Prediction of Short- and Medium-term Efficacy of Biosimilar Infliximab Therapy. Do Trough Levels and Antidrug Antibody Levels or Clinical And Biochemical Markers Play the More Important Role?

Gönczi, Lóránt; Végh, Zsuzsanna; Golovics, Petra A.; Rutka, Mariann; Gecse, Krisztina; Bor, Renáta; Farkas, Klaudia; Szamosi, Tamás; Bene, László; Gasztonyi, Beáta; Kristóf, Tünde; Lakatos, László; Miheller, Pál; Palatka, Károly; Papp, Mária; Patai, Árpád V.; Salamon, Ágnes; Tóth, Gábor; Vincze, Áron; Bíró, E; Lovász, Barbara D.; Kürti, Zsuzsanna; Szepes, Zoltán; Molnár, Tamás; Lakatos, Péter L.

doi:10.1093/ecco-jcc/jjw203

Cited by 35 publications

(36 citation statements)

References 31 publications

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“…Data on predictors on long-term are missing. However, the study by Gonczi et al revealed that week 2 trough levels of CT-P13 were predictive for short- and medium-term clinical efficacy in UC and were associated only with short-term clinical outcomes in CD [22]. In our study, we were not able to show any of the examined parameters to predict the outcome of CT-P13 therapy at week 54 neither in CD nor in UC.…”

Section: Discussioncontrasting

confidence: 96%

Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn’s disease and ulcerative colitis – experiences from a single center

Farkas

Rutka

Ferenci

et al. 2017

Expert Opinion on Biological Therapy

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Background: CT-P13, the first biosimilar monoclonal antibody to infliximab (IFX), has been confirmed to be efficacious in inducing remission in inflammatory bowel diseases (IBD). The aim of this study was to evaluate the long-term efficacy and safety of CT-P13 therapy in Crohn's disease (CD) and ulcerative colitis (UC), and to identify predictors of sustained clinical response during a 54-week CT-P13 treatment period. Patients and methods: Patients with CD and UC, who were administered CT-P13, were prospectively enrolled. Clinical response was assessed at week 14 and week 54. Predictive factors for disease outcome at week 54 were evaluated. Results: 57 CD and 57 UC patients were included; 55 CD and 49 UC patients completed the induction therapy and 50 CD and 46 UC patients completed the 54-week treatment period. Clinical remission was achieved in 65.5% of CD and 75.5% of UC patients at week 14. Rate of continuous clinical response was 51% in both CD and UC at week 54. None of the examined parameters were predictive to the clinical outcome neither in CD, nor in UC. Conclusion: This study confirmed the long-term efficacy and safety of CT-P13 therapy in IBD. Response rates at week 54 were similar in CD and UC.ARTICLE HISTORY

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Section: Discussioncontrasting

confidence: 96%

Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn’s disease and ulcerative colitis – experiences from a single center

Farkas

Rutka

Ferenci

et al. 2017

Expert Opinion on Biological Therapy

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“…97 Although well-designed large prospective studies are lacking, there are preliminary data mainly from retrospective studies that demonstrate that proactive TDM is associated with better therapeutic outcomes compared with empiric dose optimization and/or reactive TDM. 38,39,103,104,128 Furthermore, numerous retrospective studies 23,24,26,29,[31][32][33]67,73,74,[77][78][79]129,130 and some post hoc analyses of RCTs [47][48][49]71,76,94,131,132 have shown that higher biologic drug concentrations are associated with favorable short-term and long-term therapeutic outcomes in IBD (Supplementary Table 1, Tables 1 and 2). There do appear to be certain clinical scenarios that proactive TDM of anti-TNF therapy can efficiently guide therapeutic decisions, such as treatment de-escalation, 133 the application of optimized monotherapy instead of combo therapy with immunomodulator, 82 restarting therapy after a long drug holiday, 27 and treatment cessation on deep remission.…”

Section: Discussionmentioning

confidence: 99%

Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases

Papamichael

Cheifetz

Melmed

et al. 2019

Clinical Gastroenterology and Hepatology

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248

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BACKGROUND & AIMS: Therapeutic drug monitoring (TDM) is widely available for biologic therapies in patients with inflammatory bowel disease (IBD). We reviewed current data and provided expert opinion regarding the clinical utility of TDM for biologic therapies in IBD. METHODS: We used a modified Delphi method to establish consensus. A comprehensive literature review was performed regarding the use of TDM of biologic therapy in IBD and presented to international IBD specialists. Subsequently, 28 statements on the application of TDM in clinical practice were rated on a scale of 1 to 10 (1 [ strongly disagree and 10 [ strongly agree) by each of the panellists. Statements were accepted if 80% or more of the participants agreed with a score ‡7. The remaining statements were discussed and revised based on the available evidence followed by a second round of voting. RESULTS: The panel agreed on 24 (86%) statements. For anti-tumor necrosis factor (anti-TNF) therapies, proactive TDM was found to be appropriate after induction and at least once during maintenance therapy, but this was not the case for the other biologics. Reactive TDM was appropriate for all agents both for primary non-response and secondary loss of response. The panellists also agreed on several statements regarding TDM and appropriate drug and anti-drug antibody (ADA) concentration thresholds for biologics in specific clinical scenarios. CONCLUSION: Consensus was achieved towards the utility of TDM of biologics in IBD, particularly anti-TNF therapies. More data are needed especially on non-anti-TNF biologics to further define optimal drug concentration and ADA thresholds as these can vary depending on the therapeutic outcomes assessed.

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“…CD patients exposed to infliximab over 12 months prior to initiating CT-P13 therapy demonstrated significantly reduced clinical response and remission up to week 54 (p < 0.005) and higher ADA levels in early treatment (week 2, p < 0.001). Previously treated UC patients demonstrated significantly reduced clinical remission (p ≤ 0.03) and ADA development up to week 6 (p < 0.02) versus infliximab-naïve UC patients [74]. No differences were observed at weeks 14 or 30.…”

Section: Impact Of Non-medical Switch On Immunogenicitymentioning

confidence: 87%

Systematic Review: Non-medical Switching of Infliximab to CT-P13 in Inflammatory Bowel Disease

2020

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Background and Aims Biosimilar approval, such as Inflectra™ (CT-P13) for treating ulcerative colitis (UC) and Crohn's disease (CD), has reduced direct drug costs. Though clinicians are comfortable with biosimilar use in treatment-naïve patients, there are concerns in some jurisdictions that there are insufficient data from well-controlled trials to support non-medical switching. A systematic review, along with a critical assessment of the study design, was conducted to assess the potential impact of switching stable CD/UC patients from infliximab to CT-P13. Methods A literature search using PubMed and abstracts/posters from 3 major gastroenterology conferences from 2014 to 2018 was completed. Two individual reviewers extracted data from each relevant report and compiled it into evidence tables to facilitate descriptive analyses. Key randomized trial and observational study designs were critically assessed to contextualize data relevance. Results A total of 49 reports (3 randomized controlled trials, 40 observational trials, and 1 case series) were included. Most studies revealed no efficacy, safety, or immunogenicity concerns with non-medical switch. Limitations of supporting data include a small number of randomized controlled trials; predominance of observational studies with varying outcome assessments and lack of appropriate controls; and scarcity of research on biosimilar switch long-term effects. Conclusions The majority of studies suggested non-medical switch is safe. However, clinicians and regulatory bodies should be aware of differences and limitations in study designs when making inferences about the risks and benefits of switching stable IBD patients to biosimilars.

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Prediction of Short- and Medium-term Efficacy of Biosimilar Infliximab Therapy. Do Trough Levels and Antidrug Antibody Levels or Clinical And Biochemical Markers Play the More Important Role?

Abstract: In UC, early TLs were predictive for short- and medium-term clinical efficacy, whereas in CD, Week 2 TLs were associated only with short-term clinical outcomes.

Cited by 35 publications

References 31 publications

Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn’s disease and ulcerative colitis – experiences from a single center

Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn’s disease and ulcerative colitis – experiences from a single center

Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases

Systematic Review: Non-medical Switching of Infliximab to CT-P13 in Inflammatory Bowel Disease

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