October 2018

Confronto di Efficacia e Sicurezza tra Tofacitinib e Baricitinib in Pazienti con Artrite Reumatoide Attiva: una Meta-analisi di Network Bayesiana di Trial Controllati Randomizzati

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

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...

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Riduzione del Dosaggio di Baricitinib Nei Pazienti con Artrite Reumatoide che Hanno Raggiunto il Controllo della Malattia Prolungato: Risultati di uno StudioProspettico

Ann Rheum Dis. 2019 Feb;78(2):171-178. DOI 10.1136/annrheumdis-2018-213271

In active RA patients, with an inadequate response (IR) to DMARDs who achieve low disease activity (LDA) following baricitinib (BARI) 4 mg treatment, disease control is better maintained with continued BARI 4 mg compared to tapering to 2 mg.The objective of this study was to investigate the effect of BARI tapering in patients achieving sustained disease control with BARI 4 mg.In the long-term extension study RA-BEYOND, patients receiving BARI 4 mg who achieved sustained LDA or remission at two c...

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Profilo di Sicurezza di Baricitinib in Pazienti con Artrite Reumatoide Attiva con un Periodo di Trattamento in Media di Oltre 2 Anni

J Rheumatol. 2019 Jan;46(1):7-18. DOI: 10.3899/jrheum.171361

Baricitinib (BARI) showed an acceptable 5.5-year safety profile in this integrated analysis of patients with moderate-to-severe, active RA.This study evaluated the safety profile of the oral, once daily Janus kinase inhibitor, BARI, in adults with moderately to severely active RA. Data from eight randomised clinical trials and one long-term extension study were pooled and analysed for placebo comparison and dose response.There were 3492 patients who received BARI for a total of 6637 patient-yea...

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August 2018

Sospensione del Tocilizumab dopo Aver Raggiunto la Remissione in Pazienti con Artrite Reumatoide Trattati con Solo Tocilizumab o in Combinazione con Methotrexate: Risultati da uno Studio Prospettico Randomizzato Controllato (secondo anno dello studio SURPRISE)

Ann Rheum Dis 2018; 77:1268–1275 DOI: 10.1093/rheumatology/key121

The second-year results from the SURPRISE study show that low disease activity (LDA) can be maintained after discontinuation of tocilizumab with continued methotrexate after remission is achieved. Discontinuation of biologic agents in patients who have achieved remission or low disease activity (LDA) is desirable from a risk–benefit point of view. Compared with TNF inhibitors, little is known regarding TCZ-free remission or LDA, but studies indicate that only a small proportion of patients remai...

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July 2018

Sicurezza ed Efficacia di Upadacitinib nei Pazienti con Artrite Reumatoide Attiva Refrattaria a Farmaci Biologici Antireumatici Modificanti l’Attività di Malattia (SELECT-BEYOND): un Trial di Fase 3, in Doppio Cieco, Randomizzato, Controllato

Lancet 2018;391:2513–24

Upadacitinib (UPA) extended release formulation was effective in treating patients with moderate-to-severe RA with an inadequate response to bDMARDs.Phase 2 study data has shown that UPA is an efficacious and safe treatment for active RA.1,2 SELECT-BEYOND was a double-blind, long-term extension, Phase 3 study to assess the efficacy of UPA in patients with RA who were bDMARD-IR. The first 12-weeks of SELECT-BEYOND were placebo-controlled, with a double-blind period followed by an ongoing double-b...

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Sicurezza ed Efficacia di Upadacitinib nei Pazienti con Artrite Reumatoide e Risposta Inadeguata a Farmaci Antireumatici Convenzionali Sintetici Modificanti l’attività di Malattia (SELECT-NEXT): un Trial di Fase 3 Randomizzato, in Doppio Cieco, Controllato con Placebo

Lancet 2018;391:2503–12

Patients with moderate-to-severe active RA had significant improvements in clinical signs and symptoms with upadacitinib (UPA) compared with placebo.In Phase 2 studies, UPA showed favourable efficacy when administered twice daily as an immediate-release formulation at doses of 6–12 mg in patients with active RA who had TNFi-IR.1,2 An extended-release formulation allowing once-daily (QD) administration was developed for Phase 3 studies. SELECT-NEXT was a double-blind, multicentre, Phase 3 study t...

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June 2018

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

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...

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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

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...

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March 2018

Conseguenze della Sospensione o dell’Inizio di Methotrexate o Glucocorticoidi sull’Efficacia del Tofacitinib in Pazienti con Artrite Reumatoide: Un’Analisi Post Hoc

Rheumatol Ther 2018 Jun; 5(1):203–14. DOI: 10.1007/s40744-018-0093-7

Methotrexate (MTX) or Glucocorticoid (GC) discontinuation has little effect on CDAI response in patients given tofacitinib (TOF) for up to 3 years. Patients receiving TOF who showed initial improvements benefitted from initiation of MTX or GCs. Concomitant treatments such as MTX or GC are commonly used in combination with RA therapies to improve or accelerate clinical responses. However, their use is associated with many adverse events so clinicians aim to use them for a minimal duration.This po...

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Risposta al Baricitinib Basata sul Precedente Uso di Biologici nei Pazienti con Artrite Refrattaria

Rheumatology (Oxford) 2018 May; 57(5):900-908

Baricitinib (BARI) 2 or 4 mg had a beneficial treatment effect on patients with moderate to severe RA compared with placebo (PBO), irrespective of the number or nature of prior patient bDMARD use. The current therapeutic target for patients with established RA is low disease activity, but many patients fail to achieve this due to inadequate responses to DMARD therapies. With this patient population growing, therapies for these patients are considered one of the greatest unmet needs in RA. This s...

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