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: BACKGROUND TNF inhibitors have improved treatment of Crohn 's disease , ulcerative colitis , spondyloarthritis , rheumatoid arthritis , psoriatic arthritis , and chronic plaque psoriasis , but are expensive therapies . The aim of NOR-SWITCH was to examine switching from originator infliximab to the less expensive biosimilar CT-P13 regarding efficacy , safety , and immunogenicity . METHODS The study is a r and omised , non-inferiority , double-blind , phase 4 trial with 52 weeks of follow-up . Adult patients on stable treatment with infliximab originator treated in a hospital setting for at least 6 months were eligible for participation . Patients with informed consent were r and omised in a 1:1 ratio to either continued infliximab originator or to switch to CT-P13 treatment , with unchanged dosing regimen . Data were collected at infusion visits in 40 Norwegian study centres . Patients , assessors , and patient care providers were masked to treatment allocation . The primary endpoint was disease worsening during 52-week follow-up .  394 patients in the primary per- protocol set were needed to show a non-inferiority margin of 15 % , assuming 30 % disease worsening in each group . This trial is registered with Clinical Trials.gov , number NCT02148640 . FINDINGS Between Oct 24 , 2014 , and July 8 , 2015 , 482 patients were enrolled and r and omised ( 241 to infliximab originator , 241 to CT-P13 group ; one patient was excluded from the full analysis and safety set for CT-P13 ) and 408 were included in the per- protocol set ( 202 in the infliximab originator group and 206 in the CT-P13 group ) . 155 ( 32 % ) patients in the full analysis set had Crohn 's disease , 93 ( 19 % ) had ulcerative colitis , 91 ( 19 % ) had spondyloarthritis , 77 ( 16 % ) had rheumatoid arthritis , 30 ( 6 % ) had psoriatic arthritis , and 35 ( 7 % ) had chronic plaque psoriasis . Disease worsening occurred in 53 ( 26 % ) patients in the infliximab originator group and 61 ( 30 % ) patients in the CT-P13 group ( per- protocol set ; adjusted treatment difference -4·4 % , 95 % CI -12·7 to 3·9 ) . The frequency of adverse events was similar between groups ( for serious adverse events , 24 [ 10 % ] for infliximab originator vs 21 [ 9 % ] for CT-P13 ; for overall adverse events , 168 [ 70 % ] vs 164 [ 68 % ] ; and for adverse events leading to discontinuation , nine [ 4 % ] vs eight [ 3 % ] , respectively ) . INTERPRETATION The NOR-SWITCH trial showed that switching from infliximab originator to CT-P13 was not inferior to continued treatment with infliximab originator according to a prespecified non-inferiority margin of 15 % . The study was not powered to show non-inferiority in individual diseases . FUNDING Norwegian Ministry of Health and Care Services Introduction : In most European countries , an infliximab biosimilar ( CT-P13 ) is currently in common use . In vitro and in vivo studies have proved a high similarity between CT-P13 and the reference infliximab . CT-P13 was licensed for use in patients with Crohn disease ( CD ) based on the extrapolation of data from pre clinical studies and clinical trials in rheumatology indications . The aim of this study was to assess the similarity between CT-P13 and the originator infliximab in induction therapy in CD paediatric patients . Methods : Thirty-six CD paediatric patients from 3 Polish academic centres who started biological therapy with CT-P13  were enrolled in this prospect i ve , observational study . Patients received 3 induction doses ( 5 mg/kg ) of CT-P13 at weeks 0 , 2 , 6 . Assessment was performed before the first infusion and at week 14 . Results : Overall 34/36 ( 94.4 % ) patients completed induction therapy with CT-P13 . A clinical response or remission after 3 initial doses was achieved in 31/36 ( 86 % ) and 24/36 ( 67 % ) of patients , respectively . Clinical ly and statistically significant decreases in Paediatric Crohn 's Disease Activity Index , C-reactive protein , and erythrocyte sedimentation rate were observed in the responders group . An allergic reaction during infusion , which led to treatment discontinuation , was observed in one case . Conclusions : Induction therapy with CT-P13 in children with CD is effective . The profile appears similar to that reported for the reference infliximab . No unexpected adverse events occurred Objectives ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab ; structural , functional and pharmacokinetic evaluations have shown that the two are highly similar . We report results from a phase III study comparing efficacy , safety and immunogenicity between ABP 501 and adalimumab . Methods In this r and omised , double-blind , active comparator-controlled , 26-week equivalence study , patients with moderate to severe active rheumatoid arthritis ( RA ) despite methotrexate were r and omised ( 1:1 ) to ABP 501 or adalimumab ( 40 mg ) every 2 weeks . Primary endpoint was risk ratio ( RR ) of ACR20 between groups at week 24 . Primary hypothesis that the treatments were equivalent would be confirmed if the 90 % CI for RR of ACR20 at week 24 fell between 0.738 and 1.355 , demonstrating that ABP 501 is similar to adalimumab . Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein ( DAS28-CRP ) . Safety was assessed via adverse events ( AEs ) and laboratory evaluations . Antidrug antibodies were assessed to determine immunogenicity . Results A total of 526 patients were r and omised ( n=264 , ABP 501 ; n=262 adalimumab ) and 494 completed the study .  ACR20 response at week 24 was 74.6 % ( ABP 501 ) and 72.4 % ( adalimumab ) . At week 24 , the RR of ACR20 ( 90 % CI ) between groups was 1.039 ( 0.954 , 1.133 ) , confirming the primary hypothesis . Changes from baseline in DAS28-CRP , ACR50 and ACR70 were similar . There were no clinical ly meaningful differences in AEs and laboratory abnormalities . A total of 38.3 % ( ABP 501 ) and 38.2 % ( adalimumab ) of patients tested positive for binding antidrug antibodies . Conclusions Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy , safety and immunogenicity in patients with moderate to severe RA . Trial registration number NCT01970475 ; Results 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 , 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 evidence on the efficacy and safety of biosimilar infliximab ( IFX ) in patients with inflammatory bowel diseases ( IBD ) is sparse . Methods : Consecutive IBD patients visiting our centre were included . One cohort composed of prospect ively followed patients who were switched from original to biosimilar IFX between January and March 2015 . The second cohort included retrospectively assessed anti-tumor necrosis factor α- 
    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: BACKGROUND TNF inhibitors have improved treatment of Crohn 's disease , ulcerative colitis , spondyloarthritis , rheumatoid arthritis , psoriatic arthritis , and chronic plaque psoriasis , but are expensive therapies . The aim of NOR-SWITCH was to examine switching from originator infliximab to the less expensive biosimilar CT-P13 regarding efficacy , safety , and immunogenicity . METHODS The study is a r and omised , non-inferiority , double-blind , phase 4 trial with 52 weeks of follow-up . Adult patients on stable treatment with infliximab originator treated in a hospital setting for at least 6 months were eligible for participation . Patients with informed consent were r and omised in a 1:1 ratio to either continued infliximab originator or to switch to CT-P13 treatment , with unchanged dosing regimen . Data were collected at infusion visits in 40 Norwegian study centres . Patients , assessors , and patient care providers were masked to treatment allocation . The primary endpoint was disease worsening during 52-week follow-up .  394 patients in the primary per- protocol set were needed to show a non-inferiority margin of 15 % , assuming 30 % disease worsening in each group . This trial is registered with Clinical Trials.gov , number NCT02148640 . FINDINGS Between Oct 24 , 2014 , and July 8 , 2015 , 482 patients were enrolled and r and omised ( 241 to infliximab originator , 241 to CT-P13 group ; one patient was excluded from the full analysis and safety set for CT-P13 ) and 408 were included in the per- protocol set ( 202 in the infliximab originator group and 206 in the CT-P13 group ) . 155 ( 32 % ) patients in the full analysis set had Crohn 's disease , 93 ( 19 % ) had ulcerative colitis , 91 ( 19 % ) had spondyloarthritis , 77 ( 16 % ) had rheumatoid arthritis , 30 ( 6 % ) had psoriatic arthritis , and 35 ( 7 % ) had chronic plaque psoriasis . Disease worsening occurred in 53 ( 26 % ) patients in the infliximab originator group and 61 ( 30 % ) patients in the CT-P13 group ( per- protocol set ; adjusted treatment difference -4·4 % , 95 % CI -12·7 to 3·9 ) . The frequency of adverse events was similar between groups ( for serious adverse events , 24 [ 10 % ] for infliximab originator vs 21 [ 9 % ] for CT-P13 ; for overall adverse events , 168 [ 70 % ] vs 164 [ 68 % ] ; and for adverse events leading to discontinuation , nine [ 4 % ] vs eight [ 3 % ] , respectively ) . INTERPRETATION The NOR-SWITCH trial showed that switching from infliximab originator to CT-P13 was not inferior to continued treatment with infliximab originator according to a prespecified non-inferiority margin of 15 % . The study was not powered to show non-inferiority in individual diseases . FUNDING Norwegian Ministry of Health and Care Services Introduction : In most European countries , an infliximab biosimilar ( CT-P13 ) is currently in common use . In vitro and in vivo studies have proved a high similarity between CT-P13 and the reference infliximab . CT-P13 was licensed for use in patients with Crohn disease ( CD ) based on the extrapolation of data from pre clinical studies and clinical trials in rheumatology indications . The aim of this study was to assess the similarity between CT-P13 and the originator infliximab in induction therapy in CD paediatric patients . Methods : Thirty-six CD paediatric patients from 3 Polish academic centres who started biological therapy with CT-P13  were enrolled in this prospect i ve , observational study . Patients received 3 induction doses ( 5 mg/kg ) of CT-P13 at weeks 0 , 2 , 6 . Assessment was performed before the first infusion and at week 14 . Results : Overall 34/36 ( 94.4 % ) patients completed induction therapy with CT-P13 . A clinical response or remission after 3 initial doses was achieved in 31/36 ( 86 % ) and 24/36 ( 67 % ) of patients , respectively . Clinical ly and statistically significant decreases in Paediatric Crohn 's Disease Activity Index , C-reactive protein , and erythrocyte sedimentation rate were observed in the responders group . An allergic reaction during infusion , which led to treatment discontinuation , was observed in one case . Conclusions : Induction therapy with CT-P13 in children with CD is effective . The profile appears similar to that reported for the reference infliximab . No unexpected adverse events occurred Objectives ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab ; structural , functional and pharmacokinetic evaluations have shown that the two are highly similar . We report results from a phase III study comparing efficacy , safety and immunogenicity between ABP 501 and adalimumab . Methods In this r and omised , double-blind , active comparator-controlled , 26-week equivalence study , patients with moderate to severe active rheumatoid arthritis ( RA ) despite methotrexate were r and omised ( 1:1 ) to ABP 501 or adalimumab ( 40 mg ) every 2 weeks . Primary endpoint was risk ratio ( RR ) of ACR20 between groups at week 24 . Primary hypothesis that the treatments were equivalent would be confirmed if the 90 % CI for RR of ACR20 at week 24 fell between 0.738 and 1.355 , demonstrating that ABP 501 is similar to adalimumab . Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein ( DAS28-CRP ) . Safety was assessed via adverse events ( AEs ) and laboratory evaluations . Antidrug antibodies were assessed to determine immunogenicity . Results A total of 526 patients were r and omised ( n=264 , ABP 501 ; n=262 adalimumab ) and 494 completed the study .  ACR20 response at week 24 was 74.6 % ( ABP 501 ) and 72.4 % ( adalimumab ) . At week 24 , the RR of ACR20 ( 90 % CI ) between groups was 1.039 ( 0.954 , 1.133 ) , confirming the primary hypothesis . Changes from baseline in DAS28-CRP , ACR50 and ACR70 were similar . There were no clinical ly meaningful differences in AEs and laboratory abnormalities . A total of 38.3 % ( ABP 501 ) and 38.2 % ( adalimumab ) of patients tested positive for binding antidrug antibodies . Conclusions Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy , safety and immunogenicity in patients with moderate to severe RA . Trial registration number NCT01970475 ; Results 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 , 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 evidence on the efficacy and safety of biosimilar infliximab ( IFX ) in patients with inflammatory bowel diseases ( IBD ) is sparse . Methods : Consecutive IBD patients visiting our centre were included . One cohort composed of prospect ively followed patients who were switched from original to biosimilar IFX between January and March 2015 . The second cohort included retrospectively assessed anti-tumor necrosis factor α- 
    Output:
    