Matriz de evidencia
Inhibidores de TNF para artritis reumatoide
This matrix includes 89 Revisiones Sistemáticas Show Hide

Estudio primario

No clasificado

Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: 52-week results of the GO-FORWARD study

Año 2010
Revista Annals of the rheumatic diseases
Enlaces DOI , Pubmed

Este artículo está incluido en 9 Revisiones sistemáticas Revisiones sistemáticas (9 referencias) 2 Síntesis amplias Síntesis amplias (2 referencias)

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Objective: To evaluate the efficacy and safety of golimumab to 52 weeks in patients with active rheumatoid arthritis despite methotrexate. Methods: Patients were randomly assigned to receive placebo plus methotrexate (group 1), golimumab 100 mg plus placebo (group 2), golimumab 50 mg plus methotrexate (group 3) and golimumab 100 mg plus methotrexate (group 4). At week 16, patients in groups 1, 2 and 3 who had less than 20% improvement in tender and swollen joints entered early escape. At week 24, patients in group 1 who had not entered early escape crossed over to 50 mg golimumab plus methotrexate. Results: At week 16, 31%, 27% and 17% of patients in groups 1, 2 and 3, respectively, entered early escape. At week 52, 44%, 45%, 64% and 58% of patients in groups 1, 2, 3 and 4, respectively, achieved 20% improvement in the American College of Rheumatology criteria; and 34%, 31%, 42% and 53%, respectively, achieved low disease activity (≤3.2) according to the 28-joint disease activity score. Patients in group 4 appeared to have an increased risk of serious adverse events and serious infections. Conclusion: The results of various outcome measures showed that the response rates achieved by patients receiving golimumab to 24 weeks were sustained to 52 weeks. The safety profile appeared to be consistent with the known safety profile of tumour necrosis factor inhibitors.

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Resumen estructurado de revisiones sistemáticas

No clasificado

Infliximab, adalimumab and golimumab for the treatment of second line sub acute manifestations ulcerative colitis (Review TA140 & TA262) (ID695)

Año 2014
Revista HTA Database
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RECORD STATUS:

This is a bibliographic record of an ongoing health technology assessment being undertaken by a member of INAHTA. Links to the published report and any other relevant documentation will be added when available.

CITATION:

Infliximab, adalimumab and golimumab for the treatment of second line sub acute manifestations ulcerative colitis (Review TA140 & TA262) (ID695) Health Technology Assessment

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Resumen estructurado de revisiones sistemáticas

No clasificado

Adalimumab, etanercept, infliximab, certolizumab pegol and golimumab for the treatment of rheumatoid arthritis. Review of TA130, TA186 and TA225) (ID537)

Año 2014
Revista HTA Database
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RECORD STATUS:

This is a bibliographic record of an ongoing health technology assessment being undertaken by a member of INAHTA. Links to the published report and any other relevant documentation will be added when available.

CITATION:

Adalimumab, etanercept, infliximab, certolizumab pegol and golimumab for the treatment of rheumatoid arthritis. Review of TA130, TA186 and TA225) (ID537) Health Technology Assessment

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Estudio primario

No clasificado

Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial.

Año 2008
Revista Arthritis and rheumatism
Enlaces DOI , Pubmed

Este artículo está incluido en 22 Revisiones sistemáticas Revisiones sistemáticas (22 referencias) 2 Síntesis amplias Síntesis amplias (2 referencias)

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OBJECTIVE:

To evaluate the efficacy and safety of golimumab in patients with ankylosing spondylitis (AS) in the GO-RAISE study.

METHODS:

Patients with active AS, a Bath AS Disease Activity Index (BASDAI) score > or =4, and a back pain score of > or =4 were randomly assigned in a 1.8:1.8:1 ratio to receive subcutaneous injections of golimumab (50 mg or 100 mg) or placebo every 4 weeks. The primary end point was the proportion of patients with at least 20% improvement in the ASsessment in AS (ASAS20) criteria at week 14.

RESULTS:

At randomization, 138, 140, and 78 patients were assigned to the 50-mg, 100-mg, and placebo groups, respectively. After 14 weeks, 59.4%, 60.0%, and 21.8% of patients, respectively, were ASAS20 responders (P < 0.001). A 40% improvement in the ASAS criteria at week 24 occurred in 43.5%, 54.3%, and 15.4% of patients, respectively. Patients receiving golimumab also showed significant improvement in the physical and mental component summary scores of the Short Form 36 Health Survey, the Jenkins Sleep Evaluation Questionnaire score, the BASDAI score, and the Bath AS Functional Index score, but not the Bath AS Metrology Index score. Through week 24, 85.6% of golimumab-treated patients and 76.6% of patients in the placebo group had > or =1 adverse event, and 5.4% and 6.5% of patients, respectively, had > or =1 serious adverse event. Eight golimumab-treated patients and 1 placebo-treated patient had markedly abnormal liver enzyme values (> or =100% increase from baseline and a value >150 IU/liter), which were transient.

CONCLUSION:

Golimumab was effective and well tolerated in a large cohort of patients with AS during a 24-week study period.

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Estudio primario

No clasificado

Golimumab reduces spinal inflammation in ankylosing spondylitis: MRI results of the randomised, placebo- controlled GO-RAISE study

Año 2012
Revista Annals of the rheumatic diseases
Enlaces DOI , Google Scholar , PMC , Pubmed

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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OBJECTIVE:

To evaluate golimumab's effect on MRI-detected spinal inflammation in ankylosing spondylitis (AS).

METHODS:

Patients were randomly assigned to subcutaneous injections of placebo (n=78), golimumab 50 mg (n=138), or golimumab 100 mg (n=140) every 4 weeks. An MRI substudy comprising 98 patients (placebo n=23, 50 mg n=37, 100 mg n=38) at eligible MRI substudy sites had serial spine MRI scans (sagittal plane, 1.5T scanners, T1 and short tau inversion recovery sequences) at baseline and weeks 14 and 104. Two blinded (treatment, image order) readers independently evaluated MRI spinal inflammation using AS spine MRI-activity (ASspiMRI-a) scores; reader scores were averaged. Changes from baseline to weeks 14 and 104 were compared among treatment groups using analysis of variance on van der Waerden normal scores both with (post-hoc) and without (prespecified) adjustment for baseline ASspiMRI-a scores.

RESULTS:

Median baseline ASspiMRI-a scores were lower in the 100 mg (3.5) than placebo (6.8) and 50 mg (7.8) groups. Median decreases in activity scores from baseline to week 14 were -0.5 for placebo, -3.5 for 50 mg (p=0.047 vs placebo), and -1.5 for 100 mg (p=0.14 vs placebo). After adjusting for baseline ASspiMRI-a score imbalance, significant improvements were observed with both 50 mg (p=0.011) and 100 mg (p=0.002) versus placebo. ASspiMRI-a scores improvement achieved with golimumab was maintained at week 104. Improvement in ASspiMRI-a scores correlated with improvement in the recently developed AS disease activity score (ASDAS) and C-reactive protein (CRP) levels but not with other key AS clinical outcomes.

CONCLUSION:

Golimumab significantly reduced MRI-detected spinal inflammation of AS; improvements were sustained to week 104 and correlated with improvement in ASDAS and CRP.

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Estudio primario

No clasificado

Eficacia y seguridad de golimumab añadido a fármacos antirreumáticos modificadores de la enfermedad en artritis reumatoide. Resultados del estudio GO-MORE en España

Traducción oficial
Año 2015
Revista Reumatol. clín. (Barc.)
Enlaces DOI , Virtual Health Library

Este artículo no está incluido en ninguna revisión sistemática

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Objetivos: Analizar la eficacia y la seguridad de golimumab en los 140 pacientes incluidos en España en la parte 1 del estudio GO-MORE, un estudio multinacional en artritis reumatoide (AR) activa a pesar del tratamiento con distintos fármacos antirreumáticos modificadores de la enfermedad (FAME). Pacientes y métodos: Los pacientes recibieron golimumab 50 mg subcutáneo una vez al mes durante 6 meses. El criterio de valoración principal fue el porcentaje con respuesta DAS28-VSG EULAR buena o moderada tras 6 meses de tratamiento. Resultados: Se incluyó a 140 pacientes. El 76,4% tenía enfermedad muy activa (DAS28-VSG > 5,1). El 76,4% estaba tomando metotrexato, el 40,0% otros FAME en monoterapia o combinación, y el 65,0% esteroides. Al mes 6, el 82,9% de los pacientes logró una respuesta EULAR buena o moderada, el 41,4% alcanzó baja actividad y el 30,7% remisión. El porcentaje de pacientes con respuesta al mes de la primera dosis administrada fue del 69,3%. La eficacia fue similar en pacientes tratados con metotrexato u otro FAME, distintas dosis de metotrexato, con/sin esteroides o que habían fallado a uno o más FAME. El golimumab fue bien tolerado y el perfil de seguridad fue coherente con estudios previos. Se comunicaron acontecimientos adversos graves en 11 pacientes (7,9%). Conclusión: La adición de golimumab 50 mg subcutáneo mensual a distintos FAME en pacientes con AR activa deparó una respuesta moderada o buena a los 6 meses en el 82,9%. La respuesta comenzó a observarse tempranamente, ya al inicio del mes 2, tras una única dosis de golimumab (AU)

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Estudio primario

No clasificado

Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study.

Año 2008
Revista Arthritis and rheumatism
Enlaces DOI , Pubmed
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OBJECTIVE:

To assess the efficacy, safety, and pharmacology of subcutaneous administration of golimumab in patients with active rheumatoid arthritis (RA) despite treatment with methotrexate (MTX).

METHODS:

Patients were randomly assigned in a double-blinded manner to receive injections of placebo plus MTX or 50 mg or 100 mg golimumab every 2 or 4 weeks plus MTX through week 48. Patients originally assigned to receive injections every 2 weeks had the interval increased to every 4 weeks starting at week 20. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 16. The study was powered to detect a difference in the primary end point when the combined golimumab groups and at least 1 of the individual dose groups were compared with placebo.

RESULTS:

The primary end point was attained. Sixty-one percent of patients in the combined golimumab plus MTX dose groups achieved an ACR20 response at week 16 compared with 37% of patients in the placebo plus MTX group (P=0.010). In addition, 79% of patients in the group receiving 100 mg golimumab every 2 weeks achieved an ACR20 response (P<0.001 versus placebo). Through week 20 (after which patients receiving placebo were switched to active infliximab therapy), serious adverse events were reported in 9% of patients in the combined golimumab groups and in 6% of patients in the placebo group.

CONCLUSION:

Golimumab plus MTX effectively reduces the signs and symptoms of RA and is generally well tolerated in patients with an inadequate response to MTX.

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Estudio primario

No clasificado

Golimumab in psoriatic arthritis: one-year clinical efficacy, radiographic, and safety results from a phase III, randomized, placebo-controlled trial.

Año 2012
Revista Arthritis and rheumatism
Enlaces DOI , Pubmed
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OBJECTIVE:

Golimumab, administered subcutaneously every 4 weeks, has been shown to be effective in reducing the signs and symptoms of active psoriatic arthritis (PsA) through week 24 of the GO-REVEAL study. Herein we report 1-year clinical, radiographic, and safety findings.

METHODS:

Adult patients with active PsA (≥3 swollen and ≥3 tender joints) were randomly assigned to receive subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks through week 20. At week 16, patients with <10% improvement from baseline in swollen and tender joint counts entered a blinded early escape phase, with placebo crossover to golimumab 50 mg, golimumab 50 mg increased to 100 mg, and golimumab 100 mg continued at 100 mg. Patients receiving placebo who did not enter the early escape phase crossed over to golimumab 50 mg at week 24. Findings through 1 year are reported, including the second of 2 coprimary end points (i.e., change from baseline to week 24 in PsA-modified Sharp/van der Heijde score [SHS]).

RESULTS:

A total of 405 patients were randomized: 113 to placebo and 146 each to the golimumab 50 mg and 100 mg groups. Mean changes in PsA-modified SHS from baseline to week 24 for the combined golimumab 50 mg and 100 mg group (-0.09) and the golimumab 50 mg group (-0.16) were significantly different versus placebo (0.27) (P = 0.015 and P = 0.011, respectively). Radiographic benefit was maintained through week 52 with golimumab. Clinical efficacy, including improvement in joint and skin responses and physical function, was maintained through 1 year. The frequency/types of adverse events were similar to those reported through week 24.

CONCLUSION:

Treatment of PsA with golimumab inhibited structural damage progression and demonstrated continued clinical efficacy and safety through 1 year.

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Estudio primario

No clasificado

Golimumab

Año 2022
Autores [No se listan los autores]
Enlaces Pubmed
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Golimumab is FDA approved for the treatment of moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PA), ankylosing spondylitis (AS), ulcerative colitis (UC), and polyarticular juvenile idiopathic arthritis (pcJIA). It is a human monoclonal antibody tumor necrosis factor-alpha (TNF-a) blocker, binding human TNF-a soluble and transmembrane structures and blocking its binding with the respective TNF-a receptors. This activity will highlight the mechanism of action, adverse event profile, and other key factors pertinent to interprofessional team members in the management of patients with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PA), ulcerative colitis (UC), and polyarticular course juvenile idiopathic arthritis (pcJIA) that is unresponsive to first-line therapy.

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Revisión sistemática

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GOLIMUMAB FOR THE TREATMENT OF AXIAL SPONDYLOARTHRITIS.

Año 2017
Revista Expert opinion on biological therapy
Enlaces DOI , Pubmed
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INTRODUCTION:

Anti-TNF drugs have represented an epochal revolution in the treatment of rheumatoid arthritis and spondyloarthritis. In the field of axial spondyloarthritis, golimumab, a fully human monoclonal anti-TNFα administered subcutaneously every 4 weeks, has shown significant efficacy and good safety in patients with ankylosing spondylitis. More recently, it was also indicated as an effective treatment for patients suffering from non-radiographic axial spondyloarthitits.

AREAS COVERED:

A systematic literature search was completed, using the largest electronic databases (Medline, Embase and Cochrane), with the aim to review all data concerning the administration of golimumab in patients suffering from axial spondyloartritis.

EXPERT OPINION:

In the 16-week GO-AHEAD study, golimumab was effective in patients with non-radiographic spondyloarthritis with high levels of CRP and/or positive MRI findings, but not in subjects with both negative CRP and MRI. This finding allows for the addressing the of anti-TNF treatment more specifically. Preliminary data concerning an open-label extension of the GO-AHEAD study outlined the high retention-rate of the drug at 52 weeks. The production of antibodies against golimumab is rare and it seems to exert scarce influence on the drug performances. In conclusion, golimumab appears as a very useful and well tolerated anti-TNF agent.

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