disease Duration ◽  
Treatment Initiation ◽  
Incidence Rate Ratio ◽  
Real Life ◽  
Life Data ◽  
Real Life Data

Abstract Objectives To evaluate long-term effectiveness of natalizumab (NTZ) and to determine demographic, clinical, and radiological predictors regarding long-term disease activity (≥ 7 years) in a nationwide observational cohort, using data collected prospectively in a real-life setting. Materials and methods We analysed data from 230 patients from the Austrian Multiple Sclerosis Treatment Registry (AMSTR), who had started treatment with NTZ at any time since 2006 and stayed on NTZ for at least 7 years without treatment gap of more than three months. Results Estimated mean annualised relapse rates (ARR) over a mean treatment period of 9.3 years were 0.07 for NTZ. Sustained EDSS progression for 12 weeks was observed in 36 (19%) patients and for 24 weeks in 31 (16.3%) cases. Sustained EDSS regression for 12 and 24 weeks was seen in 45 (23.7%) and 42 (22.1%) cases. The baseline parameters ≥ 1 Gadolinium-enhancing MRI lesion(s) [incidence rate ratio (IRR) of 0.409 (95% CI 0.283–0.593), p = 0.001], ARR ≤ 1 in the prior 12 month before treatment initiation with NTZ [IRR of 0.353 (95% CI 0.200–0.623), p = 0.001] and EDSS ≤ 1 [incidence rate ratio (IRR) of 0.081 (95% CI 0.011–0.581), p = 0.012] were significantly associated with a reduced relapse risk, whereas a disease duration ≤ 5 years increased significantly the ARR [IRR of 1.851 (95% CI 1.249–2.743), p = 0.002]. The only predictive baseline parameter for experiencing EDSS progression (sustained for 12 and 24 weeks) was age > 35 years [HR of 2.482 (95% CI 1.110–5.549), p = 0.027, and HR of 2.492 (95% CI 1.039–5.978), p = 0.041, respectively]. Conclusions These real-life data show a stable disease course regarding relapse activity and disease progression under NTZ treatment for more than 7 years. The main predictors for disease activity were higher relapse rate before treatment initiation, higher disability, shorter disease duration and absence of Gadolinium-enhancing MRI lesions at baseline. Older age at NTZ start was the only significant risk factor for disease progression over long-term.

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