Physicians' Opinions on the Required Information about Biosimilars and the Need for Biosimilars Related Education

Nehad J. Ahmed

Aim: The aim of this study was to investigate physicians' opinions on the required information about biosimilars and the need for biosimilars related education. Methodology: The study included a survey that was prepared using a survey from a previous study and after face validation and content validation, it was prepared as an online form using the SurveyMonkey platform. Results: The majority of physicians stated that the most important information about biosimilars are studies that provide clinical immunogenicity data for the biosimilar and reference product (93.33%) in addition to studies that directly compare clinical efficacy and safety between reference products and biosimilars (88.89%). The majority of physicians stated that tracking safety events with biosimilars (94.45%) and access to information on studies comparing biosimilars with reference biologics (91.11%) are important issues related to biosimilars in professional environments. Conclusion: The present study highlights the needs of physicians for biosimilar education. More efforts are needed to increase the awareness regarding biosimilars by different formats in order to integrate biosimilars into clinical practice and to counsel patients about biosimilars.

D. P. Kamilova ◽  
M. M. Ovchinnikova ◽  
E. Sh. Ablyaeva ◽  
M. M. Leviashvili ◽  
N. S. Stuleva ◽  

Introduction. The efficacy and safety of biosimilar follitropin alpha have been demonstrated in randomized, blinded, prospective clinical trials of phases I and III. Unfortunately, there is a gap between the clinical trials and real clinical practice data. The real-world patient data helps to create an evidence-based background for successful implementation of a medicine at everyday practice in a nonselected population.Aim: to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.Materials and Methods. A retrospective observational anonymized cohort study of follitropin alpha biosimilar as a pre-filled pen injector with a dose adjustment of 5 IU (Primapur®), aimed at investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART). The ovarian stimulation (OS) protocols included: monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists gonadotropin-releasing hormone (GnRH) antagonist and long protocols with GnRH agonists. The stimulation protocols analyzed where Primapur® was applied for at least 5 days.Results. The overall clinical efficacy of ovarian stimulation cycles (N = 5484) was: oocytes retrieved – 9.5 ± 7.2, mature (MII) – 6.8 ± 6.6, fertilized (2PN) – 6.1 ± 5.8, clinical pregnancy per ET (PR) – 38.4 %. Mixed gonadotropin protocols (N = 2625) vs. monotherapy with Primapur® (N = 2859): oocytes retrieved – 8.6 ± 6.8 vs. 10.3 ± 7.4 (p < 0.001), mature (MII) – 6.7 ± 6.2 vs. 7.7 ± 6.9 (p < 0.001), fertilized (2PN) – 5.8 ± 5.2 vs. 7.2 ± 6.2 (p < 0.001). There were statistically significant differences between oocyte yields in mixed vs. monotherapy protocols due to subgroup differences, including age, body mass index (BMI) and IVF/ICSI attempts. No statistically significant differences were found for PR: 39.3 % vs. 37.6 % (p = 0.314). Monotherapy protocols with GnRH antagonist OS (N = 2183) vs. GnRH agonist (N = 676) revealed: oocytes retrieved – 10.5 ± 7.5 vs. 9.6 ± 7.0 (p = 0.032), mature (MII) – 7.6 ± 6.9 vs. 6.7 ± 5.7 (p < 0.001), fertilized (2PN) – 7.3 ± 6.3 vs. 5.7 ± 5.0 (p < 0.001). There were statistically significant differences between BMI and IVF/ICSI attempts. No statistically significant differences were found for PR: 37.9 % vs. 35.9 % (p = 0.482). All medicines were well tolerated and no serious adverse reactions were reported.Conclusion. This was the largest retrospective observational study conducted in the field of fertility in Russia and involved 5484 ovarian stimulation protocols at 35 IVF clinics. The obtained results demonstrated similar clinical efficacy for follitropin alpha biosimilar Primapur® in different OS protocols in real clinical practice.

Flávia Oliveira de Almeida Marques da Cruz ◽  
Elaine Barros Ferreira ◽  
Christiane Inocêncio Vasques ◽  
Luciana Regina Ferreira da Mata ◽  
Paula Elaine Diniz dos Reis

Abstract Objective: develop the content and face validation of an educative manual for patients with head and neck cancer submitted to radiation therapy. Method: descriptive methodological research. The Theory of Psychometrics was used for the validation process, developed by 15 experts in the theme area of the educative manual and by two language and publicity professionals. A minimum agreement level of 80% was considered to guarantee the validity of the material. Results: the items addressed in the assessment tool of the educative manual were divided in three blocks: objectives, structure and format, and relevance. Only one item, related to the sociocultural level of the target public, obtained an agreement rate <80%, and was reformulated based on the participants' suggestions. All other items were considered appropriate and/or complete appropriate in the three blocks proposed: objectives - 92.38%, structure and form - 89.74%, and relevance - 94.44%. Conclusion: the face and content validation of the educative manual proposed were attended to. This can contribute to the understanding of the therapeutic process the head and neck cancer patient is submitted to during the radiation therapy, besides supporting clinical practice through the nursing consultation.

2020 ◽  
Vol 6 (2) ◽  
pp. 209-213

To investigate the clinical efficacy and safety of apatinib in combination with oral VP-16 for the treatment of chemotherapy-resistant advanced ovarian carcinoma. Twenty-seven advanced ovarian carcinoma patients were treated with oral VP-16 chemotherapy combined with oral apatinib mesylate (500 mg/d). CA125, VEGF, and CEA were examined every 3-4 weeks, and tumour changes were monitored by CT every 8-12 weeks. PFS was obtained by follow-up after discharge. For all patients, the ORR (including CR and PR) was 25.0%, and the DCR (including CR, PR and SD) was 75.0%. CEA and CA199 significantly decreased (p<0.05), but the decrease in VEGF was not significant. The average PFS was 5.13 months. The ECOG score had a significant effect on PFS (p<0.05), while there were no significant differences in PFS based on age (p=0.394). The main side effects of this regimen were hypertension, proteinuria, hand-foot syndrome and myelosuppression, which were tolerated by patients after active symptomatic treatment. Apatinib combined with oral VP-16 is an effective regimen for the treatment of chemotherapy-resistant advanced ovarian cancer. This combination therapy should be widely used in clinical practice.

2021 ◽  
Vol 5 (4) ◽  
pp. 196-199
M.V. Khruslov ◽  
A.S. Sorokina ◽  
Yu.A. Sapel'nikova ◽  
T.V. Vavilova ◽  

Aim: to assess the efficacy and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AFib) in real-world clinical practice. Patients and Methods: this non-interventional prospective study enrolled 356 patients aged 50-75 years with AFib and creatinine clearance ≥50 ml/min. All patients were divided into three age-matched groups based on DOACs prescribed. Group 1 patients (n=120) received rivaroxaban 20 mg daily. Group 2 patients (n=112) received dabigatran etexilate 150 mg twice daily. Group 3 patients (n=124) received apixaban 5 mg twice daily. The groups were comparable in comorbidities and the risks of thrombotic and hemorrhagic complications. Followup was 2 years after starting treatment. Thrombotic complications, massive bleedings, and death for any reason were considered end-points. Results: no significant differences in the rate of cardiogenic thrombotic complications between the groups were reported. In patients who received apixaban, fewer bleeding complications were diagnosed (insignificant differences). Conclusions: the efficacy and safety of DOACs in patients over 50 years are similar. KEYWORDS: atrial fibrillation, oral anticoagulants, thrombotic complications, infarction, stroke, bleedings. FOR CITATION: Khruslov M.V., Sorokina A.S., Sapel'nikova Yu.A., Vavilova T.V. Clinical efficacy and safety of direct oral anticoagulants in patients with atrial fibrillation in real-world clinical practice. Russian Medical Inquiry. 2021;5(4):196–199 (in Russ.). DOI: 10.32364/2587-6821-2021-5-4-196-199.

2015 ◽  
Vol 42 (5) ◽  
pp. 786-793 ◽  
Nobunori Takahashi ◽  
Toshihisa Kojima ◽  
Atsushi Kaneko ◽  
Daihei Kida ◽  
Yuji Hirano ◽  

Objective.Our study aimed to evaluate the longterm efficacy and safety of abatacept (ABA), and to explore factors that increase its longterm efficacy in patients with rheumatoid arthritis (RA) treated in routine clinical practice.Methods.There were 231 participants with RA treated with ABA who were prospectively registered in a Japanese multicenter registry. They were followed up for at least 52 weeks.Results.Mean age of the patients was 64.3 years, mean disease duration was 12.1 years, mean 28-joint Disease Activity Score (DAS28)-C-reactive protein was 4.49, and 48.5% of patients were concomitantly treated with methotrexate (MTX). Overall retention rate of ABA was 77.1% at 52 weeks; 14.8% of patients discontinued because of inadequate response and 3.5% because of adverse events. The proportion of patients achieving DAS28-defined low disease activity (LDA) significantly increased from baseline to 52 weeks (7.3% to 43.8%, p < 0.01); 40.9% of patients who did not achieve LDA at 24 weeks had more than 1 categorical improvement in DAS28-defined disease activity at 52 weeks. Multivariate logistic regression revealed concomitant MTX use to be an independent predictor of the categorical improvement in DAS28-defined disease activity from 24 to 52 weeks (adjusted OR 3.124, p = 0.010).Conclusion.In routine clinical practice, ABA demonstrated satisfactory clinical efficacy and safety in patients with established RA for 52 weeks. The clinical efficacy of ABA increased with time even after 24 weeks, and this was strongly influenced by concomitant MTX use. Our study provides valuable real-world findings on the longterm management of RA with ABA.

2016 ◽  
Vol 13 (3) ◽  
pp. 49-50
O G Elisyutina ◽  
O V Shtyrbul

Levocetirizine is an effective H1-blocker of histamine receptors in complex treatment of various allergic diseases. The article presents the literature data and own observational data on clinical efficacy and safety of levocetirizine in the treatment of allergic diseases such as allergic rhinitis, bronchial asthma, allergic dermatoses.

2016 ◽  
Vol 2 (1) ◽  
pp. 51 ◽  
Mohammad S Alzahri ◽  
Anita Rohra ◽  
W Frank Peacock ◽  

The purpose of this article is to review the clinical efficacy and safety of nitrates in acute heart failure (AHF) by examining various trials on nitrates in AHF. Management of AHF can be challenging due to the lack of objective clinical evidence guiding optimal management. There have been many articles suggesting that, despite a benefit, nitrates are underused in clinical practice. Nitrates, when appropriately dosed, have a favourable effect on symptoms, blood pressure, intubation rates, mortality and other parameters.

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