Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab After One Year in a Prospective Nationwide Cohort

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

doi:10.1097/mib.0000000000001237

Cited by 46 publications

(43 citation statements)

References 27 publications

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“…Several studies have reported positive results on the efficacy of CT‐P13 and supported its use in the treatment of IBD, which is consistent with our results . A Norwegian prospective observational study showed that 79% of CD and 56% of UC patients achieved remission at week 14 .…”

Section: Discussionsupporting

confidence: 91%

“…Another Korean study reported that clinical response and remission rates were 95.5% and 77.3% at week 30, and 87.8% and 75.0% at week 54, respectively, in anti‐TNF‐naïve CD patients, and 91.3% and 47.8% at week 30, and 100.0% and 50.0% at week 54, respectively, in anti‐TNF‐naïve UC patients . Recently, a prospective, multicenter, nationwide cohort study documented that 49%, 53%, and 48% and 86%, 81%, and 65% of CD patients reached clinical remission and response by weeks 14, 30, and 54, respectively, while 56%, 41%, and 43% and 74%, 66%, and 50% of UC patients achieved clinical remission and response by weeks 14, 30, and 54, respectively . However, the sample size of previous studies was small and/or the follow‐up period was relatively short.…”

Section: Discussionmentioning

confidence: 99%

“…Several studies have reported positive results on the efficacy of CT-P13 and supported its use in the treatment of IBD, which is consistent with our results. 7,[16][17][18][19] A Norwegian prospective observational study showed that 79% of CD and 56% of UC patients achieved remission at week 14. 17 Another prospective study from Spain reported that clinical remission was reached in 66.7% and 50% of anti-TNF-naive CD and 44.4% and 66.7% of anti-TNF-naïve UC patients at months 3 and 6 of CT-P13 therapy.…”

Section: Discussionmentioning

confidence: 99%

“…To date, the clinical experiences and evidence using CT‐P13 therapy in IBD patients are still limited. Only a few studies have reported the clinical outcomes of CT‐P13 therapy in IBD, with relatively small sample sizes and short follow‐up periods . Although CT‐P13 has been used in clinical practice since 2012 for the treatment of CD and UC after marketing approval, to the best of our knowledge, long‐term clinical results beyond 1 year of CT‐P13 treatment in patients with IBD has not been reported.…”

Section: Introductionmentioning

confidence: 99%

“…Only a few studies have reported the clinical outcomes of CT-P13 therapy in IBD, with relatively small sample sizes and short follow-up periods. 7,[16][17][18][19] Although CT-P13 has been used in clinical practice since 2012 for the treatment of CD and UC after marketing approval, to the best of our knowledge, long-term clinical results beyond 1 year of CT-P13 treatment in patients with IBD has not been reported. Therefore, the current study aimed to evaluate the long-term efficacy and safety of CT-P13 treatment in a large, real-life cohort of IBD patients.…”

Section: Introductionmentioning

confidence: 99%

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Long‐term efficacy and safety of CT‐P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study

Kim

Lee

Hong

et al. 2019

J of Gastro and Hepatol

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Background and Aim A biosimilar of infliximab, CT‐P13 (Remsima®) has the potential to reduce treatment costs and enhance access to biological therapy for inflammatory bowel disease (IBD) patients. However, long‐term clinical data on its use for IBD treatment are currently sparse. We aimed to investigate the long‐term efficacy and safety of CT‐P13 therapy in a large, real‐life IBD cohort. Methods A total of 368 IBD patients (227 with Crohn's disease [CD] and 141 with ulcerative colitis [UC]) treated with CT‐P13 at 16 referral hospitals in Korea between July 2012 and December 2017 were retrospectively analyzed. Results The cumulative retention rates at years 1, 3, and 5 were 86.1%, 68.5%, and 58.7% and 69.7%, 46.0%, and 26.7% in anti‐tumor necrosis factor (TNF)‐naïve CD and UC patients, respectively. The clinical response and remission rates at week 14 and at years 1, 3, and 5 were 94.3%, 92.7%, 76.8%, and 17.6% and 78.6%, 82.4%, 72.2%, and 17.6% in anti‐TNF‐naïve CD and 85.6%, 80.0%, 55.2%, and 6.7% and 42.6%, 59.8%, 44.2%, and 6.7% in anti‐TNF‐naïve UC patients, respectively. Among patients who switched from the biologic originator to CT‐P13, the cumulative retention rates at years 1, 3, and 5 were 88.5%, 66.1%, and 44.8% in CD, and 73.9%, 42.5%, and 42.5% in UC patients, respectively. Significant improvements in disease activity scores were accompanied by marked reductions in inflammatory marker levels, and no unexpected adverse events including death or malignancy occurred during the study period. Conclusions Long‐term treatment with CT‐P13 is effective in inducing and maintaining disease improvement and is well‐tolerated in patients with IBD. CT‐P13 may be a promising treatment option for IBD.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%