Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort. Issue 8 (3rd August 2017)

• Record Type: Journal Article
• Authors: Bálint, Anita; Rutka, Mariann; Végh, Zsuzsanna; Kürti, Zsuzsanna; Gecse, Krisztina B.; Banai, János; Bene, László; Gasztonyi, Beáta; Kristóf, Tünde; Lakatos, László; Miheller, Pál; Palatka, Károly; Patai, Árpád; Salamon, Ágnes; Szamosi, Tamás; Szepes, Zoltán; Tóth, Gábor Tamás; Vincze, Áron; Bor, Renáta; Milassin, Ágnes; Fábián, Anna; Nagy, Ferenc; Kolar, Martin; Bortlik, Martin; Duricova, Dana; Hruba, Veronika; Lukas, Martin; Mitrova, Katarina; Malickova, Karin; Lukas, Milan; Lakatos, Péter L.; Molnár, Tamás; Farkas, Klaudia;
• Is Part Of: Expert opinion on drug safety. Volume 16:Issue 8(2017:Aug.)
• Page Start: 885
• Page End: 890
• Publication Date: 2017-08-03
• Subjects: Crohn's disease -- ulcerative colitis -- infliximab -- biosimilar -- CT-P13 -- infusion reaction; Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1080/14740338.2017.1323330
• Languages: English
• ISSNs: 1474-0338

Abstract

ABSTRACT: Background: Safety data of the 'real life' use of an infliximab biosimilar, CT-P13 in inflammatory bowel disease (IBD) are still lacking. Ouraim was to assess the frequency and characteristics of infusion reactions during CT-P13 therapy in 13 Hungarian and 1 Czech IBD centres. Methods: Clinical and safety data was registered at fixed appointments. Trough levels and anti-drug antibody (ADA) concentration were measured by ELISA. Association between demographic, clinical, laboratory parameters and infusion reaction rates were evaluated statistically. Results: Three hundred and eighty-four IBD patients were included. Twenty-eight Hungarian IBD patients (9.6%) developed infusion reaction during the treatment, 64.3% of them was previously exposed to anti TNF therapy. No infusion reaction occurred in the Czech population. CT-P13 therapy had to be stopped in 17 patients who developed infusion reaction and was switched to adalimumab in 12 patients. However in 39.3% of patients developing infusion reaction CT-P13 therapy was continued with the use of premedication. Cumulative ADA positivity rates were 8.7%, 19.3%, and 28.0% at weeks 0, 14, and 30. Previous anti-TNF-alpha exposure (30% vs. 3.1%, p < 0.001, OR 6.3 (2.7–14.6)) and ADA positivity (32.6% vs. 4.1%, p < 0.001, OR 19(5–73)) during the induction therapy were predictive factors for infusion reactions. Conclusions: Patients with previous exposure to anti-TNF-alpha and ADA positivity during the induction therapy were more likely to develop infusion reactions.