September 2019

Resultados de la Reducción de Dosis, Retirada y Reinicio de Tofacitinib en Pacientes con Artritis Reumatoide: Un Estudio Prospectivo Observacional

Clin Rheumatol. 2019 Aug 9. DOI: 10.1007/s10067-019-04721-z

Following achievement of remission or low disease activity (LDA), a dose reduction strategy of TOF to a 5mg QD dose was preferable to immediate withdrawal of TOF, with lower relapse rates.Clinical remission or LDA early in the disease course is a target for every RA patient. Although maintaining a state of remission or LDA is beneficial to patients, the AEs and costs associated with DMARDs, have significant burdens on patients during life-long RA treatment. This long-term study was performed to ...

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Comparación de la Regulación de la Señalización de Citoquinas Mediada por Baricitinib, Upadactinib y Tofacitinib en Subpoblaciones de Leucocitos Humanos

Arthritis Res Ther. 2019 Aug 2;21(1):183

Different JAKinibs modulated distinct cytokine pathways to varying degrees, and no agent potently or continuously inhibited an individual cytokine signalling pathway throughout the dosing interval. This study aimed to compare the in vitro cellular pharmacology of BARI, TOF and UPA across relevant leukocyte subpopulations, coupled with their in vivo PK, to determine their effects on distinct cytokine pathways. Peripheral blood mononuclear cells from healthy donors were incubated with different JA...

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August 2019

Eficacia y Seguridad de Peficitinib (ASP015K) en Pacientes con Artritis Reumatoide con Respuesta Inadecuada a Metotrexate: Resultados de un Estudio Fase III Aleatorizado, Doble-Ciego, controlado con Placebo (RAJ4) en Japán

Ann Rheum Dis 2019 DOI: 10.1136/annrheumdis-2019-215164

Peficitinib (PEF) 100 and 150 mg demonstrated robust clinical and structural efficacy in patients with RA who have an inadequate response to MTX. In Japan, two JAK inhibitors, TOF and BARI are currently available for RA patients with an inadequate response to conventional therapies. This randomized phase 3 study (RAJ4), assessed the efficacy and safety of two PEF doses in combination with MTX compared to PBO, in Japanese MTX-IR. Patients were randomized 1:1:1 to PBO, PEF 100 mg and 150 mg with M...

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Efecto de FIlgonitib vs Placebo en la Respuesta Clínica en Pacientes con Artritis Reumatoide Moderada a Grave Refractaria a una Terapia con Fármacos Antirreumáticos Modificadores de la Enfermedad: El Estudio Aleatorizado FINCH 2

JAMA 2019 322(4):315-325

Among RA patients with an inadequate response or intolerance to bDMARDs, filgotinib (FIL) doses, compared to PBO resulted in significantly greater proportions achieving a clinical response at Wk12.Patients with active RA despite treatment with bDMARD therapy need treatment options. The FINCH 2 Phase 3 study compared the effects of FIL vs PBO for the treatment of RA patients with inadequate response or intolerance to ≥1 prior bDMARDs. Patients were randomized in a 1:1:1 ratio, receiving FIL 200 m...

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Upadacitinib versus Placebo o Adalimumab en Pacientes con Artritis Reumatoide y una Respuesta inadecuada a Metotrexate: Resultados de un Estudio de Fase 3, aleatorizado, controlado doble ciego

Arthritis Rheumatol 2019 DOI: 10.1002/art.41032

UPA demonstrated superiority to ADA in terms of clinical, functional and patient-reported outcomes with comparable radiographic inhibition. As many RA patients fail to achieve LDA and remission with TNF inhibitors and MTX there is a requirement for additional treatment options. In this SELECT-COMPARE study the clinical and functional outcomes of UPA were compared to ADA in MTX-IR patients. 1629 MTX-IR were randomly assigned 2:2:1 to; UPA 15mg QD, ADA 40mg Q2W or PBO, with background MTX. Key end...

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Seguridad y Efectividad de Upadacitinib o Adalimumab más Metotrexate en Pacientes con Artritis Reumatoide:Más de 48 Semanas de Troca para una Terapia Alternativa con Respuesta Insuficiente

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

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...

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July 2019

Vacuna Viva Zoster en Pacientes con Artritis Reumatoide Tratados con Tofacitinib con o sin Metotrexato, o Adalimumab con Metotrexato

Arthritis Care and Research 2019 DOI: 10.1002/acr.24010

Live zoster vaccine (LZV) was well tolerated, and herpes zoster (HZ) incidence rates were generally similar between treatment groups in vaccinated versus non-vaccinated patients in a subset of RA who received LZV before TOF ± MTX, or ADA + MTX, in ORAL Strategy. It is known that patient with RA are at increased risk of developing HZ though the mechanisms behind this are currently not well understood though therapies, such as TOF, are thought to increase the risk. ACR and EULAR recommend using LZ...

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Desenlaces Clínicos en Pacientes que Cambiaron de Adalimumab a Baricitinib debido a falta de respuesta y/o Diseño del Estudio: Fase 3 en Pacientes con Artritis Reumatoide

Ann Rheum Dis. 2019 Jul;78(7):890-898.

Switching from ADA to BARI without a lengthy washout period can be executed with acceptable safety and tolerability and was associated with maintained disease control. Switching therapies in RA is commonplace in myriad scenarios including inadequate responses, intolerances and patient preference. Assessing the safety and efficacy of new treatments such as BARI, in the context of use as a replacement therapy, is beneficial. A previous study (RA-BEACON) has demonstrated that safely switching from ...

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June 2019

Efficacy and Safety of Filgotinib for Patients With Rheumatoid Arthritis Naïve to Methotrexate Therapy: FINCH 3 Primary Outcome Results

EULAR 2019 Abstract LB0003 Presentation

Filgotinib is an orally administered, selective inhibitor of JAK1. Filgotinib has shown good efficacy and was well tolerated for the treatment of RA in Phase 2 and 3 studies evaluating MTX-IR or bDMARD-IR patients. The objective of this study was to compare the efficacy and safety of filgotinib with and without MTX in patients with RA who were naïve to MTX therapy....

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Efficacy and Safety of Filgotinib for Patients With Rheumatoid Arthritis With Inadequate Response to Methotrexate: FINCH 1 Primary Outcome Results

EULAR 2019 Abstract LB0001 Presentation

Filgotinib is an orally administered, selective inhibitor of JAK1. Filgotinib has shown good efficacy and was well tolerated for the treatment of rheumatoid arthritis (RA) in Phase 2 studies.The objective of this Phase 3 study was to evaluate the efficacy and safety of filgotinib treatment in patients with RA who have had an inadequate response to methotrexate (MTX)....

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