May 2021

Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies

Rheumatology (Oxford). 2021;60(4):1708-1716.

Long-term evaluation of tofacitinib has found limited progression of structural damage in patients with RA treated with tofacitinib for up to 5 years. Similar results were also observed for patients receiving tofacitinib monotherapy or combination therapy for up to 3 years.It is well known that inflammation in RA leads to structural damage over time, and therapies such as DMARDS have the ability to reduce inflammation whilst inhibiting the progression of structural damage. In this study, van der...

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Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis

N Engl J Med. 2021;384(13):1227-1239.

Upadacitinib efficacy proves to be greater than placebo, and non-inferior to adalimumab, in treating patients with psoriatic arthritis (PsA). Already approved for the treatment of rheumatoid arthritis, McInnes, et al. studied oral upadacitinib at a dose of 15 mg or 30 mg, alongside placebo or adalimumab, in this 24-week, Phase III trial, in over 1700 patients with PsA. At the primary endpoint (Week 12), ACR20 response was greater with upadacitinib than placebo, and non-inferior to adalimumab; wi...

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April 2021

Filgotinib, a Novel JAK1-Preferential Inhibitor for the Treatment of Rheumatoid Arthritis: An Overview from Clinical Trials

Mod Rheumatol. 2021 Mar 19:1-26. Epub ahead of print. DOI 10.1080/14397595.2021.1902617

Filgotinib is the latest JAKinib to enter the international market for the treatment of RA, receiving regulatory approval in Japan and Europe late last year. In this review paper, Tanaka Y et al. examine the clinical evidence supporting its use as a later-line treatment, in accordance with international RA management guidelines, and provide their expert opinions on JAKinibs from a clinical perspective.The core clinical programme evaluating filgotinib in patients with moderately-to-severely activ...

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March 2021

Upadacitinib in Rheumatoid Arthritis: A Benefit–Risk Assessment Across a Phase III Program

Drug Saf. 2021 Feb 2. DOI: 10.1007/s40264-020-01036-w

Upadacitinib 15 mg has a favourable benefit–risk profile according to an assessment of data from the phase III SELECT clinical trial programme.In this review of data for the once-daily, oral JAK inhibitor, Conaghan PG, et al. provided insights into the benefit–risk profile of upadacitinib in approximately 4400 patients with RA. Based on pooled data from five pivotal studies, benefits and risks were assessed up to the time of regulatory submission, and additional long-term integrated safety revie...

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Effects of One-Year Tofacitinib Therapy on Bone Metabolism in Rheumatoid Arthritis

Osteoporos Int 2021 Feb 9 DOI 10.1007/s00198-021-05871-0

Thought to be the first study of its kind, Hamar, et al. have demonstrated the effect of one-year tofacitinib treatment on bone mineral density (BMD) in RA patients. While the association between RA and osteoporosis is well known, and evidence indicates that up to 70% of these patients have reduced BMD, little information is available on how the JAK inhibitor tofacitinib affects bone status, areal and volumetric BMD, and bone turnover markers. In this prospective study, 30 patients were assessed...

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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.

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...

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Post-Approval Comparative Safety Study of Tofacitinib and Biological Disease-Modifying Antirheumatic Drugs: 5-Year Results from a United States–Based Rheumatoid Arthritis Registry

ACR Open Rheumatol. 2021 Feb 11.

Analysis from the US Corrona RA registry has provided the longest-term real-world safety data for a JAK inhibitor to date. The analysis showed that the cohorts had similar adverse events, except for higher herpes zoster rates for tofacitinib initiators vs bDMARDs.Kremer JM, et al. analysed adult patients with RA newly initiating tofacitinib, or a bDMARD, to compare incidence rates of MACE, SIEs, HZ, malignancies and death. VTE data were also collected prospectively and assessed descriptively thr...

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Which Patient-reported Outcomes do Rheumatology Patients Find Important to Track Digitally? A Real-world Longitudinal Study in Arthritis Power

Arthritis Res Ther. 2021;23(1):53.

Fatigue, physical function, pain, and morning joint stiffness are the most important PROs to track, according to the rheumatology patients who experience these symptoms. Increasingly used, alongside clinical measures, to track symptoms and assess disease activity over time, patient-reported outcomes (PROs) are also important indicators of quality of life and treatment effectiveness. To enable us to better understand which PROs patients with rheumatic and musculoskeletal disease consider most imp...

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February 2021

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

PLoS ONE 2021;16(1):e0244187

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...

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January 2021