Publications

View and download slide summaries of the latest original articles focusing on therapies in immune-mediated inflammatory diseases including rheumatology, dermatology, and gastroenterology. All materials produced by the team are subsequently reviewed and approved by individual Steering Committee members.

June 2020

Safety Profile of Baricitinib For the Treatment of Rheumatoid Arthritis Over a Median of 3 Years of Treatment: An Updated Integrated Safety Analysis

Lancet Rheumatol 2020;2:e347–57

Zhong J,

Issa M,

Wu W-S,

Winthrop KL

RA is a chronic, life-long disease requiring long-term treatment. As such, it is important to understand the long-term safety profile of DMARDs. In this analysis, baricitinib maintained a stable safety profile during long-term exposure. This baricitinib safety analysis included integrated data from nine Phase 3, 2, and 1b clinical trials, and one long-term extension, with data up to 360 weeks. 3700 patients were included, with maximum follow-up of almost 7 years – representing an additional 3,54...

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March 2019

Safety Profile of Baricitinib in Japanese Patients with Active Rheumatoid Arthritis with Over 1.6 Years Median Time in Treatment: An Integrated Analysis of Phase 2 and 3 Trials

Mod Rheumatol. 2019 Feb 20:1-23. DOI: 10.1080/14397595.2019.1583711

Issa M,

Isaka Y,

Akashi N,

Ishii T,

Tanaka Y

In this integrated analysis, BARI showed an acceptable safety profile in Japanese patients with up to 3.2 years of exposure. Other than incidences of herpes zoster (HZ), no major differences were noted with BARI safety in Japanese patients with RA, compared to the patients in the integrated database.BARI has previously demonstrated significant clinical efficacy and acceptable safety. Japanese patients who participated in the BARI clinical development programme, were comparable to those from the ...

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February 2019

Sicurezza Cardiovascolare Durante il Trattamento con il Baricitinib nell’Artrite Reumatoide.

Arthritis Rheumatol. 2019 Jul;71(7):1042-1055.

Witt S,

Issa M,

Zhang X,

This study indicates no association between exposure to BARI and MACE, arterial thrombotic events (ATE), or congestive heart failure (CHF). Overall IRs for venous thromboembolic event (VTE) in BARI-treated patients falls within the reported range for patients with RA.RA patients have a greater risk of cardiovascular (CV) diseases of arterial ischemic origin, and an increased risk of VTE. Studied frequencies of thromboembolic events in RA populations in the last decade has been reported as 2–3x h...

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September 2018

Profilo Lipidico e Effetti del Trattamento con Statina in Studi Raggruppati di Fase 2 e Fase 3 sul Baricitinib

Ann Rheum Dis. 2018 Jul;77(7):988-995. DOI 10.1136/annrheumdis-2017-212461

Emery P,

Zhong J,

Chen L,

Witt S,

Baricitinib (BARI) was associated with increased lipid levels; baseline statins did not alter these profiles. The introduction of statins during treatment reduced total cholesterol and LDL-C.The use of anti-inflammatory drugs in RA patients has been shown to alter lipid levels and is associated with reduced atherogenic risk. Increases in lipid levels, specifically HDL-C and LDL-C, have been observed in Phase 2 BARI studies1.This study analysed data from seven randomised RA Phase 2/3 studies of ...

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August 2018

Due Anni di Sarilumab in Pazienti con Artrite Reumatoide e una Risposta Inadeguata al MTX: Sicurezza, Efficacia e Conseguenze Radiografiche

Rheumatology 2018;57:1423–1431 DOI: 10.1093/rheumatology/key121

Fan C,

for the EXTEND study investigators

Two-year treatment of active, moderate-to-severe RA with sarilumab, along with dose reduction in the event of laboratory abnormalities, resulted in durable efficacy outcomes and a safety profile consistent with previous reports involving IL-6R inhibition. Durable long-term safety and efficacy, reduced joint damage progression, and conserving health-related quality of life and work productivity are important goals of therapy in RA.1 Sarilumab significantly reduced disease activity, improved physi...

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October 2016

Sarilumab plus Methotrexate Improves Patient-reported Outcomes in Patients with Active Rheumatoid Arthritis and Inadequate Responses to Methotrexate: Results of a Phase III Trial

Arthritis Res Ther 2016; 18:198. DOI.10.1186/s13075-016-9

Fan C,

Evidence is presented that treatment with sarilumab improves patient-reported outcomes (PROs). These improvements complement the clinical efficacy previously reported for sarilumab.Data were analysed from the 52-week Phase 3 MOBILITY randomised controlled trial in adult patients with active RA and previous inadequate response to MTX. Patients received subcutaneous placebo or sarilumab 150 mg or 200 mg every 2 weeks in combination with MTX, for 52 weeks.PROs assessed were: Patient Global Assessme...