Home / Biosimilars / Research / Switching from reference infliximab to CT P13 in IBD patients

Switching from reference infliximab to CT P13 in IBD patients Posted 01/12/2017

Argüelles-Arias and colleagues from the Hospital Universitario Virgen Macarena and the University of Seville in Spain carried out an observational study assessing the efficacy and safety of switching from Remicade to CT P13 in patients with inflammatory bowel disease (IBD) for up to 12 months [1].

A prospective observational study was conducted at the Hospital Universitario Virgen Macarena, Seville, Spain, from March 2015 to February 2016 in patients with moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). All patients were switched from reference infliximab (Remicade) to CT‑P13 treatment and followed for up to 12 months. The efficacy endpoint was the change in clinical response assessed at 3-monthly intervals, according to the Harvey-Bradshaw (HB) score and partial Mayo score for patients with CD and UC, respectively.

A total of 98 patients with IBD (67 with CD and 31 with UC) were included in the study. In CD patients according to Montreal Classification:  A2 73.1%, L2 38.8%, L3 31.3%, B1 56.7%, were B1, and 55.2% had perineal disease. In CU 41.9% were E1, and 51.6% were S2.

At the start of the study, 83.6% (56/67) of patients with CD were in remission. After patients were switched from reference infliximab to CT‑P13, 79.1% (53/67), 76.1% (51/67), 71.6% (48/67) and 62.7% (42/67) of CD patients were in remission at 3, 6, 9, and 12 months, respectively, see Figure 1. In total, 91.0% (61/67) of patients with CD completed 12 months of follow-up. The HB score showed significant changes over the 12-month period [median HB score (95% CI): 1 (1–2); 1 (1–3); 1 (1–3); 2 (1–2); 1 (1–3) at months 0, 3, 6, 9, and 12, respectively; p <0.001]. No significant changes in median C‑reactive protein (CRP) levels were observed in patients with CD over the same period (p = 0.364).

At the start of the study, 80.6% (25/31) of patients with UC were in remission. After patients were switched from reference infliximab to CT‑P13, 77.4% (24/31), 75.9% (22/29), 69.0% (20/29) and 64.3% (18/28) of patients were in remission at 3, 6, 9, and 12 months, respectively, see Figure 2. In total, 80.6% (25/31) of patients with UC completed 12 months of follow-up. Of the six patients with UC who were not in remission at the time of the switch, only one patient reached remission at 3, 6, 9, and 12 months.

No significant changes in the median (95% CI) partial Mayo score were observed in switched patients over the 12 months (2 (1–3); 1 (1–3); 1 (0–9); 1 (0–4); 1 (0–3) at 0, 3, 6, 9, and 12 months, respectively; p = 0.058). No significant changes in the median CRP level (95% CI) were observed over the same period (p = 0.329).

In total 12 patients (CD 6, CU 6) were withdraw from the study. In total, 11 AEs occurred in 11/98 (11.2%) patients: one skin reaction, one case of abdominal pain, two cases of headache and two of paresthesia during infusion, one case of Sweet’s syndrome, two of polyarthralgia, and two of palpitations. Six patients discontinued treatment because of AEs. Two AEs were considered to be serious: one patient with CD who had Sweet’s syndrome needed hospitalization and discontinued treatment. In addition, one patient with UC discontinued because of paresthesia during the infusion.

The results indicate, according to the authors, that ‘CT‑P13 treatment is effective and safe for up to one year in patients switched from [reference] infliximab’. At 12 months, remission was maintained in 69.8% (37/53) of patients with CD and 81.0% (17/21) of patients with UC. Thus, disease worsening occurred in 30.2% and 19.0% of patients with CD and UC who were in remission at study commencement, respectively. Among CD patients, HB score was significantly altered between baseline and months 9 and 12, yet despite these changes, the median overall score did not disagree with the classification of remission (≤ 4). No significant changes in median partial Mayo score were observed in UC patients and CRP levels remained unchanged in both groups.

A review by Gisbert [2] et al. found that 37% of patients with CD lost their response to infliximab and calculated that the annual risk for this loss to be 13% per patient/year. In the ACT I and II trials, approximately 45% of patients with UC had a sustained response to infliximab at Week 54, meaning that 55% of patients lost their response during the year. The authors point out that the results of the current study support these previous findings.

The authors also point out that the study has some limitations. First of all, and perhaps most importantly, as an observational study of the long-term efficacy and safety of switching from reference infliximab to CT‑P13 in patients with IBD, the study demonstrates the long-term outcomes of these patients, but does not enable comment to be made on the comparative efficacy compared with patients who did not switch. The authors were also unable to measure mucosal healing or fecal calprotectin as a biomarker of relapse in patients with IBD.

The authors concluded that ‘this study provides valuable data on the long-term efficacy of CT‑P13 maintenance treatment after switching from [reference] infliximab, and demonstrates effectiveness and safety at 12 months’.

Conflict of interest
Several of the authors of the research paper [1] reported conflict of interest, including having received honoraria from Sandoz for speaking at educational events, congress presentations and attending advisory boards.For full details of the authors’ conflict of interest, see the research paper [1].

Abstracted by Maria Fernanda Guerra Veloz, Department of Gastroenterology,Hospital Universitario Virgen Macarena, Seville, Spain.

Related article
Switching to biosimilar infliximab in IBD patients

References
1. Argüelles-Arias F, Guerra Veloz MF, Perea Amarillo R, Vilches-Arenas A, Castro Laria L, Maldonado Pérez B, et al. Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results. Eur J Gastroenterol Hepatol. 2017;29(11):1290-5.
2. Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn’s disease: a review. Am J Gastroenterol. 2009;104(3):760‑7.

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2017 Pro Pharma Communications International. All Rights Reserved.

Comments (0)

Generics News Research General

more

Biosimilars News Research General

more