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

Revisión sistemática

No clasificado

An indirect comparison of in?iximab versus adalimumab or golimumab for active ulcerative colitis

Año 2016
Autores Kawalec P , Pilc A
Revista Archives of medical science : AMS
Enlaces Pubmed , PMC , DOI

Este artículo incluye 8 Estudios primarios 7 Estudios primarios (8 referencias)

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Introduction: The aim of the study was to compare adalimumab or golimumab with infliximab in patients with moderately-to-severely active ulcerative colitis (UC). Material and methods: This paper was prepared according to the PRISMA guidelines. The systematic literature search was performed in PubMed, Embase, and Cochrane Library. No direct head-to-head comparisons for infliximab vs. adalimumab or golimumab were available so an indirect comparison according to the Bucher method was performed after a homogeneity evaluation of the included studies. Results: Six RCTs were included in the systematic review. An indirect comparison was performed, which revealed that infliximab was more effective in inducing clinical response compared with both doses of adalimumab (160/80 mg or 80/40 mg; p < 0.05), and, in clinical remission, infliximab was more effective than adalimumab (only for a dosage regime of 80/40 mg; p < 0.05). No statistically significant differences in clinical response and clinical remission were observed between infliximab and golimumab in the induction phase. A significant (p < 0.05) advantage only of infliximab compared with adalimumab at doses of 80/40 mg and 80/160 mg was seen in terms of clinical response in the maintenance phase (up to 52-54 weeks). The indirect comparison revealed that serious adverse events were significantly more frequent among patients treated with a maintenance dose of 100 mg of golimumab compared with those treated with infliximab (p < 0.05). Conclusions: No significant differences in efficacy in the maintenance phase between infliximab and golimumab or adalimumab were revealed. Infliximab proved to be more effective than adalimumab but of similar efficacy to that of golimumab in the induction phase.

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Resumen estructurado de revisiones sistemáticas

No clasificado

Golimumab for rheumatoid arthritis: a systematic review

Año 2010
Autores Singh JA , Noorbaloochi S , Singh G
Revista Database of Abstracts of Reviews of Effects (DARE)
Enlaces

Este artículo incluye 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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Resumen estructurado de revisiones sistemáticas

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Golimumab (CNTO-148) for ankylosing spondylitis

Año 2010
Revista HTA Database
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RECORD STATUS:

None

CITATION:

National Horizon Scanning Centre. Golimumab (CNTO-148) for ankylosing spondylitis Birmingham: National Horizon Scanning Centre (NHSC). Horizon Scanning Technology Briefing. 2007

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Resumen estructurado de revisiones sistemáticas

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Etanercept, adalimumab, infliximab y golimumab para el tratamiento de artritis idiopática juvenil [Etanercept, adalimumab, infliximab and golimumab for the treatment of juvenile idiopathic arthritis]

Año 2014
Revista HTA Database
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RECORD STATUS:

This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.

CITATION:

Pichon Riviere A, Augustovski F, Garcia Marti S, Glujovsky D, Alcaraz A, Lopez A, Rey-Ares L, Bardach A, Ciapponi A, Mengarelli C. Etanercept, adalimumab, infliximab y golimumab para el tratamiento de artritis idiopática juvenil. [Etanercept, adalimumab, infliximab and golimumab for the treatment of juvenile idiopathic arthritis] Buenos Aires: Institute for Clinical Effectiveness and Health Policy (IECS). Informe de Respuesta Rápida N° 302. 2013

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Resumen estructurado de revisiones sistemáticas

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Golimumab (Simponi) for ulcerative colitis - second line

Año 2011
Revista HTA Database
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RECORD STATUS:

None

CITATION:

National Horizon Scanning Centre. Golimumab (Simponi) for ulcerative colitis - second line Birmingham: National Horizon Scanning Centre (NHSC). Horizon Scanning Review. 2011

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Resumen estructurado de revisiones sistemáticas

No clasificado

Adalimumab, etanercept, infliximab y golimumab para el tratamiento de las espondilitis anquilosante y artritis reactiva [Adalimumab, etanercept, infliximab and golimumab for the treatment of ankylosing spondylitis and reactive arthritis]

Año 2014
Revista HTA Database
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RECORD STATUS:

This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.

CITATION:

Pichon Riviere A, Augustovski F, Garcia Marti S, Glujovsky D, Alcaraz A, Lopez A, Bardach A, Ciapponi A, Mengarelli C. Adalimumab, etanercept, infliximab y golimumab para el tratamiento de las espondilitis anquilosante y artritis reactiva. [Adalimumab, etanercept, infliximab and golimumab for the treatment of ankylosing spondylitis and reactive arthritis] Buenos Aires: Institute for Clinical Effectiveness and Health Policy (IECS). Informe de Respuesta Rápida N° 294. 2013

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Revisión sistemática

No clasificado

Golimumab: review of the efficacy and tolerability of a recently approved tumor necrosis factor-α inhibitor.

Año 2010
Revista Clinical Therapeutics
Enlaces Pubmed , DOI

Este artículo incluye 7 Estudios primarios 7 Estudios primarios (7 referencias)

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BACKGROUND:

Golimumab (GLM) is a tumor necrosis factor-α (TNF-α) inhibitor that was approved in the United States in 2009 for use with methotrexate (MTX) in adults with moderate to severe active rheumatoid arthritis (RA), and with or without MTX or other non-biologic disease-modifying antirheumatic drugs in adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). GLM is administered as a 50-mg subcutaneous injection once a month.

OBJECTIVES:

The goals of this article were to review the current literature on GLM and to provide recommendations for the use of GLM based on the published information.

METHODS:

The PubMed, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, International Pharmaceutical Abstracts, and other databases, as well as the Web sites for the American College of Rheumatology (ACR) and the European Union League Against Rheumatism, were searched for relevant articles published in English between the inception of the databases through April 2010. Search terms included golimumab and CNTO 148. Pharmacologic, pharmacokinetic, clinical, outcomes, and economic studies as well as meta-analyses, case reports, and select abstracts were eligible for inclusion. Review articles on GLM were not used except to identify other primary papers.

RESULTS:

Seven clinical studies were identified and used to evaluate the efficacy and tolerability of

GLM:

5 in patients with RA (4 subcutaneous administration and 1 intravenous administration), 1 in patients with PsA (subcutaneous), and 1 in patients with AS (subcutaneous). In MTX-naive patients with RA, the number of patients satisfying the ACR20 response criteria (>20% improvement in ACR response rate) at 24 weeks was significantly higher for the GLM + MTX groups than for the MTX-only groups (62% vs 49%, respectively; P < 0.05). In patients with active RA despite MTX therapy, ACR20 responses at 14 to 16 weeks were significantly higher for the combined GLM + MTX groups than for the MTX groups (50%–79% vs 33%–37%, respectively; P < 0.001). GLM was more effective than placebo, both with and without MTX, in patients with RA and a history of treatment with 1 or 2 TNF-α inhibitors (ACR20 at 14 weeks, 35%–37% vs 18%, respectively; P < 0.001). Studies of other TNF-α inhibitors reported ACR20 responses in 53% to 59% of patients with active RA at 24 weeks. GLM was also more effective than placebo at 24 weeks in patients with PsA (ACR20, 52%–61% vs 12%, respectively; P < 0.001) (ASAS40 [40% improvement based on Assessment in Ankylosing Spondylitis International Working Group criteria], 44%–54% vs 15%, respectively; P < 0.001). Studies of other TNF-α inhibitors reported ACR20 responses at 24 weeks in 55% to 57% of patients with PsA and ASAS40 responses in 46% to 47% of patients with AS. The incidence of any adverse effect appeared to be comparable in the GLM (61.2%–93.9%) and placebo groups (59.3%–85.3%), but withdrawals because of adverse effects were higher in the GLM groups (0%–12.1%) than in the placebo groups (0%–5.9%). The incidence of serious infections was comparable for GLM (0%–4.4%) and placebo (0.8%–3.5%). The most frequently reported adverse effects in the GLM groups were injection-site reactions (2.7%–37.1%), nausea (2.7%–22.9%), headache (3.8%–21.2%), nasopharyngitis (1.9%–15.0%), and upper respiratory tract infections (5.7%–13.8%).

CONCLUSIONS:

Based on the results of the studies included in this review, GLM appeared to be more effective than placebo in patients with RA, PsA, or AS. Clinical studies have not directly compared GLM with other TNF-α inhibitors. However, according to the available efficacy and tolerability data, GLM should be considered as the first or second TNF-α inhibitor for the treatment of PsA or AS and as the second or possibly first TNF-α inhibitor in combination with MTX for the treatment of RA.

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Revisión sistemática

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Direct and indirect comparison of the efficacy and safety of adalimumab, etanercept, infliximab and golimumab in psoriatic arthritis.

Año 2013
Revista Journal of clinical pharmacy and therapeutics
Enlaces Pubmed , DOI

Este artículo incluye 5 Estudios primarios 5 Estudios primarios (5 referencias)

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WHAT IS KNOWN AND OBJECTIVE:

Psoriatic arthritis is an autoimmune disease characterized by chronic inflammation of the skin and joints. Anti-TNF drugs reduce the severity of the disease in the long term. This study compares the efficacy and safety of adalimumab, etanercept, infliximab and golimumab in patients with psoriatic arthritis.

METHODS:

Direct comparison was based on a literature search of drug comparison studies, whereas indirect treatment comparison was based on phase III clinical trials with biological agents, involving similar populations and durations, and with the same outcome. ACR50 was taken as primary outcome for comparison, whereas ACR20 and ACR70 were used as secondary outcomes. Indirect comparisons were made using infliximab as the reference drug and the Bucher method. In calculating δ (the maximum acceptable difference as a clinical criterion of equivalence), use was made of half of the absolute risk reduction obtained in the meta-analysis of the clinical trials included in the indirect comparison (ARR 32%; δ: 16%). The four anti-TNF drugs were also compared in relation to the secondary outcomes and adverse effects.

RESULTS AND DISCUSSION:

Reported direct and indirect comparisons of the four drugs did not include golimumab, and did not yield conclusive results. Four clinical trials - one for each drug studied - were identified. The estimated differences for the primary outcome, ACR50, between infliximab and the other drugs were adalimumab (ARR 4%, 95% CI -9·5 to 17·5), etanercept (ARR 4%, 95% CI -10·5 to 18·5) and golimumab (ARR 9%, 95% CI -5·4 to 23·4). Likewise, there were no relevant differences between the drugs in relation to the secondary efficacy outcomes, except for etanercept, which was less effective in ACR70 response. For adverse reactions, there were also no significant differences except for injection site, reactions which were more frequent with etanercept, with a mean difference of 26% relative to infliximab.

WHAT IS NEW AND CONCLUSION:

No significant differences were found in ACR50 responses to the four drugs after 24 weeks. Injection-site reactions were more common with etanercept, but this was insufficient to invalidate the inference that clinically the four drugs can be regarded as clinically equivalent for the treatment of psoriatic arthritis.

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Golimumab (Simponi - Janssen Inc.) new indication: ulcerative colitis

Año 2014
Autores CADTH
Revista HTA Database
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RECORD STATUS:

This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.

CITATION:

CADTH. Golimumab (Simponi - Janssen Inc.) new indication: ulcerative colitis Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). CDEC final recommendation. 2014

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Estudio primario

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Subcutaneous Golimumab Maintains Clinical Response in Patients With Moderate-to-Severe Ulcerative Colitis

Año 2014
Revista Gastroenterology
Enlaces Pubmed , DOI

Este artículo está incluido en 24 Revisiones sistemáticas Revisiones sistemáticas (24 referencias)

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Background & Aims: Subcutaneous golimumab, a fully human monoclonal antibody to tumor necrosis factor-α (TNFα), was evaluated as maintenance therapy in TNFα antagonist-naive adults with moderate-to-severe active ulcerative colitis, despite conventional therapy, who responded to golimumab induction therapy. Methods: We performed a phase 3, double-blind trial of patients who completed golimumab induction trials (Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment, eg, PURSUIT). Patients who responded to induction therapy with golimumab (n = 464) were assigned randomly to groups given placebo or injections of 50 or 100 mg golimumab every 4 weeks through week 52. Patients who responded to placebo in the induction study continued to receive placebo. Nonresponders in the induction study received 100 mg golimumab. The primary end point was clinical response maintained through week 54; secondary end points included clinical remission and mucosal healing at both weeks 30 and 54. Results: Clinical response was maintained through week 54 in 47.0% of patients receiving 50 mg golimumab, 49.7% of patients receiving 100 mg golimumab, and 31.2% of patients receiving placebo (P = .010 and P < .001, respectively). At weeks 30 and 54, a higher percentage of patients who received 100 mg golimumab were in clinical remission and had mucosal healing (27.8% and 42.4%) than patients given placebo (15.6% and 26.6%; P = .004 and P = .002, respectively) or 50 mg golimumab (23.2% and 41.7%, respectively). Percentages of serious adverse events were 7.7%, 8.4%, and 14.3% among patients given placebo, 50 mg, or 100 mg golimumab, respectively; percentages of serious infections were 1.9%, 3.2%, and 3.2%, respectively. Among all patients given golimumab in the study, 3 died (from sepsis, tuberculosis, and cardiac failure, all in patients who received 100 mg golimumab) and 4 developed active tuberculosis. Conclusions: Golimumab (50 mg or 100 mg) maintained clinical response through week 54 in patients who responded to induction therapy with golimumab and had moderate-to-severe active ulcerative colitis; patients who received 100 mg golimumab had clinical remission and mucosal healing at weeks 30 and 54. Safety was consistent with that reported for other TNFα antagonists and golimumab in other approved indications. ClinicalTrials.gov number: NCT00488631. © 2013 AGA Institute.

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