October 2017

Impacto de Tocilizumab Monoterapia en los Resultados Informados por los Pacientes (PROs) con Artritis Reumatoide de dos Ensayos Controlados Aleatorizados

RMD Open;3:e000496. doi: 10.1136/rmdopen-2017-000496

This post hoc analysis of 2 randomised controlled trials (RCTs) AMBITION and ADACTA found that tocilizumab monotherapy results in substantial and clinically meaningful improvements in patient-reported outcomes (PROs) over 24 weeks.PROs assessed included patient global assessment (PtGA), pain, HAQ-DI, Functional Assessment of Chronic Illness Therapy (FACIT-F) and Short-Form-36 (SF-36) physical component summary (PCS) and mental component summary (MCS) and eight domain scores.Tocilizumab (TCZ) mon...

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July 2017

Eficacia y seguridad de Tofacitinib en Monoterapia, Tofacitinib con Metotrexato y Adalimumab con Metotrexato en pacientes con Artritis Reumatoide (ORAL Strategy): Un Ensayo Controlado fase 3b/4, aleatorizado, doble ciego, head-to-head.

Lancet. 2017 Jul 29;390(10093):457-468. doi: 10.1016/S0140-6736(17)31618-5

In this first head-to-head non-inferiority trial assessing a JAKi ± MTX directly compared with a TNFi + MTX in patients with RA, tofacitinib (TOF) + MTX showed non-inferiority to adalimumab (ADA) + MTX. Non-inferiority was not shown for TOF monotherapy versus TOF + MTX, or versus ADA + MTX.In this 52-week study, MTX-inadequate responder (IR) patients were randomised 1:1:1 to receive TOF 5 mg BID monotherapy, TOF 5 mg BID + MTX or ADA 40 mg every other week + MTX. The primary endpoint, ACR50 resp...

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June 2017

Biológicos o Tofacitinib para personas con Artritis Reumatoide naïve a metotrexate: Una revisión Sistemática y Metaanálisis en red

Cochrane Database Syst Rev. 2017 May 8;5:CD012657. doi: 10.1002/14651858.CD012657

This Cochrane systemic review and network meta-analysis looked at the benefits and harms of biologics or tofacitinib in patients with RA not previously treated with MTX.Using data from 19 RCTs including 6,485 participants, the review found that biologics (abatacept, adalimumab, etanercept, golimumab, infliximab, rituximab) in combination with MTX improved signs and symptoms of RA (ACR50) and increased the chances of remission (DAS <1.6 or DAS28 <2.6). There was also some evidence of an improveme...

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Filgotinib (GLPG0634/GS-6034), un inhibidor selectivo oral de JAK1, es efectivo en combinación con metotrexate (MTX) en pacientes con artritis reumatoide activa y respuesta insuficiente: resultados de un estudio aleatorizado para definición de dosis (DARWIN 1)

Ann Rheum Dis 2017;76:998–100

In these two Phase 2b studies, filgotinib (a selective JAK-1 inhibitor) was shown to improve the signs and symptoms of RA (compared with placebo), either as monotherapy or when added to MTX.DARWIN 1 included 594 patients with moderate to severe RA on a stable dose of MTX, while DARWIN 2 included 283 patients who stopped taking MTX before the start of the study. After 12 weeks’ treatment, significantly more patients who were receiving filgotinib 100 mg or 200 mg daily in DARWIN 1 or any filgotini...

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May 2017

Tocilizumab Combination Therapy or Monotherapy or Methotrexate Monotherapy in Methotrexate-naïve Patients with Early Rheumatoid Arthritis: 2-year Clinical and Radiographic Results from the Randomized, Placebo-controlled FUNCTION Trial

Ann Rheum Dis Published Online First: 7 April 2017. Doi 10.1136/annrheumdis-20160210561

Burmester et al. present data showing that 52-week efficacy and safety of intravenous tocilizumab plus methotrexate, or tocilizumab monotherapy are maintained through to Week 104 in patients with early rheumatoid arthritis. Patients were assigned to four treatment groups: 4 mg/kg TCZ + MTX, 8 mg/kg TCZ + MTX, 8 mg/kg TCZ + placebo or placebo + MTX. Patients not achieving DAS28 ≤3.2 at Week 52 and who were not receiving 8 mg/kg TCZ were rescued to 8 mg/kg TCZ + MTX. Of the 1162 randomly assigned ...

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March 2017

Efficacy and Safety of ABT-494, a Selective JAK-1 Inhibitor, in a Phase IIb Study in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Arthritis Rheumatol 2016;68:2857–66

The summary and accompanying slide deck have been developed in conjunction with the Kremer et al. study (Study 2) which examined ABT-494 in TNF-IR patients in order to compare and contrast the data. In these two Phase 2b studies, ABT-494 (a novel selective JAK-1 inhibitor) was shown to be effective in patients with active RA who were non-responders to MTX or at least one TNF inhibitor.Patients with active RA who had an inadequate response to MTX (study 1) or were refractory to or intolerant of p...

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January 2017

Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis who were Methotrexate- and Biologic-naïve or Free of Methotrexate for 6 Months: the AMBITION Study

J Rheumatol 2017;44:2. DOI 10.3899/jrheum.160287.

Results from the AMBITION study (Actemra versus Methotrexate double-Blind Investigate Trial In mONotherapy), showed the continuing efficacy and safety of tocilizumab up to 264 weeks.AMBITION was a 24-week randomised controlled trial in patients with active RA who were either MTX-naïve or MTX-free for 6 months prior to study entry. Patients received TCZ 8 mg/kg IV Q4W or oral MTX weekly (7.5 mg dose escalating to 20 mg). For those patients who then entered the long-term extension (LTE) study (N=1...

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