scholarly journals A 2:1 formulation of follitropin alfa and lutropin alfa in routine clinical practice: a large, multicentre, observational study

2010 ◽  
Vol 27 (9) ◽  
pp. 650-654 ◽  
Author(s):  
Klaus Bühler ◽  
Olaf Naether
Keyword(s):  
Clinical Practice ◽  
Observational Study ◽  
Routine Clinical Practice ◽  
Follitropin Alfa

scholarly journals A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial

2021 ◽  
pp. 1-1
Author(s):  
Giovanni Abbruzzese ◽  
Jaime Kulisevsky ◽  
Bruno Bergmans ◽  
Juan C. Gomez-Esteban ◽  
Georg Kägi ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Observational Study ◽  
Routine Clinical Practice

P–592 Safety and effectiveness of follitropin alfa biosimilar to originator follitropin alfa in real-world clinical practice: A Multinational Comparative, Prospective Cohort Study

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
S Kaplan ◽  
R Levy-Toledano ◽  
M Davies ◽  
D Roy ◽  
C Howles ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Live Birth ◽  
Treatment Cycle ◽  
Controlled Ovarian Hyperstimulation ◽  
Routine Clinical Practice ◽  
Clinical Pregnancy ◽  
Infertile Women ◽  
Live Birth Rates ◽  
Follitropin Alfa ◽  
Incidence Proportion

Abstract Study question Are safety and effectiveness of Ovaleap® (follitropin alfa), and Gonal-f®, comparable in one treatment cycle of ART in routine clinical practice? Summary answer Safety in terms of incidence proportions of OHSS and OHSS severity, as well as pregnancy and live birth rates, were similar between Ovaleap® and Gonal-f®. What is known already Ovaleap® (Theramex), a r-hFSH, is a biosimilar medicinal product to Gonal-f® (Merck). As a biosimilar, it went through a rigorous series of physio-chemical, in vitro, in vivo tests and confirmatory Phase I and III studies, to demonstrate similarity/equivalence in quality, safety and efficacy to the reference medicinal product, per the European Medicines Agency (EMA) guidelines. Ovaleap® was approved by the EMA in 2013 for use at the same dose and for the same therapeutic indications as Gonal-f®. Further outcome data from a broader patient population on safety and live birth outcomes provides clinically important insights on newly introduced FSH medicines. Study design, size, duration SOFIA (Safety of Ovaleap® Follitropin alfa in Infertile women undergoing superovulation for Assisted reproductive technologies) was a multi-national, comparative, non-interventional, prospective cohort study. The study was performed at 56 centers specializing in ART from six European countries, (Belgium, France, Germany, Italy, Spain, and the United Kingdom) from January 2017 to September 2019 and comprised of 817 infertile women undergoing controlled ovarian hyperstimulation in one treatment cycle for ART Participants/materials, setting, methods The study population comprised of infertile women undergoing controlled ovarian hyperstimulation for ART, who were administered Ovaleap® or Gonal-f® and were naïve to any FSH containing products. Eligible patients were enrolled at a ratio of approximately 1:1, both within and between countries. They were followed up to 30 days after the last FSH dose administration. Women who had a confirmed clinical pregnancy were followed until the end of the pregnancy or until delivery. Main results and the role of chance A total of 408 and 409 women who were administered Ovaleap® or Gonal-f®, respectively, were eligible for analysis. A total of 382 patients (94%) in the Ovaleap® and 390 patients (95%) in the Gonal-f® cohort completed FSH treatment (up to oocyte maturation triggering), respectively. The two cohorts were generally similar with regard to demographic and baseline characteristics. The incidence proportion of OHSS was 5.1% (95% CI: 3.4, 7.7) in the Ovaleap® and 3.2% (95% CI: 1.9, 5.4) in the Gonal-f® cohort. This difference in OHSS incidence proportion between the two cohorts was not statistically significant neither before (p = 0.159) nor after univariate adjustment for each potential confounder (p > 0.05). The incidence proportion of OHSS severity grades was similar in the two treatment groups (3.4% versus 2.0% for Grade I, 1.2% versus 1.0% Grade II, and 0.5% versus 0.2% Grade III, in the Ovaleap® and Gonal-f® cohorts, respectively) and without a significant statistical difference (p = 0.865, for each grade). Among patients who had embryo transfer, clinical pregnancy rates were 33% and 31%, live birth rates 27% and 26% in the Ovaleap® and Gonal-f® cohorts, respectively. Limitations, reasons for caution Since treatment was non-randomised, the study may have been susceptible to selection bias. This was addressed at both the design stage, by balancing recruitment to a 1:1 ratio for Ovaleap® and Gonal-f® treatments, and also at the analysis stage in which, a univariate analysis was performed. Wider implications of the findings: Findings from this first large European prospective comparative real-world SOFIA study demonstrated that effectiveness (pregnancy and delivery rates) and safety (risk and severity of OHSS), were similar between Ovaleap®and Gonal-f® treatments. Ovaleap, a biosimilar r-hFSH is therefore a suitable option for follicular stimulation in routine clinical practice. Trial registration number EUPAS17328

Patient (pt) characteristics and treatment patterns in the radium (Ra)-223 REASSURE observational study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5042-5042 ◽  
Author(s):  
Celestia S. Higano ◽  
Shawn H. Zimberg ◽  
Sabina Dizdarevic ◽  
Lauren Christine Harshman ◽  
John Logue ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Observational Study ◽  
Interim Analysis ◽  
Routine Clinical Practice ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Observation Methods ◽  
Short And Long Term ◽  
Grade 3

5042 Background: Ra-223, a targeted alpha therapy, prolonged survival with good safety in metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 ALSYMPCA trial. REASSURE will evaluate Ra-223 short- and long-term safety in routine clinical practice settings. This is the first planned interim analysis (median 7 mo observation). Methods: This global, prospective, single-arm, observational study enrolled pts with mCRPC with bone metastases (mets) for whom Ra-223 therapy was planned. Follow-up will continue up to 7 years after last Ra-223 dose. Results: 1106 pts (437 N. America, 665 Europe, 4 not recorded) enrolled from 2 Sep 2014 to 22 Sep 2016. Baseline data are available from 583 pts receiving 1st- (1L), 2nd- (2L), or ≥3rd-line (≥3L) Ra-223 for mCRPC(Table). The majority of pts (n=369, 63%) completed 5–6 doses (1L, 70%; 2L, 64%; ≥3L, 49%); median 6 doses (1L,6; 2L, 6; ≥3L, 4). Treatment-emergent drug-related AEs occurred in 215 pts (37%). Post-treatment grade 3/4 thrombocytopenia occurred in 14 pts (2.4%) and anemia in 45 (7.7%). Conclusions: In routine clinical practice, Ra-223 was associated with no short-term safety concerns and appeared to be used in pts with less advanced mCRPC than in ALSYMPCA. The majority of pts on 1L/2L Ra-223 therapy received 5–6 doses. Ra-223 was often used with abiraterone or enzalutamide, but not chemotherapy. The next interim analysis in 2019 will report long-term safety and outcomes on all pts. Clinical trial information: NCT02141438. [Table: see text]

Clinical outcomes and patient (pt) profiles in REASSURE: An observational study of radium-223 (Ra-223) in metastatic castration-resistant prostate cancer (mCRPC).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 32-32
Author(s):  
Celestia S. Higano ◽  
Fred Saad ◽  
A. Oliver Sartor ◽  
Kurt Miller ◽  
Peter Conti ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Clinical Practice ◽  
Observational Study ◽  
Clinical Outcomes ◽  
Bone Fractures ◽  
Bone Marrow Suppression ◽  
Routine Clinical Practice ◽  
Metastatic Sites

32 Background: Ra-223 is a targeted alpha therapy that showed a survival advantage and favorable safety profile in the phase 3 ALSYMPCA trial in pts with mCRPC. REASSURE (NCT02141438) is evaluating the long-term safety of Ra-223 in routine clinical practice in pts with mCRPC over a 7-year follow-up period. Methods: In this global, prospective, single-arm, observational study, the second prespecified interim analysis (data cut-off March 2019) evaluated safety and clinical outcomes of Ra-223 in pts with mCRPC. Primary outcome measures were incidence of second primary malignancies (SPM), bone marrow suppression and short- and long-term safety in pts who had ≥1 Ra-223 dose. Secondary outcomes included overall survival (OS). Results: For 1465 pts in the safety analysis, median follow up was 11.5 months. Median PSA (n=1053), ALP (n=1048), and LDH (n=555) levels at baseline were 59 ng/mL, 135 U/L, and 269 U/L, respectively. 81% of pts had bone metastases only at baseline; 19% of pts had other metastatic sites, mostly in the lymph nodes. 19% of pts had <6 metastatic sites, 47% had 6–20 sites, 20% had >20 lesions but not a superscan, and 6% had a superscan. 45%, 38%, 37%, 9%, and 8% of pts received prior abiraterone, docetaxel, enzalutamide, cabazitaxel, or sipuleucel-T as prior therapies, respectively. Median number of Ra-223 doses received was 6; 67% of pts had ≥5 doses. SPM occurred in 1% of pts. The most common treatment-emergent drug-related adverse event (AE) of any grade was diarrhea (11%). 10% of pts had a bone-associated event, 5% had fractures, and 15% had a hematological AE. Median OS was 15.6 months (95% CI 14.6–16.5). Conclusions: In REASSURE, there was a low incidence of SPM, bone fractures, and bone marrow suppression after Ra-223 treatment, with no new AEs identified. This study confirms that in routine clinical practice, Ra-223 AE rates were low, and pts generally received ≥5 doses. Clinical trial information: NCT02141438. [Table: see text]

P3849Baseline profile of patients treated for acute venous thromboembolism in routine clinical practice according to age and renal function in the RE-COVERY DVT/PE global cohort study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
W Ageno ◽  
I B Casella ◽  
C K Han ◽  
S Schellong ◽  
S Schulman ◽  
...  
Keyword(s):  
Renal Function ◽  
Clinical Practice ◽  
Venous Thromboembolism ◽  
Renal Impairment ◽  
Observational Study ◽  
Anticoagulant Therapy ◽  
Patient Characteristics ◽  
Routine Clinical Practice ◽  
Moderate Renal Impairment ◽  
Acute Venous Thromboembolism

Abstract Background Observational studies provide the opportunity to evaluate routine practice without the selection and treatment criteria imposed in randomized clinical trials (RCTs). Purpose Using data from the RE-COVERY DVT/PE global observational study (enrolment January 2016 to May 2017), we describe the baseline profile of patients treated for acute venous thromboembolism (VTE) in routine clinical practice according to age and renal function. Methods Baseline patient characteristics, clinical features (comorbidities/medical history), and anticoagulant therapy were tabulated descriptively for the subgroups of age (<75, ≥75 years) and creatinine clearance (<30, 30 to <50 [moderate impairment], 50 to <80 [mild impairment], ≥80 mL/min). Anticoagulant therapy at baseline and at hospital discharge or 14 days after diagnosis (whichever was later) was recorded. Results In this observational study of 6122 patients with acute deep vein thrombosis, the proportions of patients at baseline who were ≥75 years of age (25.2%) or who had mild to moderate renal impairment (38.1%) were higher than in RCTs of non-vitamin K antagonist oral anticoagulants (NOACs) for acute VTE treatment (∼12–13% elderly and ∼26–29% with mild or moderate renal impairment) (from analyses of the RE-COVER trials; Hokusai-VTE and AMPLIFY). Older patients and those with renal impairment were more often female and were more likely to have comorbidities than the younger or normal renal function groups (Table). At the time of hospital discharge or 14 days after diagnosis, whichever was later, the majority was treated with NOACs (54%). Vitamin K antagonists were prescribed to approximately 1 in 5 patients. The use of NOACs decreased with worsening renal function, whereas the proportions treated with parenteral anticoagulation alone increased in the moderate renal impairment group compared with patients with normal renal function. Conclusion The population treated for acute VTE in routine clinical practice includes more elderly and renally impaired patients than represented in RCTs. These baseline data provide a snapshot of patient characteristics and patterns of anticoagulant therapy. Acknowledgement/Funding Funded by Boehringer Ingelheim

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