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    Gut and Liver is an international journal of gastroenterology, focusing on the gastrointestinal tract, liver, biliary tree, pancreas, motility, and neurogastroenterology. Gut atnd Liver delivers up-to-date, authoritative papers on both clinical and research-based topics in gastroenterology. The Journal publishes original articles, case reports, brief communications, letters to the editor and invited review articles in the field of gastroenterology. The Journal is operated by internationally renowned editorial boards and designed to provide a global opportunity to promote academic developments in the field of gastroenterology and hepatology. +MORE

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    Yong Chan Lee Professor of Medicine
    Director, Gastrointestinal Research Laboratory
    Veterans Affairs Medical Center, Univ. California San Francisco
    San Francisco, USA

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    Deputy Editor
    Jong Pil Im Seoul National University College of Medicine, Seoul, Korea
    Robert S. Bresalier University of Texas M. D. Anderson Cancer Center, Houston, USA
    Steven H. Itzkowitz Mount Sinai Medical Center, NY, USA
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Infliximab versus Adalimumab, Which One Is Better for Ulcerative Colitis?

Eun Soo Kim

Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea

Correspondence to:Eun Soo Kim
ORCID https://orcid.org/0000-0003-0806-9136
E-mail dandy813@hanmail.net

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Gut and Liver 2021; 15(2): 149-150

Published online March 15, 2021 https://doi.org/10.5009/gnl210098

Copyright © Gut and Liver.

Since the introduction in the mid-2000s, anti-tumor necrosis factor (TNF) have been considered as paradigm-changing treatment in the management of patients with ulcerative colitis (UC). In the pivotal clinical trials of anti-TNF agents for the management of UC, the rates of clinical remission and clinical response in anti-TNF treated group were significantly higher than in the placebo group during induction and maintenance phase. Use of these agents reduces the risk of poor clinical outcomes including hospitalization,1 cumulative corticosteroid exposure,2 and early phase surgery in patients with UC.3 In addition, they also improve health related quality of life which is an important patient-reported outcome.4

Infliximab and adalimumab comprise the main part of anti-TNF agents; infliximab was first to be approved for the treatment of UC, followed by adalimumab in several years. Infliximab is administered by intravenous infusion in every 8 weeks after induction, while adalimumab is injected subcutaneously in every 2 weeks. Although both drugs are proved to be effective in controlling disease activity of moderate to severe UC, there remains a naïve question; which one is better? This question has never been answered because there is no head-to-head trial comparing these agents in terms of the efficacy and safety for patients with UC. Using data from pivotal studies of each drug, network meta-analysis has been performed to answer that question.5 However, this was criticized by indirect methodology as the results was calculated based on data against placebo, not each other drug.

In the current issue, Lee et al.6 reported data directly comparing treatment efficacy and long-term outcomes between infliximab and adalimumab in 113 biologic-naïve patients with moderate to severe UC. Patients with acute severe UC were excluded. This retrospective study showed that clinical remission and response rates at 8 and 52 weeks were comparable between infliximab and adalimumab (clinical remission 47% vs 56.7% [p=0.364] at 8 weeks, 39.8% vs 50% [p=0.331] at 52 weeks; clinical response 86.7% vs 76.7% [p=0.196] at 8 weeks, 72.3% vs 76.7% [p=0.642] at 52 weeks). They also found no difference between groups in poor outcomes including hospitalization, discontinuation of drug, corticosteroid prescription, and switching to another drug during median 26 months follow-up period although infliximab group showed marginally higher rate of UC-related hospitalization than adalimumab group (p=0.051). Despite the drawbacks of the study such as retrospective design, small sample size and inadequate measurement of endpoint (not using endoscopic parameters), the result of the study is meaningful as this is the first study to directly compare clinical remission and response rates between two drugs for UC patients in the routine clinical practice.

There are several real-world studies comparing various outcomes between infliximab and adalimumab in biologic-naïve patients with UC. A nationwide Danish cohort study showed a higher risk of hospitalization and serious infections in adalimumab compared with infliximab.7 The U.S. cohort study using an administrative claims database showed that infliximab users had lower corticosteroid use than adalimumab users while both groups had a similar risk of hospitalization and serious infections.8 A French single-center study reported that these two drugs showed comparable levels of persistence while the U.S. study found that adalimumab had the high persistence for 1 year after treatment compared with infliximab.9,10 The disparity among different studies might be attributed to various factors like different study design and distinct ethnicity of patients.

As phenotype of UC is different in various ethnic groups which may be linked to different genetic backgrounds, it is crucial to have data of specific drug efficacy in diverse populations. In line with this notion, the study by Lee et al. is clinically relevant in that it was conducted in Korea where inflammatory bowel disease incidence has been rapidly rising. The real-world study from other Asian countries is warranted to confirm the result of the current study.

Although the above question cannot be answered without head-to-head trial, infliximab and adalimumab seem to be equally effective for patients with moderate to severe UC. Therefore, these agents might be selected based on various factors like socioeconomic condition or patients’ preference.


See “Comparison of Long-term Outcomes of Infliximab versus Adalimumab Treatment in Biologic-Naïve Patients with Ulcerative Colitis” by Yong Il Lee, et al. on page 232, Vol. 15, No. 2, 2021


No potential conflict of interest relevant to this article was reported.

  1. Feagan BG, Sandborn WJ, Lazar A, et al. Adalimumab therapy is associated with reduced risk of hospitalization in patients with ulcerative colitis. Gastroenterology 2014;146:110-118.
    Pubmed CrossRef
  2. Targownik LE, Tennakoon A, Leung S, Lix LM, Singh H, Bernstein CN. Temporal trends in initiation of therapy with tumor necrosis factor antagonists for patients with inflammatory bowel disease: a population-based analysis. Clin Gastroenterol Hepatol 2017;15:1061-1070.
    Pubmed CrossRef
  3. Jenkinson PW, Plevris N, Lyons M, et al. Analysis of colectomy rates for ulcerative colitis in pre- and postbiological eras in Lothian, Scotland. Colorectal Dis. Epub 2020 Dec 21. https://doi.org/10.1111/codi.15491
    Pubmed CrossRef
  4. LeBlanc K, Mosli MH, Parker CE, MacDonald JK. The impact of biological interventions for ulcerative colitis on health-related quality of life. Cochrane Database Syst Rev 2015;9:CD008655.
    Pubmed CrossRef
  5. Thorlund K, Druyts E, Mills EJ, Fedorak RN, Marshall JK. Adalimumab versus infliximab for the treatment of moderate to severe ulcerative colitis in adult patients naïve to anti-TNF therapy: an indirect treatment comparison meta-analysis. J Crohns Colitis 2014;8:571-581.
    Pubmed CrossRef
  6. Lee YI, Park Y, Park SJ, Kim TI, Kim WH, Cheon JH. Comparison of long-term outcomes of infliximab versus adalimumab treatment in biologic-naïve patients with ulcerative colitis. Gut Liver 2021;15:232-242.
    Pubmed CrossRef
  7. Singh S, Andersen NN, Andersson M, Loftus EV Jr, Jess T. Comparison of infliximab and adalimumab in biologic-naive patients with ulcerative colitis: a nationwide Danish cohort study. Clin Gastroenterol Hepatol 2017;15:1218-1225.
    Pubmed KoreaMed CrossRef
  8. Singh S, Heien HC, Sangaralingham LR, et al. Comparative effectiveness and safety of infliximab and adalimumab in patients with ulcerative colitis. Aliment Pharmacol Ther 2016;43:994-1003.
    Pubmed KoreaMed CrossRef
  9. Pouillon L, Baumann C, Rousseau H, et al. Treatment persistence of infliximab versus adalimumab in ulcerative colitis: a 16-year single-center experience. Inflamm Bowel Dis 2019;25:945-954.
    Pubmed CrossRef
  10. Chen C, Hartzema AG, Xiao H, et al. Real-world pattern of biologic use in patients with inflammatory bowel disease: treatment persistence, switching, and importance of concurrent immunosuppressive therapy. Inflamm Bowel Dis 2019;25:1417-1427.
    Pubmed CrossRef

Article

Editorial

Gut and Liver 2021; 15(2): 149-150

Published online March 15, 2021 https://doi.org/10.5009/gnl210098

Copyright © Gut and Liver.

Infliximab versus Adalimumab, Which One Is Better for Ulcerative Colitis?

Eun Soo Kim

Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea

Correspondence to:Eun Soo Kim
ORCID https://orcid.org/0000-0003-0806-9136
E-mail dandy813@hanmail.net

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Body

Since the introduction in the mid-2000s, anti-tumor necrosis factor (TNF) have been considered as paradigm-changing treatment in the management of patients with ulcerative colitis (UC). In the pivotal clinical trials of anti-TNF agents for the management of UC, the rates of clinical remission and clinical response in anti-TNF treated group were significantly higher than in the placebo group during induction and maintenance phase. Use of these agents reduces the risk of poor clinical outcomes including hospitalization,1 cumulative corticosteroid exposure,2 and early phase surgery in patients with UC.3 In addition, they also improve health related quality of life which is an important patient-reported outcome.4

Infliximab and adalimumab comprise the main part of anti-TNF agents; infliximab was first to be approved for the treatment of UC, followed by adalimumab in several years. Infliximab is administered by intravenous infusion in every 8 weeks after induction, while adalimumab is injected subcutaneously in every 2 weeks. Although both drugs are proved to be effective in controlling disease activity of moderate to severe UC, there remains a naïve question; which one is better? This question has never been answered because there is no head-to-head trial comparing these agents in terms of the efficacy and safety for patients with UC. Using data from pivotal studies of each drug, network meta-analysis has been performed to answer that question.5 However, this was criticized by indirect methodology as the results was calculated based on data against placebo, not each other drug.

In the current issue, Lee et al.6 reported data directly comparing treatment efficacy and long-term outcomes between infliximab and adalimumab in 113 biologic-naïve patients with moderate to severe UC. Patients with acute severe UC were excluded. This retrospective study showed that clinical remission and response rates at 8 and 52 weeks were comparable between infliximab and adalimumab (clinical remission 47% vs 56.7% [p=0.364] at 8 weeks, 39.8% vs 50% [p=0.331] at 52 weeks; clinical response 86.7% vs 76.7% [p=0.196] at 8 weeks, 72.3% vs 76.7% [p=0.642] at 52 weeks). They also found no difference between groups in poor outcomes including hospitalization, discontinuation of drug, corticosteroid prescription, and switching to another drug during median 26 months follow-up period although infliximab group showed marginally higher rate of UC-related hospitalization than adalimumab group (p=0.051). Despite the drawbacks of the study such as retrospective design, small sample size and inadequate measurement of endpoint (not using endoscopic parameters), the result of the study is meaningful as this is the first study to directly compare clinical remission and response rates between two drugs for UC patients in the routine clinical practice.

There are several real-world studies comparing various outcomes between infliximab and adalimumab in biologic-naïve patients with UC. A nationwide Danish cohort study showed a higher risk of hospitalization and serious infections in adalimumab compared with infliximab.7 The U.S. cohort study using an administrative claims database showed that infliximab users had lower corticosteroid use than adalimumab users while both groups had a similar risk of hospitalization and serious infections.8 A French single-center study reported that these two drugs showed comparable levels of persistence while the U.S. study found that adalimumab had the high persistence for 1 year after treatment compared with infliximab.9,10 The disparity among different studies might be attributed to various factors like different study design and distinct ethnicity of patients.

As phenotype of UC is different in various ethnic groups which may be linked to different genetic backgrounds, it is crucial to have data of specific drug efficacy in diverse populations. In line with this notion, the study by Lee et al. is clinically relevant in that it was conducted in Korea where inflammatory bowel disease incidence has been rapidly rising. The real-world study from other Asian countries is warranted to confirm the result of the current study.

Although the above question cannot be answered without head-to-head trial, infliximab and adalimumab seem to be equally effective for patients with moderate to severe UC. Therefore, these agents might be selected based on various factors like socioeconomic condition or patients’ preference.

Footnote


See “Comparison of Long-term Outcomes of Infliximab versus Adalimumab Treatment in Biologic-Naïve Patients with Ulcerative Colitis” by Yong Il Lee, et al. on page 232, Vol. 15, No. 2, 2021

CONFLICTS OF INTEREST


No potential conflict of interest relevant to this article was reported.

References

  1. Feagan BG, Sandborn WJ, Lazar A, et al. Adalimumab therapy is associated with reduced risk of hospitalization in patients with ulcerative colitis. Gastroenterology 2014;146:110-118.
    Pubmed CrossRef
  2. Targownik LE, Tennakoon A, Leung S, Lix LM, Singh H, Bernstein CN. Temporal trends in initiation of therapy with tumor necrosis factor antagonists for patients with inflammatory bowel disease: a population-based analysis. Clin Gastroenterol Hepatol 2017;15:1061-1070.
    Pubmed CrossRef
  3. Jenkinson PW, Plevris N, Lyons M, et al. Analysis of colectomy rates for ulcerative colitis in pre- and postbiological eras in Lothian, Scotland. Colorectal Dis. Epub 2020 Dec 21. https://doi.org/10.1111/codi.15491.
    Pubmed CrossRef
  4. LeBlanc K, Mosli MH, Parker CE, MacDonald JK. The impact of biological interventions for ulcerative colitis on health-related quality of life. Cochrane Database Syst Rev 2015;9:CD008655.
    Pubmed CrossRef
  5. Thorlund K, Druyts E, Mills EJ, Fedorak RN, Marshall JK. Adalimumab versus infliximab for the treatment of moderate to severe ulcerative colitis in adult patients naïve to anti-TNF therapy: an indirect treatment comparison meta-analysis. J Crohns Colitis 2014;8:571-581.
    Pubmed CrossRef
  6. Lee YI, Park Y, Park SJ, Kim TI, Kim WH, Cheon JH. Comparison of long-term outcomes of infliximab versus adalimumab treatment in biologic-naïve patients with ulcerative colitis. Gut Liver 2021;15:232-242.
    Pubmed CrossRef
  7. Singh S, Andersen NN, Andersson M, Loftus EV Jr, Jess T. Comparison of infliximab and adalimumab in biologic-naive patients with ulcerative colitis: a nationwide Danish cohort study. Clin Gastroenterol Hepatol 2017;15:1218-1225.
    Pubmed KoreaMed CrossRef
  8. Singh S, Heien HC, Sangaralingham LR, et al. Comparative effectiveness and safety of infliximab and adalimumab in patients with ulcerative colitis. Aliment Pharmacol Ther 2016;43:994-1003.
    Pubmed KoreaMed CrossRef
  9. Pouillon L, Baumann C, Rousseau H, et al. Treatment persistence of infliximab versus adalimumab in ulcerative colitis: a 16-year single-center experience. Inflamm Bowel Dis 2019;25:945-954.
    Pubmed CrossRef
  10. Chen C, Hartzema AG, Xiao H, et al. Real-world pattern of biologic use in patients with inflammatory bowel disease: treatment persistence, switching, and importance of concurrent immunosuppressive therapy. Inflamm Bowel Dis 2019;25:1417-1427.
    Pubmed CrossRef
Gut and Liver

Vol.15 No.3
May, 2021

pISSN 1976-2283
eISSN 2005-1212

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