Publications

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

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

van der Heijde D,

Landewé RBM,

Wollenhaupt J,

Strengholt S,

Terry K,

Kwok K,

Wang L,

Cohen S.

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...

Keywords:

• JAK,
• Tofacitinib,
• LTE,
• Radiographic

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

Filgotinib Versus Placebo or Adalimumab in Patients with Rheumatoid Arthritis and Inadequate Response to Methotrexate: A Phase III Randomised Clinical Trial

Ann Rheum Dis. 2021 Jan 27:annrheumdis-2020-219214

Combe B,

Kivitz A,

Tanaka Y,

van der Heijde D,

Simon JA,

Baraf HSB,

Kumar U,

Matzkies F,

Bartok B,

Ye L,

Guo Y,

Tasset C,

Sundy JS,

Jahreis A,

Genovese MC,

Mozaffarian M,

Landewé RBM,

Bae S-C,

Keystone EC,

Nash P

Filgotinib improved RA signs and symptoms, physical function, and inhibited radiographic progression. FIL 200mg plus MTX, but not FIL 100mg plus MTX showed non-inferiority to ADA plus MTX, based on DAS28(CRP) low disease activity. FIL was also well tolerated in RA patients with inadequate response to MTX.This 52-week, phase 3 randomised clinical trial (FINCH 1) evaluated the efficacy and safety of FIL in patients with RA randomised to FIL 200 or 100mg, ADA 40mg, or placebo, all with background M...

Keywords:

• JAK,
• Fenebrutinib,
• Phase 3

Assessment of the association of baseline anti-CarbV and anti-MCV antibodies with response to treatment and radiographic progression in an RA population treated with either methotrexate or baricitinib: post-hoc analyses from RA-BEGIN

Arthritis Res Ther. 2020;22(1):193

López-Romero P,

Martinez-Gamboa L,

Bang H,

de la Torre I,

Holzkämper T,

Feist E

Autoantibodies associated with the onset of RA have gained attention in recent years as prognostic biomarkers. Though not used diagnostically, anti-CarbV (carbamylated vimentin) and anti-MCV (vimentin modified by citrullination) baseline titers are being investigated as predictors of treatment response. In this post-hoc analysis of data from the RA-BEGIN cohort of active RA patients, López-Romero and colleagues consider the potential predictive values of baseline anti-CarbV and anti-MCV titers r...

Keywords:

• JAK,
• Baricitinib,
• Efficacy,
• Bone,
• Radiographic

Upadacitinib versus Placebo or Adalimumab in Patients with Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase 3, Double-Blind, Randomized Controlled Trial

Arthritis Rheumatol 2019 DOI: 10.1002/art.41032

Fleischmann R,

Pangan AL,

Song IH,

Mysler E,

Bessette L,

Peterfy C,

Durez P,

Ostor AJ,

Li Y,

Zhou Y,

Othman AA,

Genovese MC

UPA demonstrated superiority to ADA in terms of clinical, functional and patient-reported outcomes with comparable radiographic inhibition. As many RA patients fail to achieve LDA and remission with TNF inhibitors and MTX there is a requirement for additional treatment options. In this SELECT-COMPARE study the clinical and functional outcomes of UPA were compared to ADA in MTX-IR patients. 1629 MTX-IR were randomly assigned 2:2:1 to; UPA 15mg QD, ADA 40mg Q2W or PBO, with background MTX. Key end...

Keywords:

• JAK,
• Updacitinib,
• Phase 3

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

Genovese MC,

van Adelsberg J,

Fan C,

Graham NMH,

van Hoogstraten H,

Parrino J,

Mangan EK,

Spindler A,

Huizinga TWJ,

van der Heijde D,

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...

Keywords:

• IL-6,
• Sarilumab,
• Phase 3,
• Safety,
• Radiographic

Effetti del Baricitinib sulla Progressione Radiografica del Danno Articolare Strutturale ad 1 Anno in Pazienti con Artrite Reumatoide e una Risposta Inadeguata a Farmaci Antireumatici Convenzionali Sintetici Modificanti l’Attività di Malattia

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

Risultati a Lungo Termine Radiografici e Riferiti dai Pazienti in Pazienti con Artrite Reumatoide Trattati con Tofacitinib: Analisi Post-hoc di ORAL Start e ORAL Scan

Rheumatol Ther. 2018 Dec;5(2):341-353. doi: 10.1007/s40744-018-0113-7

Strand V,

Kavanaugh A,

Kivitz AJ,

van der Heijde D,

Kwok K,

Akylbekova E,

Soonasra A,

Snyder M,

Connell C,

Bananis E,

Smolen JS

Tofacitinib (TOF) therapy reduced the progression of structural joint damage at 2 years, in patients of all disease states, compared with patients given methotrexate (MTX). Early intervention with DMARDs aim to prevent the development of future RA symptoms and inhibit the progression of structural damage to the joints. This post-hoc analysis uses data from two Phase 3 TOF studies, to examine the efficacy of early intervention with TOF on long-term radiographic outcomes and disease activity state...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3,
• PRO / QoL,
• Radiographic

Valutazione dell’Attività di Malattia nei Pazienti con Artrite Reumatoide Trattati con Tofacitinib da RAPID3: Analisi Post Hoc da Due Sperimentazioni di Fase 3

Clin Rheumatol 2018 Aug; 37(8):2043–53

Strand V,

Lee EB,

Yazici Y,

Dikranian A,

Wilkinson B,

Takiya L,

Zang C,

Bananis E,

Bergman MJ

Patients given tofacitinib (TOF) who achieved Routine Assessment of Patient Index Data 3 (RAPID3) remission or low disease activity (LDA) at 6 months, had improved long-term outcomes at 2 years, compared to patients with moderate or high disease activity (MDA/HDA) at 6 months.RAPID3¹ is a patient-reported evaluation of disease activity, based on pooled PROs; patient global assessment, patient assessment of arthritic pain and HAQ-DI scores. Previous studies with tocilizumab have suggested that RA...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3

Effetto dei Glucocorticoidi sull’Efficacia Clinica e Radiografica di Tofacitinib nei Pazienti con Artrite Reumatoide: Analisi Post-hoc di Dati da 6 Studi di Fase III

J Rheumatol 2018 Feb; 45(2):177-87

Charles-Schoeman C,

van der Heijde D,

Bumester GR,

Nash P,

Zerbini CAF,

Connell CA,

Fan H,

Kwok K,

Bananis E,

Fleischmann R

In this post hoc analysis, six Phase 3 studies were used to analyse the effect of glucocorticoids (GC) on the efficacy of tofacitinib (TOF) in patients with RA. Concomitant use of GC did not affect the clinical or radiographic outcomes of patients treated with TOF. Data from all six clinical trials were evaluated, with four studies (ORAL Scan, ORAL Standard, ORAL Sync and ORAL Step) being pooled for analysis. In these studies, MTX was used as a comparison and patients were required to maintain a...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3,
• Meta Analysis,
• Radiographic