Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial Induction Therapy With Biosimilar Infliximab in Children With Crohn Disease Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study Clinical Outcomes Following a Switch from Remicade® to the Biosimilar CT-P13 in Inflammatory Bowel Disease Patients: A Prospective Observational Cohort Study. Switching from Remicade® to Remsima® is well Tolerated and Feasible: A Prospective, Open-label Study Clinical monitoring: infliximab biosimilar CT-P13 in the treatment of Crohn’s disease and ulcerative colitis Infliximab Biosimilar (Remsima™) in Therapy of Inflammatory Bowel Diseases Patients: Experience from One Tertiary Inflammatory Bowel Diseases Centre Effectiveness and Safety of CT-P13 (Biosimilar Infliximab) in Patients with Inflammatory Bowel Disease in Real Life at 6 Months Switching Between Infliximab Originator and Biosimilar in Paediatric Patients with Inflammatory Bowel Disease. Preliminary Observations. Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis – experiences from a single center Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: A Norwegian observational study Efficacy and Safety of the Biosimilar Infliximab CT-P13 Treatment in Inflammatory Bowel Diseases: A Prospective, Multicentre, Nationwide Cohort. Infliximab biosimilar CT-P13 therapy is effective in maintaining endoscopic remission in ulcerative colitis – results from multicenter observational cohort Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease Implementation of CT-P13 via a Managed Switch Programme in Crohn’s Disease: 12-Month Real-World Outcomes An open-label extension study to demonstrate long-term safety and efficacy of ABP 501 in patients with rheumatoid arthritis Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54 Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab After One Year in a Prospective Nationwide Cohort
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-naïve patients who started therapy between January 2015 and January 2016 . Disease activity was assessed using st and ard clinical indices , endoscopic evaluation , and laboratory parameters ( blood count , C-reactive protein ( CRP ) and fecal calprotectin ( FC ) ) . Trough levels and anti-drug antibodies ( ATIs ) were also measured . Patients were evaluated 56 weeks ( W56 ) after switch and at week 14 ( W14 ) and week 46 ( W46 ) in the naïve cohort . Results : Seventy-four IBD patients were switched to biosimilar IFX  and 119 naïve patients newly initiated therapy with the preparation . Disease activity remained stable in a majority of switched patients ( remission at week 0 ( W0 ) vs. W56 : 72.2 vs. 77.8 % ; median difference of both Harvey-Bradshaw index and Simple Clinical Colitis Activity Index between W0 and W56 was 0 ) . When W0 and W56 were compared , no significant difference in CRP ( 4.3 ± 8.0 vs. 3.3 ± 3.8 mg/l ; p = 0.89 ) and FC ( 135 ± 153 vs. 199 ± 225 µg/g ; p = 0.17 ) was observed . In total , 92 % of Crohn 's disease ( CD ) and 83 % of ulcerative colitis ( UC ) patients responded to induction therapy ( W14 ) with biosimilar IFX . At W46 , the response rate was 86 % in CD and 64 % in UC . Moreover , half of UC patients experienced mucosal healing at W14 and improvement of perianal disease occurred in 95 % of CD at W46 . In this cohort , clear steroid-sparing effect was observed . No increase in immunogenicity was found in switched patients ( ATI positivity : 9.5 vs. 6.0 % , p = 0.54 ) and the type and frequency of adverse events were comparable to the original preparation in both cohorts . Conclusion : Switching of IBD patients from original to biosimilar IFX  is effective and safe Background CT-P13 is a biosimilar of Remicade ® , an agent approved in some countries for use in inflammatory bowel disease ( IBD ) . Controlled clinical trials have demonstrated the efficacy and safety of CT-P13 in rheumatic diseases , but not in IBD . Aims To assess the effectiveness and safety of CT-P13 in IBD patients in real clinical practice . Methods This is a prospect i ve observational study in patients with moderate to severe Crohn ’s disease or ulcerative colitis treated with CT-P13 .  The study was performed in one single center . Patients included were naive or switched to anti-TNF treatment from the reference infliximab ( Remicade ® ) to CT-P13 .  Efficacy and safety were assessed in naive and switched patients who were in remission at the time of the switch at months 3 and 6 of therapy . Results 87.5 and 83.9 % of switched CD patients who were in remission at the time of the switch continued in remission , and 66.7 and 50 % of naive CD patients reached remission , at months 3 and 6 . In UC switched cases , 92 and 91.3 % of patients in remission at the time of the switch continued in remission , at 3 and 6 months . In naive UC patients , the remission rates were 44.4 and 66.7 % , at months 3 and 6 . Adverse events occurred in 7.5 % of patients during 6 months of study . Conclusions CT-P13 was efficacious and well tolerated in patients with CD or UC 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 switched from infliximab originator to its biosimilar ( Remsima ) .  Patient characteristics , disease severity , laboratory parameters and adverse events were recorded . Means , medians and ranges were calculated . RESULTS Mean age at diagnosis of CD and UC was 11.1 ( 2.7 - 15.3 ) and 12.3 years ( 8.5 - 14.8 ) , respectively .  Mean number of infliximab originator infusions before switching to the biosimilar was 9.9 ( median 8 , range 4 - 29 ) and 5.1 ( 5 , 1 - 12 ) for the CD and UC group , respectively . Evaluation efficacy of last biosimilar doses of all patients revealed rates of clinical remission of 88 and 57 % for CD and UC patients , respectively . Last follow-up assessment of patients who continued with biosimilar therapy showed that 16/20 ( 80 % ) CD patients and all 4 UC individuals were in remission . One infusion reaction to infliximab biosimilar was observed in a CD patient , which led to treatment discontinuation . The incidence of sporadic mild adverse events prior to and after switching did not differ significantly and was consistent with the safety profile of the infliximab molecule . CONCLUSION Switching from infliximab originator to its biosimilar seems to be a safe option in children with CD . After the switch the biosimilar was just as effective as the originator Background Biological agents , such as infliximab , have transformed the outcomes of patients with immune-mediated inflammatory diseases . The advent of biosimilar treatment options such as CT-P13 promises to improve the availability of biological therapy , yet real-world switching data are currently limited . Here , we assess the effectiveness and safety of switching to CT-P13 from infliximab reference product ( RP ) in patients with inflammatory bowel disease . Material s and methods This was a prospect i ve single-center observational study in patients with moderate to severe Crohn ’s disease ( CD ) and ulcerative colitis ( UC ) . All patients were switched from infliximab RP ( Remicade ) to CT-P13 treatment and followed up for up to 12 months . The efficacy endpoint was the change in clinical response assessed at 3-monthly intervals , according to the Harvey – Bradshaw score and partial Mayo score for patients with CD and UC , respectively . C-reactive protein ( CRP ) was also measured . Adverse events were monitored and recorded throughout the study . Results A total of 98 patients with inflammatory bowel disease ( 67 CD/31 UC ) were included . A total of 83.6 % ( 56/67 ) of patients with CD were in remission at the time of the switch and 62.7 % were in remission at 12 months . The Harvey – Bradshaw score showed a significant change at 12 months ( P=0.007 ) but no significant change was observed in median CRP at this timepoint ( P=0.364 ) . A total of 80.6 % ( 25/31 ) of patients with UC were in remission at the time of the switch and 65.3 % ( 18/28 ) were in remission at 12 months . No significant changes in the median partial Mayo score ( P=0.058 ) or CRP ( P=0.329 ) were observed at 12 months . Serious adverse events related to medication were reported in 11 ( 11.2 % ) patients . Conclusion Switching from infliximab RP to CT-P13 is efficacious and well tolerated in patients with CD or UC for up to 12 months Objective : To evaluate the safety and efficacy of CT-P13 ( Remsima ® ) in patients with inflammatory bowel disease ( IBD ) in South Korea . Methods : This post-marketing study included patients with active moderate-to-severe Crohn ’s disease ( CD ) , fistulizing CD ( FCD ) , or moderate-to-severe ulcerative colitis ( UC ) treated with CT-P13 and followed for 30 weeks . Assessment s included treatment-emergent adverse events ( TEAEs ) and disease-specific clinical response and remission . Results : No unexpected TEAEs were observed in the 173 patients recruited to date . TEAEs occurred in 18.1 , 16.7 , and 26.9 % of CD , FCD , and UC patients , respectively . Treatment-related TEAEs occurred in 10 % of patients and were mostly mild-moderate in severity . There were five serious TEAEs ( two infusion-related reactions , two infections , one abdominal pain ) and no cases of malignancy , pneumonia , or death . Positive outcomes for response/remission were reported regardless of whether patients had received prior infliximab or not . Conclusion : CT-P13 was well tolerated and efficacious in patients with IBD Background : CT-P13 is the first biosimilar monoclonal antibody to infliximab ( IFX ) ; it has been approved for the same indications as its IFX counterpart in Hungary . The aim of this study was to assess the efficacy of CT-P13 induction therapy in patients with Crohn ’s disease ( CD ) and ulcerative colitis ( UC ) . Methods : Patients diagnosed with CD and UC , who were administered CT-P13 , were prospect ively enrolled . Disease activity was estimated at the start and after the induction therapy . In patients with UC , sigmoideoscopy was also performed at the end of the induction therapy . Results : Eighteen CD and 21 UC patients were enrolled . Induction treatment was completed in 16 of the CD and 15 of the UC patients . In those with luminal CD , clinical response and remission was achieved in 6 ( 37.5 % ) and 8 ( 50 % ) of the patients at Week 8 . In UC , clinical response and remission was achieved in 3 ( 20 % ) and 10 ( 66.7 % ) patients at Week 8 . Mucosal healing was shown in 11 patients . Conclusions : This was the first study to prospect ively evaluate the outcome of  CT-P13 induction therapy in CD and UC . Our results confirm that induction with CT-P13 is safe and effective Objective : To assess the efficacy , tolerability , and safety of CT-P13 ( Remsima ® ) in patients with Crohn ’s disease ( CD ) or ulcerative colitis ( UC ) . Methods : This was a prospect i ve observational study performed in a single center in Norway . Patients with CD ( n = 46 ) or UC ( n = 32 )  received CT-P13 ( 5 mg/kg ) by intravenous infusion at weeks 0 , 2 , and 6 . Efficacy end points included remission at week 14 , measured by a Harvey-Bradshaw Index score of ≤4 or partial Mayo score of ≤2 . Levels of the inflammatory markers C-reactive protein and calprotectin were measured . Adverse events up to week 14 were also recorded . Results : Seventy-nine percent of CD and 56 % of UC patients achieved remission at week 14 . Significant reductions in C-reactive protein and calprotectin occurred between baseline and week 14 . There were no unexpected adverse events reported during the study . Conclusion : CT-P13  is efficacious and well tolerated in patients with CD or UC BACKGROUND AND AIMS Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe . Prospect i ve data on its efficacy , safety , and immunogenicity in inflammatory bowel diseases are lacking . METHODS A prospect i ve , nationwide , multicentre , observational cohort was design ed to examine the efficacy , safety , and immunogenicity of CT-P13 infliximab biosimilar in the induction treatment of Crohn 's disease [ CD ] and ulcerative colitis [ UC ] . Demographic data were collected and a harmonised monitoring strategy was applied . Early clinical remission , response , and early biochemical response were evaluated at Week 14 , steroid-free clinical remission was evaluated at Week 30 . Therapeutic drug level was monitored using a conventional enzyme-linked immunosorbent assay . RESULTS In all , 210 consecutive inflammatory bowel disease [ 126 CD and 84 UC ] patients were included in the present cohort . At Week 14 , 81.4 % of CD and 77.6 % of UC patients showed clinical response and 53.6 % of CD and 58.6 % of UC patients were in clinical remission . Clinical remission rates at Week 14 were significantly higher in CD and UC patients who were infliximab naïve , compared with those with previous exposure to the originator compound [ p < 0.05 ] . Until Week 30 , adverse events were experienced in 17.1 % of all patients . Infusion reactions and infectious adverse events occurred in 6.6 % and 5.7 % of all patients , respectively . CONCLUSIONS This prospect i ve multicentre cohort shows that CT-P13 is safe and effective in the induction of clinical remission and response in both CD and UC . Patients with previous infliximab exposure exhibited decreased response rates and were more likely to develop allergic reactions ABSTRACT Background : CT-P13 , the first biosimilar monoclonal antibody to infliximab ( IFX ) , has previously been confirmed to be efficacious in inducing mucosal healing in ulcerative colitis ( UC ) patients . The aim of this study was to evaluate the efficacy of CT-P13 therapy in maintaining mucosal healing in UC . Methods : CT-P13  trough levels , antibody positivity , serum inflammatory markers as CRP level , fecal calprotectin at weeks 14 and 54 , concomitant steroid and azathioprine therapy at the time of induction therapy and at weeks 14 and 54 , previous use of anti TNF drug and the need of dose intensification as possible predictive factors for mucosal healing at week 54 were evaluated in this prospect i ve study . Results : 61 patients had already completed the 54-week treatment period .  Mucosal healing was shown in 65.5 % and 62.1 % , complete mucosal healing was present in 31 % and 38 % at week 14 and 54 , respectively . The median values of CRP , leukocytes , thrombocytes , and albumin showed significant difference between baseline and week 54 . Serum antibody positivity was proved in 6.5 % and 19.7 % of cases at week 14 and 54 , respectively . Conclusion : Our study confirmed the long-term efficacy of CT-P13 therapy on mucosal healing in UC Background : As the patents of originator biologics are expiring , biosimilar versions are becoming available for the treatment of inflammatory bowel disease ( IBD ) . However , published switch studies of the first infliximab biosimilar , CT-P13 , have delivered ambiguous results that could be interpreted as showing a trend towards inferior effectiveness in Crohn ’s disease ( CD ) compared with ulcerative colitis ( UC ) . The aim of this study was to investigate the effectiveness and safety of switching IBD patients from treatment with Remicade  to CT-P13 . Methods : In this prospect i ve observational cohort study , all adult IBD patients on Remicade treatment , at four hospitals , were switched to CT-P13 . The primary endpoint was change in clinical disease activity at 2 , 6 , and 12 months after the switch . Secondary endpoints were subgroup analyses of patients with and without concomitant immunomodulators ; changes in biomarkers , quality of life , drug trough levels and anti-drug antibodies ( ADAbs ) ; and adverse events . Results : A total of 313 IBD patients were switched ( 195 CD ; 118 UC ) . There were no significant changes in clinical disease activity , quality of life , biomarkers ( except a small but significant increase in albumin in CD ) including F-calprotectin , drug trough levels , or proportion of patients in remission . Disease worsening rates were 14.0 % for CD and 13.8 % for UC ; and 2.7 % developed ADAbs and 2.2 % developed serious adverse events . Conclusions : This is the largest study of switched IBD patients published to date , and it demonstrates that switching from Remicade to CT-P13 may be done with preserved therapeutic effectiveness and safety in both CD and UC Background Switching from Remicade to CT-P13 allows for significant cost savings and has been shown to be non-inferior to continued therapy with Remicade for the treatment of Crohn ’s disease . Aim The aim of this work was to prospect ively evaluate clinical outcomes in a cohort of patients with Crohn ’s disease switching from Remicade to CT-P13 .  Methods A prospect i ve service evaluation was performed . The Harvey-Bradshaw index , CRP , faecal calprotectin and serum for infliximab/antibody levels were collected prior to patients ' final Remicade infusion and at 6 and 12 months after switching to CT-P13 as part of routine clinical care . All adverse events during follow-up were also recorded . Results One hundred and ten patients on Remicade  switched to CT-P13 . No significant difference was observed between the Harvey-Bradshaw Index ( p = 0.07 ) , CRP ( p = 0.13 ) , faecal calprotectin ( p = 0.25 ) or trough infliximab levels ( p = 0.47 ) comparing before and at 6 and 12 months after the switch to CT-P13 . Seven patients developed new infliximab antibodies after switching from Remicade to CT-P13 . The majority of patients remained on CT-P13 at 12 months ( 84.5 % ) and the rate of adverse events and serious adverse events was 53.8 and 13.5 per 100 patient-years of follow-up , respectively . Switching to CT-P13 result ed in a cost saving of approximately 46.4 % . Conclusion The transition to CT-P13 from Remicade for the treatment of Crohn ’s disease is safe and has no negative effect on clinical outcomes at 12 months Background ABP 501 was evaluated in a phase 3 single-arm , open-label extension ( OLE ) study to collect additional safety and efficacy data in patients with rheumatoid arthritis ( RA ) . Methods Subjects completing the final visit in the parent phase 3 r and omized , double-blind , controlled equivalence study comparing the efficacy and safety of the biosimilar  ABP 501 with adalimumab reference product (  RP ) were enrolled in this open-label extension ( OLE ) study . All subjects received 40 mg ABP 501 every other week for 68 weeks . Key safety endpoints included treatment-emergent adverse events ( TEAEs ) , serious adverse events ( SAEs ) , and anti-drug antibody ( ADA ) incidences . Efficacy endpoints included ACR20 ( at least 20 % improvement in American College of Rheumatology core set measurements from baseline ) and Disease Activity Score 28-joint count C-reactive protein ( DAS28-CRP ) change from baseline . Results Among 466/467 patients treated with ABP 501 , 229 transitioned from the ABP 501 arm of the parent study ( ABP 501/ABP 501 ) and 237 from the adalimumab RP arm ( RP/ABP 501 ) ; 412/467 ( 88.2 % ) patients completed the study .  The overall TEAE incidence was 63.7 % ( 297/466 ) ; grade ≥ 3 TEAE incidence was 9.0 % ( 42/466 ) . The incidence of TEAEs leading to discontinuation of investigational product was 3.6 % ( 17/466 ) . The SAE incidence was 9.9 % ( 46/466 ) . Overall , 18.2 % ( 85/466 ) of subjects developed binding ADAs and 6.9 % ( 32/466 ) developed neutralizing ADAs in the OLE study . The ACR20 response rate was 73.3 % ( 340/464 subjects ) at OLE baseline , and 78.8 % ( 327/415 subjects ) at week 70 of the OLE study . The overall mean DAS28-CRP change from the parent study baseline was − 2.25 at the OLE study baseline ( n = 440 ) , − 2.36 at week 4 ( n = 463 ) , − 2.41 at week 24 ( n = 450 ) , − 2.55 at week 48 ( n = 433 ) , and − 2.60 at week 70 ( n = 412 ) . Efficacy was maintained throughout the study . Conclusions Efficacy previously demonstrated in the parent study was maintained in this OLE study with no new safety findings . Long-term safety , immunogenicity , and efficacy were similar in the ABP 501/ABP 501 and RP/ABP 501 groups . The single switch from RP to ABP 501 did not impact immunogenicity . Trial registration Clinical Trial.gov , Objective To investigate the efficacy , safety and immunogenicity of PF-06438179/GP1111 ( PF-SZ-IFX ) compared with European reference infliximab ( Remicade ® ; ref-IFX ) in patients with moderate-to-severe , active rheumatoid arthritis after continued long-term use of PF-SZ-IFX  , and in patients who were switched from ref-IFX to PF-SZ-IFX . Methods REFLECTIONS B537 - 02 was a double-blind , active-controlled , multinational study in which patients ( N=650 ) were initially r and omised to PF-SZ-IFX or ref-IFX for 30 weeks ( treatment period [ TP ] 1 ) . During weeks 30–54 ( TP2 ) , the PF-SZ-IFX group ( n=280 ) continued treatment with PF-SZ-IFX ( PF-SZ-IFX/PF-SZ-IFX ) and patients in the ref-IFX group ( n=286 ) were rer and omised ( 1:1 ) to continue ref-IFX ( ref-IFX/ref-IFX ) ( n=143 ) or switch to PF-SZ-IFX ( ref-IFX/PF-SZ-IFX ) ( n=143 ) for a further 24 weeks . Efficacy , safety , immunogenicity and pharmacokinetics were evaluated . Results During TP2 , patients in all three treatment groups continued to maintain comparable treatment response . At week 54 , the American College of Rheumatology ( ACR20 ) response rates were 71.1 % ( PF-SZ-IFX/PF-SZ-IFX ) , 64.3 % ( ref-IFX/ref-IFX ) and 70.6 % ( ref-IFX/PF-SZ-IFX ) . Observations for other endpoints , including ACR50/70 , Disease Activity Score in 28 Joints Based on High-Sensitivity C Reactive Protein(DAS28-CRP ) remission , and mean change in DAS28-CRP and Health Assessment Question naire-Disability Index , were also comparable . Treatment-emergent adverse events were reported in 36.8 % ( PF-SZ-IFX/PF-SZ-IFX ) , 33.6 % ( ref-IFX/ref-IFX ) and 37.8 % ( ref-IFX/PF-SZ-IFX ) of patients ; there were no clinical ly meaningful differences in the safety profiles between groups . The percentage of patients who were antidrug antibody-positive was generally stable through the treatment period and comparable overall between the PF-SZ-IFX/PF-SZ-IFX ( 52.1 % ; neutralising : 80.8 % ) , ref-IFX/ref-IFX ( 60.1 % ; neutralising : 84.9 % ) and ref-IFX/PF-SZ-IFX ( 58.0 % ; neutralising 78.3 % ) groups . Conclusions The similar efficacy , safety and immunogenicity of PF-SZ-IFX compared with ref-IFX were maintained for up to 54 weeks and were not affected by blinded treatment switch from ref-IFX to PF-SZ-IFX at week 30 . Trial registration number NCT02222493 Background : It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases . We report here the 1-year outcomes from a prospect i ve nationwide inflammatory bowel disease cohort . Methods : A prospect i ve , nationwide , multicenter , observational cohort was design ed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn 's disease ( CD ) and ulcerative colitis ( UC ) . Demographic data were collected and a harmonized monitoring strategy was applied . Clinical remission , response , and biochemical response were evaluated at weeks 14 , 30 , and 54 , respectively . Safety data were registered . Results : Three hundred fifty-three consecutive inflammatory bowel disease ( 209 CD and 144 UC ) patients were included , of which 229 patients reached the week 54 endpoint at final evaluation . Age at disease onset : 24/28 years ( median , interquartile range : 19–34/22–39 ) in patients with CD/UC . Forty-nine , 53 , 48 % and 86 , 81 and 65 % of patients with CD reached clinical remission and response by weeks 14 , 30 , and 54 , respectively . Clinical remission and response rates were 56 , 41 , 43 % and 74 , 66 , 50 % in patients with UC . Clinical efficacy was influenced by previous anti – tumor necrosis factor ( TNF ) exposure in patients with a drug holiday beyond 1 year . The mean C-reactive protein level decreased significantly in both CD and UC by week 14 and was maintained throughout the 1-year follow-up ( both UC/CD : P < 0.001 ) . Thirty-one ( 8.8 % ) patients had infusion reactions and 32 ( 9 % ) patients had infections . Antidrug antibody positivity rates were significantly higher throughout patients with previous anti-TNF exposure ; concomitant azathioprine prevented antidrug antibody formation in anti – TNF-naive patients with CD . Conclusions : Results from this prospect i ve nationwide cohort confirm that CT-P13 is effective and safe in inducing and maintaining long-term remission in both CD and UC . Efficacy was influenced by previous anti-TNF exposure ; no new safety signals were detected
We aim ed to evaluate the efficacy and safety of infliximab biosimilar , CT-P13 , for patients with inflammatory bowel disease .