Analysis of comorbid conditions and tolerability of treatment with genetically engineered biological drugs and methotrexate in patients with psoriasis

Pharmateca ◽  
2021 ◽  
Vol 8_2021 ◽  
pp. 20-26
Author(s):  
S.E. Zhufina Zhufina ◽  
K.A. Fomin Fomin ◽  
E.V. Svechnikova Svechnikova ◽  
◽  
Keyword(s):  
Genetically Engineered ◽  
Comorbid Conditions ◽  
Biological Drugs

scholarly journals THU0206 А VERY EARLY (7-28 DAYS) RESPONSE ON JAK INHIBITOR TOFACITINIB IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS: EFFECT ON PAIN AND CENTRAL SENSITIZATION.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 327.3-327
Author(s):  
A. Karateev ◽  
E. Filatova ◽  
E. Pogozheva ◽  
V. Amirdzhanova ◽  
E. Nasonov ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Central Sensitization ◽  
Early Time ◽  
National Registry ◽  
Genetically Engineered ◽  
Pain Severity ◽  
Signal Pathways ◽  
Jak Inhibitor ◽  
Jak Inhibitors ◽  
Biological Drugs

Background:The presence of central sensitization (CS) significantly burdens the course of rheumatoid arthritis (RA). JAK inhibitors block intracellular signal pathways including the ones responsible for synthesis of mediators and cytokines causing pain and CS. The application of JAK inhibitors is supposed to relieve pain and reduce CS severity promptly.Objectives:To evaluate JAK inhibitor effect on pain and signs of CS in patients with active RA 7 and 28 days after the start of therapy.Methods:Study group included 39 patients with RA, their age was 50.9±11.1, 79.5% of women, 89.7% of RF “+”, DAS28 5.8±0.6, receiving DMARDs (methotrexate 82.0% and leflunomide 18.0%), who were administered with tofacitinib 5 mg 2 times a day due to inefficiency or intolerance of genetically engineered biological drugs. There were assessed the pain severity using Brief pain inventory (BPI) questionnaire, the presence of neuropathic pain component (NPC) using PainDETECT questionnaire and signs of CS using Central Sensitisation Inventory (CSI) questionnaire at early time after tofacitinib administration.Results:Patients initially experienced a severe pain – 5.72±2.21 according to the visual analogue scale (VAS), 53.8% had signs of central sensitization (CSI ≥ 40), 17.9% had NPC (PainDETECT ≥18). 7 days after tofacitinib intake there was statistically reliable reduction of pain severity – up to 4.37±2.2 (р=0.01), pain decrease of 29.4±17.9% (BPI), NCP – PainDETECT from 12.9±5.5 to 10.6±5.6 (р=0.047) and CS – CSI from 43.1±12.8 to 35.9±11.2 (р=0.01). The effect had increased after 28 days: pain level (VAS) was 2.84±1.57 (р=0.000), pain decrease of 43.6±29.6% (BPI), PainDETECT 29.8±12.4 (р=0.000), CSI 26.4±13.9 (р=0.000).During this period there were no serious adverse reactions.Conclusion:The application of JAK inhibitor tofacitinib allows to reach a fast analgesic effect, also due to impact on CS and NCP.Source: National Registry patients with RADisclosure of Interests: :Andrey Karateev: None declared, Ekaterina Filatova: None declared, Elena Pogozheva: None declared, Vera Amirdzhanova: None declared, Evgeny Nasonov: None declared, Alexander Lila: None declared, V Mazurov: None declared, N Lapkina: None declared, Galina Lukina Speakers bureau: Novartis, Pfizer, UCB, Abbvie, Biocad, MSD, Roche, Tatiana Salnikova: None declared, Ruzana Samigullina: None declared, Diana Chakieva: None declared, Irina Marusenko: None declared, Olga Semagina: None declared, Marina Semchenkova: None declared

scholarly journals Use of Janus kinase inhibitors in the treatment of immunoinflammatory rheumatic diseases: safety issues

2021 ◽  
pp. 76-84
Author(s):  
B. S. Belov ◽  
N. V. Muravyeva ◽  
G. M. Tarasova ◽  
M. M. Baranova
Keyword(s):  
Rheumatic Diseases ◽  
Kinase Inhibitors ◽  
Infectious Complications ◽  
Genetically Engineered ◽  
Janus Kinase ◽  
Biological Drugs ◽  
Janus Kinase Inhibitors ◽  
Safety Issues ◽  
European League Against Rheumatism ◽  
Poor Tolerance

There has been clear progress in rheumatology in recent decades with the introduction of genetically engineered biological drugs (GEBDs) as well as targeted baseline anti-inflammatory drugs, which include Janus kinase inhibitors (i-JAKs). To date, i-JAKs have been actively used and studied in various immunoinflammatory rheumatic diseases (IIRDs) – rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (AS), as well as psoriasis, atopic dermatitis and inflammatory bowel disease. In order to summarize the accumulated experience, the experts of the European League Against Rheumatism developed a consensus, which outlined the main principles and provisions concerning the rational use of i-JAKS in patients with IIRDs. At the same time, much attention is paid to the problem of the safety of these drugs. In the present article, issues related to various aspects of the safety of the use of i-JAKs in patients with IIRDs are discussed in detail, namely: dose adjustments due to drug interactions, contraindications, pre-screening, and risk assessment. Possible adverse events related to infectious complications, malignancies, thromboembolic phenomena, and gastrointestinal perforation were analyzed. The significance of clinical and laboratory monitoring in catamnestic follow-up of patients receiving i-JAKs is emphasized. A program for further research on the mentioned problem is presented. It includes studies of the efficacy and safety of «switching» between i-JAKs in patients with poor tolerance of a particular drug or who do not respond to treatment, evaluation of the effect of i-JAKs on comorbidities including cardiovascular disease and osteoporosis, studies of the long-term safety of i-JAKs based on actual practice data, and of the effectiveness and safety of i-JAKs and GEBDs combination therapy in patients with severe RA or other conditions, etc. This consensus is designed to inform and target physicians seeking to achieve optimal use of these drugs in patients with IIRDs, as well as patients themselves and other interested parties, including facility administrators. The recommendations will undoubtedly be expanded and supplemented as new data accumulate.

Main Changes in the Model of Diagnosis-Related Groups in Russia in 2020

2020 ◽  
pp. 19-29
Author(s):  
Maria Leonidovna Lazareva ◽  
Inna Alexandrovna Zheleznyakova ◽  
Maria Vladimirovna Avxentyeva ◽  
Denis Valerievich Fedyaev ◽  
Alexandr Vladimirovich Zuev ◽  
...  
Keyword(s):  
Diagnosis Related Groups ◽  
Chronic Viral Hepatitis ◽  
Genetically Engineered ◽  
Classification Criteria ◽  
Correction Factors ◽  
Biological Drugs ◽  
Viral Hepatitis C ◽  
Inpatient Settings ◽  
Day Hospitals ◽  
Chronic Viral Hepatitis C

Since 2013 a diagnosis-related groups (DRG) model has been introduced for the payment of medical care provided in inpatient settings and the day hospitals in Russia at the federal level. The DRG model is improved annually by the increasing of DRG number and specifying the classification criteria for attributing treatment cases to a particular group. In this article, we describe the main changes in the DRG model in 2020 compared with the last year. Main changes include the creation of new classification criteria for the formation of DRG, new DRG in the oncology profile, the changes in the DRG for epilepsy and chronic viral hepatitis C treatment, as well as for the use of genetically engineered biological drugs and selective immunosuppressants. The article also describes the innovations regarding the general approaches to paying for health care with respect to DRG: the rules for applying regional correction factors and for simultaneous payment for two DRG within one treatment case.

Immunogenicity, Tolerability, and Clinical Effectiveness of 23-Valent Polysaccharide Pneumococcal Vaccine in Patients with Systemic Lupus Erythematosus

2020 ◽  
Vol 65 (5-6) ◽  
pp. 35-40
Author(s):  
G. M. Tarasova ◽  
B. S. Belov ◽  
M. V. Cherkasova ◽  
S. K. Soloviev ◽  
E. A. Aseeva ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Pneumococcal Vaccine ◽  
Single Case ◽  
Clinical Effectiveness ◽  
Genetically Engineered ◽  
Systemic Lupus ◽  
Biological Drugs ◽  
Polysaccharide Pneumococcal Vaccine

The aim of the work is to study the immunogenicity, tolerability, and clinical efficacy of the 23-valent polysaccharide pneumococcal vaccine (PPV-23) in patients with systemic lupus erythematosus (SLE). Material and methods. The study included 61 patients with a confirmed diagnosis of SLE, including 53 women, 8 men, aged 19 to 68 years. The disease activity at the time of vaccination: in 9 patients — high, in 13 — medium, in 34 — low, in 5 — remission. Therapy outline: 59 patients received glucocorticoids (GC) 5–30 mg/day in terms of prednisolone, 45 — hydroxychloroquine (GC), 33 — cytostatics (CS), 22 — genetically engineered biological drugs (GEBD): 11 — rituximab (RTM), 10 — belimumab (BLM). 23-valent polysaccharide pneumococcal vaccine in an amount of 0.5 ml (1 dose) was injected subcutaneously. Follow-up period: 9 patients — 3 months, 52 — 1 year after the vaccination. Patients were examined before vaccination, as well as in 1, 3, and 12 months after the vaccination. Results and discussion. After a year of observation, the number of «responders» to vaccination was 61.5%, «non-responders» — 38.5%. There was a decreased response to vaccine in patients receiving GEBD compared with patients who did not receive GEBD (40% and 75%, respectively), p=0.02. No differences were found against the background of RTM and BLM therapy. Administering GC in a dose exceeding 10 mg/day did not lead to a more significant decrease in response to vaccine compared to other patients. Standard local vaccination reactions of mild to moderate severity were noted in 50.8% of the patients, general reaction of mild severity — in 1 patient (1.6%), hyperergic Arthus-like reaction — in 1 patient (1.6%), the symptoms of which were relieved in 7 days. During the observation period (1 year), not a single case of exacerbation of SLE, reliably associated with the vaccination, was registered, and no new autoimmune phenomena were identified. Clinically positive dynamics was noted in the form of a decrease in the number of episodes of pneumonia, as well as acute and exacerbated chronic bronchitis, sinusitis. Conclusion. Sufficient immunogenicity, good tolerance, and clinical effectiveness of PPV-23 in patients with SLE, incl. those, who received combined immunosuppressive therapy. Further studies are needed in large groups of patients with long follow-up periods.

Possibilities of personalized approach to genetically engineered biological therapy of rheumatoid arthritis

2021 ◽  
pp. 35-40
Author(s):  
L. N. Shilova ◽  
S. S. Spitsina
Keyword(s):  
Rheumatoid Arthritis ◽  
Biological Therapy ◽  
Predictive Biomarkers ◽  
Empirical Therapy ◽  
Pathological Process ◽  
Genetically Engineered ◽  
Patient Centered ◽  
Biological Drugs ◽  
Potential Association ◽  
Personalized Approach

Rheumatoid arthritis is the most common rheumatic disease characterized by damage to the synovium, progressive destruction of cartilage and bone tissue. As a result of the establishment of the biological role of cytokines, it became possible to intervene in the main links of the pathogenesis of the disease, which led to inhibition of the main pathological process in RA – autoimmune inflammation.The aim. To consider the possibilities of optimizing the biological therapy of rheumatoid arthritis by identifying predictors of anti-inflammatory efficacy among clinical and laboratory markers.Basic provisions. Despite the success of genetically engineered biological drugs in the treatment of inflammatory arthritis, due to the lack of predictive biomarkers, the use of a trial and error approach, empirical therapy, is inevitable, which does not always lead to satisfactory results. The study of the main biomarkers of RA provides new insights into their potential association with various clinical phenotypes.Conclusion. This patient-centered approach offers the prospect of improving treatment outcomes through the use of specific drugs in certain patient groups.

scholarly journals Targeted anti-inflammatory therapy effect on various indicators of the psoriatic arthritis activity: Moscow Unified Arthritis Registry (MUAR) data

2021 ◽  
Vol 5 (2) ◽  
pp. 78-83
Author(s):  
K.A. Lytkina ◽  
◽  
G.V. Lukina ◽  
E.N. Koltsova ◽  
E.I. Shmidt ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Certolizumab Pegol ◽  
Genetically Engineered ◽  
Targeted Drugs ◽  
Biological Drugs ◽  
Synthetic Drugs ◽  
Das 28 ◽  
Therapy Effect ◽  
Anti Inflammatory ◽  
The Impact

Background: the number of genetically engineered biological drugs and targeted synthetic drugs for the treatment of psoriatic arthritis (PA) is rapidly increasing. Data on their comparative efficacy is limited. The results of individual studies suggest that the drugs may show different efficacy concerning different disease manifestations (arthritis, spondylitis, entesitis, cutaneous and nail lesions). Aim: to compare the effect of targeted drugs on the results achieved in different PA domains in real clinical practice. Patients and Methods: the data were taken from the Moscow Unified Arthritis Registry (MUAR). We analyzed treatment episodes in which there was a completed visit no earlier than 6 months from therapy initiation with targeted drug (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, tofacitinib, ustekinumab). Drug comparison was carried out according to the achieved values of the DAS-28, BASDAI, MASES, LEI, DLQI, PASI and BSA indices. The most significant confounders (factors that characterize the patient and are significantly related to the studied indicator) were established for each group of indicators to eliminate the impact of differences between patients who received different drugs. The comparisons were adjusted for confounders. Results: the analysis included 184 treatment episodes with targeted drugs in 156 patients with PA. There were no significant differences between the drugs in their effect on the following domains: «joints» domain (DAS-28), «spine/entheses» domain (BASDAI, MASKS, LEI), «skin» domain (DLQI, PASI, BSA). Conclusion: the achieved values of activity indicators concerning the involvement of joint, spine, entheses and skin in patients with PA didn’t significantly differ when treated with various targeted drugs. KEYWORDS: psoriatic arthritis, enthesitis, spondylitis, sacroiliitis, targeted therapy, treatment efficacy, confounder. FOR CITATION: Lytkina K.A., Lukina G.V., Koltsova E.N. et al. Targeted anti-inflammatory therapy effect on various indicators of the psoriatic arthritis activity: Moscow Unified Arthritis Registry (MUAR) data. Russian Medical Inquiry. 2021;5(2):78–83. DOI: 10.32364/2587-6821- 2021-5-2-78-83.

scholarly journals Comparative efficacy of genetically engineered biological drugs in real clinical practice according to the Moscow Unified Arthritis Registry (MUAR) data

2021 ◽  
Vol 5 (2) ◽  
pp. 58-63
Author(s):  
E.A. Rosochkina ◽  
◽  
G.V. Lukina ◽  
E.N. Koltsova ◽  
K.A. Lytkina ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Ankylosing Spondylitis ◽  
Certolizumab Pegol ◽  
Genetically Engineered ◽  
Comparative Efficacy ◽  
Biological Drugs ◽  
Reactive Protein ◽  
Activity Preservation ◽  
New Treatment ◽  
Real Clinical Practice

Background: the list expansion of genetically engineered biological drugs (GEBD) used for the treatment of ankylosing spondylitis (AS) determines the relevance of studies aimed at comparing them and determining their place in this disease treatment. Real clinical practice studies are the preferred source of this data type. Aim: to evaluate the efficacy of various GEBD in patients with AS according to the Moscow Unified Arthritis Registry (MUAR). Material and methods: the analysis of the MUAR data was carried out. These included clinical cases with GEBD, for which there were data of a completed visit after 6 months or more after the treatment initiation. Parameters values achieved during treatment with various drugs were analyzed. The comparison was conducted during a multivariate analysis with adjustments for the identified confounders. Non-clinical parameters that were reliably and independently associated with the achieved BASDAI index (CRP) values were considered as confounders. Results: the study included 363 treatment episodes with GEBP in 361 patients. As mutually independent significant predictors of the achieved ASDAS (confounders) values, GEBD treatment duration were established until the evaluation of indicators (p<0.001) and the age of the patient (p=0.006). Significant association between the established values of the studied parameters and the used GEBD were found for the achieved ASDAS (p=0.033) and ESR (p=0.007) values. In a pairwise drug comparison using the conservative Šidák correction, the achieved values of ASDAS and ESR during infliximab and adalimumab administration were significantly less than during certolizumab pegol administration. Conclusion: infliximab, adalimumab, etanercept, certolizumab pegol, golimumab, secukinumab in real clinical practice demonstrate generally similar clinical efficacy in the treatment of AS. The effect of golimumab and secukinumab, recently introduced into clinical practice, does not significantly differ from the effect produced by long-term TNF-α inhibitors. Certain disease activity preservation in a significant part of patients gives grounds to continue the search for new treatment methods. KEYWORDS: ankylosing spondylitis, genetically engineered biological drugs, tumor necrosis factor inhibitors, C-reactive protein, confounders, registry. FOR CITATION: Rosochkina E.A., Lukina G.V., Koltsova E.N. et al. Comparative efficacy of genetically engineered biological drugs in real clinical practice according to the Moscow Unified Arthritis Registry (MUAR) data. Russian Medical Inquiry. 2021;5(2):58–63. DOI: 10.32364/2587-6821-2021-5-2-58-63.

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