scholarly journals A Multicenter, Prospective, Noninterventional Study in a Norwegian Cohort of Patients with Moderate-to-Severe Allergic Rhinitis Treated with MP-AzeFlu

2017 ◽  
Vol 8 (3) ◽  
pp. ar.2017.8.0216 ◽  
Author(s):  
Ralph Dollner ◽  
Petter Lorentz Larsen ◽  
Sinan Dheyauldeen ◽  
Sverre Steinsvåg
Keyword(s):  
Allergic Rhinitis ◽  
Clinical Practice ◽  
Disease Control ◽  
Symptom Severity ◽  
Symptom Control ◽  
Real Life ◽  
Routine Clinical Practice ◽  
Vas Score ◽  
Receive Treatment ◽  
Noninterventional Study

Background Allergic Rhinitis and its Impact on Asthma guidelines recently recommended a treatment strategy for allergic rhinitis (AR) based on disease control rather than symptom severity by using a visual analog scale (VAS) to categorize control Objectives To evaluate the effectiveness of MP-AzeFlu (Dymista®) by using this VAS in routine clinical practice in Norway. MP-AzeFlu comprises a novel formulation that contains azelastine hydrochloride, fluticasone propionate and excipients delivered in a single spray. Methods This multicenter, prospective, noninterventional study enrolled patients (n = 160) with moderate-to-severe AR and acute symptoms who were eligible to receive treatment with MP-AzeFlu according to its summary of product characteristics. Patients assessed symptom severity by using a VAS from 0 (not at all bothersome) to 100 mm (very bothersome) in the morning before MP-AzeFlu use on days 0, 1, 3, 7, and after ~14 days. On day 3, the patients assessed their level of disease control as well controlled, partly controlled, or uncontrolled. The proportion of Norwegian patients who achieved defined VAS score cutoffs for “well-controlled” and “partly controlled” AR were also calculated. Results MP-AzeFlu reduced the mean ± standard deviation VAS score from 68.1 ± 16.4 mm at baseline to 37.4 ± 25.9 mm on the last day, a reduction of 30.8 ± 27.2 mm. The results were consistent, irrespective of disease severity, phenotype (i.e., seasonal AR [SAR], perennial AR [PAR], SAR plus PAR, unknown) or age (i.e., 12–17, 18–65, and >65 years). Of the patients (with recorded data), 88.1% considered their symptoms to be partly or well controlled at day 3; and 19.5, 32.0, 50.0, and 61.0% of the patients achieved a ≤38 mm well-controlled VAS score cutoff on days 1, 3, 7, and the last day, respectively. Conclusions MP-AzeFlu provided rapid sustained symptom control in a routine clinical practice in Norway, which provided support for its effectiveness for the treatment of AR in real life.

scholarly journals Real-life study showing better control of allergic rhinitis by immunotherapy than regular pharmacotherapy

2016 ◽  
Vol 54 (3) ◽  
pp. 214-220
Author(s):  
V. Droessaert ◽  
M. Timmermans ◽  
E. Dekimpe ◽  
S. Seys ◽  
J.J. Ceuppens ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Symptom Severity ◽  
Symptom Control ◽  
Medication Use ◽  
Real Life ◽  
Life Study ◽  
Vas Score ◽  
Nasal Symptoms ◽  
Current Medication ◽  
Real Life Study

Background: Treatment for allergic rhinitis (AR) aims at reducing the burden of allergic inflammation, either by suppression of the nasal inflammation with pharmacotherapy or by inducing tolerance via immunotherapy (IT). At present, we lack information on the comparison between the degree of symptom control in AR patients treated with IT and those on pharmacotherapy. Aims: An observational study was conducted evaluating the degree of symptom control, the total and individual nasal symptom severity and current medication use at 3 years after starting either pharmacotherapy or subcutaneous immunotherapy (SCIT) for AR. Methods: A total number of 800 patients diagnosed with AR between October 2007 and February 2010 at the Ear, Nose and Throat Unit and Allergology Clinical Department of the University Hospitals of KU Leuven, Belgium, were included. Among these patients, 120 had been started on IT at the time of their initial visit, and 680 were prescribed guideline-based pharmacotherapy. In 2013, patients were sent a questionnaire asking for the current severity of nasal symptoms using a visual analogue scale (VAS) score, duration of nasal symptoms and presence or absence of abnormal sleep, impairment of daily activities, sport, leisure, impaired functioning at work/school, troublesome symptoms, and current medication use. A VAS score for total nasal symptoms (TNS) was used to distinguish between controlled and uncontrolled AR. Results: An overall response rate of 54%. At 3 years after the initiation of the treatment, the IT group showed lower VAS scores for TNS than the pharmacotherapy group, with lower percentages of patients having a VAS score of equal or higher than 5. The IT group consisted of more patients with mild AR than the pharmacotherapy group despite the higher percentage of polysensitization at the onset of treatment in the IT group. 18% of the IT patients met the criteria of persistent AR whereas this was 51% amongst non-IT patients. Interestingly, 70% of IT patients did not use any medical treatment for AR anymore, whereas 61% of pharmacotherapy patients were still on medical treatment. Conclusions: This observational study demonstrates that IT is associated with higher control of AR, reduced symptom severity and reduced medication use at 3 years after the onset of treatment. Therefore, this real-life study reinforces the clinical value of immunotherapy in allergic rhinitis.

scholarly journals OSSMAR: An Observational Study to Describe the Use of Sunitinib in Real-Life Practice for the Treatment of Metastatic Renal Cell Carcinoma

2019 ◽  
pp. 1-10 ◽  
Author(s):  
Marwan Ghosn ◽  
Roland Eid ◽  
Emad Hamada ◽  
Hamdy Abdel Azim ◽  
Jamal Zekri ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Clinical Practice ◽  
Middle East ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Real Life ◽  
Routine Clinical Practice ◽  
The Mean

PURPOSE Sunitinib offers improved efficacy for patients with metastatic renal cell carcinoma (mRCC). To provide better disease management in the Middle East, we studied its use in mRCC in real-life practice in this region. MATERIAL AND METHODS Patients diagnosed with mRCC and started on sunitinib between 2006 and 2016 from 10 centers in Africa and the Middle East region were studied in this regional, multicenter, observational, retrospective trial to obtain routine clinical practice data on the usage patterns and outcomes of sunitinib in mRCC in real-life practice. RESULTS A total of 289 patients were enrolled. Median age at diagnosis was 58.7 years. The patient characteristics were as follows: 73.6% of patients were males; 85.8% had clear-cell renal cell carcinoma (RCC); 97.5% had unilateral RCC; 66.3% had metastatic disease at initial diagnosis; 56.3% received previous treatment for RCC, among which 98.7% had undergone surgery; and 15.2% and 31.4% were classified in the favorable and poor-risk groups (expanded Memorial Sloan Kettering Cancer Center criteria), respectively. On treatment initiation, the mean total sunitinib dose was 48.1 mg, and 87.6% of patients were started on a sunitinib dose of 50 mg. The mean duration of sunitinib treatment was 9.6 months. Overall response rate was 20.8%, with a median duration of 8.2 months. Median time to progression was 5.7 months. Median follow-up time was 7.8 months. By months 12 and 24, 34.3% and 11.4% of patients, respectively, were still alive. Seventy-six patients (60.9%) experienced 314 adverse events. Twenty-three patients (8.0%) experienced 28 serious adverse events. Overall, 83 patients (28.7%) discontinued their sunitinib treatment. CONCLUSION The results are indicative of the general treatment outcomes of patients with mRCC in the Middle East using sunitinib in routine clinical practice. Reported adverse events are similar to those described in the literature but at lower frequencies.

scholarly journals Effectiveness, durability, and safety of darunavir/ritonavir in HIV-1-infected patients in routine clinical practice in Italy: a postauthorization noninterventional study

2016 ◽  
pp. 1589
Author(s):  
Roberta Termini ◽  
Andrea Antinori ◽  
Paola Meraviglia ◽  
Antonella d'Arminio Monforte ◽  
Antonella Castagna ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Routine Clinical Practice ◽  
Noninterventional Study ◽  
Hiv 1

Effectiveness of MP29-02 for the treatment of allergic rhinitis in real-life: Results from a noninterventional study

2015 ◽  
Vol 36 (1) ◽  
pp. 40-47 ◽  
Author(s):  
Ludger Klimek ◽  
Claus Bachert ◽  
Ralph Mösges ◽  
Ullrich Munzel ◽  
David Price ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Real Life ◽  
Noninterventional Study

Efficacy and tolerability of linaclotide in the treatment of irritable bowel syndrome with constipation in a real‑world setting – results from a German noninterventional study

2018 ◽  
Vol 56 (07) ◽  
pp. 738-744 ◽  
Author(s):  
Viola Andresen ◽  
Stephan Miehlke ◽  
Elmar Beck ◽  
Gwen Wiseman ◽  
Peter Layer
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Clinical Practice ◽  
Real World ◽  
Common Adverse Event ◽  
Routine Clinical Practice ◽  
Guanylate Cyclase C ◽  
Bowel Movements ◽  
Irritable Bowel ◽  
Noninterventional Study

Abstract Background Linaclotide is a minimally absorbed peptide guanylate cyclase-C agonist approved for the treatment of irritable bowel syndrome with constipation (IBS-C). This study assessed the efficacy and tolerability of linaclotide in IBS-C in routine clinical practice in Germany. Methods This was a 52-week, noninterventional study of linaclotide in patients aged ≥ 18 years with moderate to severe IBS-C. Severity of abdominal pain and bloating and frequency of bowel movements were assessed over 5 study visits. Treatment-related adverse events were recorded. Results The study enrolled 375 patients; the mean observation duration was 4.4 months. Linaclotide marketing was halted during the study period for economic reasons, accounting for low patient numbers and short observation duration. Linaclotide significantly reduced mean (standard deviation [SD]) scores between treatment start (visit 1) and study end (visit 5) for abdominal pain intensity (visit 1: 4.87 [2.63] vs. visit 5: 2.40 [2.20], p < 0.0001), mean [SD] bloating intensity (visit 1: 5.30 [2.70] vs. visit 5: 2.86 [2.34], p < 0.0001), and increased mean [SD] bowel movement frequency (visit 1: 2.71 [1.80] vs. 4.38 [1.86], p < 0.0001). Diarrhea, occurring in 5.1 % of patients, was the most common adverse event. Conclusion Linaclotide is effective in improving the major symptoms of IBS-C and demonstrates a favorable safety profile in the real-world environment of routine clinical practice. DRKS (www.drks.de/): DRKS00005088.

P.0724 Vortioxetine in routine clinical practice: results from the real-life effectiveness of vortioxetine (RELIEVE) study

2021 ◽  
Vol 53 ◽  
pp. S529-S530
Author(s):  
G. Mattingly ◽  
H. Ren ◽  
M. Cronquist Christensen ◽  
K. Simonsen ◽  
L. Hammer-Helmich
Keyword(s):  
Clinical Practice ◽  
Real Life ◽  
Routine Clinical Practice ◽  
Life Effectiveness ◽  
The Real

scholarly journals The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design

2019 ◽  
Vol 42 (12) ◽  
pp. 1147-1154 ◽  
Author(s):  
Raffaele De Caterina ◽  
Giancarlo Agnelli ◽  
Petra Laeis ◽  
Martin Unverdorben ◽  
Heiko Rauer ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Routine Clinical Practice ◽  
Study Program ◽  
Noninterventional Study

scholarly journals THU0386 PREDICTORS OF MAINTENANCE OF SECUKINUMAB TREATMENT IN A MULTICENTER COHORT OF 561 SPONDYLARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 427.1-428
Author(s):  
B. Flachaire ◽  
J. G. Letarouilly ◽  
C. Labadie ◽  
N. Cohen ◽  
V. Pradel ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Smoking Status ◽  
Safety Issue ◽  
Real Life ◽  
Routine Clinical Practice ◽  
Interleukin 17 ◽  
Sustained Remission ◽  
Concomitant Treatment ◽  
First Line ◽  
Research Support

Objectives:Secukinumab (SEC) is an interleukin-17 inhibitor used to treat patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA). Drug maintenance is often used as a proxy for treatment effectiveness and safety in real life settings. We aim to assess SEC maintenance in routine clinical practice and to identify survival predictors associated.Methods:We conducted a retrospective, longitudinal, observational, multicenter study including all patients (pts) with axSpA or PsA who received at least 1 injection of SEC between July 2016 and October 2019. We collected patient’s demographics and clinic characteristics, SEC date of initiation and dosage and dosage modification of SEC, previous biologic Disease-modifying antirheumatic drugs (bDMARDs) and concomitant treatments. Date and reasons of discontinuation – i.e., lack of efficacy, safety issue, sustained remission or others – were collected. Several potential maintenance predictors were tested: age, gender, disease (axSpA or PsA), smoking status, bDMARDs history and concomitant treatment. Among patients with non-radiographic axSpA (nr-axSpA), evidence of MRI sacroiliitis or elevated CRP were also assessed as potential maintenance predictors. Drug maintenance was analyzed by the Kaplan-Meier method and adjusted for baseline factors were estimated by log rank analysis.Results:The main characteristics of the 561 pts included were the following: 363 (64.7%) axSpA, 198 (35.3%) PsA, 329 (58.6%) female, mean age 45,6 +/- 12 years, 221 (39.4%) smokers, 175 (31.2%) radiographic sacroiliitis, 259 (46.2%) MRI sacroiliitis, 198 (35.3%) elevated CRP, 247 (44.0%) HLA B27 positive, mean BASDAI 48,3 +/- 26.8%. SEC was associated to methotrexate (MTX) in 139 pts (24.8%) and was the first line bDMARD in 55 pts (9.8%). The median drug maintenance (MDM) of SEC was 79 weeks (wk) [73-84]. At 52 wk, 245 pts (60%) SpA were still treated with SEC. During the 3-year follow-up, 264 pts discontinued SEC: 180 (68.2%) pts for lack of effectiveness, 47 (17.8%) for adverse events, 14 (5.3%) for others and 23 (8.7%). SEC prescription as first line bDMARD was associated with longer survival versus second line or more: 111 wk [83-138] vs. 69 wk [57-80] (p=0. 017) (figure 1). MDM was not significantly different depending on gender, MTX combo, elevated CRP, axSpA vs PsA and smoking status. Among the nr-axSpA pts, MRI sacroiliitis or elevated CRP did not modify SEC maintenance (p=0.68) (figure 2).Figure 1.Secukinumab maintenance according to therapeutic lineFigure 2.Secukinumab maintenance in nr-axSpA populationConclusion:In routine clinical practice, SEC median maintenance was 79 weeks. Fist line administration was the only independent factor associated with improved SEC retention. Lack of effectiveness was the most common reason of discontinuation.Disclosure of Interests:Benoît Flachaire: None declared, Jean-Guillaume Letarouilly Grant/research support from: Research grant from Pfizer, Céline Labadie: None declared, Nicolas Cohen Speakers bureau: Novartis, Janssen, Vincent Pradel: None declared, Bruno Fautrel Grant/research support from: AbbVie, Lilly, MSD, Pfizer, Consultant of: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Lilly, Janssen, Medac MSD France, Nordic Pharma, Novartis, Pfizer, Roche, Sanofi Aventis, SOBI and UCB, Guy Baudens: None declared, Pascal Claudepierre Speakers bureau: Janssen, Novartis, Lilly, Corinne Miceli Richard: None declared, Philippe Dieudé: None declared, Jean-Hugues Salmon Speakers bureau: Novartis, Janssen, Jérémie SELLAM: None declared, Eric Houvenagel Speakers bureau: Janssen, Novartis, Marie-Hélène Guyot: None declared, Chi Duc Nguyen: None declared, Xavier Deprez Speakers bureau: Novartis, Janssen, Isabelle CHARY VALCKENAERE: None declared, Pierre Lafforgue Speakers bureau: Novartis, Janssen, Damien LOEUILLE: None declared, Christophe Richez Consultant of: Abbvie, Amgen, Mylan, Pfizer, Sandoz and UCB., Rene-Marc Flipo Speakers bureau: Novartis, Janssen, Lilly, Thao Pham Speakers bureau: Novartis, Janssen, Lilly

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