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 Six-month therapy of CGRP monoclonal antibodies in real-world clinical practice: an interim analysis of efficacy and safety data

2022 ◽  
pp. 64-70
Author(s):  
N. V. Vashchenko ◽  
A. M. Uzhakhov ◽  
M. V. Bogorodskaya ◽  
D. Z. Korobkova ◽  
Ju. E. Azimova ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Clinical Practice ◽  
Adverse Events ◽  
Chronic Migraine ◽  
Real World ◽  
Safety Data ◽  
Antibody Therapy ◽  
Preventive Therapy ◽  
Efficacy And Safety ◽  
Acute Therapy

Introduction. Migraine is one of the most common disabling neurological disorders. Recently developed monoclonal antibodies to calcitonin gene-related peptide (CGRP) or its receptor are the first targeted medication for preventive therapy of both episodic and chronic migraine. They have been thoroughly investigated in clinical trials; however, there is little data from real-world clinical practice available to date. The aim of this study is to assess the efficacy and safety of 6 months of treatment with erenumab in real-world clinical practice and investigate the effect of the drug on the patients’ sensitivity to medicines for migraine headaches relief and patient satisfaction after treatment.Materials and methods. Our observational cohort prospective study included patients in our Headache Clinic prescribed monoclonal antibodies blocking the  CGRP-receptor  – erenumab. During the  investigation, we evaluated the  previous preventive therapy and its efficacy, the number of days with migraine per month, adverse events occurring during the erenumab treatment, depression and anxiety (HADS), migraine disability (MIDAS), the presence of allodynia (ACS-12) and improved response to acute therapy after treatment. A total of 42 patients participated in the study: 6 men, 36 women, the average age was 43.9 ± 12.2. Of them, 38 patients (90%) had chronic migraine. Thirty-two patients (76%) had previously been prescribed preventive therapy, which proved ineffective, and 10 patients (24%) had not once received any type of migraine prevention.Results. Among our patients, we identified 11 patients with resistant migraine and one patient with refractory migraine. During the study, two patients dropped out due to adverse events (constipation). Thirty patients continued the administration of erenumab 70 mg for at least six months. The average number of migraine days per month before treatment was 22.8, and after six months of treatment, it dropped to 7.3. Twenty-nine patients (72.5%) also noted that the response to acute headache treatment improved after the therapy.Conclusion. The results of our study are consistent with the international experience of using erenumab and confirm its effectiveness for migraine preventive therapy, including difficult-to-treat migraine cases. However, further studies with more participants and evaluation of predictors of successful monoclonal antibody therapy are still needed.

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

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.

scholarly journals Calcitonin Gene–Related Peptide Monoclonal Antibody Versus Botulinum Toxin for the Preventive Treatment of Chronic Migraine: Evidence From Indirect Treatment Comparison

2021 ◽  
Vol 12 ◽  
Author(s):  
Jiajie Lu ◽  
Quanquan Zhang ◽  
Xiaoning Guo ◽  
Wei Liu ◽  
Chunyang Xu ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Botulinum Toxin ◽  
Adverse Events ◽  
Chronic Migraine ◽  
Preventive Treatment ◽  
Efficacy And Safety ◽  
Indirect Treatment Comparison ◽  
Treatment Comparison ◽  
Calcitonin Gene ◽  
Indirect Treatment

Background: The previously approved botulinum toxin and nowadays promising calcitonin gene-related peptide (CGRP) monoclonal antibody have shown efficacy for preventing chronic migraine (CM). However, there is no direct evidence for their relative effectiveness and safety. In this study, we conducted an indirect treatment comparison to compare the efficacy and safety of CGRP monoclonal antibody with botulinum toxin for the preventive treatment of chronic migraine.Methods: Up to August 31, 2020, we systematically searched PubMed, Embase, and Cochrane Library Central Register of Controlled Trials (Central). Weighted mean difference (WMD) and relative risk (RR) were used to evaluate clinical outcomes. Indirect treatment comparison (ITC) software was used to conduct indirect treatment comparison.Results: Ten studies were pooled with 6,325 patients in our meta-analysis. Both botulinum toxin and CGRP monoclonal antibody demonstrated favorable efficacy in the change of migraine days, headache days, HIT-6 score, and 50% migraine responder rate compared with placebo. In indirect treatment comparison, CGRP monoclonal antibody was superior to botulinum toxin in the frequency of acute analgesics intake (WMD = −1.31, 95% CI: −3.394 to 0.774, p = 0.02113), the rate of treatment-related adverse events (AEs) (RR = 0.664, 95% CI: 0.469 to 0.939, p = 0.04047), and the rate of treatment-related serious adverse events (RR = 0.505, 95% CI: 0.005 to 46.98, p &lt; 0.001).Conclusion: For chronic migraine patients, CGRP monoclonal antibody was slightly better than botulinum toxin in terms of efficacy and safety. In the future, head-to-head trials would be better to evaluate the efficacy and safety between different medications in the prevention of chronic migraine.

scholarly journals Serum CGRP, VIP, and PACAP Usefulness in Migraine: A Case-Control Study in Chronic Migraine Patients in Real Clinical Practice.

2020 ◽  
Author(s):  
Sara Pérez Pereda ◽  
María Toriello-Suárez ◽  
Gonzalo Ocejo-Vinyals ◽  
Sandra Guiral-Foz ◽  
Jesús Castillo-Obeso ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Chronic Migraine ◽  
Serum Levels ◽  
Diagnostic Value ◽  
Episodic Migraine ◽  
Medical Centers ◽  
Calcitonin Gene ◽  
Multinomial Modeling ◽  
Global Accuracy ◽  
Real Clinical Practice

Abstract Background: Calcitonin gene-related peptide (CGRP), vasoactive intestinal peptide (VIP) and pituitary adenylate cyclase activating polypetide-38 (PACAP-38) have relevant roles in migraine pathophysiology. Their serum levels have been proposed as biomarkers for migraine. Our aim was to assess their diagnostic value in real clinical practice in a cohort of chronic migraine (CM), episodic migraine (EM) and healthy controls (HC).Methods: We recruited subjects with CM, EM and HC at two medical centers. Blood samples were drawn under fasting conditions in the interictal period, immediately centrifuged and stored at -80º C. Serum levels were determined by ELISA. Neuropeptide levels, the effect of preventatives, correlations with clinical and demographic variables, and their diagnostic value were studied among clinical categories.Results: 296 age- and sex-matched subjects (101 CM, 98 EM and 97 HC) were included. All three neuropeptide serum levels were higher in CM [median and IQ for CGRP= 18.023 pg/ml (14.4-24.7); VIP= 121.732 pg/ml (48.72-186.72) and PACAP= 204.931 pg/ml (101.08-597.64)] vs EM [CGRP = 14.659 pg/ml (10.29-17.45); VIP = 75.603 pg/ml (28.722-107.10); and PACAP = 94.992 pg/ml (65.77-128.48)] and vs HC [CGRP = 13.988 pg/ml (10.095-17.87); VIP = 84.685 pg/ml (35.32-99.79), and PACAP = 103.142 pg/ml (59.42-123.97)]. Using multinomial modeling, only VIP (OR 1.011, 95% CI=1.003-1.018, p=0.005) and PACAP (OR=1.003, 95% CI=1.001-1.005, p=0.002) increased the risk for CM, but not for EM. CGRP did not predict CM or EM. This model could correctly classify only 62/101 (61.38%) of CM, 75/98 (76.53%) of EM, and 5/97 (4.12%) of HC [globally 147/296 (49.8%)]. Individually, PACAP performed the best for classifying clinical categories [global accuracy 150/296 (50.67%)]. In CM, neuropeptide levels were higher in those OnaBT-treated than in no-treated patients.Conclusions: Although interictal serum CGRP and VIP were higher in CM than both EM or HC, their utility to discriminate migraine categories was low. Contrary to other studies, PACAP serum levels were also higher in CM than in EM or HC and had more discriminative capability to distinguish CM from EM and HC. Further investigation is needed for determination technique standardization.

Safety and tolerability of calcitonin-gene-related peptide binding monoclonal antibodies for the prevention of episodic migraine – a meta-analysis of randomized controlled trials

Cephalalgia ◽  
2019 ◽  
Vol 39 (9) ◽  
pp. 1164-1179 ◽  
Author(s):  
Da Xu ◽  
Deng Chen ◽  
Li-na Zhu ◽  
Ge Tan ◽  
Hai-jiao Wang ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Adverse Events ◽  
Injection Site ◽  
Meta Analysis ◽  
Peptide Binding ◽  
Episodic Migraine ◽  
Calcitonin Gene Related Peptide ◽  
Serious Adverse Events ◽  
Related Peptide ◽  
Calcitonin Gene

Aim To systematically evaluate the safety and tolerability of calcitonin-gene-related peptide binding monoclonal antibodies from the results of randomized controlled trials. Methods Online databases were searched on calcitonin-gene-related peptide binding monoclonal antibodies for the prevention of episodic migraine. Overall withdrawal, withdrawal due to adverse events, adverse events, serious adverse events and specific adverse events were extracted from the included studies. A meta-analysis was performed with Revman 5.3.0 software. Results Ten studies that investigated four drugs (galcanezumab, erenumab, fremanezumab and eptinezumab) with 5817 participants were included in this study. Serious adverse events, overall withdrawals, withdrawal due to adverse events and any adverse events were not significantly associated with monoclonal antibody treatment. Injection site pain and erythema were significantly higher in the calcitonin-gene-related peptide binding monoclonal antibodies treatment group than in the placebo group. The rates of serious adverse events were significantly higher in the galcanezumab 120 mg group. Injection site erythema was associated with galcanezumab 120 mg and 240 mg. Injection site pain and nasopharyngitis were associated with galcanezumab 150 mg and 5 mg, respectively. Overall adverse events were significantly higher with erenumab 70 mg and 140 mg. Treatment-related adverse events were significantly higher with fremanezumab 225 mg/month and 675 mg/quarter. Conclusions This study provides data on the safety and tolerability profiles of calcitonin-gene-related peptide binding monoclonal antibodies and confirms their potential use as preventive treatments for episodic migraine. In addition to the acceptable withdrawal rates, serious adverse events were rare, and the severity of most adverse events was mild to moderate. Injection site reaction may be the major adverse event associated with galcanezumab.

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
Sign in / Sign up

Export Citation Format

Share Document