The efficacy and safety of biosimilar infliximab CT-P13 in IBD: a prospective, nationwide, observational cohort (Biosimilar infliximab in IBD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/9054
• EU PAS number:
  EUPAS9053
• Study ID:
  9054
• Official title and acronym:
  The efficacy and safety of biosimilar infliximab CT-P13 in IBD: a prospective, nationwide, observational cohort (Biosimilar infliximab in IBD)
• DARWIN EU® study:
  No
• Study countries:
  Hungary
• Study description:
  Biosimilars are biologic medicines that enter the market subsequent to an original reference product whose patent has expired. Biosimilar infliximab CT-P13 received EMA approval in 2013 and was granted marketing authorization for all of the indications of the reference product, based on parallel-group clinical trials in rheumatoid arthritis (RA) and ankylosing spondylitis. Therefore, inflammatory bowel diseases (IBD) are considered as extrapolated indications. Concerns have been expressed regarding extrapolated indications. The dosing is different in RA (3 mg/kg b.w.) and in rheumatologic diseases combination therapy is more frequently used, which may influence immunogenicity. As of May, 2014 the Hungarian National Health Fund only reimburses the biosimilar infliximab for new induction treatment in IBD. New induction is defined as no infliximab treatment in the previous 12 month, switch was not allowed. Data on the safety and efficacy of biosimilar infliximab in clinical practice in IBD is limited so far. Therefore, the aim of the present study was to conduct a prospective, nationwide, multicentre, observational cohort to examine the efficacy and safety of CT-P13 infliximab biosimilar in the induction and maintenance treatment of Crohn’s disease and ulcerative colitis. The primary endpoint of the study was early clinical remission at week 14. Secondary endpoints include early clinical response at week 14, steroid-free clinical remission at week 30, sustained clinical remission and response at week 54, early and sustained biochemical response at week 14 and week 54, mucosal healing at week 54 and safety. Consecutive IBD patients starting on infliximab biosimilar were prospectively enrolled and a standardized monitoring strategy was applied. Demographic data, medication history, clinical, laboratory and endoscopic/radiological imaging were collected. Infliximab trough and anti-drug antibodies were measured at regular intervals. Adverse events were registered.
• Study status:
  Ongoing

Research institution and networks

Institutions

Semmelweis University

Hungary

First Department of Internal Medicine

First Department of Internal Medicine, University of Szeged Szeged, Military Hospital – State Health Centre Budapest, First Department of Medicine, Peterfy Hospital, Budapest, Second Department of Medicine, Zala County Hospital Zalaegerszeg, Second Department of Medicine, B-A-Z County and University Teaching Hospital Miskolc, Department of Internal Medicine, Csolnoky Ferenc Regional Hospital Veszprem, Second Departement of Internal Medicine, Semmelweis University Budapest, Clinical Center Institute of Medicine, Department of Gastroenterology Debrecen, Department of Medicine and Gastroenterology, Markusovszky Hospital Szombathely, Department of Gastroenterology, Tolna County Teaching Hospital Szekszárd

Networks

Hungarian IBD Study Group

Study timelines

Date when funding contract was signed

Planned: 15/04/2014

Actual: 15/04/2014

Study start date

Planned: 01/05/2014

Actual: 12/05/2014

Date of final study report

Planned: 31/12/2016

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Kéry Pharma, National Health Fund

Regulatory

• Was the study required by a regulatory body?:
  No