Adalimumab and Infliximab Are Equally Effective for Crohn's Disease in Patients Not Previously Treated With Anti–Tumor Necrosis Factor-α Agents

Kestens, Christine; Oijen, Martijn G.H. van; Mulder, Charlotte L. J.; Bodegraven, Ad A. van; Dijkstra, Gerard; Jong, Dirk de; Ponsioen, Cyriel Y.; Tuyl, Bas A C van; Siersema, Peter D.; Fidder, Herma H.; Oldenburg, Bas; Crohn, Dutch Initiative on; Colitis,

doi:10.1016/j.cgh.2013.01.012

Cited by 74 publications

(54 citation statements)

References 24 publications

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“…Adverse events were observed in 12.6% of patients and a 4.5% discontinuation rate due to antibody formation was seen during at least 1 year of TNF-inhibitor treatment. Outcomes or adverse effects did not differ between infliximab and adalimumab, similar to findings for other chronic inflammatory diseases [34,37,38].…”

Section: Discussionsupporting

confidence: 79%

Association of the TNF- G-308A polymorphism with TNF-inhibitor response in sarcoidosis

Wijnen

Cremers

Nelemans

et al. 2014

European Respiratory Journal

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Responsiveness to tumour necrosis factor (TNF) inhibitors has been associated with the TNF-a G-308A polymorphism in rheumatoid arthritis. The aim of this study was to examine the association between the presence of this polymorphism and the response to TNF inhibitors in patients with refractory sarcoidosis.Patients (n5111) who started TNF-inhibitor treatment (76 infliximab, 35 adalimumab) were followed for at least 1 year. The main symptoms in these patients were fatigue (n5100, 90.1%), small fibre neuropathy (n591, 82.0%), pulmonary involvement (n569, 62.2%), and/or uveitis (n531, 27.9%). Patients were additionally genotyped for the presence of the TNF-a G-308A polymorphism. Treatment response was assessed using clinical outcome measures and questionnaires.Three-quarters (n583, 74.8%) of the patients responded well. Of the patients without the variant A-allele 93.6% (73 out of 78, p,0.001) improved, while 30.3% (10 out of 33) of variant A-allele carriers responded favourably to TNF inhibitors. For patients with the GG-genotype, the probability of improving compared with remaining stable or deteriorating was three times higher (risk ratio 3.09, 95% CI 1. 84-5.20).Sarcoidosis patients without the TNF-a -308A variant allele (GG-genotype) had a three-fold higher response to TNF inhibitors (adalimumab or infliximab). Further research is needed to evaluate the value of genotyping for the TNF-a G-308A polymorphism in order to tailor TNF-inhibitor treatment. @ERSpublications TNF-a G-308A polymorphism predicts TNF-inhibitor response in refractory sarcoidosis: a step to personalised medicine?

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Section: Discussionsupporting

confidence: 79%

Association of the TNF- G-308A polymorphism with TNF-inhibitor response in sarcoidosis

Wijnen

Cremers

Nelemans

et al. 2014

European Respiratory Journal

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“…Thirteen observational studies with 17,444 patients reported on the comparative risk of discontinuation of TIMs due to AEs (see Supplementary Table 1, available Six observational studies reported only crude rates of discontinuation and did not provide comparative estimates (22)(23)(24)(25)(26)(27). These studies generally observed a higher proportion of patients discontinuing infliximab than adalimumab, etanercept, or anakinra treatment due to AEs in CD, RA, and plaque psoriasis.…”

Section: Resultsmentioning

confidence: 99%

Comparative Risk of Harm Associated With the Use of Targeted Immunomodulators: A Systematic Review

Desai

Thaler

Mahlknecht

et al. 2016

Arthritis Care & Research

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ObjectiveTo systematically compare the risk of adverse events (AEs) for 13 targeted immunomodulators (TIMs) indicated for ankylosing spondylitis (AS), inflammatory bowel diseases, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis (PsA), or rheumatoid arthritis (RA).MethodsWe searched electronic databases through July 2015 to retrieve randomized controlled trials (RCTs) and observational studies comparing AEs between 2 or more TIMs head‐to‐head. We reported on the following outcomes: number of AEs, discontinuation due to AEs, serious AEs, mortality, serious infections, tuberculosis, herpes zoster, and malignancies. We qualitatively synthesized the literature and conducted random‐effects meta‐analyses if 3 or more studies provided data for an outcome.ResultsTen head‐to‐head RCTs and 51 observational studies were included in this systematic review. A majority of the studies (70%) were conducted in RA patients. Risk of treatment discontinuation due to AEs was higher with infliximab than with adalimumab or etanercept in RA, PsA, and AS. A higher risk for serious infections was noted with infliximab than with abatacept, adalimumab, or etanercept in RA. Risk for treatment discontinuation due to AEs, serious infections, and tuberculosis was lower with etanercept than with adalimumab in RA. Limited evidence suggested no comparative differences in risk for mortality, malignancies, and herpes zoster for adalimumab, etanercept, and infliximab in RA.ConclusionImportant differences were noted in the safety profile of TIMs in RA, generally favoring abatacept, adalimumab, and etanercept over infliximab. Head‐to‐head comparative evidence for other TIMs and non‐RA populations was insufficient to draw conclusions for most of the safety outcomes.

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“…11,12 Retrospective and nonrandomised studies have demonstrated IFX and ADA to have similar clinical outcomes in avoidance of corticosteroids, surgery, hospitalisation and improvement in quality of life in patients with CD. [13][14][15][16][17] In summary, biologic and retrospective clinical data suggest similar therapeutic activity of these agents in CD. Head-to-head direct comparative efficacy trials among anti-TNF agents for CD have not been performed.…”

Section: Introductionmentioning

confidence: 88%

Systematic review with network meta‐analysis: the efficacy of anti‐TNF agents for the treatment of Crohn's disease

Stidham

Lee

Higgins

et al. 2014

Aliment Pharmacol Ther

181

107

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SummaryBackgroundAnti‐tumour necrosis factor‐alpha agents (anti‐TNF) are effective therapies for the treatment of Crohn's disease (CD), but their comparative efficacy is unknown.AimTo perform a network meta‐analysis comparing the efficacy of anti‐TNF therapies in CD.MethodsAfter screening 506 studies, reviewers extracted information on 10 studies. Traditional meta‐analysis (TMA) was used to compare each anti‐TNF agent to placebo. Bayesian network meta‐analysis (NMA) was performed to compare the effects of anti‐TNF agents to placebo. In addition, sample sizes for comparative efficacy trials were calculated.ResultsCompared to placebo, TMA revealed that anti‐TNF agents result in a higher likelihood of induction of remission and response (RR: 1.66, 95% CI: 1.17–2.36 and RR: 1.43, 95% CI: 1.17–1.73, respectively) as well as maintenance of remission and response (RR: 1.78, 95% CI: 1.51–2.09 and RR: 1.68, 95% CI: 1.46–1.93, respectively). NMA found nonsignificant trends between infliximab and adalimumab or certolizumab pegol. Among subcutaneous therapies, NMA demonstrated superiority of adalimumab to certolizumab pegol for induction of remission (RR: 2.93, 95% CrI: 1.21–7.75). Sample size calculations suggest that adequately powered head‐to‐head comparative efficacy trials would require greater than 3000 patients.ConclusionsAll anti‐TNF agents are effective for induction and maintenance of response and remission in the treatment of CD. Although adalimumab is superior to certolizumab pegol for induction of remission, there is no evidence of clinical superiority among anti‐TNF agents. Head‐to‐head trials among the anti‐TNF agents are impractical in terms of size and cost.

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Adalimumab and Infliximab Are Equally Effective for Crohn's Disease in Patients Not Previously Treated With Anti–Tumor Necrosis Factor-α Agents

Cited by 74 publications

References 24 publications

Association of the TNF- G-308A polymorphism with TNF-inhibitor response in sarcoidosis

Association of the TNF- G-308A polymorphism with TNF-inhibitor response in sarcoidosis

Comparative Risk of Harm Associated With the Use of Targeted Immunomodulators: A Systematic Review

Systematic review with network meta‐analysis: the efficacy of anti‐TNF agents for the treatment of Crohn's disease

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