Loss of response and frequency of adverse events in patients with ulcerative colitis and Crohn’s disease when switching from the original infliximab to its biosimilars

Abstract

Aim. To define the frequency of adverse events and loss of the response in patients with ulcerative colitis (UC) and Crohns disease (CD), treated with original medicine infliximab (IFX) Remicaide and its biosimilars.
 Materials and methods. We included 154 patients with IBD: 78 UC patients (50.6%) и 76 CD patients (49.4%), treated with original medicine IFX Remicade and its biosimilars. In our study we did not include patients, who previously underwent induction treatment with IFX and its biosimilar.
 Results. Among 78 UC patients, IFX was cancelled in 25 (32.0%) patients and they were switched to the other anti-TNF inhibitor or medicine with the another mechanism of action; in patients group, treated with biosimilar 16 (20.5%) and 9 (11.5%) patients, who were interchanged biosimilar and/or original IFX. Among 76 CD patients IFX was cancelled in 20 (26.3%) patients: 11 (14.5%) patients in group, treated with similar trade name biosimilar, 8 (10.5%) patients, who were interchanged biosimilar and/or original IFX and 1 patient (1,3%), receiving original IFX. We found no difference in the secondary loss of response and adverse events in patients with CD and UC, switched from original IFX to biosimilar (p=0.6257 and p=0.6635, correspondingly). The frequency of the secondary loss of response or adverse events in patients with UC and CD, switched from original IFX to IFX biosimilar, was similar (p0.05).
 Conclusion. Approximately 30% of IBD patients, receiving IFX biosimilar, will be switched to the other anti-TNF therapy or medicine with the another mechanism of action because of secondary loss of response or adverse events.

Novel bispecific nanobody mitigates experimental intestinal inflammation in mice by targeting TNF‐α and IL‐23p19 bioactivities

“…The mean ± standard error of the mean was used to express the findings 69 . Software called GraphPad Prism 8.4.3 was used to analyse the data, and was calculated using a ordinary one‐way ANOVA (and Nonparametric or mix) 9 . Statistical significance was defined as a p ‐value < .05.…”

“…However, a significant proportion of Crohn's disease (CD) patients exhibit inadequate response to anti-TNF-α therapy, and a substantial percentage experiences secondary loss of response. [4][5][6][7][8][9] In patients refractory to anti-TNF-α treatment, a distinct subset of TNFR2 + IL23R + CD4 + T cells with heightened IL-23 receptor expression has been implicated in anti-TNF-α treatment molecular resistance in CD. 10 Notably, ustek-inumab (UST), an antibody that targets the p40 subunit shared by IL-12 and IL-23, has shown high rates of clinical remission in CD patients' refractory or intolerant to anti-TNF-α therapy.…”

“…These mAbs target membrane‐bound TNF‐α (mTNF‐α) on CD14 + macrophages and T cells in the intestinal mucosa, impeding the mTNF‐α‐TNFR2 co‐stimulatory pathway in CD4 + T cells, which results in apoptosis induction, suppression of inflammatory signal amplification and mitigation of intestinal mucosal damage instigated by inflammatory cytokines. However, a significant proportion of Crohn's disease (CD) patients exhibit inadequate response to anti‐TNF‐α therapy, and a substantial percentage experiences secondary loss of response 4–9 …”

“…However, a significant proportion of Crohn's disease (CD) patients exhibit inadequate response to anti‐TNF‐α therapy, and a substantial percentage experiences secondary loss of response. 4 , 5 , 6 , 7 , 8 , 9 …”

The effectiveness and safety of switching therapy with an original drug to biosimilars in treatment of inflammatory bowel diseases

“…Имеющиеся данные не сообщают о существенном их отличии [14,15] и большинство исследований подтверждают долгосрочную эффективность и безопасность терапии [16]. Эти данные противоречат результатам, полученным нашими соотечественниками, что при переходе на терапию биосимилярами у пациентов с ВЗК в 3 раза чаще регистрируется неэффективность терапии, по сравнению с пациентами, которые продолжают получать терапию оригинальным препаратом [17].…”