CT-P13 In Patients Research Articles

Long-term follow up after switching from original infliximab to an infliximab biosimilar: real-world data.

Background:Several studies have reported positive efficacy outcomes for patients with inflammatory bowel disease treated with CT-P13, an infliximab biosimilar. Data from follow-up periods longer than 1 year are still scarce. Here, we assessed the long-term efficacy data, loss of response and safety after switching from infliximab to CT-P13 in patients with inflammatory bowel disease.Methods:This was a prospective single-center observational study involving patients with moderate-to-severe Crohn’s disease and ulcerative colitis switched from infliximab to CT-P13 treatment and reviewed up to 24 months. Efficacy and loss of response were measured using the Harvey–Bradshaw (HB) index and partial Mayo score for patients with Crohn’s disease and ulcerative colitis respectively. C-reactive protein, infliximab drug levels, adverse events and antidrug antibodies were also monitored throughout the study.Results:A total of 64 patients with Crohn’s disease and 36 patients with ulcerative colitis were included. Most of them (72%) remained on CT-P13. Overall, 28% of patients discontinued the therapy due to loss of response, adverse events or long-lasting clinical remission. Remission at 18 and 24 months occurred in 69.9% and 68.5% of patients, respectively. Dose increase was performed in 22% of patients, with remission being reached in 60% of them. HB index, partial Mayo score, C-reactive protein and infliximab drug levels did not show significant changes. Serious adverse events were reported in 14% of patients. Overall, two patients developed low levels of antidrug antibodies.Conclusions:Most of the patients switching from original infliximab were maintained on CT-P13 at 2 years of follow up with a good profile of efficacy and safety.

Infliximab biosimilar CT-P13 therapy in patients with Takayasu arteritis with low dose of glucocorticoids: a prospective single-arm study

To evaluate the efficacy and safety of infliximab biosimilar CT-P13 in patients with active Takayasu arteritis (TAK). In this single-center open-label trial, patients with active TAK received CT-P13 at a starting dose of 5 mg/kg at weeks 0, 2, 6, and then every 8 weeks up to week 46. They were followed up until week 54. From week 14 to week 46, patients with inadequate response received increased dose of CT-P13 by 1.5 mg/kg. Concomitant prednisolone was allowed ≤ 10 mg/day. The primary efficacy end point was the achievement of partial or complete remission at week 30. All patients underwent positron emission tomography–computed tomography (PET–CT) at baseline and week 30. Twelve patients with TAK received CT-P13; one patient with protocol violation was excluded from analysis. Nine (81.8%) patients had taken concomitant prednisolone with median dose of 5.0 mg/day. At week 30, three (27.3%) patients achieved complete remission and six (54.5%) patients achieved partial remission. Statistically significant improvements in modified Indian Takayasu Clinical Activity Score (ITAS2010), ITAS-A, and serum levels of erythrocyte sedimentation rate and C-reactive protein were seen at week 30 from baseline. PET parameters were significantly reduced from baseline to week 30, including maximum standardized uptake value, target-to-vein ratio, target-to-liver ratio, and PET Vascular Activity Score. There were no serious adverse events. Treatment with CT-P13 may lead to improvement in clinical, radiographic, and serological activities with lower glucocorticoid requirement in TAK.Trial registration number NCT02457585.

Does a mandatory non-medical switch from originator to biosimilar infliximab lead to increased use of outpatient healthcare resources? A register-based study in patients with inflammatory arthritis

ObjectivesNational Danish guidelines in May 2015 dictated a mandatory switch from originator infliximab (INX) to biosimilar CT-P13 in patients with inflammatory rheumatic disease. We investigated if this non-medical switch changed...

Serum concentrations after switching from originator infliximab to the biosimilar CT-P13 in patients with quiescent inflammatory bowel disease (SECURE): an open-label, multicentre, phase 4 non-inferiority trial

Biological treatment of chronic inflammatory diseases has improved patient outcomes but increased health-care costs. Switching patients from originator infliximab to a biosimilar can reduce costs, but prospective data about pharmacokinetics and potential immunogenicity are scarce. We aimed to show that infliximab serum concentrations with biosimilar CT-P13 are non-inferior to those with originator infliximab after switching from originator infliximab in patients with inflammatory bowel disease. SECURE was a prospective, open-label, interventional, non-inferiority, multicentre, phase 4 trial at 13 academic and non-academic sites in Belgium and the Netherlands. Eligible participants were aged 18 years or older, had ulcerative colitis or Crohn's disease, were in clinical remission, and were on continuous treatment with originator infliximab for more than 30 weeks. Patients were switched from originator infliximab to CT-P13 at a dose and infusion duration identical to those of originator infliximab (ie, ∼5 mg/kg every 7-9 weeks). Patients were followed up for 16 weeks after switching, with serum concentrations of infliximab measured at baseline (before the first dose of CT-P13), 8 weeks, and 16 weeks. The primary endpoint was serum concentrations of infliximab 16 weeks after switching, assessed separately in patients with ulcerative colitis and those with Crohn's disease in the per-protocol population, which included all patients with available serum concentrations and without major protocol violations. A non-inferiority margin of 15% was set (the null hypothesis was that the geometric mean of the ratio of serum infliximab concentrations at 16 weeks to those at baseline was 85% or less). Safety analyses were done in the safety population, which included participants who received at least one dose of CT-P13 and attended at least one safety assessment after that dose. This trial is registered at www.ClinicalTrialsRegister.eu, number 2014-004904-31, and is completed. Between June 5, 2015, and April 6, 2016, 120 consecutive patients with inflammatory bowel disease were recruited: 59 with ulcerative colitis and 61 with Crohn's disease. 46 patients with ulcerative colitis and 42 patients with Crohn's disease comprised the per-protocol population. The geometric mean ratio of serum infliximab concentrations at week 16 (CT-P13) compared with those at baseline (originator) was 110·1% (90% CI 96·0-126·3) in patients with ulcerative colitis and 107·6% (97·4-118·8) in those with Crohn's disease. In both cases, the lower bound of the 90% CI was higher than the prespecified non-inferiority margin of 85%. Six serious adverse events were reported in six patients. Only one of these adverse events, a perianal abscess, was judged to be related to study treatment. Switching to CT-P13 is safe and well tolerated in patients with inflammatory bowel disease in remission. Future trials should assess switching to CT-P13 in patients with active disease. Mundipharma.

P724 Unchanged infliximab serum concentrations after switching from the originator infliximab to the biosimilar CT-P13 in patients with quiescent inflammatory bowel disease: Results from a prospective study (SECURE)

P724 Unchanged infliximab serum concentrations after switching from the originator infliximab to the biosimilar CT-P13 in patients with quiescent inflammatory bowel disease: Results from a prospective study (SECURE)

P519 Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: Multicentre study at 12 months results

P519 Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: Multicentre study at 12 months results

Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 months

infliximab has changed the natural history of inflammatory bowel disease (IBD). The advent of biosimilar treatments such as CT-P13 will hopefully improve the availability of biological therapies. Data with regard to drug switching are currently limited. The objective of the study was to assess the effectiveness and safety of switching from the reference product (RP), infliximab, to CT-P13 in patients with IBD. this was a multicenter prospective observational study in patients with Crohn's disease (CD) and ulcerative colitis (UC). All patients had switched from infliximab RP (Remicade®) to CT-P13 treatment and were followed up for 12 months. The efficacy endpoint was the change in clinical remission assessed at 0 and 12 months, according to the Harvey-Bradshaw score and partial Mayo score for patients with CD and UC, respectively. Adverse events were monitored and recorded throughout the study. a total of 167 patients (116 CD/51 UC) were included; 88.8% (103/116) of patients with CD were in remission at the time of the drug switch and 69.7% were in remission at 12 months. The Harvey-Bradshaw (HB) score significantly changed at 12 months (p = 0.001); 84.3% (43/51) of patients with UC were in remission at the time of the drug switch and 76.7% were in remission at 12 months. No significant changes in the median partial Mayo score (p = 0.87) were observed at 12 months. Serious adverse events related to medication were reported in 12/167 (7.2%) cases. switching from infliximab RP to CT-P13 is safe and effective at 12 months. The loss of efficacy at 12 months was 15.7%.

A review on biosimilar infliximab, CT-P13, in the treatment of inflammatory bowel disease.

The introduction of biological agents has led to significant changes in the treatment of inflammatory bowel disease (IBD). The relatively high price of infliximab (IFX) and the expiration of the patents led to the introduction of biosimilar agents. CT-P13 was the first IFX biosimilar approved in the same indications as the reference product; however, the approval was based on randomized clinical trials conducted in patients with rheumatoid arthritis and ankylosing spondylitis. In the past 2-3years, new findings from prospective observational studies supported the short-, medium- and long-term clinical efficacy and safety of CT-P13 in patients with IBD. This review summarized the clinical use and efficacy of the first biosimilar IFX, CT-P13, in the treatment of IBD.

Efficacy of Infliximab Biosimilar for Induction and Maintenance Therapy in Inflammatory Bowel Disease After Switch From Drug Originator: A Meta-Analysis

Introduction: Few studies investigated the efficacy of infliximab (IFX) biosimilar (CT-P13) in inflammatory bowel disease (IBD), after switch from the originator drug. We aim to assess the efficacy of CT-P13 for induction or maintenance therapy in Crohn's disease (CD) and ulcerative colitis (UC) after switch from IFX. Methods: Searching the literature through May of 2017, we identified the studies which reported the results of the switch strategy. To assess the efficacy of CT-P13, we used a per-protocol analysis. Only, patients who were considered as treatment failure (loss or lack of response to CT-P13, or adverse events after switch), counted toward the efficacy analysis. Overall efficacy was defined as the percentage of patients who continued CT-P13 (improve or no change in the disease activity) at the end of the study follow-up. Maintenance efficacy was defined as maintaining remission at the end of the study follow-up, among patients in remission at the time of switch. A meta-analysis was performed to calculate the pooled estimate of overall and maintenance efficacy, using a random effect model with assessment of heterogeneity by I2 statistic. Results: 8 studies (7 prospective, 1 retrospective), comprising 594 IBD patients, were included in the final analysis. Studies' follow-up period ranged from 8 to 24 weeks. Meta-analysis of all studies showed that the pooled estimate of overall efficacy was 83.5% (confidence interval [CI]: 75-92%; P:0.30, I2:16.64) (Fig. 1A). Pooled estimate of maintenance efficacy (calculated in 5 studies) was 82.6% (CI: 73-93%; P:0.94, I2:0.00) (Fig. 1B). Pooled estimate of overall and maintenance efficacy of CT-P13 in patients with CD and UC are shown in Table 1. Overall efficacy of CT-P13 for CD and UC was reported in 5 studies. Pooled estimate of overall efficacy in CD vs UC was not different (odds ratio [OR]: 0.85; CI: 0.39-1.85; P:0.19, I2: 34.97) (Fig. 2A). Pooled estimate of maintenance efficacy in CD vs UC (3 studies) was not different (OR: 1.04; CI: 0.53-2.07; P:0.83, I2: 0.00) (Fig. 2B). Conclusion: Switch from IFX to CT-P13 is an efficacious strategy in IBD patients. This strategy is equally effective in CD and UC patients. Considering the cost-effectiveness, switch strategy is a viable option in management of IBD.Figure: Pooled estimate of overall (A) and maintenance (B) efficacy of CT-P13 in IBD patients.Figure: Pooled estimate of overall (A) and maintenance (B) efficacy of CT-P13 in CD vs. UC.Table: Table. Pooled estimate of overall and maintenance efficacy of CT-P13 in patients with CD and UC

Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results.

BackgroundBiological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options such as CT-P13 promises to improve the availability of biological therapy, yet real-world switching data are currently limited. Here, we assess the effectiveness and safety of switching to CT-P13 from infliximab reference product (RP) in patients with inflammatory bowel disease.Materials and methodsThis was a prospective single-center observational study in patients with moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). All patients were switched from infliximab RP (Remicade) to CT-P13 treatment and followed up for up to 12 months. The efficacy endpoint was the change in clinical response assessed at 3-monthly intervals, according to the Harvey–Bradshaw score and partial Mayo score for patients with CD and UC, respectively. C-reactive protein (CRP) was also measured. Adverse events were monitored and recorded throughout the study.ResultsA total of 98 patients with inflammatory bowel disease (67 CD/31 UC) were included. A total of 83.6% (56/67) of patients with CD were in remission at the time of the switch and 62.7% were in remission at 12 months. The Harvey–Bradshaw score showed a significant change at 12 months (P=0.007) but no significant change was observed in median CRP at this timepoint (P=0.364). A total of 80.6% (25/31) of patients with UC were in remission at the time of the switch and 65.3% (18/28) were in remission at 12 months. No significant changes in the median partial Mayo score (P=0.058) or CRP (P=0.329) were observed at 12 months. Serious adverse events related to medication were reported in 11 (11.2%) patients.ConclusionSwitching from infliximab RP to CT-P13 is efficacious and well tolerated in patients with CD or UC for up to 12 months.

250 - Unchanged Infliximab Serum Concentrations After Switching from the Originator Infliximab to the Biosimilar CT-P13 in Patients with Quiescent Crohn's Disease: A Prospective Study

250 - Unchanged Infliximab Serum Concentrations After Switching from the Originator Infliximab to the Biosimilar CT-P13 in Patients with Quiescent Crohn's Disease: A Prospective Study

The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar.

Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease. A prospective, multicenter, cohort study using a structured database. Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers; 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab. The mean follow-up was 4.3 ± 2.8 months, and the total follow-up time was 195 patient-years. After 2061 infusions, 66 serious adverse events were reported (12.1%), 38 (6.9%) of them were infusion-related reactions. The biosimilar had to be stopped in 29 (5.3%) cases for severe infusion reactions (8 naive, 19 previous exposed, and 2 switch), and in further 16 patients (2.9%) for other serious adverse events. Infusion reactions were significantly more frequent in patients pre-exposed to infliximab than to other anti-tumor necrosis factor alpha (incidence rate ratio = 2.82, 95% CI: 1.05-7.9). The efficacy of the biosimilar was evaluated in 434 patients who received treatment for at least 8 weeks, using time-to-event methods for censored observations: 35 patients were primary failures (8.1%). After further 8, 16, and 24 weeks, the efficacy estimations were 95.7%, 86.4%, and 73.7% for naive, 97.2%, 85.2%, and 62.2% for pre-exposed, and 94.5%, 90.8%, and 78.9% for switch, respectively (log-rank P = 0.64). Although no direct comparison was performed, preliminary data on efficacy and safety of CT-P13 were in line with those of infliximab.

P665 Unchanged infliximab serum concentrations after switching from the reference infliximab to the biosimilar CT-P13 in patients with quiescent Crohn's disease: a prospective study

P665 Unchanged infliximab serum concentrations after switching from the reference infliximab to the biosimilar CT-P13 in patients with quiescent Crohn's disease: a prospective study

Safety and efficacy of CT-P13 in Japanese patients with rheumatoid arthritis in an extension phase or after switching from infliximab

Objectives: This study aimed to evaluate the safety of CT-P13 in patients with rheumatoid arthritis (RA) during long-term treatment or after switching from innovator infliximab (IFX).Methods: Patients who completed 54 weeks of treatment in a phase I/II study (PI/II) received CT-P13 at an initial dose of 3 mg/kg at Week 62, with dose increases permitted up to 10 mg/kg. The primary endpoint was adverse event (AE) incidence.Results: Thirty-four of 38 patients in the maintenance group and 29 of 33 in the switch group reported at least one AE. Safety profiles in both groups were similar to those in PI/II. Eleven of 28 patients who were positive for anti-drug antibodies (ADA) at Week 62 discontinued the study before Week 110. Forty-one of 43 ADA-negative patients remained negative, and 10 of 28 ADA-positive patients became negative during the study. The mean DAS28 (ESR) at Week 134 was 3.166 in the maintenance group and 3.955 in the switch group.Conclusions: CT-P13 was well tolerated in patients who maintained the treatment after 54 weeks and in patients who switched to CT-P13 after 54 weeks of IFX treatment. The study also demonstrated a stable clinical efficacy of CT-P13 in RA patients.

Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study

ObjectivesTo assess the efficacy and safety of switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing CT-P13 in patients with rheumatoid arthritis (RA)...

FRI0421 A randomised, double-blind, parallel-group, phase 1 study comparing the pharmacokinetics, safety and efficacy of ct-p13 and infliximab in patients with active ankylosing spondylitis: 54 week results from the planetas study

BackgroundCT-P13 is a biosimilar product of infliximab (INX). Data up to week 30 has been reported at EULAR 2012.1ObjectivesTo assess the PK, efficacy and safety of CT-P13 in patients with...