scholarly journals AB0210 COMPARISON OF EFFICACY AND SAFETY OF BIOSIMILAR RITUXIMAB AND ORIGINATOR RITUXIMAB IN REAL CLINICAL PRACTICE

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1131.2-1131
Author(s):  
D. Kusevich ◽  
Y. Olyunin ◽  
E. Nasonov
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Normal Distribution ◽  
Group Treatment ◽  
Repeated Administration ◽  
Continuous Variables ◽  
Efficacy And Safety ◽  
The Third ◽  
Baseline Examination ◽  
Real Clinical Practice

Background:Due to the expiration of many originator biologics patents, their biosimilars (BS) have appeared and were put into clinical practice. The introduction of such drugs reduces the cost of treatment and thereby increases its availability. BS rituximab (RTX) Acellbia was developed by the Russian company “BIOCAD”. Its effectiveness and safety have been proven in two clinical trials. It was licensed in Russia for the treatment of rheumatoid arthritis (RA) in 2017.Objectives:To compare efficacy and safety of BSRTX and originator RTX (ORTX) in real clinical practice.Methods:RA patients fulfilling the EULAR/ACR 2010 criteria and followed-up at the V. A. Nasonova Research Institute of Rheumatology were included. All of them had previously received methotrexate without effect. They were divided into 4 groups. The first and second groups included patients who had not previously received biologics. Treatment with BSRTX was started in the first group, ORTX was administered in the second group. The third and fourth groups included patients who received ORTX with significant improvement. Patients of the third group were switched to BSRTX, in the fourth group treatment with ORTX was continued. ORTX and BSRTX were administered twice 500 mg over 2 weeks. The indication for repeated administration of ORTX and BSRTX was an exacerbation of RA. Patients were examined before the first or regular administration of ORTX or BSRTX and before the planned repeat course of treatment with these drugs. RA activity was evaluated with the DAS28. Adverse events (AE) were recorded. Data were tested for normality using the Kolmogorov-Smirnov test. Continuous variables are presented as mean ±SD if they obey normal distribution, and as median [quartile interval] if they were not consistent with normal distribution. Mann–Whitney U test was used for comparison between groups.Results:127 patients with RA were included. 66 patients had not previously received biologics. BSRTX was started in 35 of them and ORTX – in 31. 61 patients already received ORTHX with clinical improvement. 31 of them were switched to BSRTX, and 30 continued therapy with ORTX. The median interval between the baseline examination and the assessment before the second treatment course in the BSRTX group was 6 [5; 13] months, in the ORTX group – 7 [7; 11] months. In group 1 median DAS28 during follow-up decreased from 5,8 [5,2; 6,9] to 3,9 [3,1; 4,5], in group 2 – from 5,7 [5,2; 6,0] to 4,1 [3,8; 4,6], respectively. These changes were comparable in both groups. The mean duration of the interval between infusion of BSRTX or ORTX and repeated examination – 11,3±8,2 and 10,1±4,8 months, respectively. These differences are not significant. In group 3 median DAS28 at the baseline examination was 5,1 [3,9; 5,9], at the second one – 4,3 [3,8; 5,3], in group 4 – 4,6 [3,7; 5,4] and 4,2 [3,5; 5,2] respectively. These values did not differ significantly. The frequency and nature of adverse events during treatment with ORTX and BSRTX did not significantly differ. We did not observe serious AE and unexpected AE.Conclusion:The results of the present study show that efficacy and safety of BSRTX and ORTX were comparable when they were used as the first biologics and when switching from ORTX to BSRTX. BSRTX can be used in routine clinical practice for the treatment of RA.Disclosure of Interests:None declared

Efficacy and safety of anti-CGRP(r) monoclonal antibodies in real clinical practice: preliminary analysis after three months of therapy

2021 ◽  
Vol 13 (6) ◽  
pp. 62-66
Author(s):  
V. N. Vashchenko ◽  
D. Z. Korobkova ◽  
K. V. Skorobogatykh ◽  
Yu. E. Azimova
Keyword(s):  
Monoclonal Antibodies ◽  
Clinical Practice ◽  
Adverse Events ◽  
Chronic Migraine ◽  
Medication Overuse Headache ◽  
Efficacy And Safety ◽  
Cutaneous Allodynia ◽  
Calcitonin Gene ◽  
Headache Diary ◽  
Real Clinical Practice

Monoclonal antibodies inhibiting calcitonin gene related peptide (CGRP) or its receptor have been widely used for migraine prophylactic therapy for the past three years. Evaluation of their efficacy and safety of therapy in real clinical practice is needed.Objective: to evaluate the efficacy and safety of Erenumab, a monoclonal antibody inhibiting the CGRP receptor during three months of therapy.Patients and methods. Sixty-eight patients (58 women and 10 men, mean age 37±10.4 years) with episodic or chronic migraine who were treated with Erenumab were observed. Patients were assessed with MIDAS, WPAI, and HADS scales; the presence of cutaneous allodynia was evaluated with ASC-12 questionnaire. Patients kept a headache diary and marked adverse events during the whole treatment period.Results and discussion. 47 patients (69%) had chronic migraine and 32 (71.9%) had medication overuse headache. In 48 patients (70%) after 3 injections of Erenumab the number of days with migraine decreased by 50% or more. In 7 patients (10%), the reduction in headache days was more than 75%; 20 (29%) did not experience sufficient effect after three months of therapy. Nineteen adverse events were noted in 15 (22%) patients. Severe constipation led to discontinuation of treatment in two patients (3%).Conclusion. The study showed the efficacy and safety of Erenumab for migraine prophylaxis in both patients with episodic and chronic migraine.

scholarly journals Experience of using a genetically engineered biological drug biosimilar in patients with rheumatoid arthritis in real clinical practice

2020 ◽  
Vol 4 (8) ◽  
pp. 492-497
Author(s):  
E.V. Zhilyaev ◽  
◽  
E.N. Koltsova ◽  
E.I. Shmidt ◽  
K.A. Lytkina ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Practice ◽  
Adverse Events ◽  
Treatment Efficacy ◽  
Genetically Engineered ◽  
Efficacy And Safety ◽  
Biological Drug ◽  
Therapy Regimen ◽  
Switching Therapy ◽  
Real Clinical Practice

The article presents the data of the Moscow Unified Arthritis Register (MUAR) and the results of rituximab therapy in patients with rheumatoid arthritis (RA).Aim: to evaluate the efficacy and safety of switching from the original rituximab (MabThera®) to its biosimilar (Acellbia®) in patients with RA in real clinical practice.Patients and Methods: patients with RA, included in MUAR register, were evaluated with an assessment of therapy efficacy and safety with the original rituximab (MabThera®), as well as after switching to the rituximab biosimilar (Acellbia®). A standard examination was performed to determine the number of swollen and tender joints, erythrocyte sedimentation rate, and C-reactive protein. Treatment efficacy was assessed using the DAS28 composite index, HAQ-DI (Health Assessment Questionnaire Disability Index) and RAPID-3 (Routine Assessment of Patient Index Data 3). In terms of safety, adverse events were recorded based on patient reports.Results: switching therapy regimen of 46 patients with RA from the original rituximab to the biosimilar was not accompanied by a decrease in the treatment efficacy. There was statistically significant increase in the proportion of the patients with low disease activity (DAS28<3.2) from 39.1% to 52.2% and remission (DAS28<2.6) from 17.4% to 23.9%, respectively. Further positive dynamics of HAQ-DI and RAPID-3 indices were noted. According to the authors, the increase in the frequency of a positive response to the treatment was associated with the duration of rituximab use in general. The frequency of adverse events during therapy with the original rituximab and its biosimilar was comparable: 9.22 and 10.9 per 100 patient years respectively.Conclusion: there were no significant differences between the original rituximab and its biosimilar. The results of switching therapy regimen of patients with RA from the original rituximab (MabThera®) to its biosimilar (Acellbia®), observed in real clinical practice, confirm their therapeutic equivalence.KEYWORDS: rheumatoid arthritis, rituximab, biosimilar, real clinical practice.FOR CITATION: Zhilyaev E.V., Koltsova E.N., Shmidt E.I. et al. Experience of using a genetically engineered biological drug biosimilar in patients with rheumatoid arthritis in real clinical practice. Russian Medical Inquiry. 2020;4(8):492–497. DOI: 10.32364/2587-6821-2020-4-8-492-497.

Efficacy and safety of ustekinumab in real clinical practice. Retrospective multicentre study. ARAINF cohort

2020 ◽  
Vol 43 (3) ◽  
pp. 126-132
Author(s):  
Diego Casas Deza ◽  
Santiago García López ◽  
Miguel Lafuente Blasco ◽  
Raquel Vicente Lidón ◽  
Juan Nerín de la Puerta ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Multicentre Study ◽  
Efficacy And Safety ◽  
Real Clinical Practice

Efficacy and safety of tofacitinib for moderate and severe ulcerative colitis in real clinical practice: an open observational prospective study

Pharmateca ◽  
2020 ◽  
Vol 2_2020 ◽  
pp. 38-44
Author(s):  
O.V. Knyazev Knyazev ◽  
T.V. Shkurko Shkurko ◽  
A.V. Kagramanova Kagramanova ◽  
A.A. Lishchinskaya Lishchinskaya ◽  
D.S. Bordin Bordin ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Practice ◽  
Prospective Study ◽  
Efficacy And Safety ◽  
Severe Ulcerative Colitis ◽  
Observational Prospective Study ◽  
Real Clinical Practice

scholarly journals Management of Chemoradiation-Induced Mucositis in Head and Neck Cancers With Oral Glutamine

2016 ◽  
Vol 2 (4) ◽  
pp. 200-206 ◽  
Author(s):  
Lucy Pattanayak ◽  
Niharika Panda ◽  
Manoj Kumar Dash ◽  
Sumita Mohanty ◽  
Sagarika Samantaray
Keyword(s):  
Squamous Cell Carcinoma ◽  
Head And Neck Cancer ◽  
Adverse Events ◽  
Head And Neck ◽  
Tube Feeding ◽  
Negative Control ◽  
Head And Neck Cancers ◽  
Glutamine Supplementation ◽  
Efficacy And Safety ◽  
The Third

Purpose Head and neck cancers are the third most common cancers worldwide. Oral mucositis is the most common toxicity seen in patients who receive chemoradiation to treat head and neck cancer. The aim of this study was to evaluate the efficacy and safety of oral glutamine supplementation in these patients. Materials and Methods From December 2013 to December 2014, we randomly assigned to two arms 162 patients who had squamous cell carcinoma of the head and neck. Patients in arm A were given oral glutamine once per day, whereas those in arm B served as negative control subjects. All patients received radiotherapy given as 70 Gy in 35 fractions over 7 weeks with an injection of cisplatin once per week. Patients were assessed once per week to evaluate for the onset and severity of mucositis, pain, use of analgesics, and for Ryle tube feeding. Results We observed that 53.1% of patients developed mucositis toward the fifth week in the glutamine arm compared with 55.5% of patients in the control arm at the third week. None in the glutamine arm compared with 92.35% of patients in the control arm developed G3 mucositis. Rates of adverse events like pain, dysphagia, nausea, edema, and cough, as well as use of analgesics and Ryle tube feeding, were significantly lower in the glutamine arm than in the control arm. Conclusion This study highlights that the onset as well as the severity of mucositis in patients receiving glutamine was significantly delayed. None of the patients receiving glutamine developed G3 mucositis. Hence, the findings emphasize the use of oral glutamine supplementation as a feasible and affordable treatment option for mucositis in patients with head and neck cancers who are receiving chemoradiation.

scholarly journals Effectiveness of inhaled corticosteroids and long-acting β-agonists combinations in real clinical practice: results of a multicenter cross-sectional study in Russian patients with asthma

2021 ◽  
Vol 31 (5) ◽  
pp. 613-626
Author(s):  
Vladimir V. Arkhipov ◽  
Zaurbek R. Aisanov ◽  
Sergey N. Avdeev
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Asthma Control ◽  
Inhalation Technique ◽  
Adherence To Treatment ◽  
Uncontrolled Asthma ◽  
Cross Sectional ◽  
Long Acting ◽  
Adherence To Therapy ◽  
Real Clinical Practice

Asthma management approaches are improving yearly, but the problem of asthma control is still acute. Combinations of inhaled glucocorticosteroids (ICS) and long-acting β2-agonists (LABA) play a crucial role in asthma therapy, but their effectiveness in real practice can be insufficient, and asthma control level in the population remains low. Optimizing the use of these drugs, changing the usual therapy regimens, and implementing upgraded inhalers can improve adherence to treatment and inhalation technique, which affects the effectiveness of the therapy.The study aimed to describe the key characteristics of the patient population getting asthma treatment in real clinical practice and assess factors influencing asthma control, including adherence to therapy.Methods. A single-stage cross-sectional observational study in 124 primary health care centers in 22 cities of the Russian Federation included 3,214 patients > 18 years old, with a clinical diagnosis of asthma for at least 1 year, who were able to perform a spirometry test and fill out the ACQ-5 and TAI-12 questionnaires.Results. Assessment of asthma control with the ACQ-5 questionnaire showed that most patients had uncontrolled asthma (56%). Controlled and partially controlled asthma was diagnosed in 21 and 19% of patients, respectively. 4% of patients had severe uncontrolled asthma. The TAI questionnaire revealed low adherence to therapy in more than half of the patients (53.6%). The rate of patients with controlled asthma and the average annual frequency of exacerbations were significantly lower in subgroups of patients who received therapy with extrafine ICS/LABA and ICS/formoterol in single inhaler regimen, compared with controller therapy using fixed and free combinations of ICS and LABA.Conclusion. The main causes of insufficient asthma control are low adherence to treatment, inhalation errors, monotherapy with ICS, asthma with small airways dysfunction, and adverse events associated with ICS. Prescribing the combinations of ICS/LABA in the form of extra-fine aerosol and using it in the Maintenance and Reliever Therapy (MART) regimen can significantly increase asthma control, reduce the risk of adverse events, and increase patient adherence to treatment. A potential alternative to improve asthma control is administering ICS-LABA combinations once daily.

scholarly journals Comprehensive assessment of the pharmacokinetic properties of a single bolus dose of colecalciferol in terms of efficacy and safety

2019 ◽  
Vol 22 (1) ◽  
pp. 4-9
Author(s):  
Liudmila A. Suplotova ◽  
Valeria A. Avdeeva ◽  
Ekaterina A. Pigarova ◽  
Liudmila Y. Rozhinskaya
Keyword(s):  
Vitamin D ◽  
Clinical Practice ◽  
Adverse Events ◽  
Vitamin D Deficiency ◽  
Calcium Metabolism ◽  
Bolus Dose ◽  
Efficacy And Safety ◽  
Single Bolus ◽  
Pharmacokinetic Properties ◽  
Single Bolus Dose

Background: The lack of a unified approach to the treatment of deficiency and vitamin D deficiency stimulated a detailed study of the dynamics of indicators of phosphorus-calcium metabolism, parathyroid hormone, 25(OH)D (calcidiol). Aim: To evaluate the pharmacokinetic properties of colecalciferol at a dosage of 150 000 IU, from the standpoint of its efficacy and safety in clinical practice. Materials and methods: Observational, single-center, prospective, selective, uncontrolled study of a comprehensive assessment of the pharmacokinetic properties of a single saturating dose of 150 000 IU of colecalciferol. To assess the pharmacokinetic properties of colecalciferol at a dosage of 150 000 IU, we set efficacy and safety criteria. The criterion for the effectiveness of treatment was to achieve an adequate level of vitamin D (more than 30 ng / ml at the initial insufficient level and more than 20 ng / ml for patients with vitamin D deficiency). The safety criteria for the correction of vitamin D deficiency or deficiency were the absence of patient complaints, adverse events and / or serious adverse events, as well as the preservation of the main laboratory parameters of phosphorus-calcium metabolism within the reference values. Results: When studying the efficacy of a dose of 150 000 IU in patients with vitamin D deficiency and insufficiency, it was found that the level of calcidiol was significantly higher in the group after treatment with colecalciferol compared with the group before treatment (p 0.05). The peak of the maximum value for patients with deficiency was established on the 14 day from the moment of administration of colecalciferol and was 37.1 6.28 ng / ml, and for patients with initial vitamin D deficiency 40.1 3.71 ng / ml. In the study of the safety of colecalciferol in a bolus dose of 150 000 IU, there were no statistically significant differences in the laboratory parameters of calcium-phosphorus metabolism, both in the group before treatment and after correction of deficiency and vitamin D insufficiency in both groups. Conclusion: Colecalciferol in the form of a single bolus dose of 150 000 IU demonstrated its efficacy and safety in real clinical practice.

scholarly journals Analysis of the use of a selective modulator of cosmulation of T‑lymphocytes abatacept in the treatment of rheumatoid arthritis: data from international clinical practice

2019 ◽  
Vol 1 (18) ◽  
pp. 13-23
Author(s):  
M. A. Borisova ◽  
G. V. Lukina
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Practice ◽  
T Lymphocytes ◽  
International Studies ◽  
Efficacy And Safety ◽  
Rheumatoid Arthritis Data ◽  
Real Clinical Practice

This article presents the results of international studies of abatacept efficacy and safety and searching for possible predictors of a good response to the therapy with this drug in real clinical practice.

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