Matriz de evidencia
Inhibidores de TNF para artritis reumatoide
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Resumen estructurado de revisiones sistemáticas

No clasificado

Golimumab (CNTO148) for rheumatoid arthritis: horizon scanning technology briefing

Año 2009
Revista HTA Database
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RECORD STATUS:

None

CITATION:

National Horizon Scanning Centre. Golimumab (CNTO148) for rheumatoid arthritis: horizon scanning technology briefing. National Horizon Scanning Centre (NHSC).

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Estudio primario

No clasificado

Adherencia al tratamiento con adalimumab, golimumab y ustekinumab en pacientes con enfermedad inflamatoria intestinal

Traducción oficial
Año 2020
Revista Farm. hosp
Enlaces Virtual Health Library , DOI
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OBJETIVO:

La enfermedad inflamatoria intestinal es un grupo de trastornos crónicos, inflamatorios y recidivantes que afectan al intestino. En la última década, los fármacos biológicos han supuesto un gran cambio en la terapia de esta enfermedad. Adalimumab, golimumab y ustekinumab son tres de ellos que se administran por vía subcutánea tras su dispensación en los servicios de farmacia de los hospitales. Para que se alcance la efectividad del tratamiento es necesaria una adecuada adherencia al mismo. El objetivo del presente trabajo fue evaluar la adherencia en pacientes que recogían los tres fármacos en el servicio de farmacia de un hospital de tercer nivel.

MÉTODO:

Se realizó un estudio analítico observacional de corte transversal en el que se incluyó a pacientes que recibían tratamiento con los anteriores fármacos durante al menos cuatro meses. Se recogió la tasa de posesión de la medicación proporcionada por el registro de dispensaciones y se seleccionó a los pacientes que presentaron un valor inferior o igual al 85%. A estos pacientes se les aplicó el cuestionario de medida del cumplimiento terapéutico de Morisky-Green.

RESULTADOS:

Se incluyeron 178 pacientes, de los cuales el 60,1% (107) fueron hombres y el 30,9% (55) habían sido tratados con otros fármacos biológicos previamente. La adherencia media, según el registro de dispensaciones, fue del 91,79% y se clasificó a 45 pacientes (25,28%) como mal adherentes (≤ 85%). La no administración en la fecha indica da y el olvido se identificaron como principales razones de la falta de cumplimiento terapéutico según el resultado del test de Morisky-Green. El sexo femenino (odds ratio 0,42; p = 0,013) y la duración del tratamiento (p = 0,002) se asociaron a una peor adherencia a la medicación.

CONCLUSIONES:

El porcentaje de adherencia obtenido resultó elevado en la población de estudio, pero se identificaron pacientes mal cumplidores susceptibles de recibir intervenciones para mejorar su adherencia. No obstante, se debería aumentar la potencia estadística para mejorar la validez de los resultados obtenidos

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Estudio primario

No clasificado

Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis.

Año 2014
Revista Gastroenterology
Enlaces Pubmed , DOI
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BACKGROUND & AIMS:

Little is known about the efficacy of golimumab, a fully human monoclonal antibody to tumor necrosis factor (TNF) -α, for treatment of ulcerative colitis (UC). We evaluated subcutaneous golimumab induction therapy in TNF-α antagonist-naïve patients with moderate-to-severe UC despite conventional treatment.

METHODS:

We integrated double-blind phase 2 dose-finding and phase 3 dose-confirmation trials in a study of 1064 adults with UC (Mayo score: 6-12; endoscopic subscore ≥ 2; 774 patients in phase 3). Patients were randomly assigned to groups given golimumab doses of 100 mg and then 50 mg (phase 2 only), 200 mg and then 100 mg, or 400 mg and then 200 mg, 2 weeks apart. The phase 3 primary end point was week-6 clinical response. Secondary end points included week-6 clinical remission, mucosal healing, and Inflammatory Bowel Disease Questionnaire (IBDQ) score change.

RESULTS:

In phase 2, median changes from baseline in the Mayo score were -1.0, -3.0, -2.0, and -3.0, in the groups given placebo, 100 mg/50 mg, 200/100 mg, and 400/200 mg golimumab, respectively. In phase 3, rates of clinical response at week 6 were 51.0% and 54.9% among patients given 200 mg/100 mg and 400 mg/200 mg golimumab, respectively, vs 30.3% among those given placebo (both, P ≤ .0001). Rates of clinical remission and mucosal healing and mean changes in IBDQ scores were significantly greater in both golimumab groups vs the placebo group (P ≤ .0014, all comparisons). Rates of serious adverse events were 6.1% and 3.0%, and rates of serious infection were 1.8% and 0.5%, in the placebo and golimumab groups, respectively. One patient in the 400 mg/200 mg group died as a result of surgical complications of an ischiorectal abscess.

CONCLUSIONS:

Treatment with subcutaneous golimumab induces clinical response, remission, and mucosal healing, and increases quality of life in larger percentages of patients with active UC than placebo. ClinicalTrials.gov Number: NCT00487539.

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Golimumab for the treatment of rheumatoid arthritis after failure of previous disease-modifying antirheumatic drugs

Año 2011
Autores [No se listan los autores]
Revista HTA Database
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RECORD STATUS:

None

CITATION:

Golimumab for the treatment of rheumatoid arthritis after failure of previous disease-modifying antirheumatic drugs.. NIHR Health Technology Assessment programme.

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Estudio primario

No clasificado

Effect of golimumab on patient-reported outcomes in rheumatoid arthritis: results from the GO-FORWARD study.

Año 2012
Revista The Journal of rheumatology
Enlaces Pubmed , DOI
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OBJECTIVE:

To evaluate the effect of golimumab on physical function, general health, and fatigue in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.

METHODS:

In the multicenter, randomized, placebo-controlled GO-FORWARD study, 444 adults with active RA despite MTX received subcutaneous placebo + MTX (crossover to golimumab 50 mg at Week 24), golimumab 100 mg + placebo, golimumab 50 mg + MTX, or golimumab 100 mg + MTX every 4 weeks. Physical function and general health were assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI) and Physical and Mental Component Summary (PCS, MCS) scores of the Medical Outcomes Study Short Form-36 questionnaire (SF-36), respectively, through Week 52. Fatigue was measured through Week 24 using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire.

RESULTS:

Mean improvements from baseline in HAQ-DI, SF-36 PCS, and FACIT-Fatigue scores (Weeks 14 and 24) were significantly greater for golimumab 50 mg + MTX and 100 mg + MTX versus placebo + MTX. Significantly greater proportions of patients treated with golimumab + MTX achieved clinically meaningful improvements from baseline to Weeks 14 and 24 in HAQ-DI, PCS, and FACIT-Fatigue scores. Mean improvements in SF-36 PCS (Week 14), MCS (Week 24), and FACIT-Fatigue (Weeks 14 and 24) scores were significantly greater for golimumab 100 mg + placebo versus placebo + MTX. Mean improvements from baseline in HAQ-DI, SF-36 PCS, and MCS scores through Week 24 were sustained through Week 52.

CONCLUSION:

Patients with active RA despite MTX had significant improvement in physical function, general health, and fatigue following golimumab + MTX therapy; improvements in physical function and general health were maintained through Week 52. (Clinical Trials Registration NCT00264550).

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Estudio primario

No clasificado

Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: results of the GO-FORTH study.

Año 2012
Revista Annals of the rheumatic diseases
Enlaces PMC , Pubmed , DOI
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OBJECTIVE:

To assess the efficacy and safety of golimumab + methotrexate (MTX) in Japanese patients with active rheumatoid arthritis (RA).

METHODS:

269 Japanese patients with active RA despite treatment with MTX were randomised (1:1:1) to placebo + MTX (Group 1), golimumab 50 mg + MTX (Group 2) or golimumab 100 mg + MTX (Group 3). Subcutaneous golimumab/placebo was injected every 4 weeks; stable doses of oral MTX (6-8 mg/week) were continued. Patients were allowed to enter early escape (Group 1 added golimumab 50 mg, Group 2 increased golimumab to 100 mg, Group 3 continued golimumab 100 mg) based on swollen/tender joint counts at week 14. The primary study endpoint was achievement of at least 20% improvement in the American College of Rheumatology (ACR20) response criteria at week 14. To control for multiplicity of testing, treatment group comparisons were first made between combined Groups 2 and 3 versus Group 1, followed by comparisons of Group 2 and Group 3 versus Group 1.

RESULTS:

The proportion of patients with an ACR20 response at week 14 was significantly higher in combined Groups 2 and 3 (73.4%, 127/173) and in each of Group 2 (72.1%, 62/86) and Group 3 (74.7%, 65/87) compared with Group 1 (27.3%, 24/88; p<0.0001 for all comparisons). Golimumab + MTX also elicited a significantly better response than placebo + MTX in other efficacy parameters, including disease activity score (DAS28) response/remission and radiographic assessments. During the 16-week fixed treatment regimen study period, 72.7%, 75.6% and 78.2% of patients had adverse events and 1.1%, 1.2% and 2.3% had serious adverse events in Groups 1, 2 and 3, respectively.

CONCLUSION:

In Japanese patients with active RA despite MTX therapy, golimumab + MTX was significantly more effective than MTX monotherapy in reducing RA signs/symptoms and limiting radiographic progression with no unexpected safety concerns.

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Resumen estructurado de revisiones sistemáticas

No clasificado

Golimumab (CNTO148) for psoriatic arthritis - DMARD resistant: horizon scanning technology briefing

Año 2009
Revista HTA Database
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RECORD STATUS:

None

CITATION:

National Horizon Scanning Centre. Golimumab (CNTO148) for psoriatic arthritis - DMARD resistant: horizon scanning technology briefing. National Horizon Scanning Centre (NHSC).

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Revisión sistemática

No clasificado

Comparative efficacy of golimumab, infliximab, and adalimumab for moderately to severely active ulcerative colitis: a network meta-analysis accounting for differences in trial designs.

Año 2015
Autores Thorlund K , Druyts E , Toor K , Mills EJ
Revista Expert review of gastroenterology & hepatology
Enlaces Pubmed , DOI
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AIM:

To conduct a network meta-analysis (NMA) to establish the comparative efficacy of infliximab, adalimumab and golimumab for the treatment of moderately to severely active ulcerative colitis (UC).

DESIGN:

A systematic literature search identified five randomized controlled trials for inclusion in the NMA. One trial assessed golimumab, two assessed infliximab and two assessed adalimumab. Outcomes included clinical response, clinical remission, mucosal healing, sustained clinical response and sustained clinical remission. Innovative methods were used to allow inclusion of the golimumab trial data given the alternative design of this trial (i.e., two-stage re-randomization).

RESULTS:

After induction, no statistically significant differences were found between golimumab and adalimumab or between golimumab and infliximab. Infliximab was statistically superior to adalimumab after induction for all outcomes and treatment ranking suggested infliximab as the superior treatment for induction. Golimumab and infliximab were associated with similar efficacy for achieving maintained clinical remission and sustained clinical remission, whereas adalimumab was not significantly better than placebo for sustained clinical remission. Golimumab and infliximab were also associated with similar efficacy for achieving maintained clinical response, sustained clinical response and mucosal healing. Finally, golimumab 50 and 100 mg was statistically superior to adalimumab for clinical response and sustained clinical response, and golimumab 100 mg was also statistically superior to adalimumab for mucosal healing.

CONCLUSION:

The results of our NMA suggest that infliximab was statistically superior to adalimumab after induction, and that golimumab was statistically superior to adalimumab for sustained outcomes. Golimumab and infliximab appeared comparable in efficacy.

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Revisión sistemática

No clasificado

Short-term risk of total malignancy and nonmelanoma skin cancers with certolizumab and golimumab in patients with rheumatoid arthritis: metaanalysis of randomized controlled trials.

Año 2012
Revista The Journal of rheumatology
Enlaces Pubmed , DOI

Este artículo incluye 6 Estudios primarios 6 Estudios primarios (6 referencias)

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OBJECTIVE:

To assess the risk of total malignancy and nonmelanoma skin cancers (NMSC) in patients with rheumatoid arthritis (RA) receiving certolizumab and golimumab through a metaanalysis of data from randomized control trials (RCT).

METHODS:

We systematically reviewed the literature up to May 2011 in Medline databases, as well as abstracts from the 2009 and 2010 annual meetings of the European League Against Rheumatism and the American College of Rheumatology. Mantel-Haenszel method was used to determine a common odds ratio (OR). Statistical heterogeneity was assessed by chi-square Q test. We selected only RCT including more than 30 RA subjects randomly assigned to an anti-tumor necrosis factor (TNF) or a nonbiological disease-modifying antirheumatic drug (DMARD) control group.

RESULTS:

The literature search identified 793 articles; 6 (2 with certolizumab and 4 with golimumab) were selected for metaanalysis. A total of 2710 patients received at least 1 dose of certolizumab or golimumab. For anti-TNF-treated patients, 18 cancers (excluding NMSC) and 9 NMSC were observed versus 4 cases of total malignancy and 3 NMSC in control groups. Metaanalysis revealed a pooled OR of 1.06 (95% CI 0.39-2.85) for risk of total malignancy and 0.69 (95% CI 0.23-2.11) for risk of NMSC with certolizumab and golimumab versus DMARD. Heterogeneity was not significant.

CONCLUSION:

Metaanalysis of RCT of golimumab and certolizumab did not find an increased risk of total malignancy and NMSC. These results must be confirmed with longterm extension studies and registry studies, and careful monitoring remains mandatory.

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Estudio primario

No clasificado

The effects of golimumab on subclinical atherosclerosis and arterial stiffness in ankylosing spondylitis—a randomized, placebo-controlled pilot trial.

Año 2014
Autores Tam LS , Shang Q , Kun EW , Lee KL , Yip ML , Li M - Más
Revista Rheumatology (Oxford, England)
Enlaces Pubmed , DOI

Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias)

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OBJECTIVE:

Our aim was to ascertain the efficacy of golimumab compared with placebo in the prevention of atherosclerosis and arterial stiffness in AS.

METHODS:

A randomized, double-blind, placebo-controlled pilot study was performed in which AS patients were treated with golimumab (n = 20) and placebo (n = 21) for 12 months. Patients from the placebo group who failed to achieve a 20% response to Assessment of SpondyloArthritis international Society criteria (ASAS20) at 6 months received open-label golimumab. Intima-media thickness (IMT), pulse wave velocity (PWV) and augmentation index (AIx) were measured at baseline, 6 and 12 months.

RESULTS:

At 6 months, 11/20 (55%) and 3/21 (14%) patients from the golimumab and placebo groups achieved an ASAS20 response, respectively (P = 0.006). There was no significant difference in the change of the vascular parameters between the two groups. In the placebo group, significantly greater progression of the mean IMT [from 0.51 mm (S.D. 0.07) at baseline to 0.53 mm (S.D. 0.08) at 6 months, P = 0.044] and PWV (from 12.2 m/s (S.D. 1.6) at baseline to 12.6 m/s (S.D. 1.3), P = 0.028] were observed. There was a trend towards progression of the mean IMT in the golimumab group (P = 0.099) but the maximum IMT, PWV and AIx remained unchanged. At 12 months the changes in vascular parameters were similar between the early and delayed (or no) golimumab groups.

CONCLUSION:

Uncontrolled inflammation may result in a significant progression in IMT and PWV in patients with AS. Arterial dysfunction may be prevented by golimumab over a period of 6 months, probably because of effective suppression of inflammation.

TRIAL REGISTRATION:

clinicaltrials.gov (NCT01212653)

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