Publications

A randomized Phase II study of efmarodocokin alfa, an interleukin-22 agonist, versus vedolizumab in patients with ulcerative colitis

Clinical Gastroenterology and Hepatology 2025;23:1387–1397 doi: 10.1016/j.cgh.2024.11.013

Danese S,

Rothenberg ME,

Lim JJ,

Ding,

HTMcBride JM,

Chen Y,

Dash A,

Mar JS,

Keir M,

Peyrin-Biroulet L,

Panes J,

Colombel JF,

Feagan B,

Valentine JF,

Schreiber S

Danese et al. observed that efmarodocokin alfa did not demonstrate efficacy compared to the PBO, and this Phase II study ended early for futility; however, there was evidence of target engagement (skin AEs, regenerating islet derived protein 3-alpha).

Keywords:

• GI,
• Outcomes,
• Phase 2,
• PK/PD,
• Safety

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

Risk of venous thromboembolism with tofacitinib versus tumor necrosis factor inhibitors in cardiovascular risk-enriched rheumatoid arthritis patients

Arthritis Rheumatol 2024 doi: 10.1002/art.42846 Epub ahead of print https://pubmed.ncbi.nlm.nih.gov/38481002/

Charles-Schoeman C,

Fleischmann R,

Mysler E,

Greenwald M,

Ytterberg SR,

Koch GG,

Bhatt DL,

Wang C,

Mikuls TR,

Chen AS,

Connell CA,

Woolcott JC,

Menon S,

Chen Y,

Lee K,

Szekanecz Z

This post hoc analysis of ORAL Surveillance showed that incidence of venous thromboembolism (VTE) events was higher in patients with RA treated with tofacitinib (10>5mg BID) versus TNFi. Across treatments, VTE risk factors (age, BMI, and VTE history) were aligned with previous studies in the general RA population.

Keywords:

• Adalimumab,
• Safety,
• Outcomes,
• Tofacitinib

Atividade de doença em artrite reumatoide e eventos adversos em pacientes que recebem tofacitinibe ou inibidores do fator de necrose tumoral: Uma Análise Post Hoc de ORAL Surveillance

Ther Adv Musculoskelet Dis. 2023;15:1759720X231201047 doi: 10.1177/1759720X231201047

Karpouzas GA,

Szekanecz Z,

Baecklund E,

Mikuls TR,

Bhatt DL,

Wang C,

Sawyerr GA,

Chen Y,

Menon S,

Connell CA,

Ytterberg SR,

Mortezavi M

Post hoc analysis of ORAL Surveillance data highlights that active disease in RA leads to higher risk of adverse medical events, regardless of medication used.

Keywords:

• Outcomes

Risco de malignidade com tofacitinibe versus inibidores de TNF na artrite reumatoide: Resultados do Estudo Open-Label, Randomizado e Controlado ORAL Surveillance

Ann Rheum Dis. 2023;82(3):331–343 doi: 10.1136/ard-2022-222543

Curtis JR,

Yamaoka K,

Chen YH,

Bhatt DL,

Gunay LM,

Sugiyama N,

Connell CA,

Wang C,

Wu J,

Menon S,

Vranic I,

Gómez-Reino JJ

Results from the open-label, randomised controlled ORAL Surveillance trial find increased risk of malignancies with tofacitinib versus TNFi, highlighting the highest incidence in patients with a history of atherosclerotic cardiovascular disease or increasing cardiovascular risk.

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Malignancy

JAK1/2 Inhibitor Baricitinib Improves Skin Fibrosis and Digital Ulcers in Systemic Sclerosis

Front Med (Lausanne). 2022 doi: 10.3389/fmed.2022.859330

Hou Z,

Su X,

Han G,

Xue R,

Chen Y,

Chen Y,

Wang H,

Yang B,

Liang Y,

Ji S

Promising results for patients with diffuse cutaneous systemic sclerosis (dcSSc) skin fibrosis and digital ulcers (DU), using JAK1/2 inhibitor baricitinib.

Keywords:

• JAK,
• Baricitinib,
• Efficacy

Avaliação do Vírus da Hepatite B em Ensaios Clínicos de Baricitinib em Artrite Reumatoide

RMD Open 2020;6:e001095

Harigai M,

Winthrop K,

Takeuchi T,

Hsieh T-Y,

Chen Y-M,

Smolen JS,

Burmester G,

Walls C,

Wu W-S,

Dickson C,

Liao R,

Genovese MC

Although hepatitis B virus (HBV) reactivation was seen in patients with RA treated with DMARDs, including BARI, who had serology suggestive of prior infection, reactivation was transient even with continued BARI treatment and did not account for any clinically relevant AEs.Reactivation of HBV replication is a recognised complication in patients receiving biologic agents for RA, such as DMARDs. Limited data exist on prevalence of occult infection and the incidence of reactivation in RA patients t...

Keywords:

• JAK,
• Baricitinib,
• Safety,
• Infections

Safety of Baricitinib in East Asian Patients With Moderate to Severe Active Rheumatoid Arthritis: An Integrated Analysis From Clinical Trials

Int J Rheum Dis . 2020 Jan;23(1):65-73. doi: 10.1111/1756-185X.13748.

Chen YC,

Yoo DH,

Lee CK

Post-hoc analyses of five completed phase II and III trials and an ongoing LTE suggested that BARI QD is well tolerated in East Asian patients with moderate-to-severe RA, with a similar safety and tolerability profile to the overall population.The majority of clinical evidence for RA treatments has been obtained from a predominantly Caucasian population, which may not be relevant to East Asian patients. In this post-hoc safety analysis, 740 Japanese, Taiwanese, Korean and Chinese patients were i...

Keywords:

• JAK,
• Baricitinib,
• Safety,
• Meta analysis

Comparações da Replicação Viral da Hepatite C em Pacientes com Artrite Reumatóide Recebendo Tocilizumabe, Abatacepte e Terapia com Tofacitinibe

Ann Rheum Dis. 2019 Jun;78(6):849-850.

Chen YM,

Huang WN,

Liao TL,

Chen JP,

Yang SS,

Chen HH,

Hsieh TY,

Hung WT,

Chen YH,

Chen DY

Tocilizumab (TCZ), abatacept (ABA) and tofacitinib (TOF) appear to have no major safety concerns for treatment of RA patients with hepatitis C virus (HCV) infections.HCV is an infectious disease which continues to present a major therapeutic challenge for clinicians in treating patients with RA. Previous reports demonstrate that the use of TNF targeted therapies in RA patients with HCV infections appear to have no major safety concerns. During short-term therapy with TCZ and ABA, data has shown ...

Keywords:

• Tofacitinib,
• Tocilizumab,
• Abatacept,
• Infections

Effects of Baricitinib on Radiographic Progression of Structural Joint Damage at 1 year in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Synthetic Disease-modifying Antirheumatic Drugs

RMD Open. 2018 May 8;4(1):e000662. DOI: 10.1136/rmdopen-2018-000662

van der Heijde D,

Dougados M,

Chen YC,

Greenwald M,

Drescher E,

Klar R,

Xie L,

de la Torre I,

Rooney TP,

Witt SL,

Schlichting DE,

de Bono S,

Emery P

Once daily baricitinib (BARI) inhibited radiographic progression of structural joint damage in patients with an inadequate response or intolerance to csDMARDs over 48 weeks.Current treatment goals aim to use DMARDs to inhibit structural joint damage and prevent long-term functional disability. In RA-BUILD¹, BARI was shown to significantly reduce radiographic joint damage progression in patients with active RA, with an intolerance or inadequate response to csDMARDs. Here, the authors report the l...

Keywords:

• JAK,
• Baricitinib,
• Phase 3,
• Radiographic