Switching from Infliximab Originator to SB2 Biosimilar in Inflammatory Bowel Diseases: A Multicentric Prospective Real-Life Study

Abstract

Background: Current literature still lacks studies evaluating the effectiveness and safety of switching from Infliximab originator to SB2 biosimilar in Inflammatory Bowel Diseases (IBDs). We aimed to verify the ability of SB2 to maintain the clinical and biochemical response induced by originator after switching. As secondary outcome, we aimed to verify safety, tolerability and immunogenicity of SB2 biosimilar compared with its IFX originator. Methods: We prospectively enrolled all patients who switched from originator to SB2 at three Italian IBD Units from August 2018 to April 2020. We collected clinical and biochemical data at the time of switch (T0), and at the first (T1) and the second (T2) visits after switching (mean time from switching: 135 and 329 days, respectively). In addition, data regarding therapeutic drug monitoring at T0 and T1 were recorded. Results: Eighty-five IBD patients (28 with Ulcerative Colitis and 57 with Crohn’s Disease) were included in the study. At T1, we observed statistically significant modifications in clinical activity of disease (70 patients were in clinical remission at baseline and 60 at T1 p = 0.02), but not at T2 (p = 0.3). Fecal calprotectin values were not different both at T1 and T2 (both p = 0.9) as well as the rate of concomitant treatment with steroids (p = 0.2 and p = 0.1) or immunosuppressants (p = 0.1 and p = 1.0). Moreover, the need for therapeutic optimization from T0 to T1 and from T1 to T2 was found significant (both p = 0.01). No anti-drug antibodies were identified at T1, and no serious adverse events were recorded. Conclusions: Overall, our data show that most of the patients switching from Infliximab originator to SB2 maintain the clinical and biochemical remission for at least 1 year. Further data are necessary to understand the clinical implications of these findings in the long term.

Monitoring a Mandatory Nonmedical Switching Policy from Originator to Biosimilar Infliximab in Patients with Inflammatory Bowel Diseases: A Population-Based Cohort Study

“…The frequencies of visits to emergency departments and hospitalizations in switchers to biosimilar infliximab were comparable to or lower than those of continuers of the originator product [40,41,[52][53][54]. Concomitant medication use in switchers, including steroids, morphine, and immunosuppressants, was comparable to that of continuers [41,52,55]. Our study results were comparable to those of a previous study that found an increased frequency of visits to gastroenterologists-most likely to discuss the switch-in patients with IBDs who switched from originator to biosimilar infliximab [53].…”

Ulcerative colitis (K51), adults

“…Именно с этих позиций систематический обзор 90 исследований при разных иммуно-воспалительных заболеваниях 2018 года показал, что в подавляющем большинстве исследований не наблюдалось различий в безопасности, эффективности или иммуногенности между биоаналогами и соответствующими оригинальными препаратами, что свидетельствует о сохранении достаточного профиля польза-риск при переходе с оригинального препарата на биоаналог [217]. Реальная клиническая практика европейских стран и США демонстрирует сходную эффективность, безопасность и иммуногенность при переключении пациентов ВЗК с оригинального инфликсимаба на его биоаналоги [218][219][220][221][222]. Лишь в одном исследовании в 9,9% случаев фиксировали необходимость обратного переключения с биосимиляра на эталонный препарат вследствие нежелательных проявлений со стороны кожи, желудочно-кишечного тракта или из-за потери ответа на препарат.…”

The Rise of Anti-TNF Biosimilars: Guidelines, Real-World Evidence, and Challenges to Acceptance

“…in children with IBD (n=87). 31 Real-world data from Italy, 32 France, 33 the Netherlands, 34 Poland, 35 and the USA 36 published on switching from infliximab to an infliximab biosimilar in patients with IBD reported that biosimilars had a similar efficacy, safety, and immunogenicity profile to that of the reference product. [32][33][34][35][36] One study showed that 9.9% (75/758) of patients with IBD 'reverse switched' from a biosimilar back to the reference product.…”

“…31 Real-world data from Italy, 32 France, 33 the Netherlands, 34 Poland, 35 and the USA 36 published on switching from infliximab to an infliximab biosimilar in patients with IBD reported that biosimilars had a similar efficacy, safety, and immunogenicity profile to that of the reference product. [32][33][34][35][36] One study showed that 9.9% (75/758) of patients with IBD 'reverse switched' from a biosimilar back to the reference product. 34 The most commonly reported reasons for reverse switching were gastrointestinal symptoms (25.5%) and dermatological symptoms (21.8%), with 12.0% of patients reverse switching due to loss of treatment response.…”