Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor α inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial

Smolen, Josef S.; Kay, Jonathan; Doyle, Mittie K.; Landewé, Robert; Matteson, Eric L.; Wollenhaupt, J.; Gaylis, Norman; Murphy, Frederick T.; Neal, Jeffrey; Zhou, Yiying; Visvanathan, Sudha; Hsia, Elizabeth C.; Rahman, Mahboob U.

doi:10.1016/s0140-6736(09)60506-7

Cited by 492 publications

(380 citation statements)

References 32 publications

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“…Two new TNF inhibitors, golimumab (a fully human anti-TNF␣ monoclonal antibody) and certolizumab pegol (a PEGylated FabЈ fragment of a humanized anti-TNF monoclonal antibody), have more recently been shown to be effective in the treatment of RA (83)(84)(85)(86)(87)(88). Thus, TNF␣ has clearly been proven to be a good target for RA treatment and has fulfilled the expectations raised during the preclinical studies performed in animal models.…”

Section: From Animal Models Toward the Clinicmentioning

confidence: 99%

Evaluation of therapeutic targets in animal models of arthritis: How does it relate to rheumatoid arthritis?

Bevaart¹,

Vervoordeldonk²,

Tak³

2010

Arthritis & Rheumatism

228

193

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There are accumulating data describing the association between diabetes and cancer mortality from Westernised populations. There are no data describing the relationship between diabetes and cancer mortality in African or South Asian populations from developing countries. We explored the relationship of abnormal glucose tolerance and diabetes on cancer mortality risk in a large, multi‐ethnic cohort from the developing nation of Mauritius. Population‐based surveys were undertaken in 1987, 1992 and 1998. The 9559 participants comprised 66% of South Asian (Indian), 27% of African (Creole), and 7% of Chinese descent. Cox's proportional hazards model with time varying covariates was used to obtain hazard ratios (HRs) and 95% confidence intervals (95% CI) for risk of cancer mortality, after adjustment for confounding factors. In men, but not women, cancer mortality risk increased with rising 2h‐PG levels with HR for the top versus bottom quintile of 2.77 (95%CI: 1.28 to 5.98). South Asian men with known diabetes had a significantly greater risk of cancer mortality than those with normal glucose tolerance (NGT) HR: 2.74 (95%CI: 1.00‐7.56). Overall, impaired glucose tolerance was associated with an elevated risk of cancer mortality compared to NGT (HR: 1.47, 95% CI: 0.98–2.19), though this was not significant. We have shown that the association between abnormal glucose tolerance and cancer extends to those of African and South Asian descent. These results highlight the importance of understanding this relationship in a global context to direct future health policy given the rapid increase in type 2 diabetes, especially in developing nations.

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Section: From Animal Models Toward the Clinicmentioning

confidence: 99%

Evaluation of therapeutic targets in animal models of arthritis: How does it relate to rheumatoid arthritis?

Bevaart¹,

Vervoordeldonk²,

Tak³

2010

Arthritis & Rheumatism

228

193

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“…Subcutaneous golimumab injections every 4 weeks reduce the signs and symptoms of disease in patients with active rheumatoid arthritis, psoriatic arthritis (PsA), and ankylosing spondylitis (1)(2)(3)(4)(5)(6). We previously reported findings for the clinical efficacy and safety of golimumab through week 24 of the GO-REVEAL study, a phase III, multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA (6).…”

Section: Ond Of 2 Coprimary End Points (Ie Change From Baseline Tomentioning

confidence: 99%

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

Kavanaugh¹,

Heijde²,

McInnes³

et al. 2012

Arthritis & Rheumatism

182

100

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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 secClinicalTrials.gov identifier: NCT00265096.

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“…[35]); and, one for GOL + MTX (GO-AFTER [36]). The company only considered fixed effect models and justified its decision based on the limited number of studies.…”

Section: Clinical Evidence Provided By the Companymentioning

confidence: 99%

Certolizumab Pegol for Treating Rheumatoid Arthritis Following Inadequate Response to a TNF-α Inhibitor: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

et al. 2017

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As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer (UCB Pharma) of certolizumab pegol (CZP;Cimzia®) to submit evidence of its clinical and cost-effectiveness for the treatment of rheumatoid arthritis (RA) following inadequate response to a tumour necrosis factor-alpha inhibitor (TNFi). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a detailed review of the evidence for the clinical and cost-effectiveness of the technology, based upon the company's submission to NICE. The clinical effectiveness evidence in the company's submission for CZP was based predominantly on six randomised controlled trials (RCTs) comparing the efficacy of CZP against placebo. The clinical-effectiveness review identified no head to head evidence on the efficacy of CZP against the comparators within the scope; therefore the company performed a network meta-analysis (NMA). The company's NMA concluded that CZP had a similar efficacy to that of its comparators. The company submitted a Markov model that assessed the incremental cost effectiveness of CZP versus comparator biologic disease-modifying antirheumatic drugs (bDMARDs) for the treatment of RA from the perspective of the National Health Service for three decision problems each of which followed an inadequate response to a TNFi. These were (i) a comparison against rituximab (RTX) in combination with methotrexate (MTX); (ii) a comparison against bDMARDs when RTX was contraindicated or withdrawn due to an adverse event; and (iii) a comparison against bDMARDs when MTX was contraindicated or withdrawn due to an adverse event. Results from the company's economic evaluation showed that CZP resulted in similar number of QALYs produced at similar, or lower, costs as comparator bDMARDs. The commercial-in-2 confidence patient access schemes for abatacept and tocilizumab could not be incorporated by the company, but were incorporated by the ERG in a confidential appendix for the NICE Appraisal Committee (AC). The company estimated that the addition of CZP before RTX in a sequence for patients who could receive MTX, produced more quality-adjusted life years (QALYs) at an increased cost, with a cost per QALY of £33,222. Following a critique of the model, the ERG undertook exploratory analyses that did not change the conclusions reached based on the company's economic evaluation in relation to the comparison with bDMARDs. The ERG estimated that where CZP replaced RTX, CZP was dominated, as it produced less QALYs at an increased cost. The AC concluded that there was little difference in effectiveness between CZP and comparator bDMARDs and that equivalence among bDMARDs could be accepted. The AC consequently recommended CZP plus MTX for people for whom RTX is contraindicated or not tolerated and CZP monotherapy for people for whom MTX is contraindicated or not to...

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Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor α inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial

Cited by 492 publications

References 32 publications

Evaluation of therapeutic targets in animal models of arthritis: How does it relate to rheumatoid arthritis?

Evaluation of therapeutic targets in animal models of arthritis: How does it relate to rheumatoid arthritis?

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

Certolizumab Pegol for Treating Rheumatoid Arthritis Following Inadequate Response to a TNF-α Inhibitor: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

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