Clinical monitoring: infliximab biosimilar CT-P13 in the treatment of Crohn’s disease and ulcerative colitis

Abstract

Objective: The infliximab biosimilar CT-P13 (Remsima®, Inflectra®) was approved in Europe for the treatment of inflammatory bowel disease (IBD) based on extrapolation of data from patients with rheumatic disease. Because there are limited published reports on clinical outcomes for IBD patients treated with CT-P13, we monitored responses to induction treatment with this biosimilar in patients with Crohn’s disease (CD) or ulcerative colitis (UC) in centres across the Czech Republic. Material and methods: Fifty-two patients with CD (n = 30) or UC (n = 22) were treated with 5 mg/kg CT-P13 for up to 14 weeks. Effectiveness of therapy was evaluated with the Crohn’s Disease Activity Index (CDAI) or the Mayo Scoring System (MSS) in patients with CD or UC, respectively, before and after 14 weeks. Additional goals were to evaluate weight changes, serum C-reactive protein (CRP) levels, and complications/adverse events. Results: In patients with CD, remission (CDAI <150) was achieved in 50.0% of cases, and partial response (≥70-point decrease in CDAI score from baseline) in the remaining 50.0%. In patients with UC, remission (total score on partial Mayo index ≤2 points) was achieved in 40.9% of cases, partial response (≥2-point decrease in partial Mayo score from baseline) in 54.5%, and no response in 4.5%. There were statistically significant improvements in CDAI, MSS and CRP serum levels after 14 weeks of therapy, and body weight increased. Four adverse events were identified (n = 1 each): lower-extremity phlebothrombosis, herpes labialis, pneumonia and allergic reaction. Conclusions: This prospective observational study provides evidence of the effectiveness of CT-P13 in IBD.

Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn’s disease and ulcerative colitis – experiences from a single center

“…After the initial concerns about the extrapolation of clinical data from rheumatic indications to IBD, some paper has published on the efficacy and safety of CT-P13 in IBD patients. The increasing data on the comparable efficacy and safety profile may further decrease the fear of using biosimilar IFX routinely [3,[12][13][14].…”

The Role of Infliximab Biosimilar CT-P13 in Inflammatory Bowel Disease

“…20 In a study by Keil et al, the median CRP levels were found to have decreased from 28 mg/L in men and 11 mg/L in women to 1 mg/L in men and 5 mg/L in women (p = 0.011). 13 Jung et al demonstrated that CRP levels decreased from 2.22 mg/L at baseline to 0.56 mg/L at 30 weeks for the treatment-naïve CD patients and from 1.89 mg/L at baseline to 0.51 mg/L at 30 weeks for the treatment-naïve UC patients. 15 Also, they reported a decrease in erythrocyte sedimentation rate (ESR) from 44 and 27 to 22 and 17 in the CD and UC patients respectively.…”

“…11 In the study by Keil et al, however, a total of 4 complications were identified during the CT-P13 therapy course, represented by pneumonia in 1 patient, herpes labialis in 1 patient, venous thrombosis in 1 patient and allergic reaction in 1 patient. 13 Park et al described 1 case of tuberculosis, 9 cases (5.2%) of infection and 9 cases (5.2%) of infusion-related reaction. 12 Jahnsen et al reported a variety of adverse events, including infusion reaction, skin rash, campylobacter enterocolitis, herpes zoster, herpes simplex, arthralgia and fatigue, pneumonia, erysipelas, elevated transaminases, palpitations and colectomy; with the exception of infusion reaction, which occurred in 2 patients, all other adverse events occurred in one patient each.…”

“…Gecse et al enrolled 13 All patients in the CD group achieved remission or clinical response in 14 weeks, whereas for the patients with UC, only 9 achieved remission and 12 achieved partial response to therapy.…”

Real-Life Efficacy, Immunogenicity and Safety of Biosimilar Infliximab

“…In the Czech study by Keil et al [13], 52 IBD patients received biosimilar IFX treatment. Efficacy and safety were evaluated at week 14: in CD, 50% of the patients achieved clinical remission and 50% achieved partial response.…”