Publications

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

Rheumatoid Arthritis Disease Activity and Adverse Events in Patients Receiving Tofacitinib or Tumor Necrosis Factor Inhibitors: A Post Hoc Analysis of 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

Malignancy Risk with Tofacitinib versus TNF Inhibitors in Rheumatoid Arthritis: Results from the Open-Label, Randomised Controlled Oral Surveillance Trial

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

Evaluation of Hepatitis B Virus in Clinical Trials of Baricitinib in Rheumatoid Arthritis

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

Comparisons of Hepatitis C Viral Replication in Patients with Rheumatoid Arthritis Receiving Tocilizumab, Abatacept and Tofacitinib Therapy

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

Worldwide, 3-year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis

Rheumatol Ther 2018 Jun; 5(1):283–91

Cohen S,

Curtis JE,

DeMasi R,

Chen Y,

Fan H,

Soonasra A,

Fleischmann R

This real-world analysis of tofacitinib (TOF) revealed that AEs reported by patients with RA from 2012 to 2015 were consistent with the known safety profile of TOF – no new safety risks were identified.As of August 2017, it is estimated that more than 102 000 patients worldwide have received TOF, but TOF safety has not been evaluated in patients with real-world experience. This analysis addressed this – by evaluating the safety of TOF from post-marketing surveillance (PMS) reports from patients ...

Keywords:

• JAK,
• Tofacitinib,
• Real-World

Analysis of Non-melanoma Skin Cancer across the Tofacitinib Rheumatoid Arthritis Clinical Programme

Clin Exp Rheumatol 2017;35:614–22

Curtis JR,

Lee EB,

Martin G,

Mariette X,

Terry TT,

Chen Y,

Geier J,

Andrews J,

Kaur M,

Fan H,

Nduaka CI

Because non-melanoma skin cancer (NMSC) is one of the most common malignancies associated with RA immunomodulatory therapies, this analysis looked to determine the rate of NMSC incidence per 100 patient-years in patients with RA receiving TOF in the clinical trial programme. The Phase 1, 2, and 3 IRs (combined) for both TOF 5- and 10 mg were low and comparable to those of adalimumab, MTX and placebo, IRs remained stable over time. TOF doses used in the 2 Phase 1; 8 Phase 2; and 6 Phase 3 studies...

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Skin,
• Malignancy