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 Limited data are available on long-term clinical outcomes regarding the switch from Remicade ® to the infliximab biosimilar CT-P13 in inflammatory bowel disease ( IBD ) patients . Aims To investigate long-term efficacy , safety , pharmacokinetic profile , and immunogenicity . Methods We performed a single-center prospect i ve observational cohort study following an elective  switch from Remicade ® to CT-P13 in IBD patients . Results Eighty-three patients were included ( 57 Crohn ’s disease , 24 ulcerative colitis , and 2 IBD unclassified ) , and 68 patients completed one-year follow-up . Disease activity ( Harvey – Bradshaw Index and Simple Clinical Colitis Activity Index ) as well as inflammatory markers ( CRP , fecal calprotectin ) did not change significantly during the 1-year follow-up . In total , 7 out of 83 patients ( 8 % ) demonstrated detectable antidrug antibodies during follow-up , and 5 out of 7 antidrug antibody titers were already detectable at baseline prior to switching . Six patients ( 7 % ) discontinued CT-P13 due to adverse events . Conclusions Following a switch from Remicade ® to CT-P13 , 82 % of IBD patients continued treatment through 1 year . Disease activity scores and inflammatory markers remained unchanged during follow-up , and no CT-P13-related serious adverse events occurred . These 1-year data suggest that switching to CT-P13 in Remicade ® -treated IBD patients is safe and feasible 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 Background : Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn 's disease . Methods : A prospect i ve , multicenter , cohort study using a structured data base . Results : Consecutive patients ( 313 Crohn 's disease and 234 ulcerative colitis ) were enrolled from 31 referral centers ; 311 patients were naive to anti – tumor necrosis factor alpha , 139 had a previous exposure to biologics , and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab .  The mean follow-up was 4.3 ± 2.8 months , and the total follow-up time was 195 patient-years . After 2061 infusions , 66 serious adverse events were reported ( 12.1 % ) , 38 ( 6.9 % ) of them were infusion-related reactions . The biosimilar had to be stopped in 29 ( 5.3 % ) cases for severe infusion reactions ( 8 naive , 19 previous exposed , and 2 switch ) , and in further 16 patients ( 2.9 % ) for other serious adverse events . Infusion reactions were significantly more frequent in patients pre-exposed to infliximab than to other anti – tumor necrosis factor alpha ( incidence rate ratio = 2.82 , 95 % CI : 1.05–7.9 ) . The efficacy of the biosimilar was evaluated in 434 patients who received treatment for at least 8 weeks , using time-to-event methods for censored observations : 35 patients were primary failures ( 8.1 % ) . After further 8 , 16 , and 24 weeks , the efficacy estimations were 95.7 % , 86.4 % , and 73.7 % for naive , 97.2 % , 85.2 % , and 62.2 % for pre-exposed , and 94.5 % , 90.8 % , and 78.9 % for switch , respectively ( log-rank P = 0.64 ) . Conclusions : Although no direct comparison was performed , preliminary data on efficacy and safety of CT-P13 were in line with those of infliximab 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 
    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 Limited data are available on long-term clinical outcomes regarding the switch from Remicade ® to the infliximab biosimilar CT-P13 in inflammatory bowel disease ( IBD ) patients . Aims To investigate long-term efficacy , safety , pharmacokinetic profile , and immunogenicity . Methods We performed a single-center prospect i ve observational cohort study following an elective  switch from Remicade ® to CT-P13 in IBD patients . Results Eighty-three patients were included ( 57 Crohn ’s disease , 24 ulcerative colitis , and 2 IBD unclassified ) , and 68 patients completed one-year follow-up . Disease activity ( Harvey – Bradshaw Index and Simple Clinical Colitis Activity Index ) as well as inflammatory markers ( CRP , fecal calprotectin ) did not change significantly during the 1-year follow-up . In total , 7 out of 83 patients ( 8 % ) demonstrated detectable antidrug antibodies during follow-up , and 5 out of 7 antidrug antibody titers were already detectable at baseline prior to switching . Six patients ( 7 % ) discontinued CT-P13 due to adverse events . Conclusions Following a switch from Remicade ® to CT-P13 , 82 % of IBD patients continued treatment through 1 year . Disease activity scores and inflammatory markers remained unchanged during follow-up , and no CT-P13-related serious adverse events occurred . These 1-year data suggest that switching to CT-P13 in Remicade ® -treated IBD patients is safe and feasible 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 Background : Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn 's disease . Methods : A prospect i ve , multicenter , cohort study using a structured data base . Results : Consecutive patients ( 313 Crohn 's disease and 234 ulcerative colitis ) were enrolled from 31 referral centers ; 311 patients were naive to anti – tumor necrosis factor alpha , 139 had a previous exposure to biologics , and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab .  The mean follow-up was 4.3 ± 2.8 months , and the total follow-up time was 195 patient-years . After 2061 infusions , 66 serious adverse events were reported ( 12.1 % ) , 38 ( 6.9 % ) of them were infusion-related reactions . The biosimilar had to be stopped in 29 ( 5.3 % ) cases for severe infusion reactions ( 8 naive , 19 previous exposed , and 2 switch ) , and in further 16 patients ( 2.9 % ) for other serious adverse events . Infusion reactions were significantly more frequent in patients pre-exposed to infliximab than to other anti – tumor necrosis factor alpha ( incidence rate ratio = 2.82 , 95 % CI : 1.05–7.9 ) . The efficacy of the biosimilar was evaluated in 434 patients who received treatment for at least 8 weeks , using time-to-event methods for censored observations : 35 patients were primary failures ( 8.1 % ) . After further 8 , 16 , and 24 weeks , the efficacy estimations were 95.7 % , 86.4 % , and 73.7 % for naive , 97.2 % , 85.2 % , and 62.2 % for pre-exposed , and 94.5 % , 90.8 % , and 78.9 % for switch , respectively ( log-rank P = 0.64 ) . Conclusions : Although no direct comparison was performed , preliminary data on efficacy and safety of CT-P13 were in line with those of infliximab 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 
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