May 2024

Guselkumab for the Treatment of Crohn’s Disease: Induction Results From the Phase 2 GALAXI-1 Study

Gastroenterology 2023;165:1588 doi 10.1053/j.gastro.2022.01.047

Guselkumab induced greater clinical and endoscopic improvements in patients with Crohn’s disease versus placebo, with a favourable safety profile in this Phase 2 trial by Sandborn, et al.

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Risankizumab as maintenance therapy for moderately to severely active Crohn’s disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal Phase 3 FORTIFY maintenance trial

Lancet 2022;399:2031–36 doi: 10.1016/S0140-6736(22)00466-4

Maintenance treatment with risankizumab was associated with an improvement in coprimary endpoints of clinical remission and endoscopic response in patients with Crohn’s disease compared with placebo.

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April 2024

Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal Phase 3 trial

Lancet 2021;397:475–86 doi: 10.1016/S0140-6736(21)00126-4

Bimekizumab therapy was associated with a rapid and sustained improvement in PASI response and IGA score in patients with moderate to severe plaque psoriasis. Dual inhibition of IL-17A/F with bimekizumab can affect a more durable response in PsO patients than sole IL-17A inhibition. Gordon et al. compared the safety and efficacy of two different maintenance dosing schedules, in addition to the effects of treatment withdrawal in the 52-week BE READY trial.

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February 2024

Impact of Upadacitinib on Laboratory Parameters and Related Adverse Events in Patients with RA: Integrated Data Up to 6.5 Years

Rheumatol Ther 2024;11(1):157–175 doi 10.1007/s40744-023-00624-3

Charles-Schoeman, et al. carried out a descriptive integrated analysis on patients with RA that were treated in the SELECT programme, with up to 6.5 years of exposure. They concluded that upadacitinib 15 mg QD had an acceptable safety profile, but long-term upadacitinib treatment was associated with dose-dependent laboratory abnormalities.

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November 2023

Risco de Eventos Cardiovasculares Adversos Maiores em Distúrbios Inflamatórios Imunomediados com Biológicos e Moléculas Pequenas: Meta-análise em rede

CClin Gastroenterol Hepatol 2023;22:961-970.e12

The results of this study show that anti-IL-12/23, JAK inhibitors, and anti-TNF-α were associated with slightly higher risk of MACE compared with placebo. The risk was no different between biologic treatments, and the magnitude of risk did not differ between IMID type.

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April 2023

Eficácia e segurança do golimumabe em pacientes com espondiloartrite axial não radiográfica: Estudo de Retirada e Retratamento (GO-BACK)

Rheumatology (Oxford) 2023;62(11):3601–3609 doi: 10.1093/rheumatology/kead112

This study highlighted that continued treatment with Golimumab (GLM) QMT or GLM Q2MT was superior to placebo. The GO-BACK study was designed to evaluate the efficacy and safety of golimumab treatment withdrawal in adults with nr-axSpA who demonstrate inactive disease during a 10-month open label GLM run-in.

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January 2023

Pacientes com Artrite Reumatoide Controlada podem Diminuir Metotrexato da Terapia Dirigida e Manter Remissão? Uma Revisão Sistemática e Meta-Análise

J Rheumatol. 2023;50(1):36–47 doi: 10.3899/jrheum.220152

This systematic review and meta-analysis of studies evaluated the proportion of patients in remission after the dosage of MTX was tapered, and concludes that patients with controlled RA may taper MTX from targeted therapy with a 10% reduction in the ability to sustain remission for up to 18 months.

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Análise das Medidas de Atividade da Doença em um Estudo de Redução de Metotrexato em Pacientes com Artrite Reumatoide Tratados com Tofacitinib e Metotrexato

Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00511-3

This post hoc analysis of data from the ORAL Shift study, concludes that DAS28-4(ESR), CDAI remission and SDAI remission are the metrics most likely to reflect actual disease activity, in the context of tofacitinib in a randomised withdrawal of MTX.

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February 2022

Efeito dos ajustes de dose na eficácia e segurança de tofacitinib em pacientes com artrite reumatoide: uma análise post hoc de um estudo aberto de extensão a longo prazo (ORAL Sequel)

Clin Rheumatol. 2022 Jan 1. Epub ahead of print doi: 10.1007/s10067-021-05908-z

Post-hoc analysis shows that dosing up from tofacitinib 5 to 10 mg BID is associated with improved efficacy for up to 12 months, versus staying on 5 mg BID, and dosing down from 10 to 5 mg BID is not generally associated with a significant loss of efficacy.Although clinical trials have generally shown no significant differences, in terms of efficacy and safety, when switching tofacitinib dose up or down, these per-protocol switches are not directly informative for clinical decision-making in dai...

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January 2020

Segurança, Tolerabilidade, Farmacocinética, Ocupação de Alvo e Análise do Intervalo QT do Novo Inibidor BTK Evobrutinib em Voluntários Saudáveis

Clin Transl Sci . 2020 Mar;13(2):325-336. doi: 10.1111/cts.12713. Epub 2019 Nov 29.

In this first in-human phase I, double-blind, placebo-controlled trial, the Bruton’s tyrosine kinase (BTK) inhibitor evobrutinib was well-tolerated, showed linear and time-independent PK, induced long-lasting BTK inhibition, and was not associated with prolongation of QT/QTc interval in healthy subjects. Evobrutinib is an oral BTK inhibitor that has demonstrated efficacy in pre-clinical and autoimmune disease models. BTK is a key regulator of B cell receptor and Fc receptor signalling, and a rat...

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