PMID- 31259042
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 2155-6660 (Print)
IS  - 2155-6660 (Electronic)
IS  - 2155-6660 (Linking)
VI  - 8
IP  - 1
DP  - 2019
TI  - Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting 
      in patients with Crohn's disease or ulcerative colitis.
PG  - 129-134
LID - 10.1080/21556660.2019.1626735 [doi]
AB  - Objective: To assess the effectiveness and safety of biosimilar infliximab 
      (CT-P13) in a real-life setting in adults with moderate-to-severe active Crohn's 
      disease (CD) or ulcerative colitis (UC). Methods: This multi-centre, 
      observational cohort study was conducted at medical centres in Romania, Czech 
      Republic, and Bulgaria. Effectiveness was measured using the Crohn's Disease 
      Activity Index (CDAI) for CD or partial Clinical Activity Index (pCAI) for UC. 
      Quality-of-life (QoL) was measured using the Short Inflammatory Bowel Disease 
      Questionnaire (SIBDQ). Safety was assessed according to treatment withdrawals and 
      adverse events (AEs) monitoring. Analyses were performed in the safety population 
      and were reported based on the observed case (OC) or last observation carried 
      forward (LOCF) method. Results: Altogether, 85 patients with CD (n = 38) or UC 
      (n = 47) received biosimilar infliximab for up to 30 weeks. Most patients 
      (n = 68; 80.0%) had no prior exposure to infliximab. At the end of treatment, 
      65.8% (95% CI = 49.8-78.9) of CD patients and 55.3% (95% CI = 41.2-68.6) of UC 
      patients showed a clinical response, and 47.4% (95% CI = 32.5-62.7) and 48.9% 
      (95% CI = 35.3-62.8), respectively, were in remission. Statistically significant 
      (p < 0.0001) improvements from baseline were observed in CDAI and pCAI scores 
      (both LOCF). In the combined CD and UC population, SIBDQ was significantly 
      improved (p < 0.0001) from baseline to end of treatment (OC). Two AEs (moderately 
      severe infusion reactions) were judged by investigators to be definitely related 
      to treatment, one of which led to treatment withdrawal. Conclusion: Results align 
      with those of previous studies demonstrating the effectiveness and safety of 
      biosimilar infliximab in CD and UC.
FAU - Gheorghe, Cristian
AU  - Gheorghe C
AD  - Center of Gastroenterology and Hepatology, Fundeni Clinical Institute, Bucharest, 
      Romania.
FAU - Svoboda, Pavel
AU  - Svoboda P
AD  - University Hospital Ostrava, Ostrava, Czech Republic.
FAU - Mateescu, Bogdan
AU  - Mateescu B
AD  - Department of Gastroenterology, Colentina Clinical Hospital, Bucharest, Romania.
LA  - eng
PT  - Journal Article
DEP - 20190618
PL  - England
TA  - J Drug Assess
JT  - Journal of drug assessment
JID - 101672979
PMC - PMC6586088
OTO - NOTNLM
OT  - Biosimilar infliximab
OT  - CT-P13
OT  - Crohn's disease
OT  - quality-of-life
OT  - ulcerative colitis
EDAT- 2019/07/02 06:00
MHDA- 2019/07/02 06:01
PMCR- 2019/01/01
CRDT- 2019/07/02 06:00
PHST- 2019/01/17 00:00 [received]
PHST- 2019/05/20 00:00 [revised]
PHST- 2019/05/30 00:00 [accepted]
PHST- 2019/07/02 06:00 [entrez]
PHST- 2019/07/02 06:00 [pubmed]
PHST- 2019/07/02 06:01 [medline]
PHST- 2019/01/01 00:00 [pmc-release]
AID - 1626735 [pii]
AID - 10.1080/21556660.2019.1626735 [doi]
PST - epublish
SO  - J Drug Assess. 2019 Jun 18;8(1):129-134. doi: 10.1080/21556660.2019.1626735. 
      eCollection 2019.