August 2025

Safety profile of upadacitinib: Descriptive analysis in over 27,000 patient‑years across rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, and inflammatory bowel disease

Adv Ther 2025 Doi: 10.1007/s12325-025-03328-y Epub ahead of print

This descriptive analysis indicates a long-term safety profile of UPA consistent with previous reports, further supporting long-term treatment of chronic diseases with UPA. Burmester at al. characterized the safety profile of UPA across multiple approved indications and offer insights into its long-term use to help inform clinical decision-making.

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Immunogenicity of adjuvanted recombinant zoster vaccine in patients with rheumatoid arthritis treated with upadacitinib: 60-week results from a randomised controlled trial substudy

RMD Open 2025;11:e005-21 Doi: 10.1136/rmdopen-2025-005521

Most patients vaccinated with RZV while using UPA 15mg QD and background MTX achieved satisfactory humoral and cell-mediated immune responses to recombinant zoster vaccine (RZV) at Weeks 4, 16 and 60. Winthrop et al. evaluated the immunogenicity of RZV through Week 60 in patients with RA who were receiving UPA 15mg QD and background MTX.

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April 2024

EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update

Ann Rheum Dis 2024 doi: 10.1136/ard-2024-225531 Epub ahead of print

The 2023 EULAR recommendations provided an updated consensus on the pharmacological management of PsA with a new overarching principle and recommendation for 2023. Recent MOA safety data emphasised the importance of patient-specific benefit-risk profiling in JAKi therapy, and extra-musculoskeletal (MSK) manifestations related to PsA should be considered during drug selection.

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Integrated safety analysis of filgotinib in patients with moderate-to-severe rheumatoid arthritis over a treatment duration of up to 8.3 years

Ann Rheum Dis 2024;0:1–8 doi: 10.1136/ard-2024-225759 Epub ahead of print

Burmester, et al. found that long-term filgotinib exposure was well tolerated in patients with moderate-to-severe active RA, with a stable rate of TEAEs over time. However, potential dose-dependent relationships for herpes zoster infections, malignancies and all-cause mortality were observed in patients aged ≥65 years, indicating the potential impact of age on the safety profile of Filgotinib. Therefore, some patients aged ≥65 years may benefit from the filgotinib 100 mg dose option.

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March 2023

Perfil de Segurança de Upadacitinibe em Mais de 15.000 Pacientes-Ano em Artrite Reumatoide, Artrite Psoriática, Espondilite Anquilosante e Dermatite Atópica

RMD Open. 2023;9(1):e002735 doi: 10.1136/rmdopen-2022-002735

Integrated analysis of the safety profile of upadacitinib demonstrates that it was generally well-tolerated in RA, PsA, AS and AD, with no new safety risks identified, compared with previous reports.

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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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December 2022

EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update

Ann Rheum Dis. 2022. Epub ahead of print [05/12/2022] doi: 10.1136/ard-2022-223356

Smolen, et al. provide a 2022 update of the EULAR recommendations for the management of RA with synthetic and biological DMARDs.

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Safety of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis

Ann Rheum Dis. 2022. Epub ahead of print doi: 10.1136/ard-2022-223357

Sepriano, et al. provide results of a systematic literature review (SLR) on the safety of synthetic and biological DMARDs, to inform the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis.

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Efficacy of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis

Ann Rheum Dis. 2022. Epub ahead of print. doi: 10.1136/ard-2022-223365

Kerschbaumer, et al. provide results of a systematic literature review (SLR) on efficacy of synthetic and biological DMARDs, to inform the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis.

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September 2022

Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions: an update

doi: 10.1136/ard-2022-222784.

Blocking the IL-6R is a major therapeutic advance for many diseases in adults and children. Updated consensus statement provides guidance to rheumatologists and other experts, as well as patients and administrators, on managing patients with the use of drugs blocking the IL-6 pathway.

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