Publications

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

Burmester GR,

Deodhar A,

Irvine AD,

Panaccione R,

Winthrop KL,

Vleugels RA,

Levy G,

Suravaram S,

Palac H,

Wegrzyn L,

Ford S,

Meerwein S,

Guttman Yassky E

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.

Keywords:

• Phase 2,
• Phase 3,
• Skin,
• Safety,
• Upadacitinib

Cardiovascular disease risk in patients with psoriasis receiving biologics targeting TNF-α, IL-12/23, IL-17, and IL-23: A population-based retrospective cohort study

PLoS Med 22(4): e1004591 DOI: org/10.1371/journal.pmed.1004591

Lin TI,

Fan YH,

Fan KS,

Juan CK,

Chen YJ,

Wu CY

Lin et al. compared the risk of CVD in patients with psoriasis who were prescribed biologics or oral therapies and assessed the association between different classes of biologics and CVD risk. Patients with psoriasis-prescribed biologics exhibited a reduced risk of incident CVDs compared with those receiving oral antipsoriatic drugs.

Keywords:

• Cardiovascular,
• IL-17,
• IL-23,
• TNF

Does obesity affect treatment response to secukinumab and survival in ankylosing spondylitis? Real-life data from the TURKBIO Registry

Modern Rheumatology. 2024;34(3):584–91 doi: 10.1093/mr/road061

Karakaş A,

Gulle S,

Can G,

Dalkılıc E,

Aktar S,

Koca SS,

Pehlivan Y,

Senel S,

Tufan A,

Ozturk MA,

Yilmaz S,

Yazici A,

Cefle A,

Inel TY,

Erez Y,

Sari I,

Merih Birklik,

Direskeneli H,

Akkoc N,

and Onen F.

This study by Karakas, et al. found that obesity did not affect secukinumab treatment response and drug retention in ankylosing spondylitis patients.

Keywords:

• ASAS,
• Efficacy,
• Recommendations,
• Secukinumab

Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis: 2-Year Results from the Phase 3 SELECT-PsA 1 Study

Rheumatol Ther. 2022 Oct 15:1–18 doi: 10.1007/s40744-022-00499-w

McInnes IB,

Kato K,

Magrey M,

Merola JF,

Kishimoto M,

Haaland D,

Chen L,

Duan Y,

Liu J,

Lippe R,

Wung P

Results from the long-term extension of SELECT-PsA 1 show efficacy responses similar or greater with upadacitinib, 15 or 30mg, versus adalimumab through 104 weeks.

Keywords:

• JAK,
• Upadacitinib,
• Phase 3,
• LTE

Upadacitinib for the Treatment of Active Non-radiographic Axial Spondyloarthritis (SELECT-AXIS 2): A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial

Lancet 2022 doi: 10.1016/S0140-6736(22)01212-0

Deodhar A,

Van den Bosch F,

Poddubnyy D,

Maksymowych WP,

van der Heijde D,

Kim TH,

Kishimoto M,

Blanco R,

Duan Y,

Li Y,

Pangan AL,

Wung P,

Song IH

Upadacitinib significantly improved the signs and symptoms of nr-axSpA compared with placebo at Week 14 in this investigation. Prior to this, upadacitinib had been shown to be effective in patients with AS. This study aimed to assess the efficacy and safety of upadacitinib in non-radiographic axial spondyloarthritis.

Keywords:

• JAK,
• Upadacitinib,
• Phase 3

Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study

RMD Open. 2021;7(3):e001838

McInnes IB,

Kato K,

Magrey M,

Merola JF,

Kishimoto M,

Pacheco-Tena C,

Haaland D,

Chen L,

Duan Y,

Zueger P,

Liu J,

Lippe R,

Pangan AL,

Behrens F

Analysis of data over 56 weeks shows that efficacy responses are maintained with upadacitinib 15 mg and 30 mg.Following the publication of 12-week data from the Phase III, randomised double-blind, SELECT-PsA 1 study, earlier this year, McInnes, et al. now report the 56-week efficacy and safety data of upadacitinib 15 mg and 30 mg in patients with PsA and an inadequate response to non-biological therapyEfficacy responses and inhibition of radiographic progression were maintained with upadacitinib...

Keywords:

• JAK,
• Upadacitinib,
• Phase 3

Safety and Efficacy of Filgotinib: Up to 4-Year Results From an Open-Label Extension Study of Phase 2 Rheumatoid Arthritis Programs

J Rheumatol. 2021 Feb 1:jrheum.201183. DOI: 10.3899/jrheum.201183.

Kavanaugh A,

Westhovens RR,

Winthrop KL,

Lee SJ,

Tan Y,

An D,

Ye L,

Sundy JS,

Besuyen R,

Meuleners L,

Stanislavchuk M,

Spindler AJ,

Greenwald M,

Alten R,

Genovese MC

A long-term extension study of filgotinib showed consistent safety profile and sustained efficacy with the drug for up to four years. The DARWIN 3 study, for patients who previously completed either the 24-week DARWIN 1 study (filgotinib + MTX) or the DARWIN 2 study (filgotinib monotherapy), enrolled 739 patients with RA. At the time of analysis, 440 patients had received four years or more of filgotinib. Exposure-adjusted incidence rate per 100 patient-years-of-exposure for TEAEs was 24.6 in th...

Keywords:

• JAK,
• Fenebrutinib,
• Phase 2,
• LTE

Filgotinib, a JAK1 Inhibitor, Modulates Disease Related Biomarkers in Rheumatoid Arthritis: Results from Two Randomized, Controlled Phase 2b Trials

Rheumatol Ther. 2020 DOI: 10.1007/s40744-019-00192-5

Tarrant JM,

Galien R,

Wanying L,

Goyal L,

Pan Y,

Hawtin R,

Zhang W,

Van der Aa A and Taylor PC

In this study examining the effect of FIL on a panel of biomarkers, FIL down-modulated several key inflammatory mediators of signalling pathways in RA - independent of MTX background therapy. This confirmed the strong network effects of the JAK1 node in autoimmunity, matrix and cartilage degradation, angiogenesis, and leukocyte adhesion and recruitment. Biomarkers key to RA pathophysiology were measured at baseline, Wk4 and Wk12 in FIL 100 mg, FIL 200 mg or PBO treatment groups from two phase 2b...

Keywords:

• JAK,
• Filgotinib,
• Phase 2,
• MOA,
• Biomarkers

Impact of Janus Kinase Inhibitors on Risk of Cardiovascular Events in Patients with Rheumatoid Arthritis: Systematic Review and Meta-Analysis of Randomised Controlled Trials

Ann Rheum Dis. 2019 Aug;78(8):1048-1054.

Xie W,

Huang Y,

Xiao S,

Sun X,

Fan Y,

Zhang Z

Existing evidence from RCTs indicated no significant change in CV risk for JAK inhibitor (JAKinib) treated RA patients in a short-term perspective compared to placebo.Patients with RA have an elevated risk of CV morbidity and mortality, which cannot be fully explained by traditional CV risk factors. Reaching remission or LDA in order to reduce CV events (CVE) is encouraged in the current EULAR recommendations. JAKinibs and their roles in the modulation of CV risk remain undetermined. This study ...

Keywords:

• JAK,
• Safety,
• Meta analysis,
• Cardiovascular

Tofacitinib with Conventional Synthetic Disease-modifying Antirheumatic Drugs in Chinese Patients with Rheumatoid Arthritis: Patient-reported Outcomes from a Phase 3 Randomised Controlled Trial

Int J Rheum Dis 2018; 21(2):402–14

Li Z,

An Y,

Su H,

Li H,

Xu J,

Zheng Y,

Li G,

Kwok K,

Wang L,

Wu Q

This Chinese sub-population of patients with RA from ORAL Sync reported significant improvements in patient-reported outcomes (PROs), which were maintained up to 12 months from tofacitinib (TOF) treatment initiation. ORAL Sync was a randomised, Phase 3 study investigating TOF therapy in combination with csDMARDs in patients with active RA who had previously had an inadequate response to csDMARDs. To date, this is the only Phase 3 study of TOF in patients from China with RA. This analysis include...

Keywords:

• JAK,
• Phase 3