***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND AND AIM The biosimilar of infliximab , CT-P13 , has recently been shown to be equivalent to infliximab in both efficacy and safety in the treatment of rheumatologic diseases . However , no data are available with respect to the drug 's efficacy in patients with inflammatory bowel disease ( IBD ) . We aim ed to assess the efficacy and safety of CT-P13 in IBD patients METHODS This was a retrospective multicenter study including both anti-tumor necrosis factor ( TNF ) naïve patients and patients who switched from the biologic originator to CT-P13 .  RESULTS In anti-TNF naïve Crohn 's disease ( CD ) patients ( n = 32 ) , clinical response and remission rates were 90.6 % and 68.8 % at week 2 , 90.6 % and 84.4 % at week 8 , 95.5 % and 77.3 % at week 30 , and 87.5 % and 75.0 % at week 54 , respectively . In anti-TNF naïve ulcerative colitis ( UC ) patients ( n = 42 ) , clinical response and remission rates were 76.2 % and 19.0 % at week 2 , 81.0 % and 38.1 % at week 8 , 91.3 % and 47.8 % at week 30 , and 100 % and 50.0 % at week 54 , respectively , while mucosal healing rates were 58.3 % at week 8 , 66.7 % at week 30 , and 66.7 % at week 54 . The efficacy of CT-P13 was maintained in 92.6 % ( 25/27 ) of CD patients and in 66.7 % ( 6/9 ) of UC patients after switching from its originator . Adverse events related to CT-P13 occurred in 11.8 % of UC patients . CONCLUSIONS CT-P13 appears to have comparable efficacy , safety , and interchangeability with its originator in the treatment of IBD . Further prospect i ve studies with long-term follow-up periods will be needed to confirm the biosimilarity of CT-P13 Background CT-P13 ( Remsima ® , Inflectra ® ) is a biosimilar of the infliximab reference product ( RP ; Remicade ® ) . The aim of this study was to compare the 54-week efficacy , immunogenicity , safety , pharmacokinetics ( PK ) and pharmacodynamics ( PD ) of CT-P13 and RP in patients with active rheumatoid arthritis ( RA ) . Methods In this multinational phase III double-blind study , patients with active RA and an inadequate response to methotrexate ( MTX ) were r and omized ( 1:1 ) to receive CT-P13 ( 3 mg/kg ) or RP ( 3 mg/kg ) at weeks 0 , 2 , 6 and then every 8 weeks to week 54 in combination with MTX ( 12.5–25 mg/week ) . Efficacy endpoints included American College of Rheumatology (ACR)20 , ACR50 and ACR70 response rates , Disease Activity Score in 28 joints ( DAS28 ) , Simplified Disease Activity Index ( SDAI ) , Clinical Disease Activity Index ( CDAI ) , European League Against Rheumatism ( EULAR ) response rates , patient-reported outcomes and joint damage progression . Immunogenicity , safety and PK/PD outcomes were also assessed . Results Of 606 r and omized patients , 455 ( CT-P13 233 , RP 222 ) were treated up to week 54 . At week 54 , ACR20 response rate was highly similar between groups ( CT-P13 74.7 % , RP 71.3 % ) . ACR50 and ACR70 response rates were also comparable between groups ( CT-P13 43.6 % and 21.3 % , respectively ; RP 43.1 % and 19.9 % , respectively ) . DAS28 , SDAI and CDAI decreased from baseline to week 54 to a similar extent with CT-P13  and RP . Radiographic progression measured by Sharp scores as modified by van der Heijde was also comparable . With both treatments , patient assessment s of pain , disease activity and physical ability , as well as mean scores on the Medical Outcomes Study Short Form Health Survey ( SF-36 ) , improved markedly at week 14 and remained stable thereafter up to week 54 . The proportion of patients positive for antidrug antibodies at week 54 was similar between the two groups : 41.1 % and 36.0 % with CT-P13 and RP , respectively . CT-P13 was well tolerated and had a similar safety profile to RP . PK/PD results were also comparable between CT-P13 and RP . Conclusions CT-P13 and RP were comparable in terms of efficacy ( including radiographic progression ) , immunogenicity and PK/PD up to week 54 . The safety profile of CT-P13 was also similar to that of RP.Trial registration Clinical Trials.gov identifier : NCT01217086 . Registered 4 Oct 2010 Background CT-P13 is the first biosimilar monoclonal antibody to infliximab . However , the antibody was tested only in rheumatoid arthritis and ankylosing spondylitis , which demonstrated equivalence to the originator in efficacy , safety , and pharmacokinetic profile . Extrapolation of its efficacy and safety to other pathologies is tenuous . Interchangeability with its originator is another unclear area . Aim We aim ed to describe the experience of CT-P13 use in inflammatory bowel disease at a tertiary center . Methods Seventeen subjects diagnosed with Crohn ’s disease ( CD , n = 8) or ulcerative colitis ( UC , n = 9 ) who were administered CT-P13 from November 2012 to October 2013 at Dongguk University Ilsan Hospital were retrospectively enrolled . Medical records analyzed included patients ’ characteristics , previous history of anti-tumor necrosis factor administration , response and remission to this biosimilar antibody , disease flare-up , and adverse drug reaction . Results Male – female ratio was 1.8 . Mean age was 35.4 years ( range 15–57 ) . Mean number of CT-P13 administrations was 4.2 ± 1.9 . Induction treatments were done in five UC and three CD patients . Clinical response and remission at 8 weeks were achieved in seven patients ( five UC and two CD ) . One CD patient did not respond to CT-P13 . Nine patients in maintenance with the originator were interchanged with CT-P13 ( four UC and five CD patients ) . One UC patient experienced arthralgia  and CT-P13 was discontinued . One patient experienced loss of response during the study period . Conclusions CT-P13 may have biosimilarity and interchangeability with its originator in inflammatory bowel disease . A large , r and omized , double-blind , prospect i ve study is needed BACKGROUND AND AIMS The biosimilar of Remicade ® , CT-P13 , recently entered the European market . Clinical data on switching from Remicade ® to CT-P13 in inflammatory bowel disease [ IBD ] are scarce . We aim ed to prospect ively investigate efficacy , safety , pharmacokinetic profile , and immunogenicity following a switch from Remicade ® to CT-P13 in IBD patients . METHODS  Remicade ® -treated IBD patients at the Radboud university medical centre who switched to CT-P13 were included in this prospect i ve observational cohort study . Primary endpoint was change in Harvey-Bradshaw Index for Crohn 's disease [ CD ] and Simple Clinical Colitis Activity Index for ulcerative colitis [ UC ] at week 16 . We measured C-reactive protein [ CRP ] , faecal calprotectin [ FCP ] , infliximab trough level [ TL ] and anti-drug antibodies [ ADAs ] and documented adverse events . RESULTS Our cohort consisted of 83 patients ( 28 males , 57 CD , 24 UC , 2 IBD-unclassified [ IBD-U ] ) . The median age was 36 years , range 18 - 79 . Median change in disease activity was 0 [ range -23 to + 7 ] for CD and 0 [ range -3 to + 6 ] for UC/IBD-U. Median CRP and FCP levels did not change significantly during follow-up . Median TL increased from 3.5 µg/ml [ range 0 - 18 ] to 4.2 µg/ml [ range 0 - 21 ] at week 16 [ p = 0.010 ] . Two patients developed a new detectable ADA response during follow-up and five patients discontinued CT-P13 . No serious adverse events occurred . CONCLUSIONS We demonstrated that switching from Remicade ® to CT-P13 in a real-life cohort of IBD patients did not have a significant impact on short-term clinical outcomes . These results suggest that switching from Remicade ® to CT-P13 for the treatment of IBD is feasible 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 prospect i ve observational study provides evidence of the effectiveness of CT-P13 in IBD Background The ability of serum infliximab level to predict clinical outcome in infliximab therapy in Crohn ’s disease is unclear . Here , we aim ed to clarify the correlation between the timing of loss of response ( LOR ) to treatment and a decrease in serum  infliximab level , and , in addition , to identify an indicator of infliximab level . Methods The study used data from a previous clinical study of infliximab for Crohn ’s disease , in which infliximab was initially given at 0 , 2 , 6 weeks at 5 mg/kg , and then at 8-week intervals to 62 week-10 responders . Of these 62 , here we analysed data from 57 in whom Crohn ’s disease activity index and serum infliximab level were evaluated at week 14 . Results Twelve patients showed a clinical response despite an infliximab level < 1 μg/mL at week 14 ; of these , 8 ( 67 % ) experienced LOR by week 54 . A decrease in infliximab level preceded LOR in 6 ( 75 % ) . In receiver operating characteristic curve analysis , C-reactive protein ( CRP ) showed better performance in detecting  an infliximab level < 1 μg/mL. Infliximab level was < 1 μg/mL in 60–80 % of patients with CRP > 0.5 mg/dL. Time to LOR ( median : 22.0 weeks ) was significantly longer than that to a decrease  in infliximab level to < 1 μg/mL ( 14.0 weeks , p < 0.05 ) or to an increase in CRP to > 0.5 mg/dL ( 14.0 weeks , p < 0.01 ) . Conclusions A decrease in serum infliximab level preceded LOR , and was easily detected by an increase in CRP . The CRP may be an indicator  of serum infliximab level in predicting LOR BACKGROUND AND AIMS The growing incidence of inflammatory bowel disease ( IBD ) in children necessitates the use of biological treatments . Recently , an infliximab biosimilar was authorized in the European Union , which may result in switching patients . We present our preliminary experiences with such switches . METHODS The prospect i ve study included 32 paediatric patients diagnosed with Crohn 's disease ( CD ) and 7 children with ulcerative colitis ( UC ) at 3 academic hospitals , who were 
    Output:
    
CONCLUSIONS CT-P13 was associated with excellent clinical efficacy and safety profile , supporting its use in the treatment of IBD