November 2018

Sicurezza ed Efficacia di Baricitinib nei Pazienti Trattati con Farmaci Antireumatici Modificanti la Malattia Sintetici Convenzionali o Corticosteroidi

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

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 ...

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L’incidenza di Herpes Zoster nel trattamento con Tofacitinib Aumenta Ulteriormente con i Glucocorticoidi ma non con il Methotrexate

Arthritis Care Res 2018 DOI 10.1002/acr.23769

The rate of Herpes Zoster (HZ) in tofacitinib (TOF) users with concomitant glucocorticoids (GC) was approximately double that of other TOF combination therapies.TOF is an effective treatment for RA. Increased HZ risk has been observed with the use of JAK inhibitors, whereas the HZ risk with biologics and targeted RA therapies are comparable. This study evaluated the HZ risk in TOF users according to concomitant GC, MTX, both, or neither. MarketScan and Medicare data were used to identify 8030 rh...

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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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September 2018

Progressione del Danno Strutturale in Pazienti con Artrite Reumatoide Precoce Trattata con Methotrexate, Baricitinib, o Barictinib più Methotrexate in Base alla Risposta Clinica nello Studio di Fase 3 RA-BEGIN

Clinical Rheumatology 2018;37:2381–90 DOI 10.1007/s10067-018-4221-0

Patients with active RA and little or no prior DMARD treatment, who achieved sustained clinical responses, were less likely to show structural damage progression, irrespective of treatment.RA-BEGIN was a 52-week double-blind, multicentre Phase 3 trial, which assessed the safety and efficacy of BARI as monotherapy or in combination with MTX versus MTX monotherapy, in RA patients with no or limited prior DMARDs use.1-4 This post-hoc analysis evaluated the structural damage progression in patients ...

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Risposta Prolungata in Seguito alla Sospensione di Methotrexate nei Pazienti con Artrite Reumatoide Trattati con Tocilizumab Sottocutaneo

Arthritis Rheumatol 2018;70:1200–08 DOI 10.1002/art.40493

The COMP-ACT study showed patients achieving low disease activity (LDA) with tocilizumab (TCZ) plus methotrexate (MTX) can discontinue MTX, while maintaining disease control for up to 16 weeks.Previous studies have shown TCZ to be efficacious as a monotherapy or in combination with MTX in patients with RA1,2. Patients frequently discontinue taking DMARDs, such as MTX, due to intolerance or adverse events.COMP-ACT is a randomised, double-blind, 52-week study evaluating the sustained efficacy of s...

Efficacia della Monoterapia con Agenti Biologici e Inibitori di Jak per il Trattamento dell’Artrite Reumatoide: Una Revisione Sistematica

ADV Ther 2018; 35(10):1525–63 DOI: 10.1007/s12325-018-0757-2

The b/tsDMARDs evaluated in this systematic literature review (SLR) were shown to be efficacious as monotherapies, although combination therapies usually achieved better treatment outcomes.Current treatment guidelines recommend combining b/tsDMARDs with MTX in the treatment of RA; however, up to a third of patients are treated with monotherapy. While previous SLRs1–3 have compared the efficacy of b/tsDMARD mono- versus MTX combination therapy they covered a limited number of randomised controlle...

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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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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

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...

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July 2018

Sarilumab per Artriti Reumatoidi Moderate o Gravi Previamente Trattate: Una Prospettiva del Gruppo di Revisione delle Evidenze su una Valutazione di Singola Tecnologia NICE

Pharmacoeconomics. 2018 Dec;36(12):1427-1437. doi: 10.1007/s40273-018-0677-7

In this National Institute for Health and Care (NICE) single technology appraisal of sarilumab (SAR) monotherapy and combination therapy with methotrexate (MTX), SAR was considered to have similar efficacy to other bDMARDs for treating moderate-to-severe RA with inadequate response to cDMARDs or TNFis. SAR was also considered a cost-effective use of National Health Service (NHS) resources versus some or all of its comparators in most considered populations.NICE is an independent organisation res...

Trombo-embolia associata agli Inibitori di Janus Kinase (JAK) per l’Artrite Reumatoide: Quanto è Reale il Rischio?

Drug Safety 2018 Jul;41(7):645–53

Current data suggests that JAK inhibitors may increase the risk of thromboembolism and pulmonary thrombosis (PT) in RA.Two JAK inhibitors – baricitinib (BARI) and tofacitinib (TOF) – are considered effective treatments for RA, however, there are concerns about the thromboembolic risks associated with them. In August 2017, the summary of product characteristics for BARI was revised to include a warning of developing DVT and pulmonary embolism (PE), with recommendations that BARI should be used wi...

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