Publications

Inibição da progressão do dano estrutural articular com upadacitinib em artrite reumatoide: resultados de um ano do programa de fase 3 SELECT

Rheumatology (Oxford). 2021. Epub ahead of print. doi: 10.1093/rheumatology/keab861

Peterfy CG,

Strand V,

Friedman A,

Hall S,

Mysler E,

Durez P,

Baraliakos X,

Enejosa JV,

Shaw T,

Li Y,

Chen S,

Song IH

.

Keywords:

• JAK,
• Updacitinib,
• Phase 3,
• Efficacy,
• Radiographic

Upadacitinib em Artrite Reumatoide: Uma Avaliação de Risco-Benefício no Programa de Fase III

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

Conaghan PG,

Mysler E,

Tanaka Y,

Da Silva-Tillmann B,

Shaw T,

Liu J,

Ferguson R,

Enejosa JV,

Cohen S,

Nash P,

Rigby W,

Burmester G

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...

Keywords:

• JAK,
• Updacitinib,
• Phase 3,
• Review

erfil de Segurança de Upadacitinib em Artrite Reumatoide: Uma análise integrada de segurança do Programa Clínico de Fase III SELECT

Ann Rheum Dis 2020 DOI:10.1136/annrheumdis-2020-218510

Cohen SB,

van Vollenhoven RF,

Winthrop KL,

Zerbini CAF,

Tanaka Y,

Bessette L,

Zhang Y,

Khan N,

Hendrickson B,

Enejosa JV,

Burmester GR.

This integrated Phase III safety analysis of UPA showed that UPA had a similar profile to ADA and MTX for serious infections, malignancies, and thromboembolic events. Patients receiving UPA had increased risk of HZ and creatine phosphokinase elevation versus ADA.This integrated Phase III safety analysis of UPA examined >3500 RA patients and 4000 patient-years of exposure. Data were pooled from 3834 patients in SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY studie...

Keywords:

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

Highlights of 2019

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

McInnes. I

2019 was another remarkable year in cytokine signalling. We can be optimistic that clinical practice for inflammatory arthritis will continue to improve, with promising long-term safety data supporting the use of established JAK inhibitors; tofacitinib and baricitinib, in addition to exciting phase III clinical data for filgotinib and newly approved upadacitinib. You can find the most notable papers, as selected by CSF Steering Committee Chair Professor Iain McInnes, with links to their respecti...

Keywords:

• Review

Segurança e Efetividade de Upadacitinib ou Adalimumab mais Metotrexato em Pacientes com Artrite Reumatoide Mais de 48 Semanas com Troca para Terapia Alternativa em Pacientes com Resposta Insuficiente

Ann Rheum Dis 2019 DOI: 10.1136/annrheumdis-2019-215764

Fleischmann RM,

Genovese MC,

 Enejosa JV,

 Mysler E,

Bessette L,

Peterfy C,

 Ostor P,

 Li Y,

 Song I

Consistent with Wk26 data, significantly more UPA patients achieved LDA and remission versus ADA and PBO over 48 weeks. RA patients often change therapy due to inadequate response and intolerance. The SELECT COMPARE study was designed to explore switching to JAK inhibitors from TNF inhibitors without a wash-out period (and vice versa). The long-term safety and efficacy of UPA was compared to ADA and PBO in MTX-IR.1629 patients were blindly assigned 2:2:1 to; UPA 15mg QD, ADA 40mg Q2W and PBO, wi...

Keywords:

• JAK,
• Updacitinib,
• Phase 3