Comparative analysis of adverse events between infliximab and adalimumab in Crohn's disease management: a Brazilian single-centre experience

Kotze, Paulo Gustavo; Akiyoshi, Fernando Kenji; Luvizotto, Mateus; Olandoski, Márcia; Kotze, Lorete Maria da Silva; Coy, Cláudio Saddy Rodrigues

doi:10.1590/s2237-93632013000100007

Cited by 1 publication

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“…These numbers are in accordance with phase three studies for both agents (54.8% to 65.81% in ADA trials (6) , up to 89% of IFX patients in the SONIC trial, for example) (7) . Comparative safety studies between agents are scarce in the literature, and we could not detect any difference in terms of prevalence of overall AE between the groups, what confirmed a previous study performed in the same unit, but with a smaller sample of patients (11) . Moreover, infectious AE in aggregation were also not different between the two groups [29.4% (20/68) in IFX and 43.5% (27/62) in ADA groups, respectively (P=0.094)].…”

Section: Discussionsupporting

confidence: 89%

“…Cephalea was also more prevalent in ADA patients, and was observed in 7/62 patients (11.2%), while none of the IFX patients reported this AE (P=0.004). Headache can be described during anti-TNF therapy, and usually is not a cause for discontinuation of therapy (11) . In IFX patients, it can be associated frequently with infusion reactions.…”

Section: Discussionmentioning

confidence: 99%

“…The efficacy of blocking the TNF in IBD was highly proved in both induction and maintenance of clinical response and remission (6,7,9,12,16) . Currently, infliximab (IFX) and adalimumab (ADA) are the most used TNF alpha inhibitors in our country (11,12) . Certolizumab Pegol was recently approved for public reimbursement, and the experience with its use is still limited.…”

Section: Introductionmentioning

confidence: 99%

“…Concerning the occurrence of AE per agent, the safety profile is very similar between these drugs, and a class effect can be suggested. Nevertheless, there is a lack of Latin American studies that explore the safety findings and compare differences between ADA and IFX in the management of CD (11) . The aim of this study was to quantify and describe AE derived from ADA and IFX use in CD patients, from a single-center cohort, and to compare the safety profile between these two agents.…”

Section: Introductionmentioning

confidence: 99%

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Safety Profile of Anti-TNF Therapy in Crohn’s Disease Management: A Brazilian Single-Center Direct Retrospective Comparison Between Infliximab and Adalimumab

Bau¹,

Zacharias²,

Ribeiro³

et al. 2017

Arq. Gastroenterol.

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BACKGROUND: Infliximab and adalimumab are considered effective drugs in the management of Crohn’s disease. However, due to significant immunossupression, they can cause important adverse events, mostly infections. OBJECTIVE: The aim of this study was to quantify and describe adverse events derived from adalimumab and infliximab use in Crohn’s disease patients, and to compare the safety profile between these two agents. METHODS: This was an observational, single-center, longitudinal, retrospective study with Crohn’s disease patients under infliximab or adalimumab therapy. Variables analyzed: demographic characteristics (including the Montreal classification), type of agent used, concomitant immunomodulators, presence and types of adverse events observed. Patients were allocated in two groups (infliximab and adalimumab) and had their adverse events accessed and subsequently compared. RESULTS: A total of 130 patients were included (68 in infliximab and 62 in adalimumab groups, respectively). The groups were fully homogeneous in all baseline characteristics, with a median follow-up of 47.21±36.52 months in the infliximab group and 47.79±35.09 in the adalimumab group (P=0.512). Adverse events were found in 43/68 (63.2%) and 40/62 (64.5%) in each group, respectively (P=0.879). There were no differences between the groups regarding infections (P=0.094) or treatment interruption (P=0.091). There were higher rates of infusion reactions in the infliximab group (P=0.016). Cephalea and injection site reactions were more prevalent in adalimumab patients. CONCLUSION: Adverse events were found in approximately two thirds of Crohn’s disease patients under anti-TNF therapy, and there were no significant differences between infliximab or adalimumab.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%