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

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Abstract

Aim. To define the frequency of adverse events and loss of the response in patients with ulcerative colitis (UC) and Crohn’s 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 (p>0.05).

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.

About the authors

O. V. Knyazev

Loginov Moscow Clinical Scientific Center; Ryzhyh State Scientific Centre of Coloproctology; Research Institute of Health Organization and Medical Management

Email: asfold@mail.ru
ORCID iD: 0000-0001-7250-0977

д.м.н., зав. отд-нием воспалительных заболеваний кишечника ГБУЗ «МКНЦ им. А.С. Логинова», проф. научно-образовательного отд. ФГБУ «НМИЦ колопроктологии им. А.Н. Рыжих», вед. специалист организационно-методического отд. по колопроктологии ГБУ «НИИ организации здравоохранения и медицинского менеджмента»

Russian Federation, Moscow; Moscow; Moscow

M. Yu. Zvyaglova

Loginov Moscow Clinical Scientific Center

Email: asfold@mail.ru
ORCID iD: 0000-0002-7937-2346

мл. науч. сотр. отд-ния воспалительных заболеваний кишечника ГБУЗ «МКНЦ им. А.С. Логинова»

Russian Federation, Moscow

A. V. Kagramanova

Loginov Moscow Clinical Scientific Center

Email: asfold@mail.ru
ORCID iD: 0000-0002-3818-6205

к.м.н., ст. науч. сотр. отд-ния воспалительных заболеваний кишечника ГБУЗ «МКНЦ им. А.С. Логинова»

Russian Federation, Moscow

I. A. Li

Loginov Moscow Clinical Scientific Center

Email: asfold@mail.ru
ORCID iD: 0000-0002-9508-7502

д.м.н., врач-гастроэнтеролог отд-ния воспалительных заболеваний кишечника ГБУЗ «МКНЦ им. А.С. Логинова»

Russian Federation, Moscow

E. A. Sabelnikova

Loginov Moscow Clinical Scientific Center

Email: asfold@mail.ru
ORCID iD: 0000-0001-7519-2041

д.м.н., ст. науч. сотр. отд-ния невоспалительной патологии кишечника, зам. дир. по научной работе

Russian Federation, Moscow

A. A. Lishchinskaya

Loginov Moscow Clinical Scientific Center

Email: asfold@mail.ru
ORCID iD: 0000-0001-7891-2702

к.м.н., ст. науч. сотр. отд-ния воспалительных заболеваний кишечника ГБУЗ «МКНЦ им. А.С. Логинова»

Russian Federation, Moscow

D. S. Kulakov

Loginov Moscow Clinical Scientific Center; Research Institute of Health Organization and Medical Management

Email: asfold@mail.ru
ORCID iD: 0000-0002-0855-5217

мл. науч. сотр. отд-ния воспалительных заболеваний кишечника ГБУЗ «МКНЦ им. А.С. Логинова», специалист организационно-методического отд. по колопроктологии ГБУ «НИИ организации здравоохранения и медицинского менеджмента»

Russian Federation, Moscow; Moscow

A. I. Parfenov

Loginov Moscow Clinical Scientific Center

Author for correspondence.
Email: asfold@mail.ru
ORCID iD: 0000-0002-9782-4860

д.м.н., проф., зав. отд. патологии кишечника ГБУЗ «МКНЦ им. А.С. Логинова»

Russian Federation, Moscow

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