Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis: results of 10 years of use

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The article justifies the need for a large arsenal of drugs to treat perennial rheumatoid arthritis. The authors present randomized controlled trial data showing high efficacy of tofacitinib at different doses as monotherapy, or in combination with methotrexate, or other conventional synthetic disease-modifying anti-inflammatory drugs in suppressing the activity and progression of the disease in various groups of patients, both non-responders to methotrexate, and non-responders to tumour necrosis factor-alpha inhibitors. Extension-phase data of randomized clinical trials demonstrated sustained efficacy of tofacitinib for up to 9.5 years. The authors presented the real-world evidence confirming high efficiency of the drug and noted the rapidity of onset of the effect and its high analgesic activity. The safety issues of tofacitinib with an emphasis on the cardiovascular safety of the drug, taking into account updates to the latest 2022 EULAR Recommendations on the need to consider risk factors for the development of cardiovascular adverse events when planning therapy with Janus kinase inhibitors are discussed. It is reported that slightly increased risk of such adverse events during use of tofacitinib, as compared with inhibitors of tumour necrosis factor alpha, was observed in elderly patients who have at least one risk factor for the development of cardiovascular events. Tofacitinib safety data were obtained from meta-analyses, systematic reviews, national registries, open observational studies, as well as outcomes of the use of the drug in real clinical practice. The launch of a domestic generic of the original drug was noted in the Russian Federation.

Tofacitinib in the treatment of rheumatoid arthritis: real-life practice and randomized clinical trial data

Chichasova,

Lila

2023

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Efficacy of tofacitinib in psoriatic arthritis: literature review and case report

Gridneva,

Aronova

2023

The article presents the results of a search in the PubMed and Google Scholar databases (meta-analyses, systematic reviews, clinical trials and case studies) evaluating the treatment of PsA with tofacitinib (TOFA). The review contains the most up-to-date information about the efficacy and safety of TOFA, a drug from the group of janus kinase inhibitors (JAKi), a brief description of the mechanism of action of TOFA is given, with mention of blocked signaling intracellular pathways. The spectrum of “key” clinical manifestations of psoriatic arthritis (PsA) is described, in which the therapeutic potential of TOFA (peripheral arthritis, psoriasis, enthesitis and dactylitis) is most fully revealed. The results of the main randomized controlled trials (OPAL Broaden and OPAL Beyond), postmarketing trials, descriptive studies and clinical observations are considered, and the high efficacy of TOFA for the treatment of PsA patients who did not respond to therapy with synthetic disease-modifying drugs and/ or Tumor Necrosis Factor inhibitors (TNFi) is demonstrated. The results (and their interpretation) of studying the safety of long-term use of different doses of TOFA – 5 mg 2 times a day and 10 mg 2 times a day and retention (“survival”) are presented therapy, with an emphasis on adverse events of special interest (“large” cardiological events (MACE), oncologics, infections). The results of treatment with tofacitinib in patients with PsA according to the All-Russian register of patients are presented. The pronounced positive effect of TOFA on the parameters that are defined as “patient-reported outcome – PRO” is particularly emphasized: indicators of fatigue, self-assessment, patient’s assessment of his condition according to VAS, assessment by HAQ-DI (Health Assessment Questionnaire), SF-36 (non-specific questionnaire for quality assessment patient’s life), etc. A clinical observation is presented that demonstrates a vivid therapeutic effect on arthritis, enteritis, dactylitis, clinical signs of spondylitis, sacroiliitis, as well as the skin process in a patient with active PsA.

Tofacitinib as a means of optimizing the treatment of rheumatoid arthritis at the outpatient stage (clinical cases)

Bashkova,

Madyanov

2024

Two clinical cases of tofacitinib use in the management of rheumatoid arthritis (RA) patients by a rheumatologist at the outpatient stage within the framework of the “Treatment to Target” strategy are presented. The first clinical case describes the case history of a female patient (age 48 years, RA duration 20 years), which demonstrates the difficulties in selecting pathogenetic therapy for late-stage RA. Consecutively prescribed four synthetic baseline anti-inflammatory drugs (methotrexate, sulfasalazine, cyclophosphamide, leflunomide) and two genetically engineered biological drugs (infliximab, rituximab) failed to achieve remission of the disease in the patient. Decrease in disease activity was noted after connection of the third biological drug – etanercept, treatment with which had to be interrupted due to pregnancy planning. The return to the combined treatment after childbirth did not lead to repeated “success”. A positive result was achieved 12 weeks after tofacitinib at a dose of 10 mg/day, which provided a decrease in RA activity to moderate and complete withdrawal of glucocorticoids. Given the incomplete clinical effect, tofacitinib dose was increased to 20 mg/day by the outpatient rheumatologist, which resulted in achieving low RA activity persisting for 5 years. The second case demonstrates the effectiveness of tofacitinib inclusion in the RA treatment regimen as a “second-line” drug. A patient (age 46 years, RA duration 10 years) with long-term drug (methotrexate 25 mg/week) clinical and laboratory remission of RA after an upper respiratory tract infection developed an exacerbation of the disease. Despite three-component therapy with baseline anti-inflammatory drugs, the patient had persistence of high RA activity, which led to the revision of pathogenetic therapy – tofacitinib at a dose of 10 mg/day with clinical effect of the drug after 4 weeks. The achieved clinical and laboratory remission of the disease has been maintained for two years. In outpatient practice tofacitinib can be an effective tool for optimizing RA treatment.