Comparison of Long-Term Outcomes of Infliximab versus Adalimumab Treatment in Biologic-Naïve Patients with Ulcerative Colitis

Lee, Yong Il; Park, Yehyun; Park, Soo Jung; Kim, Tae Il; Cheon, Jae Hee

doi:10.5009/gnl19433

Cited by 21 publications

(25 citation statements)

References 38 publications

(76 reference statements)

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Section: Head-to-head Comparisons Of Biologicals In Ibd Arising From Rwementioning

confidence: 99%

“…23 A recent small Korean study compared IFX and ADA among patients naive to TNF-α inhibitors, confirming no significant differences between the two groups in the rates of clinical remission and clinical response at 8 or 52 weeks. 24 Focusing on the comparison between ADA and GOL, the SN-IBD performed a comparative realworld study between the two biologicals. 25 Clinical benefit was reported in 79% of patients in the ADA group and 63% in the GOL group (p = 0.026) after 8 weeks, and in 67% in the ADA group and 47% in the GOL group (p = 0.008) at the end of follow-up.…”

Section: Comparisons Between Different Tnf-α Inhibitorsmentioning

confidence: 99%

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Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience

Macaluso

Maida²,

Grova

et al. 2021

Therap Adv Gastroenterol

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During past years, the increasing knowledge of molecular mechanisms of inflammatory bowel disease (IBD) have led to the development of several targeted biological therapies. This great expansion of available medical options has prompted the need for comparative data between drugs. For years, given that most randomized controlled trials (RCTs) were performed only versus placebo, this demand has clashed with the absence of head-to-head trials comparing two or more treatments. The quality of evidence coming from real-world experience was low overall, so it was extremely difficult to clarify the correct positioning of the biologicals inside the therapeutic algorithms for IBD. Fortunately, times are changing: head-to-head comparative RCTs have been conducted or are ongoing, and the methodological quality of real-world studies is gradually increasing, mainly thanks to a higher rate of application of statistical methods capable of reducing the selection bias, such as the propensity score. In this evolving scenario, the increasing number of comparative RCTs is providing high-quality data for a correct drug positioning in IBD. In parallel, real-world observational studies are supporting the data coming from RCTs, and covering those comparisons not performed in the RCT setting. We believe that there is moderate evidence already available to support clinicians in the correct choice between different biologicals, and data will certainly be more robust in the near future.

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Section: Head-to-head Comparisons Of Biologicals In Ibd Arising From Rwementioning

confidence: 99%

Section: Comparisons Between Different Tnf-α Inhibitorsmentioning

confidence: 99%

Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience

Macaluso

Maida²,

Grova

et al. 2021

Therap Adv Gastroenterol

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“…Recent studies have ascertained the effectiveness and safety of these new classes of medications in Asian patients. [11][12][13][14][15][16] Their different biologic mechanisms and, most importantly, side effects are not well-known because of their relatively short period of time since development. 16,17 Among them, golimumab belongs to a relatively new class of anti-TNF-α agents (a fully human antibody to TNF-α).…”

Section: Introductionmentioning

confidence: 99%

Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Multicenter, Prospective, Postmarketing Surveillance Study

Park

Kim

et al. 2021

Gut and Liver

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Background/Aims: Golimumab has been used for patients with ulcerative colitis (UC) since 2013. However, there is limited data on the effectiveness and safety of the real-world use of golimumab in Asian patients. Methods:This was a multicenter, prospective, observational study. We enrolled patients with moderate-to-severe UC who were administered subcutaneous golimumab at 46 medical centers between May 2014 and November 2019. The primary outcome was the effectiveness and safety of golimumab at week 22. Clinical outcomes and adverse events were assessed according to partial Mayo score at weeks 0, 2, 6, 14, and 22.Results: A total of 130 patients were included (mean age: 45.7±16.0 years). The clinical response/ remission rates at weeks 2, 6, 14, and 22 were 40.4%/22.9%, 56.0%/35.8%, 70.6%/49.5%, and 67.9%/48.6%, respectively. Based on full Mayo score at week 14, clinical response and remission rates were 84.2% and 39.5%, respectively. Mucosal healing rate was 65.8%. In multivariate analysis with logistic regression, longer disease duration was significantly associated with a higher clinical response rate (adjusted odds ratio [aOR], 1.136; 95% confidence interval [CI], 1.006 to 1.282; p=0.040 at week 6; aOR, 1.256; 95% CI, 1.049 to 1.503; p=0.013 at week 22). A higher baseline Mayo endoscopic subscore was significantly associated with a lower clinical response rate at week 6 (aOR, 0.248; 95% CI, 0.089 to 0.692; p=0.008). The incidence of adverse drug reactions was 4.6% (6/130, nine events). No serious unexpected adverse drug reactions or deaths were reported. Conclusions:Golimumab was effective and safe as an induction and maintenance treatment for Korean patients with moderate-to-severe UC.

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“…

We read with great interest the article by Lee et al 1 comparing the efficacy of infliximab and adalimumab for biologic-naïve patients with ulcerative colitis (UC). The authors emphasize the similar efficacy and long-term outcomes between these two antitumor necrosis factor (TNF) agents for biologic-naïve patients with moderate-to-severe UC.

…”

mentioning

confidence: 99%

“…15,16 Although efficacy data for anti-TNF agents in Asian IBD patients have been reported, [17][18][19][20][21][22] there has been a lack of comparative efficacy data for biologic agents used to treat IBD, especially for non-Caucasian populations. Realistically, head-to-head clinical trials comparing infliximab and adalimumab, so-called first-generation anti-TNFs, would not be feasible in the future; therefore, the real-world data garnered from studies like that conducted by Lee et al 1 are helpful for guiding optimal therapies for IBD patients in Korea. In addition to the findings of this study, we should consider other factors, such as patients' preferences, costs, and safety profiles, to optimize IBD care under a shared decision-making paradigm because one size does not fit all in this context.…”

mentioning

confidence: 99%

Infliximab versus Adalimumab: Can We Choose the Right One for the Right Patients with Ulcerative Colitis?

Park

Yang

2022

Gut and Liver

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We read with great interest the article by Lee et al. 1 comparing the efficacy of infliximab and adalimumab for biologic-naïve patients with ulcerative colitis (UC). The authors emphasize the similar efficacy and long-term outcomes between these two antitumor necrosis factor (TNF) agents for biologic-naïve patients with moderate-to-severe UC. In their retrospective study, the authors compared various outcomes, including clinical remission and response, hospitalization, discontinuation or switching of drugs, and rescue corticosteroid use, between biologic-naïve UC patients who received infliximab (n=83) and those who received adalimumab (n=30). During the median 26 months of follow-up, the above outcomes were comparable between infliximab and adalimumab users. However, there were differences between the two groups. At baseline, the Physician Global Assessment subscore of the Mayo score was significantly better in the adalimumab group (p=0.028), and the rates of UC-related hospitalization and corticosteroid use during follow-up seemed higher in the infliximab group, but these differences were not statistically significant (p=0.085 and p=0.082, respectively). Additionally, colectomies (n=2) were performed on only patients treated with infliximab, and the rates of adverse events seemed higher in the infliximab group than in the adalimumab group, although this difference was not statistically significant. With their article, Lee et al. fill the knowledge gap on the comparative efficacy of representative anti-TNF agents, i.e., infliximab and adalimumab, for UC among biologic-naïve patients, particularly Korean patients, for whom there are limited data on this topic.Although a head-to-head trial has not been performed to compare the efficacy of these two drugs directly, there have been several relevant observational studies conducted in Western countries. A recent study using a nationwide Danish cohort and a propensity score matching analysis reported a higher risk of hospitalization and serious infections among UC patients treated with adalimumab (n=104) than among those treated with infliximab (n=171). 2 Another population-based study from the United States addressing this issue showed no difference in all-cause and UC-related hospitalization between the infliximab (n=1112) and adalimumab (n=288) groups; however, adalimumab users may have had a higher risk of corticosteroid use and a lower rate of drug persistence. 3 In network meta-analyses, infliximab seemed superior to adalimumab in the induction or maintenance phase of UC treatment. [4][5][6] These studies reported that infliximab is slightly more efficacious than adalimumab, whereas the study by Lee et al. 1 seemed to favor adalimumab over infliximab. This discrepancy among studies comparing these two drugs for UC treatment could be partly due to the different study designs, the heterogeneity of the study populations, or adalimumab being relatively underdosed in Caucasian populations whose body weights are usually higher than those of Asian patients.

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Comparison of Long-Term Outcomes of Infliximab versus Adalimumab Treatment in Biologic-Naïve Patients with Ulcerative Colitis

Cited by 21 publications

References 38 publications

Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience

Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience

Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Multicenter, Prospective, Postmarketing Surveillance Study

Infliximab versus Adalimumab: Can We Choose the Right One for the Right Patients with Ulcerative Colitis?

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