Publications

Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database

Ann Rheum Dis. 2021. Epub ahead of print. doi: 10.1136/annrheumdis-2021-221276.

Taylor PC,

Takeuchi T,

Burmester GR,

Durez P,

Smolen JS,

Deberdt W,

Issa M,

Terres JR,

Bello N,

Winthrop KL

Analysis of data from the highest level of patient exposure to baricitinib across the spectrum of the RA population demonstrates that baricitinib maintained a similar safety profile to earlier analyses, with no new safety signals identified.Using integrated data from nine randomised controlled trials, Taylor, et al. assessed the safety of baricitinib 2 mg and 4 mg once-daily. Analysis of data from 3770 patients (median 4.6 years, up to 9.3 years) with active RA showed that baricitinib maintained...

Keywords:

• JAK,
• Baricitinib,
• Safety,
• LTE

Effect of janus kinase inhibitors and methotrexate combination on malignancy in patients with rheumatoid arthritis: a systematic review and meta-analysis of randomized controlled trials

Auto Immun Highlights. 2021;12(1):8.

Solipuram V,

Mohan A,

Patel R,

Ni R.

The combination of JAK inhibitors with MTX is not associated with an increased risk of malignancy when compared to MTX alone. Although long-term studies are needed to confirm this conclusion from short-term studies. Although it is now known that patients with RA are predisposed to an increased risk of malignancy, especially malignant lymphomas, lung cancers and non-melanoma skin cancer, it remains unclear whether the combination therapy is associated with a higher risk.To this end, Solipuram, et...

Keywords:

• JAK,
• Meta Analysis,
• Safety,
• Malignancy

Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study

Rheumatol Ther. 2021;8(2):903–919

Mease PJ,

Lertratanakul A,

Papp KA,

van den Bosch FE,

Tsuji S,

Dokoupilova E,

Keiserman MW,

Bu X,

Chen L,

McCaskill RM,

Zueger P,

McDearmon-Blondell EL,

Pangan AL,

Tillett W.

Fifty-six-week data suggest that upadacitinib could be a favourable long-term treatment option in patients with PsA who are refractory to biologic therapy.As the need for additional therapeutic agents that can effectively control disease activity continues, new data from a 56-week analysis of the oral reversible JAK1 inhibitor, upadacitinib, currently under investigation for the treatment of PsA, shows that efficacy of the drug is maintained over the duration of this study.Mease, et al. explored...

Keywords:

• JAK,
• Updacitinib,
• Phase 3,
• Safety,
• Efficacy

Comparison of the effects of baricitinib and tocilizumab on disease activity in patients with rheumatoid arthritis: a propensity score matching analysis

Clin Rheumatol. 2021 Jun 16. DOI: 10.1007/s10067-021-05815-3

Asai S,

Takahashi N,

Kobayakawa T,

Kaneko A,

Watanabe T,

Kato T,

Nishiume T,

Ishikawa H,

Yoshioka Y,

Kanayama Y,

Watanabe T,

Hirano Y,

Hanabayashi M,

Yabe Y,

Yokota Y,

Suzuki M,

Terabe K,

Ishiguro N,

Imagama S,

Kojima T.

The influence of inflammation on patient global assessment (PGA) improvements differs between baricitinib and tocilizumab differs. Adequate PGA improvement remains one of the unmet needs in current RA treatment.Asai, et al. compared the effects of baricitinib and tocilizumab on disease activity in patients with RA while investigating the influence of inflammation on PGA improvement.Using data from a multicentre registry, 48 propensity-matched pairs of patients, who had been observed for longer t...

Keywords:

• JAK,
• IL-6,
• Baricitinib,
• Tocilizumab,
• Efficacy

Efficacy of Long-Term Treatment with Once-Daily Baricitinib 2 mg in Patients with Active Rheumatoid Arthritis: Post Hoc Analysis of Two 24-Week, Phase III, Randomized, Controlled Studies and One Long-Term Extension Study

Wells AF, et al. Rheumatol Ther. 2021. Epub ahead of print. DOI: 10.1007/s40744-021-00317-9.

Wells AF,

Jia B,

Xie L,

Valenzuela GJ,

Keystone EC,

Li Z,

Quebe AK,

Griffing K,

Otawa S,

Haraoui B.

Analysis by Wells, et al. demonstrates long-term efficacy and tolerability of baricitinib 2 mg daily for up to 120 weeks in patients with rheumatoid arthritis.Using data from two completed phase III studies, RA-BEAM (csDMARD-IR patients) and RA-BEACON (TNFi-IR patients), and one ongoing long-term extension study (RA-BEYOND), results demonstrated that the long-term maintenance of clinically relevant treatment goals, including LDA, remission and normative physical function, is achievable with bari...

Keywords:

• JAK,
• Baricitinib,
• Efficacy,
• LTE,
• Phase 3

Risk of venous thromboembolism associated with tofacitinib in patients with rheumatoid arthritis: a population-based cohort study

Rheumatology (Oxford). 2021 Mar 22:keab294. Epub ahead of print. DOI: 10.1093/rheumatology/keab294

Desai RJ,

Pawar A,

Khosrow-Khavar F,

Weinblatt ME,

Kim SC

A population-based cohort study of 87,653 RA patients has found no evidence for an increased risk of venous thromboembolism (VTE) for tofacitinib, versus TNFis, in patients with RA.The introduction of JAKinibs, almost a decade ago, has provided an important oral option for the treatment of RA. However, in recent years, a safety concern, relating to incidence of VTE after treatment, has emerged. Consequently, both the US and European regulatory authorities now recommend caution for use of tofacit...

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Real-World

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

Diminished cytokine-induced Jak/STAT signaling is associated with rheumatoid arthritis and disease activity

PLoS ONE 2021;16(1):e0244187

Ptacek J,

Hawtin RE,

Sun D,

Louie B,

Evensen E,

Mittleman BB,

Cesano A,

Cavet G,

Bingham CO III,

Cofield SS,

Curtis JR,

Danila MI,

Raman C,

Furie RA,

Genovese MC,

et al

This analysis provides evidence that immune cell signalling pathways are important in RA. There were consistent differences between RA patients and healthy controls in IFNα, IL-6, IL-10 and GM-CSF+ IL-2 induced JAK/STAT signalling in multiple immune cell subsets.We know that RA is characterised by dysregulation of immune responses, but the exact cause is unknown. Recently, single-cell transcriptomics and mass cytometry confirmed the critical role of activated immune cells and fibroblasts, increa...

Keywords:

• JAK,
• Basic Science

Baricitinib Inhibits Structural Joint Damage Progression in Patients with Rheumatoid Arthritis – A Comprehensive Review

Arthritis Res Ther 2021;23(1):3.

Emery P,

Durez P,

Hueber AJ,

Ide la Torre I,

Larsson E,

Holzkämper T,

Tanaka Y

MRI studies have shown that BARI reduces joint inflammation and damage in patients with moderate-to-severe active RA. This review summarises the effects of BARI on structural joint damage progression and the mechanisms underlying these effects, using MRI data from across the clinical trial program. Early preclinical animal models showed a significant reduction in joint inflammation, ankle width, and bone resorption. Efficacy and safety of BARI have been confirmed in an extensive programme, inclu...

Keywords:

• JAK,
• Baricitinib,
• Radiographic,
• Review

EULAR Definition of Difficult-to-Treat Rheumatoid Arthritis

Ann Rheum Dis 2021;80:31–35.

Nagy G,

Roodenrijs NMT,

Welsing PMJ,

Kedves M,

Hamar A,

van der Goes MC,

Kent A,

Bakkers M,

et al.

A significant proportion of people with RA remain symptomatic despite treatment according to current management recommendations. Different terms have traditionally been used to describe this subpopulation, including severe, refractory, resistant to multiple drugs or treatments, established and difficult-to-treat. A recent survey indicated that – in addition to new drugs – new management approaches are needed for optimal treatment in these patients.A EULAR Task Force agreed the uniform terminolog...

Keywords:

• EULAR