Infliximab biosimilar CT-P13 is effective and safe in treating inflammatory bowel diseases: a real-life multicenter, observational study in Italian primary inflammatory bowel disease centers

Abstract

Background The purpose of this study was to assess the efficacy and safety of biosimilar infliximab (IFX) CT-P13 in treating outpatients with inflammatory bowel disease (IBD) in Italian primary gastroenterology centers. Methods Consecutive IBD outpatients who completed the induction treatment were evaluated retrospectively. Clinical activity was scored according to the Mayo score for ulcerative colitis (UC) and to the Harvey-Bradshaw Index (HBI) for Crohn’s disease (CD). The primary endpoint was the achievement of clinical remission (Mayo score ≤2 in UC and HBI ≤5 in CD). Secondary endpoints were clinical response to treatment, achievement of mucosal healing, and safety. Results One hundred forty-one patients (96 UC and 45 CD) were enrolled. Previous treatment with anti-tumor necrosis factor (TNF)α had been provided to 26% of UC patients and 28.9% of CD patients. Remission was achieved in 57.3% UC patients and in 75.6% CD patients during a median (interquartile range) follow up of 24 (6-24) months. Clinical response and mucosal healing were achieved in 87.5% and 75.0% of UC patients and in 84.4% and 84.2% of CD patients, respectively. By both univariate and multivariate analysis, age >40 years, presence of comorbidities, and naivety to anti-TNFα were significantly related to remission. Only one (0.7%) adverse event was reported in the CD group. Surgery was performed in 2.1% of UC patients and 6.7% of CD patients. Switching from IFX originator to biosimilar did not influence the maintenance of the clinical remission. Conclusion This study confirmed the long-term efficacy and safety of CT-P13 therapy in IBD, in both naïve patients and those switching from IFX originator.

Real-life burden of adverse reactions to biological therapy in inflammatory bowel disease: a single-centre prospective case series

“…The incidence of the ADRs in our case series have confirmed that the safety of IFX-Remsima is comparable to that of the originator, as previously reported [15]. Accordingly, VDZ seemed to display the better safety profile in our cohort, as demonstrated in other multicenter experience [16].…”

The Reality of Patient-Reported Outcomes of Health-Related Quality of Life in an Italian Cohort of Patients with Inflammatory Bowel Disease: Results from a Cross-Sectional Study

“…IBD represents a life-long disease which might require daily medication, frequent doctor's appointments, and possible hospitalizations or surgery in a considerable number of patients [2]. Furthermore, in light of increasing treatment options, the safety issue of short-and long-term biological treatment should not be underestimated [3]. Consequently, IBD has a negative impact on patients' physical and psychological well-being, social performance, and working capacity [4].…”

Post-Marketing Pooled Safety Analysis for CT-P13 Treatment of Patients with Immune-Mediated Inflammatory Diseases in Observational Cohort Studies

“…For CT-P13, uncommon AEs include infections, such as tuberculosis, and immune system disorders, such as serum sickness and anaphylactic reactions [5,7]. For inflammatory bowel disease (IBD), multiple studies enrolling over 100 patients investigated the safety of CT-P13 [12][13][14][15][16][17][18][19][20][21][22][23][24], likely reflecting the need for safety data in these indications, for which regulatory approval was based on extrapolation [25]. In contrast, few such studies have evaluated the safety profile of CT-P13 in patients with AS or RA [26][27][28][29], and data for PsA and Ps are lacking.…”

“…Regulatory approval of CT-P13 was supported by two randomised, double-blind studies that compared CT-P13 with reference infliximab in patients with RA (PLANETRA) and those with AS (PLANETAS) [10,11]. In the phase III PLANETRA study, CT-P13 had equivalent efficacy Previous Presentation Selected data from four of the contributing studies were reported in a poster (FRI0104) at the European League Against Rheumatism (EULAR) Annual Congress 2019 (12)(13)(14)(15) June; Madrid, Spain). Selected data for patients with inflammatory bowel disease were reported in a poster (P0422) at United European Gastroenterology (UEG) Week 2019 (19)(20)(21)(22)(23) October; Barcelona, Spain).…”