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Estudio primario

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An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Autores Centocor, Inc.
Registro de estudios ClinicalTrials.gov
Año 2005
Enlaces Registro de estudios

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The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.

Estudio primario

No clasificado

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy

Autores Centocor B.V.
Registro de estudios EU Clinical Trials Register
Año 2005
Enlaces EUCTR - DE EUCTR - HU

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INTERVENTION: Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 Pharmaceutical Form: Solution for injection INN or Proposed INN: Golimumab Other descriptive name: Human Anti‐TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti‐TNFalfa Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50 and‐100 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA Pharmaceutical Form: Tablet INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: Golimumab Pre‐Filled Syringe Product Code: CNTO 148 Pharmaceutical Form: Solution for injection INN or Proposed INN: Golimumab Other descriptive name: Human Anti‐TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti‐TNFalfa Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50 and‐100 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy PRIMARY OUTCOME: Main Objective: to assess the efficacy of golimumab in subjects with active RA despite MTX therapy as measured by the reduction of the signs and symptoms of RA at Week 14 and improvement in physical function at Week 24. Primary end point(s): ACR 20 response at Week 14 and change from baseline in health assessment questionnaire at Week 24. Secondary Objective: to assess the safety, the effects of golimumab on structural damage and quality of life, and the population pharmacokinetics of golimumab in subjects with active RA despite MTX therapy. INCLUSION CRITERIA: 1. Are women or men 18 years of age or older. 2. Have a diagnosis of RA for at least 3 months prior to screening. 3. Must have been treated with and tolerated MTX at a dose of at least 15 mg/week for at least 3 months prior to screening, and have a MTX dose of equal to or more than 15 mg/week and equal to or less than 25 mg/week and stable for at least 4 weeks prior to screening. 4. Have active RA as defined, for the purpose of this study, by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and at baseline and at least 2 of the following 4 criteria: a. CRP equal to or more than 1.5 mg/dL at screening or ESR by Westergren method of equal to or greater than 28 mm in the first hour at screening or baseline. b. Morning stiffness of equal to or more than 30 minutes at screening and baseline. c. Bone erosion by x‐ray and/or by MRI prior to the first administration of study agent. d. Anti‐cyclic citr

Estudio primario

No clasificado

Golimumab significantly improves physical function, health-related quality of life, and fatigue in rheumatoid arthritis patients: results from the GO-FORWARD study

Revista ACR/ARHP Annual Scientific Meeting; San Francisco, CA.
Año 2008

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

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Estudio primario

No clasificado

Golimumab significantly improves physical function, health-related quality of life, and fatigue in patients with active rheumatoid arthritis despite methotrexate: results from the GO-FORWARD study

Revista EULAR Meeting
Año 2009

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

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Estudio primario

No clasificado

Impact of golimumab on physical function, health-related quality of life, productivity and employment in rheumatoid arthritis patients: Week 52 results from GO-FORWARD

Revista Arthritis and Rheumatism
Año 2009
Enlaces DOI www.cochranelibrary.com

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Purpose: To evaluate impact of SC golimumab (GLM) on physical function, HRQoL and fatigue. Methods: 444 pts with active RA (2 4 TJC and 24 SJC) despite MTX were randomized to PBO+MTX, GLM 100 mg+PBO, GLM 50 mg+MTX, or GLM 100 mg+MTX q4 wks through wk48. At wk16, any pt with <20% improvement from baseline in SJC & TJC entered early escape (EE) in a double-blinded fashion such that PBO+MTX received GLM 50mg+MTX, MTX was added for GLM 100 mg+PBO, and GLM 50 mg+MTX received GLM 100 mg+MTX; dosing for GLM 100 mg+MTX was unchanged. PBO+MTX crossed over to GLM 50 mg+MTX at wk24. Physical function was assessed using HAQ disability index and SF-36 PCS score. HRQoL was assessed using the PCS and MCS scores of the SF-36. Productivity was assessed on a 10-cm VAS. An ANOVA on van der Waerden normal scores was performed for between-group comparisons at wk24. At wk52, observed efficacy was summarized; no treatment grp comparisons were performed. Results: Mean baseline HAQ scores indicated moderate functional impairment; PCS scores were lower than US population norm (50±10). GLM+MTX was significantly better than PBO+MTX in improving physical function, HRQoL, productivity, and time lost from work by pt (50 mg only) at wk24 (p<0.05). Through wk24, there were no statistically significant improvements in employability, time lost from work by caregiver or healthcare resource consumption. Improvements in HAQ, PCS, MCS, and productivity observed at wk24 were sustained/enhanced through wk52. By wk52, approx 75% of pts receiving GLM 50 or 100 mg+MTX achieved improvement in baseline HAQ >= 0.25 and mean changes in productivity ranged from -2.4 to -2.7 across GLM grps. Time lost from work by pts and caregivers decreased from wks24-52. (Table presented) Conclusion: In pts with active RA despite MTX, GLM 50 mg or 100 mg q4wks + MTX improved physical function, HRQoL, and productivity.

Estudio primario

No clasificado

Golimumab, un anticuerpo humano para el factor de necrosis tumoral alpha} {dada por mes inyecciones subcutáneas, en la artritis reumatoide activa a pesar de la terapia con metotrexato: el Estudio de GO-FORWARD.

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Revista Annals of the Rheumatic Diseases
Año 2009
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 52 Revisiones sistemáticas Revisiones sistemáticas (52 referencias) 6 Síntesis amplias Síntesis amplias (6 referencias)

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OBJETIVO: La fase III-GO FORWARD estudio examinó la eficacia y seguridad de golimumab en pacientes con artritis reumatoide activa (AR), a pesar de la terapia con metotrexato. MÉTODOS: Los pacientes fueron asignados al azar en un 3: 3: 2: 2 Ratio de recibir inyecciones de placebo más metotrexato cápsulas (grupo 1, n = 133), golimumab 100 mg inyecciones, además de cápsulas de placebo (grupo 2, n = 133), golimumab 50 mg cápsulas, más inyecciones de metotrexato (el grupo 3, n = 89), o golimumab 100 mg cápsulas de inyecciones más metotrexato (Grupo 4, n = 89). Las inyecciones se administraron subcutáneamente cada 4 semanas. Los criterios de valoración co-primarios fueron la proporción de pacientes con una mejoría del 20% o mayor en el Colegio Americano de Reumatología criterios (ACR20) en la semana 14 y el cambio desde la basal en la evaluación de salud en cuestionarios índice de discapacidad (HAQ-DI) Resultado en la semana 24. Resultados: La proporción de pacientes que alcanzaron una respuesta ACR20 en la semana 14 fue del 33,1% en el grupo de placebo más metotrexato, el 44,4% (p = 0,059) en el golimumab 100 mg y placebo, 55,1% (p = 0,001) en el golimumab 50 mg más metotrexato y el 56,2% (p <0,001) en el golimumab 100 mg y metotrexato. En la semana 24, la mejora de la mediana desde el inicio en el HAQ-DI resultados fueron 0,13, 0,13 (p = 0,240), 0,38 (p <0,001) y 0,50 (p <0,001), respectivamente. Durante la parte controlado con placebo del estudio (hasta la semana 16), los eventos adversos graves se produjeron en el 2,3%, 3,8%, 5,6% y 9,0% de los pacientes y de infecciones graves se produjeron en el 0,8%, 0,8%, 2,2% y 5,6%, respectivamente. CONCLUSIÓN: La adición de golimumab y metotrexato en pacientes con AR activa a pesar de la terapia de metotrexato reduce significativamente los signos y síntomas de la AR y la función física mejorada.

Estudio primario

No clasificado

El golimumab en los pacientes con artritis reumatoide activa a pesar del tratamiento con metotrexato: resultados de 52 semanas del estudio-GO FORWARD.

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Revista Annals of the rheumatic diseases
Año 2010
Enlaces Pubmed DOI

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

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OBJETIVO: Evaluar la eficacia y seguridad de golimumab a 52 semanas en pacientes con artritis reumatoide activa a pesar de metotrexato. MÉTODOS: Los pacientes fueron asignados aleatoriamente para recibir placebo más metotrexato (grupo 1), golimumab 100 mg más placebo (grupo 2), golimumab 50 mg y metotrexato (grupo 3) y golimumab 100 mg más metotrexato (grupo 4). En la semana 16, los pacientes de los grupos 1, 2 y 3 que tuvieron mejoría inferior al 20% en articulaciones dolorosas e inflamadas entraron fuga temprana. En la semana 24, los pacientes en el grupo 1 que no habían concertado de escape temprano pasaron a 50 mg de golimumab más metotrexato. RESULTADOS: En la semana 16, el 31%, 27% y 17% de los pacientes de los grupos 1, 2 y 3, respectivamente, entraron fuga temprana. En la semana 52, el 44%, 45%, 64% y 58% de los pacientes de los grupos 1, 2, 3 y 4, respectivamente, lograron una mejora del 20% en el American College of Rheumatology criterios y el 34%, 31%, 42% y 53%, respectivamente, logra actividad de la enfermedad baja (<o = 3,2) de acuerdo con la puntuación de 28 articulaciones actividad de la enfermedad. Los pacientes en el grupo 4 que parecía tener un mayor riesgo de eventos adversos graves y las infecciones graves. CONCLUSIÓN: Los resultados de las diversas medidas de resultado mostraron que las tasas de respuesta obtenidos por los pacientes que recibieron golimumab 24 semanas se mantuvieron a 52 semanas. El perfil de seguridad parece ser coherente con el perfil de seguridad conocido de inhibidores del factor de necrosis tumoral.

Estudio primario

No clasificado

Golimumab, a human anti-TNF monoclonal antibody administered subcutaneously every four weeks as monotherapy in patients with active rheumatoid arthritis despite DMARD therapy: 24-week results of clinical and radiographic assessments.

Revista Arthritis and Rheumatism
Año 2010
Enlaces DOI www.cochranelibrary.com

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Objective: To assess the efficacy and safety of golimumab (GLM) as a monotherapy in Japanese patients with active rheumatoid arthritis (RA) despite DMARD therapy. Methods: In this multicenter, randomized, double-blind, placebo (PBO)-controlled study, patients with active RA with >=6 swollen and >=6 tender joints (SJC/TJC) despite treatment with DMARD were randomized to subcutaneous injections of PBO, GLM 50mg, or GLM 100mg administered q4 wks. Starting at wk 16, GLM 50mg was administered q4 wks to patients in the PBO group. The primary endpoint was the proportion of patients achieving ACR20 at wk 14. Secondary endpoints included the proportion of patients achieving ACR50, ACR70 response, DAS28 (ESR) response, and improvement in Health Assessment Questionnaire (HAQ) at wk 14, and change from baseline in van der Heijde/Sharp-Score (vdH-S) at wk 24. Data was analyzed using Full Analysis Set (modified Intent-To-Treat: all patients receiving one dose of study treatment included) population. The results of the non-parametric data analyzed using van der Waerden method is being reported. Results: 308 patients received treatment (105 PBO, 101 GLM 50mg, and 102 GLM 100mg). Treatment groups were balanced for baseline demographic and disease characteristics [mean (SD) values for all patients: CRP 2.46(2.62) mg/dL, ESR 47.9(30.18) mm/hr, SJC 12.9(6.49), TJC 15.7(9.25), DAS 28(ESR) 5.89 (1.04)]. The baseline vdH-S(TSS) for the GLM 50mg and 100mg groups were 44.05(50.80) and 56.66 (56.74), respectively. At wk 14, the GLM 50mg and 100mg groups were significantly better than PBO in improving signs and symptoms of RA and physical function (Table). At wk 24, the GLM 100mg group significantly inhibited radiographic progression compared with PBO; the median and IQ ranges clearly showed better inhibition with the GLM 100 mg dose. Through wk 16, the overall incidence of adverse events (AEs) was 63.8%, 62.4%, and 59.8% in the PBO, GLM 50mg, and GLM 100mg groups, respectively; serious AEs occurred in 1.9%, 1.0%, and 2.0% of the patients in the PBO, GLM 50mg, and GLM 100mg groups, respectively. Serious infections occurred in 1.0%, 0%, and 1.0% of patients, respectively, in the PBO, GLM 50mg, and GLM 100mg. Injection site reactions occurred in 6.7%, 7.9%, and 7.8% of patients, respectively. There were no reports of tuberculosis or death. Conclusion: Both doses of GLM significantly improved signs, symptoms, and physical function compared with PBO. In addition GLM 100 mg significantly inhibited progression of structural damage compared with PBO. Injection site reactions were mild and not increased compared with PBO. GLM monotherapy was welltolerated with safety profile similar to other anti-TNF agents. (Table presented).

Estudio primario

No clasificado

Association of serum markers with improvement in clinical response measures after treatment with golimumab in patients with active rheumatoid arthritis despite receiving methotrexate: results from the GO-FORWARD study.

Revista Arthritis research & therapy
Año 2010
Enlaces Pubmed DOI PubMed Central

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INTRODUCTION: The goal of this study was to identify serum markers that are modulated by treatment with golimumab with or without methotrexate (MTX) and are associated with clinical response. METHODS: Sera were collected at weeks 0 and 4 from a total of 336 patients (training dataset, n = 100; test dataset, n = 236) from the GO-FORWARD study of patients with active rheumatoid arthritis despite MTX. Patients were randomly assigned to receive placebo plus MTX; golimumab, 100 mg plus placebo; golimumab, 50 mg plus MTX; or golimumab, 100 mg plus MTX. Subcutaneous injections were administered every 4 weeks. Samples were tested for select inflammatory, bone, and cartilage markers and for protein profiling using multianalyte profiles. RESULTS: Treatment with golimumab with or without MTX resulted in significant decreases in a variety of serum proteins at week 4 as compared with placebo plus MTX. The American College of Rheumatology (ACR) 20, ACR 50, and Disease Activity Score (DAS) 28 responders showed a distinct biomarker profile compared with nonresponding patients. CONCLUSIONS: ACR 20 and ACR 50 responders among the golimumab/golimumab + MTX-treated patients had a distinct change from baseline to week 4 in serum protein profile as compared with nonresponders. Some of these changed markers were also associated with multiple clinical response measures and improvement in outcome measures in golimumab/golimumab + MTX-treated patients. Although the positive and negative predictive values of the panel of markers were modest, they were stronger than C-reactive protein alone in predicting clinical response to golimumab. TRIAL REGISTRATION: http://ClinicalTrials.gov identification number: NCT00264550.

Estudio primario

No clasificado

Los efectos de golimumab en la progresión radiográfica en la artritis reumatoide: resultados de los estudios controlados aleatorios de golimumab antes de la terapia con metotrexato y golimumab tras la terapia con metotrexato.

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Revista Arthritis and rheumatism
Año 2011
Enlaces Pubmed DOI

Este artículo está incluido en 5 Revisiones sistemáticas Revisiones sistemáticas (5 referencias)

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OBJETIVO: Evaluar los efectos de golimumab en la progresión radiográfica en pacientes con artritis reumatoide (AR). MÉTODOS: El metotrexato (MTX) pacientes -naive (en el golimumab antes de emplear metotrexato como thefirst-Line opción en el tratamiento de la artritis reumatoide de inicio temprano estudio [GO-ANTES]; n = 637) y pacientes con AR activa a pesar del tratamiento con MTX ( en el golimumab en Active artritis reumatoide A pesar de la terapia con metotrexato estudio [GO-FORWARD]; n = 444) fueron asignados al azar para recibir placebo más MTX (grupo 1), golimumab 100 mg más (grupo 2) placebo, golimumab 50 mg más MTX ( grupo 3), o golimumab 100 mg más MTX (grupo 4). Orplacebo golimumab se administró por vía subcutánea cada 4 semanas. Las radiografías de las manos y los pies se tomaron al inicio del estudio, la semana 28 y la semana 52 en el estudio-GO ANTES y al inicio del estudio, la semana 24 (semana 16 para los pacientes que ingresaron a escapar antes de tiempo), y la semana 52 en el estudio de seguir adelante. Las radiografías fueron anotados por 2 lectores independientes en cada estudio utilizando el van der Heijde modificación del índice de Sharp. Resultados: En el estudio-GO ANTES, la media ± SD cambios en el índice de Sharp modificado desde la línea base hasta la semana 52 (período de control) fueron 1,4 ± 4,6 en el grupo 1, 1,3 ± 6,2 en el grupo 2 (p = 0,266), 0.7 ± 5,2 en el grupo 3 (P = 0,015), y 0,1 ± 1,8 en el grupo 4 (P = 0,025). En el estudio de ir hacia adelante, los cambios desde el inicio hasta la semana 24 (período de control) fueron 0,6 ± 2,4 en el grupo 1, 0,3 ± 1,6 en el grupo 2 (p = 0,361), 0,6 ± 2,7 en el grupo 3 (P = 0,953), y 0,2 ± 1,3 en el grupo 4 (P = 0,293). CONCLUSIÓN: El golimumab en combinación con MTX inhibe la progresión radiográfica significativamente mejor que hizo MTX solo en el estudio-GO ANTES. La progresión radiográfica en el estudio-GO FORWARD fue mínima en todos los grupos de tratamiento, lo que impide una evaluación adecuada del efecto de golimumab en la progresión radiográfica en este estudio.

Estudio primario

No clasificado

Efecto de golimumab en los resultados informados por los pacientes en la artritis reumatoide: resultados del estudio a seguir adelante.

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Revista The Journal of rheumatology
Año 2012
Enlaces Pubmed DOI
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OBJETIVO: Evaluar el efecto de golimumab en la función física, la salud general, y la fatiga en pacientes con artritis reumatoide (AR) activa a pesar de la terapia con metotrexato (MTX). MÉTODOS: En el estudio multicéntrico, aleatorizado-GO ADELANTE controlado con placebo, 444 adultos con AR activa a pesar de MTX recibieron placebo + MTX subcutánea (cruce con golimumab 50 mg en la semana 24), golimumab 100 mg + placebo, golimumab 50 mg + MTX o golimumab 100 mg + MTX cada 4 semanas. La función física y la salud general se evaluaron utilizando el Índice de Salud de Evaluación Cuestionario de Discapacidad (HAQ-DI) y físicas y componente mental Resumen (PCS, MCS) las puntuaciones del cuestionario Medical Outcomes Study Short Form-36 (SF-36), respectivamente, hasta la semana 52. La fatiga se midió hasta la semana 24 utilizando la evaluación funcional de la enfermedad crónica fatiga debida al tratamiento (FACIT-fatiga) cuestionario. RESULTADOS: mejoras medio desde el inicio en HAQ-DI, SF-36 PCS, y las puntuaciones-FACIT Fatiga (semanas 14 y 24) fueron significativamente mayores para golimumab 50 mg + MTX y 100 mg + MTX versus placebo + MTX. Una proporción significativamente mayor de pacientes tratados con golimumab más MTX lograron mejorías clínicamente significativas desde el inicio hasta las semanas 14 y 24 en HAQ-DI, PCS, y las puntuaciones-FACIT fatiga. La media de las mejoras en la SF-36 PCS (Semana 14), MCS (Semana 24), y FACIT-Fatiga (semanas 14 y 24) resultados fueron significativamente mayores para golimumab 100 mg + placebo versus placebo + MTX. Mejoras medio desde el inicio en HAQ-DI, SF-36 PCS y MCS resultados hasta la semana 24 se mantuvieron hasta la semana 52. CONCLUSIÓN: Los pacientes con AR activa a pesar de MTX tuvieron una mejoría significativa en la función física, la salud general y la fatiga después golimumab + tratamiento con MTX; mejoras en la función física y la salud general se mantuvieron hasta la semana 52. (ensayos clínicos de registro NCT00264550).

Estudio primario

No clasificado

Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: results through 2 years of the GO-FORWARD study extension.

Revista The Journal of rheumatology
Año 2013
Enlaces Pubmed DOI
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OBJECTIVE: To assess the longterm efficacy and safety of golimumab in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. METHODS: We randomized 444 RA patients with inadequate response to MTX (3:3:2:2) to placebo + MTX (Group 1), golimumab 100 mg + placebo (Group 2), golimumab 50 mg + MTX (Group 3), or golimumab 100 mg + MTX (Group 4). Subcutaneous golimumab/placebo was injected every 4 weeks. Patients could escape early (Group 1 added golimumab 50 mg, Group 2 added MTX, Group 3 increased golimumab to 100 mg, Group 4 continued 100 mg) based on Week 16 swollen and tender joint counts. From Week 24, Group 1 patients received golimumab 50 mg + MTX. After the Week 52 database lock, patients in the longterm extension received golimumab 50-100 mg ± MTX. Coprimary endpoints [Week 14 American College of Rheumatology (ACR)20, Week 24 Health Assessment Questionnaire Disability Index (HAQ-DI)] and Week 52 findings have been published; 2-year findings (observed data by randomized group, no imputation) are presented. RESULTS: Of 444 randomized patients, 392 continued from Week 52 (Group 1: n = 116, Group 2: n = 116, Group 3: n = 84, Group 4: n = 76). Clinical improvement was maintained through Week 104; ~75% and 72% of patients randomized to golimumab 50 mg + MTX and 100 mg + MTX achieved ACR20 response, respectively. The majority [88% (105/120)] of golimumab + MTX-treated patients with Week 24 HAQ-DI improvement ≥ 0.25 maintained improved physical function through Week 104. Group 1 patients with delayed golimumab treatment exhibited more Week 104 radiographic progression (mean change score = 1.15) than golimumab + MTX-randomized patients (0.52). Incidences of serious infections were 2.24, 4.77, 5.78/100 patient-years of followup for golimumab 50 mg + MTX, 100 mg + placebo, and 100 mg + MTX, respectively. CONCLUSION: Clinical improvement was maintained and no new safety signals were identified with 2 years of golimumab + MTX. Golimumab efficacy and safety, including serious infections, will continue to be monitored through 5 years (Clinical Trial No. NCT00264550).

Estudio primario

No clasificado

Effects of golimumab, an anti-tumour necrosis factor-alpha human monoclonal antibody, on lipids and markers of inflammation

Revista Annals of the Rheumatic Diseases
Año 2013
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Estudio primario

No clasificado

Sustained improvement in health related quality of life, work productivity, employability, and reduced healthcare resource utilization of patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis treated with golimumab:5yr results

Revista Annals of the Rheumatic Diseases
Año 2013
Enlaces DOI www.cochranelibrary.com
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Objectives To summarize changes from baseline in HRQOL, impact of disease on work productivity, employability, and healthcare resource utilization among patients with rheumatoid arthritis(RA), psoriatic arthritis(PsA), and ankylosing spondylitis(AS) treated with golimumab(GLM) through 5yrs. Methods Patients with active RA despite MTX (GO-FORWARD), active PsA (GO-REVEAL), and active AS (GO-RAISE) were randomized to placebo (PBO) or GLM (50mg or 100mg Q4w). In GO-FORWARD, treatment also included concomitant MTX (GLM monotherapy in GO-FORWARD was not included in this analysis). Patients randomized to PBO crossed over to GLM at wk 24, with follow-up through wk256. HRQOL was measured using 36-item short -form of health survey (SF-36); impact of disease on work productivity was measured using a VAS scale (0=no impact, 10=impact very much); Employable was defined as being actively employed or to be able to work if a job was available. Healthcare resource utilization included the number of physician visits in the past 4 wks, ER visit in the past 3 months, and hospitalizations in the past 12 months. Changes from baseline through wk 256 in SF-36 PCS and MCS, work productivity, employability, and healthcare resource utilization were summarized from observed patients. Results At baseline, both mean SF-36 PCS (30.19, 32.91, and 30.00) and MCS (43.65, 45.19, and 44.03) scores in the combined GLM group for RA, PsA, and AS, respectively were below the US norm, indicating impaired HRQOL. Baseline percent of RA, PsA, and AS patients unemployable before retirement were 13.7%, 12.1%, and 14.1%, respectively. At wk24, RA, PsA, and AS GLM-treated pts had statistically significant greater improvement in both mean SF-36 PCS (7.65, 7.83, and 9.36, p<0.001) and MCS (3.07, 3.84, and 4.01, p <0.05) and had a statistically significant greater mean change from baseline in reduction in impact of disease on work productivity in the combined GLM-treated patients vs PBO (-1.987, -2.242, -2.805, all p<0.001) in RA, PsA and AS, respectively. At wk256, sustained improvement in SF-36 PCS and MCS was observed in the RA, PsA, and AS GLM-treated patients (mean change from baseline: PCS 9.3, 9.8, and 13.0 and MCS 4.5, 4.7, and 5.1, respectively), while mean change in impact of disease on work productivity for RA, PsA, and AS was -2.71, -3.0, and, -3.9, respectively. In addition, RA, PsA, and AS patients employable at baseline remained employable (all >95%), while those unemployable at baseline became more likely to be employable (RA 33.3%, PsA 64.3%, and AS 76.5%) at Wk256. A reduction in physician visits (RA -84%, PsA -89%, and AS -88%) was observed, as well as a reduction in the number of hospitalizations, ER visits, and days hospitalized, although these events were rare. Patients randomized to PBO at baseline and crossed-over to active treatment achieved similar outcomes overtime as those patients who were randomized to active treatment at baseline. Conclusions GLM-treated patients showed sustained improvement in HR QoL, reduced impact of disease on work productivity, improved employability, and less healthcare resource utilization through 5yrs.

Estudio primario

No clasificado

Five-year safety and efficacy of golimumab in patients with active rheumatoid arthritis despite prior treatment with methotrexate: Final study results of the phase 3, randomized placebo-controlled go-forward trial

Revista Annals of the Rheumatic Diseases
Año 2013
Enlaces DOI http://ard.bmj.com/content/72/Suppl_3/A867.3.abstract
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Objectives Final 5yr safety and efficacy results of subcutaneous golimumab (GLM)+/-MTX in a phase 3 trial (GO-FORWARD) of pts with active rheumatoid arthritis (RA) despite MTX therapy are reported. Methods Pts were randomized to placebo(PBO)+MTX, GLM 100mg+PBO, GLM 50mg+MTX, or GLM 100mg+MTX q4w. PBO+MTX pts crossed over to GLM+MTX at wks 16 (blinded early escape) or 24 (crossover). Pts continued treatment at wk52 (start of long-term extension). After the last pt completed wk52 and unblinding occurred, MTX and corticosteroid use could be adjusted, and a one-time GLM dose increase (50 to 100mg) or decrease (100 to 50mg) was permitted based on investigator judgment. The last GLM injection was at wk252. Observed efficacy results (ACR20/50/70, DAS28-CRP, HAQ-DI, radiographic) by randomized treatment group and cumulative safety data are reported through wks 256 and 268, respectively. Results A total of 444 pts were randomized; 313 pts continued treatment through wk252, and 131 pts withdrew (64 for AE, 25 for lack of efficacy, 1 protocol violation, 6 lost to follow-up, 32 for other reasons, 3 deaths). 301 completed the safety follow-up through wk268. Efficacy results are presented in the table. At wk256, 76.0% of all pts had an ACR20, 89.5% had a DAS28-CRP EULAR response, and 68.5% had improvement in HAQ-DI ≥0.25. Changes from baseline in mean total vdH-S scores were small; 54% of pts randomized to GLM+MTX had no radiographic progression (ΔvdH-S≤0). The most common AEs were upper respiratory tract infection (32.9%), nasopharyngitis (17.1%), and bronchitis (17.1%); 9.2% of pts had an injection-site reaction. Through wk268, 172/434 pts (39.6%) had an SAE; 14.1% of pts discontinued study agent due to AEs. The rates of serious infections, malignancies, and death were 11.5%, 6.2%, and 1.8%, respectively. Of 429 pts with available samples, 33 (7.7%) were positive for antibodies to GLM. Conclusions The retention rate was high (70.5%), and improvements in signs/symptoms of RA and in physical function with GLM+MTX therapy were maintained long-term. Radiographic progression appeared controlled with small changes in mean vdH-S scores observed through 5yrs. The long-term safety of GLM is consistent with other anti-TNFα agents. (Figure Presented).

Estudio primario

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Improvements in physical function, health related quality of life and work productivity in patients with rheumatoid arthritis treated with golimumab: Sub-analysis of latin america n patients enrolled in mulitcentre phase III clinical trials

Revista Value in Health
Año 2013
Enlaces DOI www.cochranelibrary.com
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Objectives: To examine physical function, health-related quality of life(HRQOL) and work productivity in patients enrolled from Latin American countries (Argentina,Chile and Mexico) in Phase III clinical trials for golimumab(GLM) in rheumatoid arthritis(RA). Methods: Active RA patients not previously treated with methotrexate(MTX)(GO-BEFORE,N= 637) or with inadequate response to MTX(GOFORWARD, N= 444) were randomized to SC GLM(50 or 100mg)+MTX or PBO+MTX, q4wks.At wk24(GO-FORWARD) or wk52(GO-BEFORE), PBO+MTX group switched to GLM 50mg+MTX. Physical function was assessed using HAQ(0-3). HRQOL was assessed using SF-36 PCS(0-100) and SF-36 MCS(0-100). Impact of disease on work productivity was assessed using a productivity VAS (0-10). Clinically meaningful improvement was defined as improvement of ≥ 0.25 point in HAQ, or ≥ 5 points in SF-36 PCS and MCS. Results: At baseline, both MTX naive (N= 96) and MTX experienced (N= 56) RA patients enrolled in Latin American region experienced moderate to severe physical disability (mean HAQ score of 1.60 to 1.75) and impaired HRQOL (mean PCS of 30.0 to 30.3 and mean MCS of 9.4 to 42.6). The impact of RA on productivity was severe (mean VAS score of 6.3-6.7). Patients treated with GLM (50 or 100 mg)+MTX had significantly greater mean improvement than PBO+MTX group in HAQ (0.87 vs. 0.56, p= 0.01), PCS (12.44 vs. 6.93, p< 0.01) and work productivity (-3.69 vs. -2.25, p< 0.01) at wk 24, and greater proportions of patients in GLM+MTX group than PBO+MTX achieved clinically meaningful improvement in HAQ (84.04% vs. 65.45%, p= 0.01), PCS (74.47% vs. 49.09%, p< 0.01) and MCS (45.74% vs. 41.82%, p= 0.73). Similar results were observed in patients who were MTX naïve and experienced although the magnitudes of improvements were greater in MTX naïve patients than MTX-experienced patients. The improvements were sustained over wk52 and 104. Conclusions: MTX naïve and MTX experienced RA patients from Latin America treated with GLM demonstrated improved physical function, HRQOL, and work productivity.

Estudio primario

No clasificado

Effects of golimumab, an anti-tumour necrosis factor-α human monoclonal antibody, on lipids and markers of inflammation.

Revista Annals of the rheumatic diseases
Año 2014
Enlaces Pubmed DOI PubMed Central
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OBJECTIVES: To assess the effect of golimumab, with or without methotrexate (MTX), on serum lipids and inflammatory markers of cardiovascular disease (CVD) in patients with rheumatoid arthritis (RA) in two phase 3, randomised, placebo-controlled trials (GO-BEFORE and GO-FORWARD). METHODS: Patients in GO-BEFORE (n=637, MTX-naïve) and GO-FORWARD (n=444, MTX-inadequate response) were randomised to placebo+MTX, golimumab 100 mg+placebo, golimumab 50 mg+MTX, or golimumab 100 mg+MTX. Subcutaneous injections (placebo and golimumab) were given every 4 weeks. Patients with an insufficient response entered early escape at week 16 (GO-FORWARD) or 28 (GO-BEFORE). All placebo+MTX patients in GO-FORWARD crossed over to golimumab 50 mg+MTX at week 24. Changes from baseline to weeks 14 (GO-FORWARD) or 24 (GO-BEFORE), and 52 in serum lipid levels and inflammatory markers were assessed. RESULTS: At week 14 in the GO-FORWARD trial, total cholesterol (TC), high-density lipoprotein (HDL) and low-density lipoprotein (LDL) increased in golimumab+MTX patients versus MTX-only patients (16.00 vs 2.00 (p<0.001); 3.00 vs 0.00 (p<0.05); 8.00 vs 4.00 (p<0.001); respectively); favourable changes in LDL subfractions were only observed in golimumab-treated patients. At week 24 in GO-BEFORE, TC and LDL increased, and LDL subfractions improved in the MTX-only and golimumab+MTX groups. Inflammatory markers of CVD risk improved significantly with golimumab+MTX versus placebo+MTX in both studies and were generally maintained through week 52. Atherogenic indices were generally stable. CONCLUSIONS: While TC and LDL levels increased mildly in RA patients receiving golimumab+MTX, atherogenic indices generally remained stable, favourable changes in LDL subfractions were observed, and inflammatory markers improved.

Estudio primario

No clasificado

Final 5-year safety and efficacy results of a phase 3, randomized placebo-controlled trial of golimumab in patients with active rheumatoid arthritis despite prior treatment with methotrexate

Revista Rheumatology
Año 2014
Enlaces DOI https://doi.org/10.1093/rheumatology/keu101.031
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Background: The safety and efficacy of s.c. golimumab (GLM)+/-MTX has been evaluated through 2 years in a phase 3 trial (GO-FORWARD) of pts with active RA despite MTX therapy. Final safety and efficacy results through 5 years are reported. Methods: Pts in GO-FORWARD were randomized to placebo(PBO)+MTX, GLM 100mg+PBO, GLM 50mg+MTX, or GLM 100mg+MTX q4w. PBO+MTX pts crossed over to GLM+MTX at weeks 16 (blinded early escape) or 24 (crossover). Pts continued treatment at week 52 (start of long-term extension). After the last pt completed week 52 and unblinding occurred, MTX and corticosteroid use could be adjusted, and a one-time GLM dose increase (50 to 100 mg) or decrease (100 to 50 mg) was permitted based on investigator judgment. The last GLM injection was at week 252. Observed efficacy results (ACR20/50/70, DAS28-CRP, HAQ-DI, radiographic) by randomized treatment group and cumulative safety data are reported through weeks 256 and 268, respectively. Results: A total of 444 pts were randomized; 313 pts continued treatment through week 252, and 131 pts withdrew (64 for AE, 25 for lack of efficacy, 1 protocol violation, 6 lost to follow-up, 32 for other reasons, 3 deaths). 301 completed the safety follow-up through week 268. At week 256, 76.0% of all pts had an ACR20, 89.5% had a DAS28-CRP EULAR response, and 68.5% had improvement in HAQDI ≥0.25. Changes from baseline in mean total vdH-S scores were small; 54% of pts randomized to GLM+MTX had no radiographic progression (ΔvdH-S≤0). The most common AEs were upper respiratory tract infection (32.9%), nasopharyngitis (17.1%), and bronchitis (17.1%); 9.2% of pts had an injection-site reaction. Through week 268, 172/434 pts (39.6%) had an SAE; 14.1% of pts discontinued study agent due to AEs. The rates of serious infections, malignancies, and death were 11.5%, 6.2%, and 1.8%, respectively. Of 429 pts with available samples, 33 (7.7%) were positive for antibodies to GLM. Conclusion: The retention rate was high (70.5%), and improvements in signs/symptoms of RA and in physical function with GLM+MTX therapy were maintained long-term. Radiographic progression appeared controlled with small changes in mean vdH-S scores observed through 5 years. The long-term safety of GLM is consistent with other anti-TNFα agents.

Estudio primario

No clasificado

Sustained improvement in health-related quality of life, work productivity, employability and reduced healthcare resource utilization of patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis treated with golimumab: 5-year results from three phase III studies

Revista Rheumatology (United Kingdom)
Año 2014
Enlaces DOI www.cochranelibrary.com
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Background: To summarize changes from baseline in health-related quality of life (HRQOL), impact of disease on work productivity, employability, and healthcare resource utilization (HRU) among patients with RA, PsA and AS treated with golimumab (GLM) through 5 years. Methods: Patients with active RA despite MTX (GO-FORWARD), active PsA (GO-REVEAL), and active AS (GO-RAISE) were randomized to PBO or GLM (50mg or 100mg Q4w). In GO-FORWARD, treatment also included concomitant MTX (GLM monotherapy in GO-FORWARD was not included in this analysis). Patients randomized to PBO crossed over to GLM at week 24, with follow-up through week 256. HRQOL was measured using 36-item short-form health survey (SF-36); impact of disease on work productivity was measured using VAS scale (0=no impact, 10=impact very much). Employable was defined as being actively employed or to be able to work if a job was available. HRU included number of physician visits in the past 4 weeks, ER visit in the past 3 months, and hospitalizations in the past 12months. Changes from baseline through week 256 in SF-36 PCS and MCS, work productivity, employability, and HRU were summarized from observed patients. Results: At baseline, both mean SF-36 PCS (30.19, 32.91 and 30.00) and MCS (43.65, 45.19 and 44.03) scores in combined GLM group for RA, PsA and AS, respectively were below the US norm, indicating impaired HRQOL. Baseline percentage of RA, PsA and AS patients unemployable before retirement were 13.7%, 12.1% and 14.1%. At week 24, RA, PsA and AS GLM-treated pts had statistically significant greater improvement in both mean SF-36 PCS (7.65, 7.83, and 9.36, P<0.001) and MCS (3.07, 3.84 and 4.01, P<0.05) and had a statistically significant greater mean change from baseline in reduction in impact of disease on work productivity in the combined GLMtreated patients vs PBO (-1.987, -2.242, -2.805, all P<0.001) in RA, PsA and AS. At week 256, sustained improvement in SF-36 PCS and MCS was observed in the RA, PsA, and AS GLM-treated patients (mean change from baseline: PCS 9.3, 9.8, and 13.0 and MCS 4.5, 4.7 and 5.1), while mean change in impact of disease on work productivity for RA, PsA, and AS was -2.71, -3.0 and -3.9. RA, PsA and AS patients employable at baseline remained employable (all >95%), while those unemployable at baseline became more likely to be employable (RA 33.3%, PsA 64.3% and AS 76.5%) at week 256. A reduction in physician visits (RA -84%, PsA -89%, and AS -88%) was observed, as well as a reduction in the number of hospitalizations, ER visits and days hospitalized, although these events were rare. Patients randomized to PBO at baseline and crossed-over to active treatment achieved similar outcomes overtime as those patients who were randomized to active treatment at baseline. Conclusion: Golimumab-treated patients showed sustained improvement in HRQoL, reduced impact of disease on work productivity, improved employability, and less HRU through 5 years.

Estudio primario

No clasificado

Safety and Efficacy of Subcutaneous Golimumab in Patients with Active Rheumatoid Arthritis despite Methotrexate Therapy: Final 5-year Results of the GO-FORWARD Trial.

Revista The Journal of rheumatology
Año 2016
Enlaces Pubmed DOI
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OBJECTIVE: To evaluate the safety and efficacy of golimumab (GOL), a human antitumor necrosis factor antibody, in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy through 5 years in the GO-FORWARD trial. METHODS: Patients with active RA despite MTX therapy were randomly assigned to receive placebo + MTX (Group 1), GOL 100 mg + placebo (Group 2), GOL 50 mg + MTX (Group 3), or GOL 100 mg + MTX (Group 4). Patients in groups 1, 2, and 3 with inadequate response could enter early escape at Week 16 to GOL 50 mg + MTX or GOL 100 mg + MTX, and all remaining Group 1 patients crossed over to GOL 50 mg + MTX at Week 24. The blind was maintained through the 52-week database lock, after which treatment adjustments were permitted. Adverse events (AE) were monitored through Week 268. Efficacy was evaluated using the American College of Rheumatology (ACR) 20/50/70 responses and a 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP). Response rates at Week 256 were analyzed by an intent-to-treat analysis. RESULTS: A total of 444 patients were randomized, and 313 received GOL through Week 252; 301 patients completed the safety followup through Week 268. Infections were the most common type of AE; 172 patients (39.6%) had ≥ 1 serious AE. No unexpected safety signals were observed. At Week 256, ACR20/50/70 responses were achieved by 63.1%, 40.8%, and 24.1%, respectively, of all randomized patients. About 78% of all patients achieved a good or moderate DAS28-CRP response. CONCLUSION: Improvements in the signs and symptoms of RA were maintained through 5 years. AE through 5 years were consistent with earlier reports of the GO-FORWARD trial; no apparent increased risk was observed over time.