An updated systematic review and meta-analysis about the safety and efficacy of infliximab biosimilar, CT-P13, for patients with inflammatory bowel disease

Ebada, Mahmoud Ahmed; Elmatboly, Abdelmagid M.; Ali, Ahmed Said; Ibrahim, Ahmed M.; Fayed, Notila; Faisal, Ahmed; Alkanj, Souad

doi:10.1007/s00384-019-03354-7

Cited by 33 publications

(20 citation statements)

References 39 publications

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“…Our study provided support with regards to the FDA's utilization of extrapolation to approve infliximab-dyyb for use in IBD. Our results were consistent with findings from previous studies in other countries, [20][21][22][23][24][25][26][27][28][29][30][31][32][33] which found no differences or non-inferiority between RP infliximab and infliximab-dyyb in various endpoints including the use of subjective measurement scales or electronic data. There was only one published study [34] which found unfavorable results in infliximab-dyyb.…”

Section: Discussionsupporting

confidence: 92%

“…Although various events and outcomes were used to define disease worsening using electronic data, we did not perform chart reviews in this study to validate disease worsening. However, given that our findings were similar to the majority of reported studies that utilized patient-reported outcomes [20][21][22][23][24][25][26][27][28][29][30][31][32][33], the ability to use electronic data allowed us to capture data on a much larger cohort of patients in a timely manner. In our healthcare system, the decision to switch from RP infliximab to infliximab-dyyb required physician approval and patient agreement, but other patientspecific factors were also considered.…”

Section: Discussionsupporting

confidence: 72%

“…Recently, more studies have been published regarding the experience of patients with IBD who switched to infliximab-dyyb from RP infliximab [22][23][24][25][26][27][28][29][30][31][32][33][34]. These included one meta-analysis [22], many single group observational studies [23][24][25][26][27][28][29][30][31][32], and two studies with comparison groups [33,34]. The length of follow-up ranged from 4 months [23] to 5 years [24].…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study

Ho¹,

Niu

Pola³

et al. 2020

BioDrugs

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Purpose The aim was to compare outcomes in adult patients with inflammatory bowel disease (IBD) who switched to infliximab-dyyb with those who remained on reference product (RP) infliximab in the United States (US) in a retrospective, propensity score-matched, non-inferiority cohort trial. Methods This study was a retrospective, non-inferiority study conducted within a US integrated healthcare system and included adult patients with a confirmed diagnosis of Crohn's disease or ulcerative colitis. A 1:1 propensity score matching was utilized to match patients who switched to infliximab-dyyb during the period April 2016-March 2018 to patients who remained on RP infliximab. The non-inferiority margin was set at + 10% of the upper limit. The primary outcome was a composite measure of disease worsening requiring acute care after the index date of switching to infliximab-dyyb or continuing RP infliximab. Disease worsening requiring acute care was defined as any IBD-related emergency room visit, hospitalization, or surgery. The secondary outcome was the composite measure of disease worsening requiring acute care or treatment failure. A switch to another biologic or tofacitinib was a proxy for treatment failure. All patients were followed for up to 9 months. Results After propensity score matching, the matched cohort included 1409 patients in the infliximab-dyyb group and 1409 patients in the RP infliximab group. The overall mean age (± standard deviation) was 47.7 ± 17.0 years, 50.9% of patients were of male gender, and 51.8% of patients had Crohn's disease, while the remainder of the cohort had ulcerative colitis. There were 144 patients (10.2%) in the infliximab-dyyb group and 245 patients (17.4%) in the RP infliximab group who experienced disease worsening requiring acute care (P < 0.01 for non-inferiority). There were 347 patients (24.6%) in the infliximab-dyyb group who experienced disease worsening requiring acute care or treatment failure compared to 375 patients (26.6%) who remained on RP infliximab (P < 0.01 for non-inferiority). Conclusion There was no increased risk of (1) disease worsening requiring acute care or (2) disease worsening requiring acute care or treatment failure in patients with IBD who switched from RP infliximab to infliximab-dyyb when compared to patients who remained on RP infliximab in this US population. Infliximab-dyyb is an option for patients with IBD who need to use RP infliximab.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 72%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study

Ho¹,

Niu

Pola³

et al. 2020

BioDrugs

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“…Both groups showed almost the same results, indicating the non-inferiority of CT-P13 to infliximab. 79 Recently Ebada et al 80 reported a study on a large pool of IBD patients (about 3,464). Thirty-two studies were conducted for CD and UC treated with CT-P13.…”

Section: Prospective Role Of Ct-p13 In Ibdmentioning

confidence: 99%

“…Overall, the study shows tolerance of CT-P13 and referral for the treatment of IBD. 80 In that same year, Bakalos and colleagues 81 also mentioned the data of the meta-analysis. In 11 studies (78.6%), higher rates of biosimilar discontinuation were reported, and in 8 studies, subjective adverse events were reported.…”

Section: Prospective Role Of Ct-p13 In Ibdmentioning

confidence: 99%

Clinical Benefits of Switching from Original Infliximab to its Biosimilar (CT-P13) as a Potential TNF-α Inhibitor

Kumari¹,

Prasad²,

Kumar³

et al. 2020

Journal of Exploratory Research in Pharmacology

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Tumor necrosis factor-alpha (TNF-α) is implicated in the process of various autoimmune and inflammatory diseases through binding to its receptor, the tumor necrosis factor receptor. Nowadays, monoclonal anti-TNF-α antibody is used for the treatment of these diseases because it can neutralize TNF-α to block the relevant signaling responsible for the pathogenesis of these diseases. Currently, such antibody-based therapies have been demonstrated to be effective in controlling rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and ulcerative colitis. Infliximab is the first monoclonal antibody for the treatment of rheumatoid arthritis and has been approved for the intervention of other autoimmune and inflammatory diseases in the clinic. Although infliximab is considered highly efficacious, more so than common medications such as methotrexate and calcipotriol, its potential disadvantages, including loss of response in some patients, drug-related adverse events and particularly high cost, have motivated chemists and researchers to shift towards its biosimilar, CT-P13. CT-P13 has a better tolerance and much less cost, attracting more attention. Here, we summarize the clinical findings of CT-P13 from clinical trials in various diseases.

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Impact of Infliximab-dyyb (Infliximab Biosimilar) on Clinical and Patient-Reported Outcomes: 1-Year Follow-up Results from an Observational Real-World Study Among Patients with Inflammatory Bowel Disease in the US and Canada (the ONWARD Study)

Abraham

Eksteen²,

Khan

et al. 2022

Adv Ther

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Introduction: To date, there are limited realworld studies published on the use of infliximab-dyyb, a biosimilar to reference product (RP) infliximab approved for the treatment of moderate to severe inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC) in North America. This study examined utilization patterns and the effects of infliximab-dyyb on clinical outcomes, patient-reported outcomes (PROs), and healthcare resource use (HCRU) in IBD patients in a real-world setting. Methods: In this prospective, observational study, adult IBD patients in the US and Canada were recruited to initiate treatment with infliximab-dyyb and followed for 12 months. Patients included biologic-naı ¨ve users of infliximab-dyyb and patients switching from RP infliximab or other biologics to infliximabdyyb. Partial Mayo (pMAYO) and Harvey Bradshaw Index (HBI) scores measured clinical outcomes for the UC and CD cohorts, respectively. Key PRO measures included the SIBDQ, EQ-VAS, and psychological outcomes. In addition, work productivity, HCRU, and adverse events (AEs) were assessed.

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An updated systematic review and meta-analysis about the safety and efficacy of infliximab biosimilar, CT-P13, for patients with inflammatory bowel disease

Cited by 33 publications

References 39 publications

Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study

Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study

Clinical Benefits of Switching from Original Infliximab to its Biosimilar (CT-P13) as a Potential TNF-α Inhibitor

Impact of Infliximab-dyyb (Infliximab Biosimilar) on Clinical and Patient-Reported Outcomes: 1-Year Follow-up Results from an Observational Real-World Study Among Patients with Inflammatory Bowel Disease in the US and Canada (the ONWARD Study)

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