Publications

Efficacy and Safety Data Based on Historical or Pre-Existing Conditions at Baseline for Patients with Active Rheumatoid Arthritis Who Were Treated with Baricitinib

Ann Rheum Dis. 2019 Aug;78(8):1135-1138.

Combe B,

Balsa A,

Sarzi-Puttini P,

Tony HP,

de la Torre I,

Rogai V,

Durand F,

Witt S,

Zhong J,

Dougados M

In a post-hoc analysis, BARI 4 mg showed similar efficacy and safety during placebo-controlled and LTE observation periods regardless of the presence or absence of select comorbidities in RA patients.Patients with RA have a high prevalence of comorbidities. This post-hoc analysis investigated the effect of select comorbidities (depression, osteoporosis, hepatic, cardiovascular or pulmonary disorders) on the efficacy and safety of BARI 4 mg QD in patients with moderate-to-severe active RA and ina...

Keywords:

• JAK,
• Baricitinib,
• Efficacy,
• Safety

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

Harigai M,

Takeuchi T,

Smolen JS,

Winthrop KL,

Nishikawa A,

Rooney TP,

Saifan CG,

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 ...

Keywords:

• JAK,
• Baricitinib,
• Safety,
• Phase 3

Network Meta‐Analysis of Tofacitinib versus Biologic Treatments in Moderate‐to‐Severe Rheumatoid Arthritis Patients

J Clin Pharm Ther. 2019 Jun;44(3):384-396.

Camean‐Castillo M,

Gimeno‐Ballester V,

Rios‐Sanchez E,

Fenix‐Caballero S,

Vázquez‐Real M,

Alegre‐del Rey E

This study suggests that many bDMARDs and tsDMARDs can be considered equivalent therapeutic alternatives in bDMARD-naïve RA patients, with inadequate response to csDMARDs.In the absence of randomised controlled trials comparing drugs, indirect comparisons and network meta-analysis may provide information to help select an optimal treatment alternative. In this network meta-analysis, 27 randomized controlled trials were analysed to assess the possibility that some drugs on the market may be consi...

Keywords:

• JAK,
• Tildrakizumab,
• Efficacy,
• Safety,
• Meta analysis

Tofacitinib in Combination with Methotrexate in Patients with Rheumatoid Arthritis: Clinical Efficacy, Radiographic and Safety Outcomes from the 24-Month Phase 3 ORAL Scan Study

Arthritis Rheumatol. 2019 Jun;71(6):878-891

van der Heijde D,

Strand V,

Tanaka Y,

Keystone E,

Kremer J,

Zerbini CAF,

Cardiel MH,

Stanley Cohen S,

Nash P,

Song YW,

Tegzová D,

Gruben D,

Wallenstein G,

Connell CA,

Fleischmann R; ORAL Scan investigators

RA patients receiving TOF 5 or 10 mg BID plus MTX showed sustained clinical and radiographic treatment effects through months 12-24. The safety profile was consistent with previous TOF studies. The 12-month data from the ORAL Scan study have been previously reported. This report assesses durability of responses, including structural damage progression, and safety with TOF through 24 months. Patients were randomized 4:4:1:1 to receive TOF 5 or 10 mg BID, or PBO advanced to TOF with stable, backgr...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3,
• Radiographic

Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis.

Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680

Tanaka Y,

McInnes IB,

Taylor PC,

Byers NL,

Chen L,

de Bono S,

Issa M,

Macias WL,

Rogai V,

Rooney TP,

Schlichting DE,

Zuckerman SH,

Emery P

This review shows that changes in lymphocyte subsets were largely within normal reference ranges and were not associated with efficacy or safety end points. BARI is a selective JAK1/JAK2 inhibitor, approved for the treatment of moderate to severe RA. BARI treatment is associated with changes to circulating lymphocyte and lymphocyte subsets, however detailed analyses of these effects, and their relevance to efficacy and safety is lacking. This study investigated the changes in lymphocyte cell sub...

Keywords:

• JAK,
• Baricitinib,
• Basic Science,
• MOA

Professor Iain McInnes Reviews the Most Notable Papers from 2018

Please click the links below to go to the CSF review of each paper

McInnes. I

2018 brought a wealth of new data in cytokine signalling and IL-6 that helps inform current clinical practice and brings the promise of new options in the future. There was good data on the use of sub cutaneous tocilizumab as well as strategies in early RA and for methotrexate tapering. For the currently marketed JAK inhibitors, tofacitinib and baricitinib, continuous long-term efficacy and safety data further support its current use and applications. On the development side, the outcomes of the...

Keywords:

• Review

Safety and Efficacy of Baricitinib in Patients Receiving Conventional Synthetic Disease-Modifying Antirheumatic Drugs or Corticosteroids

Rheumatol Ther 2018 Dec;5(2):525-536. DOI 10.1007/s40744-018-0128-0

van Vollenhoven R,

Helt C,

Arora V,

Zhong J,

Correia AP,

de la Torre I,

Muram D

Baricitinib (BARI) in combination with MTX and concomitant csDMARDs was shown to be efficacious, regardless of corticosteroid use in RA patients. MTX is prescribed to most RA patients but concomitant csDMARDs and/or corticosteroids can be added. This study assessed the efficacy and safety of BARI in two arms; with/without corticosteroids and; with MTX only/MTX plus csDMARD/csDMARDs only. Baseline characteristics and adverse reactions were also compared. Data were pooled from two phase 3 studies ...

Keywords:

• JAK,
• Baricitinib,
• Safety,
• Efficacy

Efficacy and Safety of Filgotinib, a Selective Janus Kinase 1 Inhibitor, in Patients with Active Ankylosing Spondylitis (TORTUGA): Results from a Randomized, Placebo-controlled, Phase 2 Trial

Lancet 2018 Dec 1;392(10162):2378-2387. DOI 10.1016/S0140-6736(18)32463-2

Van der Heijde D,

Baraliakos X,

Gensler LS,

Maksymowych WP,

Tseluyko V,

Nadashkevich O,

Abi-Saab W,

Tasset C,

Meuleners L,

Besuyen R,

Hendrikx T,

Mozafarian N,

Liu K,

Greer JM,

Deodhar A,

Landewé R

In this first clinical trial of filgotinib in patients with active AS, filgotinib significantly reduced disease activity, and the signs and symptoms of AS compared with placebo. The TORTUGA trial was a randomized, double-blind, placebo-controlled, Phase 2 trial, that enrolled 263 adult patients from 30 sites in seven countries. Patients with active AS and an inadequate response or intolerance to two or more NSAIDs were assigned 1:1 to receive filgotinib 200 mg or placebo once daily for 12 weeks....

Keywords:

• JAK,
• Filgotinib,
• Phase 2

Efficacy and Safety of Filgotinib, a Selective Janus Kinase 1 Inhibitor, in Patients with Active Psoriatic Arthritis (EQUATOR): Results from a Randomised, Placebo-controlled, Phase 2 Trial

Lancet. 2018 Dec 1;392(10162):2367-2377. DOI 10.1016/ S0140-6736(18)32483-8

Mease P,

Coates LC,

Helliwell PS,

Stanislavchuk M,

Rychlewska-Hanczewska A,

Dudek A,

Abi-Saab W,

Tasset C,

Meuleners L,

Harrison P,

Besuyen R,

Van der Aa A,

Mozafarian N,

Greer JM,

Kunder R,

Van den Bosch F,

Gladman DD

In this first clinical trial of filgotinib in patients with PsA, filgotinib was effective in treating the signs and symptoms of active PsA across various disease manifestations.The EQUATOR trial was a randomized, double-blind, placebo-controlled, Phase 2 trial, that enrolled 191 adult patients from 25 sites in seven countries. Patients with active moderate-to-severe PsA and an insufficient response or intolerance to at least one csDMARD were assigned 1:1 to receive filgotinib 200 mg or placebo o...

Keywords:

• JAK,
• Filgotinib,
• Phase 2

A Network Meta-Analysis Comparing Efficacy and Safety of Tofacitinib and Baricitinib

Z Rheumatol. 2018 Sep 6. DOI 10.1007/s00393-018-0531-5

Bae SC and Lee YH

Tofacitinib (TOF) 10mg and baricitinib (BARI) 4mg, in combination with methotrexate (MTX), were the most efficacious treatments in RA patients with an inadequate response to DMARDs or biologics. Both combination treatments presented acceptable safety profiles and were not associated with a significant risk of serious adverse events.This study employed a Bayesian approach to Meta-Analysis; combining the available evidence across a network of Randomised Controlled trials (RCTs).Twelve RCTs contai...

Keywords:

• JAK,
• Baricitinib,
• Tofacitinib,
• Efficacy,
• Safety,
• Meta analysis