Results of studying the clinical efficacy and safety of tofacitinib in the treatment of psoriatic arthritis

Коротаева, Т. В.; Логинова, Е. Ю.

doi:10.14412/1996-7012-2019-2-112-118

Cited by 4 publications

(2 citation statements)

References 33 publications

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“…Актуальной становится проблема выбора терапии при неэффективности или непереносимости БПВП, в частности МТ, или ГИБП. Полученные к настоящему времени данные позволяют рекомендовать использование ингибиторов JAK в качестве нового патогенетически обоснованного подхода к лечению больных ПсА, в том числе резистентных к терапии иФНОα [25,26], о чем свидетельствует и наше исследование, в котором часть пациентов ранее получали ГИБП.…”

Section: Discussionunclassified

Efficacy and Safety of Tofacitinib in Patients With Psoriatic Arthritis in Real Clinical Practice

Логинова¹,

Корсакова²,

Gubar³

et al. 2020

Naučno-praktičeskaâ revmatologiâ

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Objective: to evaluate the clinical efficacy and safety of the targeted synthetic disease-modifying anti-rheumatic drug (DMARD) tofacitinib (TOFA; Yakvinus®) in patients with active psoriatic arthritis (PsA) at 12 and 24 weeks after starting treatment. To define the place of TOFA in the therapy of PsA patients. Subjects and methods. Examinations were made in 41 patients (17 men and 24 women) with active PsA and an insufficient response to previous treatment with synthetic DMARDs and/or biological agents (BA). Before starting therapy, the median disease activity for psoriatic arthritis (DAPSA) and disease activity score (DAS28) were 44.2 [37.8; 55.3] and 5.5 [4.7; 6.1], respectively. TOFA tablets were prescribed at a dose of 5 mg twice daily for 24 weeks with possible dose escalation to 10 mg twice daily after 12 weeks. At the beginning of the investigation, at 12 and 24 weeks, the investigators assessed disease activity and TOFA therapy efficiency of according to DAPSA, DAS28 and minimal disease activity (MDA) criteria: tender joint count ≤1, swollen joint count ≤1, a psoriasis area severity index (PASI) ≤1 or body surface area (BSA) ≤3%, pain intensity ≤15 mm, patient global assessment ≤20 mm, Health Assessment Questionnaire (HAQ) ≤0.5, and enthesitis ≤1. They also determined the number of patients who had achieved remission (DAPSA ≤4, DAS28 score <2.6), low disease activity (DAPSA 5-14, ≤2.6, DAS28 <3.2) or MDA (5 out of the 7 criteria) during TOFA therapy at 24-week follow-up. The safety of therapy was evaluated by analyzing the drug-induced adverse events (AE): the frequency, severity and time of their occurrence were studied. Results and discussion. At 24 weeks after initiation of TOFA therapy, there was a significant decrease of median DAPSA and DAS28 values as compared to baseline, to 11 [4.3; 17.3] and 2.6 [1.7; 3.4] respectively. The median Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) also significantly decreased from 6 [4.2; 7] and 3.8 [2.8; 4.4] to 1.4 [0.6; 3.2] and 1.5 [1; 2.1] respectively. The median BSA was significantly reduced from 3 [1; 5] to 0.5 [0.1; 2]. At 24 weeks after initiation of TOFA therapy, DAPSA and DAS28 low disease activity/remission were achieved by 38.5/23.1% and 17.9/53.9% of patients, respectively. Fifteen (38.5%) patients achieved MDA. 38 (92.7%) of the 41 patients completed a full TOFA therapy cycle. Two patients dropped out of the investigation due to ineffective therapy and one due to AE (diarrhea occurring up to 10 times daily, headache, elevated blood pressure, and lacrimation). At 24 weeks, 14 (34.2%) patients reported to have AE. The most common AE noted in 7 (17.1%) patients were infections: acute respiratory viral infection (n=3), fever (n=2), and folliculitis (n=2). In addition, two patients had diarrhea and two had headache. Conclusion. TOFA is an effective drug for the treatment of PsA patients with moderate or high inflammatory activity, has a significant effect on all clinical manifestations of PsA and has a satisfactory safety profile.

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Section: Discussionunclassified

Efficacy and Safety of Tofacitinib in Patients With Psoriatic Arthritis in Real Clinical Practice

Логинова¹,

Корсакова²,

Gubar³

et al. 2020

Naučno-praktičeskaâ revmatologiâ

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“…In addition to its effect on interferons, tofacitinib also inhibits the activity of T-lymphocytes. By affecting the transmission of interferon-mediated signals, it helps prevent the development of pathological changes in skin and bone tissue that are characteristic to rheumatoid and psoriatic arthritis [6]. Therefore, tofacitinib can be an effective and safe option for the treatment of these conditions in pharmacotherapy [1,6].…”

Section: Introductionmentioning

confidence: 99%

Development and validation of a high-performance liquid chromatography with tandem mass spectrometry method for quantification of tofacitinib in human plasma

Vetrova,

Karnakova,

Bagaeva

et al. 2024

Razrabotka i registraciâ lekarstvennyh sredstv

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Introduction. The use of tofacitinib as a pharmacological treatment for rheumatoid arthritis remains relevant in the light of the predicted increase in prevalence of the disease. At the same time, due to the withdrawal of several foreign pharmaceutical companies from the Russian pharmaceutical market, there has been a heightened demand for domestically produced medications, including generic formulations of tofacitinib. Registration of generic drugs necessitates the conduct of bioanalytical studies. Development and validation of a method for quantifying the analyte in biosamples remains to be a crucial part of the bioequivalence studies.Aim. The aim of this research is to develop and validate a method for the quantitative determination of tofacitinib in human plasma using high-performance liquid chromatography as the separation system coupled with a tandem mass spectrometer for detection purposes.Materials and methods. Biosample preparation was based on plasma proteins precipitation using acetonitrile. Baricitinib was selected as an internal standard. The analytical range of the method was 1.00 to 200.00 ng/mL and was further expanded to 0.30 to 200.00 ng/mL during the analytical phase of the study. The mobile phase consisted of water and acetonitrile, both acidified with formic acid (0.1 % v/v). The stationary phase was a Phenomenex Kinetex C18 column [100 × 3.0 mm, with a particle size of 5 µm (Phenomenex, USA)]. Sample separation and detection were carried out using high-performance liquid chromatography coupled with a tandem mass spectrometry (HPLC-MS/MS), operating in positive ion mode. The multiple reaction monitoring (MRM) transitions selected for the analyte and the internal standard were 313.30 to 173.00 m/z and 371.90 to 186.00 m/z, respectively.Results and discussion. The developed assay was validated in accordance with the current requirements of regulatory documentation from the EAEU (Eurasian Economic Union), FDA (US Food and Drug Administration), and EMA (European Medicines Agency) with the following parameters being evaluated: selectivity, specificity, carry-over, matrix effect, recovery, calibration curve, lower limit of quantitation, accuracy, precision, stability. The validated method was applied in the analytical part of a bioequivalence study of domestically produced generic tofacitinib.Conclusion. A method for the quantitative determination of tofacitinib in human blood plasma with an analytical range of 0.30–200.00 ng/mL was developed and validated. Application of the assay during the analytical phase of bioequivalence study of generic tofacitinib confirms the possibility of using the method in similar bioanalytical investigations.

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Prospects for the use of janus kinase inhibitors in the treatment of ankylosing spondylitis and psoriatic arthritis. Literature review

Fleyshman

2022

Clinical Medicine and Pharmacology

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The Janus kinase inhibitors are oral targeted synthetic basic anti-inflammatory drugs that exert their influence on the intracellular signaling system, preventing the activation of inflammatory processes. Now, there are a sufficient number of janus kinase inhibitors that have found application not only in rheumatology, but also in other specialties (gastroenterology, dermatology, hematology, oncology and even veterinary medicine). Thanks to janus kinase inhibitors, suppression of the intracellular signaling pathway of several cytokines simultaneously became available, as a result of which it became possible to exert a complex pathogenic effect. This explains the wide range of applications of these drugs in many areas of medicine. In rheumatology, janus kinase inhibitors are finding new and new applications in the treatment of not only rheumatoid arthritis, but also other diseases. This article presents studies on ankylosing spondylitis and psoriatic arthritis, the results of which demonstrate high rates regarding the use of janus kinase inhibitors for the treatment of these diseases.

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Results of studying the clinical efficacy and safety of tofacitinib in the treatment of psoriatic arthritis

Cited by 4 publications

References 33 publications

Efficacy and Safety of Tofacitinib in Patients With Psoriatic Arthritis in Real Clinical Practice

Efficacy and Safety of Tofacitinib in Patients With Psoriatic Arthritis in Real Clinical Practice

Development and validation of a high-performance liquid chromatography with tandem mass spectrometry method for quantification of tofacitinib in human plasma

Prospects for the use of janus kinase inhibitors in the treatment of ankylosing spondylitis and psoriatic arthritis. Literature review

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