ANALYSIS OF THE RESULTS OF TOFACITINIB THERAPY IN REAL CLINICAL PRACTICE ACCORDING TO THE ALL-RUSSIAN ARTHRITIS REGISTRY (OREL)

2020 ◽  
Vol 58 (3) ◽  
pp. 262-267
Author(s):  
A. S. Avdeeva ◽  
A. S. Misiyuk ◽  
A. M. Satybaldyev ◽  
G. V. Lukina ◽  
V. N. Sorotskaya ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Age At Onset ◽  
Similar Efficacy ◽  
Moderate Activity ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Number Of Patients ◽  
Low Activity ◽  
Necrosis Factor ◽  
Real Clinical Practice

Objective: to analyze the results of tofacitinib (TOFA) therapy in real clinical practice according to the All-Russian Arthritis Registry (OREL). Subjects and methods. The OREL Registry included 347 patients (286 (82%) women and 61 (18%) men) with rheumatoid arthritis (RA) who initiated TOFA therapy. The male:female ratio was 1:4.7. The patients’ median age at onset of the disease was 42 years; its duration was 8 years. Most of the patients included in the registry had extended- (n=171 (52%)) or late- (n=148 (45%)) stage of RA. Results and discussion. Prior to initiation of TOFA therapy, RA activity according to DAS28 was high and moderate in 91 (64.5%) and 40 (28.4%) patients, respectively; the median DAS28 value was 5.5 [4.6; 6.2]; SDAI – 30.5 [21.4; 42.9], and CDAI – 28.2 [20.0; 37.1]. The use of TOFA was accompanied by significant decrease of disease activity. After 12 weeks, high RA activity was persistent in 32 (22.7%) patients; the number of patients with moderate activity increased to 77 (54.6%), that of those with low activity rose to 15 (10.6%); remission was observed in 17 (12.1%) patients. 216 (62.6%) and 76 (22%) patients received TOFA as first- and second-line therapy, respectively. TOFA was most frequently prescribed when tumor necrosis factor-á inhibitors (19.6%), rituximab (7.8%), tocilizumab (4.3%), and abatacept (5.2%) were insufficiently effective or poorly tolerated. Conclusion. The results of using TOFA in real clinical practice may suggest that the drug has high efficacy in patients with RA. TOFA can be used at a dose of 5 or 10 mg twice daily as both alone and in combination with disease-modifying anti-rheumatic drugs. TOFA showed similar efficacy in patients who had earlier taken biological agents and in those who had not.

scholarly journals Comparative efficacy of tofacitinib and adalimumab in patients with psoriatic arthritis in real clinical practice. Data from the Russian nationwide register of patients with psoriatic arthritis

2021 ◽  
Vol 15 (3) ◽  
pp. 35-42
Author(s):  
E. Yu. Loginova ◽  
T. V. Korotaeva ◽  
E. E. Gubar ◽  
Yu. L. Korsakova ◽  
S. I. Glukhova ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Median Duration ◽  
Comparable Efficacy ◽  
Number Of Patients ◽  
Group 2 ◽  
Low Activity ◽  
Real Clinical Practice ◽  
Group 1

Objective: to compare the clinical efficacy in real clinical practice of the targeted synthetic disease-modifying antirheumatic drug (sDMARD) tofacitinib (TOFA) and the biologic DMARD (bDMARD), an inhibitor of tumor necrosis factor alpha (TNFα), adalimumab (ADA) in patients with psoriatic arthritis (PsA), included in the Russian nationwide register of patients with PsA.Patients and methods. The study included 77 patients with PsA (43 men and 34 women) who met the CASPAR criteria and were observed in the Russian nationwide register. Patients were divided into two groups depending on the treatment. Group 1, in which oral TOFA was prescribed, 5 mg 2 times a day, included 41 patients: 24 (58.5%) men and 17 (41.5%) women, the median age was 41 [34; 50] years, the median duration of PsA was 72 [35; 120] months. Group 2, in which subcutaneous ADA was used, 40 mg every 2 weeks, included 36 patients: 19 (52.8%) men and 17 (47.2%) women, the median age was 44 [34; 51] years, the median duration of PsA was 59 [22; 102] months. Combination therapy, including methotrexate (MT), received 80.5% of patients in the TOFA group and 52.8% of patients in the ADA group. At the beginning of the study and every 6 months further, the activity and efficacy of PsA therapy were assessed in all patients according to DAPSA and criteria for minimal disease activity – MDA (number of painful joints ≤1, number of swollen joints ≤1, PASI ≤1 or BSA ≤3 , pain score ≤15, patient's general assessment of disease activity ≤20 mm on a visual analogue scale, HAQ ≤0.5, enthesitis ≤1), dynamics of BASDAI and BSA were also assessed. The number of patients who achieved remission (DAPSA ≤4) or MDA (5 criteria out of 7) during therapy with TOFA and ADA was determined.Results and discussion. Before the start of the therapy in the 1st group, the median DAPSA was 44.2 [37.8; 55.3]: moderate PsA activity was in 5 (12.2%) patients, high in 36 (87.8%) patients. In group 2, the median DAPSA was 35.8 [21.1; 52]: low activity was detected in 3 (8.6%), moderate – in 11 (31.4%), high – in 21 (60%) patients (data from 35 patients was available). 6 months after the start of treatment in patients of the 1st and the 2nd group, there was a significant decrease in all indicators of PsA activity compared to the baseline. The median DAPSA was 11 [4.3; 17.3] and 9.1 [6; 19.6]; remissions according to DAPSA reached 11 (26.8%) and 6 (20.8%) patients, respectively, low activity – 15 (36.6%) and 13 (44.8%), MDA – 16 (40%) and 9 (30%). The number of patients with dactylitis in the 1st and in the 2nd group significantly decreased: from 22 (53.7%) to 5 (13.2%) and from 13 (36.1%) to 6 (20%), respectively. Median HAQ decreased from 1 [0.625; 1.5] to 0.5 [0; 0.875] and from 0.875 [0.5; 1.38] to 0.5 [0; 0.875]; median BASDAI – from 6 [4.2; 7] to 1.4 [0.6; 3.2] and from 4.4 [1.9; 5.8] to 3 [0.8; 4.5], respectively. In group 1, the number of patients with BSA> 3% decreased from 16 (39%) to 8 (26.7%; p<0.225), and in group 2, due to insufficient data (5 patients), we failed to evaluate BSA dynamics.Conclusion. In real clinical practice TOFA and ADA both had comparable efficacy on all clinical manifestations of PsA: after 6 months of therapy, most patients with PsA achieved MDA, low disease activity and remission according to DAPSA and BASDAI.

Optimizing Second-Line Therapy for Hodgkin Lymphoma: A Work in Progress

2021 ◽  
pp. JCO.21.01552
Author(s):  
Nancy L. Bartlett
Keyword(s):  
Clinical Practice ◽  
Hodgkin Lymphoma ◽  
Relevant Literature ◽  
Second Line ◽  
Clinical Context ◽  
Second Line Therapy ◽  
Case Presentation ◽  
Line Therapy ◽  
Management Approaches ◽  
Grand Rounds

The Oncology Grand Rounds series is designed to place original reports published in the Journal into clinical context. A case presentation is followed by a description of diagnostic and management challenges, a review of the relevant literature, and a summary of the authors' suggested management approaches. The goal of this series is to help readers better understand how to apply the results of key studies, including those published in Journal of Clinical Oncology, to patients seen in their own clinical practice.

scholarly journals Comorbidity in real clinical practice - the patient with gout, cardiovascular disease and kidney damage

2021 ◽  
Vol 2 (3) ◽  
pp. 112-117
Author(s):  
N. A. Kosheleva ◽  
N. A. Magdeeva
Keyword(s):  
Clinical Practice ◽  
Progressive Increase ◽  
Control Treatment ◽  
Comorbid Conditions ◽  
Treatment Efficiency ◽  
Number Of Patients ◽  
High Prevalence ◽  
Systemic Side Effects ◽  
Adherence To Therapy ◽  
Real Clinical Practice

In real clinical practice more and more often doctors treat comorbid patients. The high prevalence of cardiovascular diseases with various comorbid conditions contributes to the progressive increase in the number of patients with a concurrence of several diseases. A comorbid patient is a serious problem for any clinician, since in this case it is necessary to take into account several components of therapy, which makes it difficult to control treatment efficiency, contributes to an increase in polypharmacy, the risk of local and systemic side effects of drugs, and reduces adherence to therapy. A comorbid patient is a serious problem for any clinician. The paper describes and discusses the clinical case of a comorbid patient, who admitted to the cardiological department initially but he had also rheumatological problems (gout), kidney affection.

scholarly journals AB0639 TREATMENT EFFICACY WITH SECUKINUMAB IN A COHORT OF SPONDYLOARTHRITIS PATIENTS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1614.2-1614
Author(s):  
A. Castilla ◽  
Á. García Martos ◽  
L. Sala Icardo ◽  
A. Prada-Ojeda ◽  
L. Barrio Nogal ◽  
...  
Keyword(s):  
New York ◽  
Clinical Practice ◽  
Clinical Manifestations ◽  
Previous Treatment ◽  
Response To Treatment ◽  
Das 28 ◽  
Number Of Patients ◽  
Symptoms And Signs ◽  
Real Clinical Practice

Background:Spondyloarthropathies are a heterogeneous group of similar diseases, with interrelated clinical manifestations, such as Psoriasis Arthritis (APs) and Ankylosing Spondylitis (EA). There are different treatments for this group of pathologies.Objectives:It is very important to differentiate between those that present predominantly axial (spine and/or sacroiliac) or peripheral involvement, since the response to treatment is very different.In some clinical trials, secukinumab significantly improved versus placebo, the symptoms and signs, physical function and quality of life, however, at present, we do not have enough data from secukinumab in real clinical practice.This is the real reason of this study: the use of secukinumab in clinical practice.Methods:Multicentric longitudinal observational study of 5 Hospitals in Madrid.Patients are over 18 years old and meet the following inclusion criteria: New York criteria for AS, ASAS for EA, CASPAR for APs, and all of them are with secukinumab or have received it.We will evaluate the effectiveness rate as well as its confidence interval at 95%. In addition, the effectiveness of secukinumab will be compared in the different pathologies by using χ2.Results:72 patients were collected, 41 of them were women (57,75%).12 patients (16,90%) had not received FAME before secukinumab and 22 patients (33,99%) were naive to biological treatment.In 4 patients, the reason for starting secukinumab was the patient’s comorbidities, in 2 the adverse effects of previous treatment and in the rest, was the lack of efficacy of the previous treatment.The patients were divided into 4 categories according to the level of DAS-28 or BASDAI, at the beginning of the treatment and the last recorded value, in: Absence of activity, mild, moderate and severe activity. Of the patients with data, they managed to improve the DAS-28 score (change category) by 30,95%, while only 4,76% worsened their score. With respect to BASDAI, of the total number of patients, only 3,03% worsened, while his score improved 27,27%.According to baseline diagnosis, a greater improvement of the disease activity in peripheral APs(66,67%) and mixed APs(61,54%) is achieved.Conclusion:In real clinical practice, treatment with secukinumab was effective in patients with spondyloarthritis, achieving improvement in previous activity rates. In this study, the most significant improvement was obtained in peripheral and mixed APs.Disclosure of Interests:None declared

scholarly journals Role of palbociclib in the treatment of hormone receptor-positive HER2-negative metastatic breast cancer. Generalizing results of randomized trials and real clinical practice

2019 ◽  
pp. 56-62
Author(s):  
L. G. Zhukova ◽  
E. I. Khatkova ◽  
P. S. Feoklistova ◽  
K. S. Grechukhina ◽  
S. A. Smolin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Practice ◽  
Hormone Receptor ◽  
Randomized Trials ◽  
Metastatic Breast ◽  
Second Line Therapy ◽  
Hormone Receptor Positive ◽  
Her2 Breast Cancer ◽  
Real Clinical Practice

Palbociclib is the first-in-class drug of CDK 4/6 inhibitors group. The use of palbociclib in combination with endocrinotherapy (ET) opens up new possibilities for the treatment of metastatic hormone receptor-positive (HRP+) HER2-negative (HER2-) breast cancer (mBC). Palbociclib has gained world attention and is included in all clinical guidelines, both international and domestic, as a new standard of first- and second-line therapy of HRP+ HER2- mBC. The article presents the updated results of PALOMA-2 and PALOMA-3 studies and the results of use of palbociclib in combination with ET in real clinical practice.

scholarly journals Evaluation of the efficacy and safety of injectable glycosaminoglycan-peptide complex (GPC) in patients with osteoarthritis: a multicenter observational study GLADIOLUS (GPC in the treatment of osteoarthritis: a follow-up study of pain relief and local symptom reduction)

2020 ◽  
Vol 14 (2) ◽  
pp. 76-83
Author(s):  
L. I. Alekseeva ◽  
A. E. Karateev ◽  
E. Yu. Pogozheva ◽  
V. N. Amirdzanova ◽  
E. S. Filatova ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Large Scale ◽  
Rating Scale ◽  
Response To Therapy ◽  
Efficacy And Safety ◽  
Functional Disorders ◽  
Peptide Complex ◽  
Number Of Patients ◽  
Pain At Rest ◽  
Real Clinical Practice

Glycosaminoglycan-peptide complex (GPC) is a popular injectable extended-release symptomatic agent (ERSA) in Russia for the treatment of osteoarthritis (OA). To date, no large-scale studies of GPC used in real clinical practice have been conducted in our country.Objective: to evaluate the efficacy and safety of GPC in the treatment of OA in real clinical practice.Patients and methods. A multicenter observational non-interventional study was performed to evaluate the efficacy of GPC (Rumalon® , a cycle of intramuscular injections thrice weekly; a total of 25 injections). A study group consisted of 2,955 patients (75.4% female) aged 61.4±11.8 years) with knee and hip OA, and generalized OA (GOA) with the previous inefficacy of oral ERSAs, moderate/severe pain, and the need for regular use of nonsteroidal anti-inflammatory drugs (NSAIDs). 414 (14%) patients received a GPC and diacerein combination 100 mg/day. The investigators assessed the dynamics of pain during movement and at rest, functional disorders (on a numeric rating scale (NRS) of 0–10), as well as the need for NSAIDs at 12 weeks after starting the GPC cycle.Results and discussion. 98.5% of the patients completed their GPC treatment cycle. The therapy decreased the intensity of pain at rest from 4 [3; 5] to 1 [0; 2] and during movement from 6 [5; 7] to 2 [1; 3] and reduced the severity of functional disorders from 5 [4; 6] to 1 [0; 3]. The number of patients with a good response to therapy (a≥50% decrease in symptom severity) for pain at rest and during movement was 55.6 and 53.5%, respectively; and for functional disorders was 50.8%. 68.1% of patients stopped taking NSAIDs. The GPC and diacerein combination was more effective than GPC monotherapy: the number of patients with a ≥50% decrease in movement pain was 62.8 and 54.3%, respectively (p <0.001). GPC was well tolerated. During treatment, there were skin allergic reactions (0.3%), moderate injection-site pain (0.37%), and adverse reactions (ARs) related to the gastrointestinal tract (8%) and cardiovascular system (6%) (which were likely to be caused by NSAIDs). There were no serious ARs that were life-threatening and required hospitalization.Conclusion. GPC allows successful control of the main symptoms of knee and hip OA and GOA, by reducing pain, and those of functional disorders, and the need for NSAIDs. The GPC and diacerein combination is more effective than GPC monotherapy. GPC therapy is well tolerated and very rarely causes ARs.

scholarly journals Vedolizumab in patients with inflammatory bowel diseases of in real clinical practice

2020 ◽  
Vol 92 (2) ◽  
pp. 67-73
Author(s):  
M. V. Shapina ◽  
B. A. Nanaeva
Keyword(s):  
Clinical Practice ◽  
Clinical Response ◽  
Inflammatory Bowel Diseases ◽  
Clinical Remission ◽  
Line Therapy ◽  
Steroid Dependent ◽  
Endoscopic Remission ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Real Clinical Practice

Vedolizumab is currently the only selective biological drug for the treatment of inflammatory bowel diseases (IBD). Its effectiveness and safety has been shown in clinical trials. This article presents the experience of using vedolizumab in real clinical practice in patients with various forms of ulcerative colitis (UC) and Crohns disease (CD). Materials and methods.96 patients with IBD (62 with CD and 34 with UC) were prescribed therapy with vedolizumab at a dose of 300 mg intravenously at 0, 2, and 6 weeks, and further maintenance therapy was continued every 8 weeks. Most patients had prolonged inflammation (27 (79.4%) with total UC, 35 patients with CD (56.5%) had ileocolitis), resistance to therapy, including biological drugs (19 (55.9%) in patients with UC and 49 (79.0%) in patients with CD). The effectiveness of therapy was evaluated after 3 months (based on clinical response and clinical remission), 6 and 12 months (endoscopic response and endoscopic remission were additionally evaluated). Results.After 3 months, clinical remission was observed in 62.5% and 36.6%, respectively. After 6 months, these indicators were 66.7% and 61.0%, and after 12 months, 70.8% and 61.0%, respectively. After 6 months, endoscopic remission was observed in 50.0% of UC patients and 26.8% of CD patients. After 12 months, it reached 58.3% and 31.7%, respectively. The analysis showed greater efficacy in bio-naive patients with CD (steroid-free remission after 12 months 62.5%, endoscopic remission 37.5%), as well as patients with non-stricturizing non-penetrating CD (58%). In patients with UC, vedolizumab showed the same effectiveness both in bio-naive patients (70.0%) and as a second-line therapy (71.2%). It turned out to be more effective in patients with moderate UC (76.2%) and steroid-dependent UC (77.8%). Conclusions.Vedolizumab is effective in achieving clinical response and clinical remission, as well as endoscopic response and endoscopic remission in patients with UC and CD. Given the selective mechanism of action of the drug, it can be recommended as a first-line therapy.

scholarly journals Tolerance of ramucirumab in the second-line therapy of patients with disseminated gastric cancer in the routine clinical practice of Russia

2019 ◽  
pp. 104-113
Author(s):  
N. S. Besova ◽  
T. A. Titova ◽  
E. V. Artamonova ◽  
D. L. Stroyakovskiy ◽  
E. V. Perminova ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Practice ◽  
Routine Clinical Practice ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy
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