human
***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: Objectives To compare the efficacy and safety of innovator infliximab ( INX ) and CT-P13 , an INX biosimilar , in active rheumatoid arthritis patients with inadequate response to methotrexate ( MTX ) treatment . Methods Phase III r and omised , double-blind , multicentre , multinational , parallel-group study . Patients with active disease despite MTX ( 12.5–25 mg/week ) were r and omised to receive 3 mg/kg of CT-P13 ( n=302 ) or INX ( n=304 ) with MTX and folic acid . The primary endpoint was the American College of Rheumatology 20 % ( ACR20 ) response at week 30 . Therapeutic equivalence of clinical response according to ACR20 criteria was concluded if the 95 % CI for the treatment difference was within ±15 % . Secondary endpoints included ACR response criteria , European League Against Rheumatism ( EULAR ) response criteria , change in Disease Activity Score 28 ( DAS28 ) , Medical Outcomes Study Short-Form Health Survey ( SF-36 ) , Simplified Disease Activity Index , Clinical Disease Activity Index , as well as pharmacokinetic ( PK ) and pharmacodynamic ( PD ) parameters , safety and immunogenicity . Results At week 30 , ACR20 responses were 60.9 % for CT-P13 and 58.6 % for INX ( 95 % CI −6 % to 10 % ) in the intention-to-treat population . The proportions in CT-P13 and INX groups achieving good or moderate EULAR responses ( C reactive protein ( CRP ) ) at week 30 were 85.8 % and 87.1 % , respectively . Low disease activity or remission according to DAS28–CRP , ACR – EULAR remission rates , ACR50/ACR70 responses and all other PK and PD endpoints were highly similar at week 30 . Incidence of drug-related adverse events ( 35.2 % vs 35.9 % ) and detection of antidrug antibodies ( 48.4 % vs 48.2 % ) were highly similar for CT-P13 and INX , respectively . Conclusions CT-P13 demonstrated equivalent efficacy to INX at week 30 , with a comparable PK profile and immunogenicity . CT-P13 was well tolerated , with a safety profile comparable with that of INX . Clinical Trials.gov Identifier Objectives To compare the pharmacokinetics ( PK ) , safety and efficacy of innovator infliximab ( INX ) and CT-P13 , a biosimilar to INX , in patients with active ankylosing spondylitis ( AS ) . Methods Phase 1 r and omised , double-blind , multicentre , multinational , parallel-group study . Patients were r and omised to receive 5 mg/kg of CT-P13 ( n=125 ) or INX ( n=125 ) . Primary endpoints were area under the concentration-time curve ( AUC ) at steady state and observed maximum steady state serum concentration ( Cmax , ss ) between weeks 22 and 30 . Additional PK , efficacy endpoints , including 20 % and 40 % improvement response according to Assessment in Ankylosing Spondylitis International Working Group criteria ( ASAS20 and ASAS40 ) , and safety outcomes were also assessed . Results Geometric mean AUC was 32 765.8 μgh/ml for CT-P13 and 31 359.3 μgh/ml for INX . Geometric mean Cmax , ss was 147.0 μg/ml for CT-P13 and 144.8 μg/ml for INX . The ratio of geometric means was 104.5 % ( 90 % CI 94 % to 116 % ) for AUC and 101.5 % ( 90 % CI 95 % to 109 % ) for Cmax , ss . ASAS20 and ASAS40 responses at week 30 were 70.5 % and 51.8 % for CT-P13 and 72.4 % and 47.4 % for INX , respectively . In the CT-P13 and INX groups more than one adverse event occurred in 64.8 % and 63.9 % of patients , infusion reactions occurred in 3.9 % and 4.9 % , active tuberculosis occurred in 1.6 % and 0.8 % , and 27.4 % and 22.5 % of patients tested positive for anti-drug antibodies , respectively . Conclusions The PK profiles of CT-P13 and INX were equivalent in patients with active AS . CT-P13 was well tolerated , with an efficacy and safety profile comparable to that of INX up to week 30 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 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 Background and Aims A biosimilar version of infliximab [ CT-P13/Remsima ® ] recently entered the European market . The clinical data on its use in inflammatory bowel disease [ IBD ] are sparse , especially on switching from the originator Remicade ® . In this study , we aim ed to prospect ively investigate the feasibility , safety and immunogenicity of switching from Remicade to Remsima in a real-life IBD population . Methods All adult patients who were treated with Remicade in the Department of Gastroenterology at Oslo University Hospital were switched to Remsima . The follow-up lasted for 6 months . In addition , a retrospective registration was performed with a start time of 6 months before switching drugs . The primary endpoints were [ i ] the proportion of patients remaining on medication 6 months after switching and [ ii ] adverse events during the 6 months after switching . The secondary endpoints included [ i ] disease activity scores [ Harvey-Bradshaw Index and Partial Mayo Score ] , C-reactive protein , haemoglobin , faecal calprotectin , infliximab dose and interval , and p-infliximab and [ ii ] the development of antidrug antibodies . Results In total , 143 IBD patients were switched , 99 with Crohn 's disease and 44 with ulcerative colitis . The large majority [ 97 % ] remained on the medication throughout follow-up . A low number of adverse events were observed . No change in disease activity , C-reactive protein , haemoglobin , faecal calprotectin , infliximab dose and interval or p-infliximab was detected . Three patients developed new detectable antidrug antibodies . Conclusions Switching from Remicade to Remsima was feasible and with few adverse events , including very limited antidrug antibody formation and loss of response 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 
    Output:
    
agent
***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: Objectives To compare the efficacy and safety of innovator infliximab ( INX ) and CT-P13 , an INX biosimilar , in active rheumatoid arthritis patients with inadequate response to methotrexate ( MTX ) treatment . Methods Phase III r and omised , double-blind , multicentre , multinational , parallel-group study . Patients with active disease despite MTX ( 12.5–25 mg/week ) were r and omised to receive 3 mg/kg of CT-P13 ( n=302 ) or INX ( n=304 ) with MTX and folic acid . The primary endpoint was the American College of Rheumatology 20 % ( ACR20 ) response at week 30 . Therapeutic equivalence of clinical response according to ACR20 criteria was concluded if the 95 % CI for the treatment difference was within ±15 % . Secondary endpoints included ACR response criteria , European League Against Rheumatism ( EULAR ) response criteria , change in Disease Activity Score 28 ( DAS28 ) , Medical Outcomes Study Short-Form Health Survey ( SF-36 ) , Simplified Disease Activity Index , Clinical Disease Activity Index , as well as pharmacokinetic ( PK ) and pharmacodynamic ( PD ) parameters , safety and immunogenicity . Results At week 30 , ACR20 responses were 60.9 % for CT-P13 and 58.6 % for INX ( 95 % CI −6 % to 10 % ) in the intention-to-treat population . The proportions in CT-P13 and INX groups achieving good or moderate EULAR responses ( C reactive protein ( CRP ) ) at week 30 were 85.8 % and 87.1 % , respectively . Low disease activity or remission according to DAS28–CRP , ACR – EULAR remission rates , ACR50/ACR70 responses and all other PK and PD endpoints were highly similar at week 30 . Incidence of drug-related adverse events ( 35.2 % vs 35.9 % ) and detection of antidrug antibodies ( 48.4 % vs 48.2 % ) were highly similar for CT-P13 and INX , respectively . Conclusions CT-P13 demonstrated equivalent efficacy to INX at week 30 , with a comparable PK profile and immunogenicity . CT-P13 was well tolerated , with a safety profile comparable with that of INX . Clinical Trials.gov Identifier Objectives To compare the pharmacokinetics ( PK ) , safety and efficacy of innovator infliximab ( INX ) and CT-P13 , a biosimilar to INX , in patients with active ankylosing spondylitis ( AS ) . Methods Phase 1 r and omised , double-blind , multicentre , multinational , parallel-group study . Patients were r and omised to receive 5 mg/kg of CT-P13 ( n=125 ) or INX ( n=125 ) . Primary endpoints were area under the concentration-time curve ( AUC ) at steady state and observed maximum steady state serum concentration ( Cmax , ss ) between weeks 22 and 30 . Additional PK , efficacy endpoints , including 20 % and 40 % improvement response according to Assessment in Ankylosing Spondylitis International Working Group criteria ( ASAS20 and ASAS40 ) , and safety outcomes were also assessed . Results Geometric mean AUC was 32 765.8 μgh/ml for CT-P13 and 31 359.3 μgh/ml for INX . Geometric mean Cmax , ss was 147.0 μg/ml for CT-P13 and 144.8 μg/ml for INX . The ratio of geometric means was 104.5 % ( 90 % CI 94 % to 116 % ) for AUC and 101.5 % ( 90 % CI 95 % to 109 % ) for Cmax , ss . ASAS20 and ASAS40 responses at week 30 were 70.5 % and 51.8 % for CT-P13 and 72.4 % and 47.4 % for INX , respectively . In the CT-P13 and INX groups more than one adverse event occurred in 64.8 % and 63.9 % of patients , infusion reactions occurred in 3.9 % and 4.9 % , active tuberculosis occurred in 1.6 % and 0.8 % , and 27.4 % and 22.5 % of patients tested positive for anti-drug antibodies , respectively . Conclusions The PK profiles of CT-P13 and INX were equivalent in patients with active AS . CT-P13 was well tolerated , with an efficacy and safety profile comparable to that of INX up to week 30 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 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 Background and Aims A biosimilar version of infliximab [ CT-P13/Remsima ® ] recently entered the European market . The clinical data on its use in inflammatory bowel disease [ IBD ] are sparse , especially on switching from the originator Remicade ® . In this study , we aim ed to prospect ively investigate the feasibility , safety and immunogenicity of switching from Remicade to Remsima in a real-life IBD population . Methods All adult patients who were treated with Remicade in the Department of Gastroenterology at Oslo University Hospital were switched to Remsima . The follow-up lasted for 6 months . In addition , a retrospective registration was performed with a start time of 6 months before switching drugs . The primary endpoints were [ i ] the proportion of patients remaining on medication 6 months after switching and [ ii ] adverse events during the 6 months after switching . The secondary endpoints included [ i ] disease activity scores [ Harvey-Bradshaw Index and Partial Mayo Score ] , C-reactive protein , haemoglobin , faecal calprotectin , infliximab dose and interval , and p-infliximab and [ ii ] the development of antidrug antibodies . Results In total , 143 IBD patients were switched , 99 with Crohn 's disease and 44 with ulcerative colitis . The large majority [ 97 % ] remained on the medication throughout follow-up . A low number of adverse events were observed . No change in disease activity , C-reactive protein , haemoglobin , faecal calprotectin , infliximab dose and interval or p-infliximab was detected . Three patients developed new detectable antidrug antibodies . Conclusions Switching from Remicade to Remsima was feasible and with few adverse events , including very limited antidrug antibody formation and loss of response 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 
    Output:
    