EVALUATION OF THE EFFICACY AND SAFETY OF ETANERCEPT USE IN PATIENTS WITH NON-SYSTEMIC JUVENILE ARTHRITIS: 10-YEAR EXPERIENCE OF USE IN A FEDERAL CENTER

TNF-α inhibitors are used in the treatment of non-systemic variants of juvenile idiopathic arthritis (JIA) in case of ineffectiveness or intolerance to methotrexate. Despite 20 years of experience of using of etanercept in pediatric rheumatology, a long-term study of the efficacy and safety of the drug in real clinical practice remains necessary. Objective of the study: to study the efficacy and safety of etanercept for treatment of various non-systemic JIA subtypes in real clinical practice. Materials and methods of research: data from the case histories of 375 patients (242 girls and 133 boys) with articular forms of JIA for 2010–2020 were included in a retrospective, open, uncontrolled, nonrandomized, continuous multicenter cohort study. The age of debut was 6.3 (2.9; 10.7) years. Demographic characteristics, subtypes of arthritis, indicators of laboratory activity of inflammation, and outcomes were estimated: achievement of remission, exacerbation, and switching from etanercept to another genetically engineered biological drug (GEBD) were assessed. Results: remission was recorded in 78.9% on average after 6 months. The factors that determine the likelihood of achieving remission were the absence of previous therapy with GEBD (p=0.001) and compliance with therapy – OR=2.5 (95% CI: 1.3; 4.7), p=0.006. Exacerbations were recorded in 29.5% and were associated with the presence of the HLA B27 antigen – OR=2.6 (95% CI: 1.1; 6.0), p=0.028, antinuclear factor seropositivity (p=0.060). Change of etanercept to another GEBD was made in 17.4% of children and was associated with a failure to achieve remission – OR=7.7 (95% CI: 4.0–14.3), p=0.000001, with previous exacerbations – OR=14,8 (5.3; 41.2), p=0.0000001 and the development of de novo uveitis – OR=2.4 (95% CI: 1.1–5.3), p=0.038. The arthritis subtype and the presence of concomitant methotrexate therapy did not significantly affect treatment outcomes. Conclusion: achievement of remission, compliance with therapy, history of previous therapy with GEBD, exacerbation of JIA and development of de novo uveitis determined the main outcomes of etanercept therapy. The JIA subtype, as well as concomitant therapy with methotrexate, did not significantly affect the outcomes of the disease, which makes it possible to consider etanercept therapy a very effective and safe method of treating JIA as a genetically engineered first-line therapy of any variants of articular forms of JIA, even in monotherapy with ineffectiveness or intolerance to methotrexate.

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The first experience of using upadacitinib in the treatment of rheumatoid arthritis in real clinical practice (results of the multicenter project “RACURS”)

Rheumatology Science and Practice ◽

10.47360/1995-4484-2021-571-577 ◽

2021 ◽

Vol 59 (5) ◽

pp. 571-577

Author(s):

V. N. Amirjanova ◽

A. E. Karateev ◽

E. Y. Pogozheva ◽

A. A. Baranov ◽

V. I. Mazurov ◽

...

Keyword(s):

Quality Of Life ◽

Rheumatoid Arthritis ◽

Clinical Practice ◽

Disease Activity ◽

Functional State ◽

High Disease Activity ◽

Efficacy And Safety ◽

Previous Therapy ◽

Real Clinical Practice

Upadacitinib (UPA), a JAK inhibitor, is a new therapeutic option that allows patients with insufficient response to therapy with basic anti-inflammatory drugs (DMARDs) or genetically engineered biological drugs (GEBDs) to achieve the goals of therapy for rheumatoid arthritis (RA). Despite the availability of convincing data from international randomized clinical trials, there is insufficient information about the efficacy and safety profile of UPA, the quality of life of patients receiving the drug in real clinical practice.Aim of the study – to assess the efficacy and tolerability of the UPA drug at a dose of 15 mg/day in patients with rheumatoid arthritis with moderate and high disease activity and to assess their quality of life in real clinical practice.Materials and methods. The study included 41 patients with RA with insufficient effect of previous therapy with DMARDs or GEBDs, persisting moderate or high disease activity, who were initiated with UPA therapy in 7 rheumatological centers of the Russian Federation. To assess the activity of the disease, standard indices were used: DAS28- ESR, DAS28-CRP, SDAI, CDAI. Functional ability was assessed according to the HAQ questionnaire, quality of life – according to the EQ-5D questionnaire, the activity of the disease according to the patient’s opinion – according to the RAPID-3 index. The HADS scale was used to identify the states of depression, anxiety and emotional disorder.Results. During the first week of taking the drug, there was a marked decrease in pain from 60 to 30 mm on a visual analogue scale, which lasted until the third month of therapy. There was a statistically significant decrease in morning stiffness, the number of painful and swollen joints, health assessments by the doctor and patient, erythrocyte sedimentation rate and C-reactive protein (p≤0.001). A decrease in disease activity was also noted according to the dynamics of the activity indices DAS28, SDAI, CDAI (p<0.001). The goals of therapy (remission or low disease activity) by the 3rd month of therapy according to the combined indices of activity DAS28-ESR and DAS28-CRP reached 44.8 and 63.4% of patients, respectively, according to the SDAI index – 56.7%, according to the CDAI index – 25.9%. A pronounced improvement in joint function (70% improvement according to the criteria of the American College of Rheumatology) was noted by 33.3% of patients, population indicators of functional state (HAQ≤0.5) had 15.8% of patients. The difference in the HAQ index by the 3rd month of therapy compared to the indicator before treatment was –0.60 points. The quality of life, assessed by patients using the EQ-5D questionnaire, improved in 98.5% of patients, with a 70% improvement noted in more than a third of them (41.7%). The drug was well tolerated, no adverse reactions were registered by the 3rd month of therapy, all patients continued treatment.Conclusions. The first results of the use of UPA in RA patients with insufficient efficacy of previous therapy with DMARDs or GEBDs in real clinical practice indicate its efficacy and safety, an improvement in the functional state and quality of life of patients by the 12th week of the study.

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

Russian Medical Inquiry ◽

10.32364/2587-6821-2020-4-8-492-497 ◽

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.

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The efficacy and safety profile of systemic isotretinoin in the treatment of patients with severe acne in real clinical practice

Klinicheskaya dermatologiya i venerologiya ◽

10.17116/klinderma202120032185 ◽

2021 ◽

Vol 20 (3) ◽

pp. 185

Author(s):

N.N. Potekaev ◽

O.V. Zhukova ◽

A.N. Lvov ◽

M.S. Kornyat ◽

V.V. Bondarenko

Keyword(s):

Clinical Practice ◽

Safety Profile ◽

Efficacy And Safety ◽

Severe Acne ◽

Real Clinical Practice

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

Gastroenterología y Hepatología (English Edition) ◽

10.1016/j.gastre.2019.09.010 ◽

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

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

Pharmateca ◽

10.18565/pharmateca.2020.2.38-44 ◽

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

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The Efficacy and Safety of Lenalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma in Real Clinical Practice : A Study of the Korean Multiple Myeloma Working Party (KMMWP)

Clinical Lymphoma Myeloma & Leukemia ◽

10.1016/j.clml.2017.03.135 ◽

2017 ◽

Vol 17 (1) ◽

pp. e74-e75

Author(s):

Ho Sup Lee ◽

Chang Ki Min ◽

Kihyun Kim ◽

Je-Jung Lee ◽

Soo-Mee Bang ◽

...

Keyword(s):

Multiple Myeloma ◽

Clinical Practice ◽

Working Party ◽

Efficacy And Safety ◽

Refractory Multiple Myeloma ◽

Real Clinical Practice

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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

Medical alphabet ◽

10.33667/2078-5631-2019-1-18(393)-13-23 ◽

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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THE EXPERIENCE WITH ERIBULIN IN REAL CLINICAL PRACTICE FROM MOSCOW AND MOSCOW REGION

Malignant tumours ◽

10.18027/2224-5057-2018-8-2-21-30 ◽

2018 ◽

Vol 8 (2) ◽

pp. 21-30

Author(s):

V. V. Marphutov ◽

D. V. Filonenko ◽

V. A. Belonogov ◽

I. I. Аndreyashkina ◽

A. V. Byakhov ◽

...

Keyword(s):

Clinical Practice ◽

Metastatic Cancer ◽

Objective Response ◽

Locally Advanced ◽

Metastatic Breast ◽

Moscow Region ◽

Previous Therapy ◽

Metastatic Setting ◽

The Status ◽

Real Clinical Practice

Introduction.Eribulin, an non-taxane microtubule inhibitor, has been registered in Russia for patients with locally advanced or metastatic breast cancer (mBC) who received at least one chemotherapy regimen for a advanced disease, previous therapy should include anthracyclines and taxanes in adjuvant or metastatic setting, except the patients who could not be prescribed these drugs. We present our experience with eribulin in real clinical practice in Moscow and the Moscow Region.Patients and methods. We conducted a retrospective analysis of the experience with the use of eribulin in Moscow and the Moscow Region in 202 patients with mBC from January 2016 to February 2017 to assess the effectiveness and safety of the drug. All patients received previous therapy with anthracyclines and taxanes for locally advanced and / or metastatic cancer. The average age of patients at the time of inclusion in the analysis was 5 years (28–81). The status of the general condition on the ECOG 0-1 scale was registered in 81.3 % (100 / 123) of patients, the status of ECOG 2-3 in 18.7 % (23 / 123) of patients. The median of the number of courses of chemotherapy with eribulin is 4 (2–17). Patients received eribulin in 1-7 chemotherapy lines for metastatic disease. The average number of affected organs is 2 (1–5).Results.Complete response (CR) was in 3 (2 %) patients. Partial response (PR) was in 24 (15.7 %) patients, stabilization of the disease – in 89 (58. 2 %). Progression of the disease was recorded in 37 (24.1 %) patients. The median of progression-free survival (PFS) on the therapy was 4.64 (95 % CI 2.97-6.87) months. Stabilization of the disease for more than 6 months was registered in 28 (18.3 %) patients. The most significant toxicity was neutropenia and polyneuropathy (21 patients (10.4 %) and 7 patients (3.5 %), respectively).Dose reduction due to neutropenia was required by 26 patients (12.9 %). The objective response rate (ORR) depended on the chemotherapy line: in 1-3 lines the efficacy of the treatment was higher: the ORR was 21.6 %, compared to the 4th and subsequent lines – 12.3 %, respectively. With HER2-positive mBC, eribulin showed clinically significant results in combination with trastuzumab.Conclusions.Our analysis confirms that eribulin has a predictable and manageable safety profile, is an effective drug for the treatment of patients with different subtypes of mBC in a real clinical setting.

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An observational study «FOLLITROPIN» comparing the efficacy of follitropin alpha biosimilar: the real-world data

Obstetrics Gynecology and Reproduction ◽

10.17749/2313-7347/ob.gyn.rep.2021.212 ◽

2021 ◽

Vol 15 (1) ◽

pp. 5-21

Author(s):

D. P. Kamilova ◽

M. M. Ovchinnikova ◽

E. Sh. Ablyaeva ◽

M. M. Leviashvili ◽

N. S. Stuleva ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Practice ◽

Observational Study ◽

Clinical Efficacy ◽

Real World ◽

Ovarian Stimulation ◽

Successful Implementation ◽

Efficacy And Safety ◽

The Real ◽

Real Clinical Practice

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 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 (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART) was carried out. The ovarian stimulation (OS) protocols included: monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation protocols were analyzed with Primapur® application 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.

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