March 2024

Long-term etanercept response for patients with radiographic axial spondyloarthritis based on achievement of early, intermediate, or late responses during index studies

Rheumatol Ther 2024 doi: 10.1007/s40744-024-00656-3

This post-hoc analysis by Baraliakos, et al. found a response in short-term index studies was maintained in the long-term OLE studies, and where no response occurred in the index studies, continued treatment led to a response in a large proportion of patients.

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July 2023

Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis

Rheumatol Ther. 2023;10(5):1255–1276 doi: 10.1007/s40744-023-00576-8

The data gathered in this post-marketing surveillance study aligned with the previously established safety profile of tofacitinib, and reports were found to have consistent safety profiles in the treatment of both patient with PsA and RA. However, the results of this study should be interpreted considering the limitations of post-marketing surveillance studies.

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March 2023

Associações entre o Risco Cardiovascular e as Taxas de Incidência de Eventos Cardiovasculares Maiores e Malignidades em Pacientes com Artrite Psoriásica Recebendo Tofacitinib

Ther Adv Musculoskelet Dis. 2023 doi: 10.1177/1759720X221149965

Baseline 10-year atherosclerotic cardiovascular disease risk and metabolic syndrome are potentially associated with the incidence of both MACE and malignancies in patients receiving TOFA in the PsA and PsO clinical trial programs. This post hoc analysis aimed to examine the baseline CV disease risk and its association with the occurrence of MACE and malignancies in TOFA-treated patients with PsA and PsO.

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February 2023

Impacto do Enriquecimento do Risco Cardiovascular na Incidência de Eventos Adversos Cardiovasculares Graves no Programa Clínico de Tofacitinibe em Artrite Reumatoide

Ann Rheum Dis. 2023;82(4):575–577 doi: 10.1136/ard-2022-223406

Data suggest that an important difference between P123LTE and ORAL Surveillance was the proportion of patients with a history of atherosclerotic CV disease (ASCVD).

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January 2023

Eventos Adversos de Influenza em Pacientes com Artrite Reumatoide, Retocolite Ulcerativa ou Pacientes com Artrite Psoriásica nos Programas de Desenvolvimento Clínico de Tofacitinib

Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00507-z

This post-hoc analysis of 31 clinical trials in ulcerative colitis, rheumatoid arthritis and psoriatic arthritis concludes that combined influenza adverse event incidence rates were highest in ulcerative colitis, while in each indication they were generally similar across tofacitinib, placebo, and comparator groups.

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October 2022

Risk of MACE with Tofacitinib Versus TNFi in Patients with RA With or Without a History of Atherosclerotic CV: A Post Hoc Analysis from ORAL Surveillance

Ann Rheum Dis. 2022. doi: 10.1136/ard-2022-222259

Post hoc analysis from ORAL Surveillance observes higher major adverse cardiovascular events (MACE) risk with tofacitinib vs TNFi in patients with RA and history of atherosclerotic cardiovascular disease (ASCVD).

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February 2022

Efeito dos ajustes de dose na eficácia e segurança de tofacitinib em pacientes com artrite reumatoide: uma análise post hoc de um estudo aberto de extensão a longo prazo (ORAL Sequel)

Clin Rheumatol. 2022 Jan 1. Epub ahead of print doi: 10.1007/s10067-021-05908-z

Post-hoc analysis shows that dosing up from tofacitinib 5 to 10 mg BID is associated with improved efficacy for up to 12 months, versus staying on 5 mg BID, and dosing down from 10 to 5 mg BID is not generally associated with a significant loss of efficacy.Although clinical trials have generally shown no significant differences, in terms of efficacy and safety, when switching tofacitinib dose up or down, these per-protocol switches are not directly informative for clinical decision-making in dai...

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January 2022

Manejo Clínico da Herpes Zoster em Pacientes com Artrite Reumatoide ou Artrite Psoriásica Recebendo Tratamento com Tofacitinib

Rheumatol Ther. 2021. Epub ahead of print. doi: 10.1007/s40744-021-00390-0

This post hoc analysis provides the first detailed description of the management and outcomes of HZ events in tofacitinib RA and PsA clinical studies.While prior studies have characterised the increased HZ risk with JAKinibs, the clinical management of these events has not been detailed.To this end, Winthrop, et al. analysed data from 21 RA and 3 PsA clinical studies to evaluate how HZ events and their sequelae were clinically managed during the RA and PsA tofacitinib clinical development progra...

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Taxas de incidência de doença intersticial pulmonar em pacientes com artrite reumatoide tratados com tofacitinib

J Clin Rheumatol. 2021;27(8):e482–e490

This post hoc analysis of pooled data from 21 clinical trials in the tofacitinib clinical trial programme highlights the importance of identifying known risk factors of RA-interstitial lung disease (ILD) in clinical practice.Citera, et al. investigated incidence rates of ILD – an extra-articular manifestation of RA – in patients with RA, receiving tofacitinib 5 or 10 mg BID and sort to identify potential risk factors for ILD in these patients....

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May 2021

Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies

Rheumatology (Oxford). 2021;60(4):1708-1716.

Long-term evaluation of tofacitinib has found limited progression of structural damage in patients with RA treated with tofacitinib for up to 5 years. Similar results were also observed for patients receiving tofacitinib monotherapy or combination therapy for up to 3 years.It is well known that inflammation in RA leads to structural damage over time, and therapies such as DMARDS have the ability to reduce inflammation whilst inhibiting the progression of structural damage. In this study, van der...

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