A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study Long-Term Clinical Outcomes After Switching from Remicade® to Biosimilar CT-P13 in Inflammatory Bowel Disease 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 The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study. Clinical Experience of the Use of CT-P13, a Biosimilar to Infliximab in Patients with Inflammatory Bowel Disease: A Case Series 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 Changes in Biosimilar Knowledge among European Crohn's Colitis Organization [ECCO] Members: An Updated Survey. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study Infliximab maintenance treatment reduces hospitalizations, surgeries, and procedures in fistulizing Crohn's disease. ECCO Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease-An Update. 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 Efficacy, Safety and Immunogenicity of Biosimilars in Inflammatory Bowel Diseases: A Systematic Review. Switching Between Infliximab Originator and Biosimilar in Paediatric Patients with Inflammatory Bowel Disease. Preliminary Observations. Experience with Biosimilar Infliximab (Remsima®) in Norway 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 CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study Viewpoint: knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn's and Colitis Organization.
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 % 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 BACKGROUND In 2013 , a ECCO survey showed that a minority of IBD specialists was aware and confident about the benefits and issues of biosimilars . We aim ed to look at the evolution of IBD specialists ' thinking about biosimilars one year after they had become available in the European Union . METHODS A 14- question anonymous survey was posted on the ECCO website . Members voluntarily responded in response to ECCO office invitations to participate in their surveys . Information on gender , job position , country , and experience with biologics also were collected . RESULTS Out of the 118 responders , only 17 % of responders had no access to biosimilars . Most responders regarded cost-sparing [ 92.4 % ] as the main advantage of biosimilars , considered immunogenicity [ 69 % ] to be their main concern , and estimated that post-marketing pharmacovigilance , well- design ed r and omized clinical trials and further studies of risk profile were needed [ 30.5 % , 27 % , 32.2 % , respectively , a 30 - 40 % reduction since 2013 ] . Only 35 % of physicians think biosimilars should carry distinct International Nonproprietary Names , as compared with 66 % in 2013 , and 89.8 % disagreed with automatic substitution of the originator with a biosimilar by a pharmacist . The originator and biosimilar were considered interchangeable by 44.4 % of responders , as compared with 6 % in 2013 . Only 32.2 % were against the extrapolation across indications , and only 25 % would not extrapolate data across IBD . Finally , only 19.5 % felt little or no confidence in the use of biosimilars , as compared with 63 % in 2013 . CONCLUSION IBD specialists are generally well informed and educated about biosimilars . Compared with in 2013 , there are now fewer concerns and more confidence about their use in clinical practice Objectives To investigate the efficacy and safety of switching from infliximab reference product ( RP ) to its biosimilar or maintaining biosimilar treatment in patients with ankylosing spondylitis ( AS ) . Methods This open-label extension study recruited patients with AS who completed a 54-week , r and omised controlled study comparing CT-P13 with RP ( PLANETAS ) .  CT-P13 ( 5 mg/kg ) was administered intravenously every 8 weeks from week 62 to week 102 . Efficacy end points included the proportion of patients achieving Assessment of SpondyloArthritis international Society (ASAS)20 . Antidrug antibodies ( ADAs ) were measured using an electrochemiluminescent method . Data were analysed for patients treated with CT-P13  in the main PLANETAS study and the extension ( maintenance group ) and those who were switched to CT-P13 during the extension study ( switch group ) . Results Overall , 174 ( 82.9 % ) of 210 patients who completed the first 54 weeks of PLANETAS and agreed to participate in the extension were enrolled . Among these , 88 were maintained on CT-P13 and 86 were switched to CT-P13 from RP . In these maintenance and switch groups , respectively , ASAS20 response rates at week 102 were 80.7 % and 76.9 % . ASAS40 and ASAS partial remission were also similar between groups . ADA positivity rates were comparable ( week 102 : 23.3 % vs 27.4 % ) . Adverse events led to treatment discontinuation during the extension study in 3 ( 3.3 % ) and 4 ( 4.8 % ) patients , respectively . Conclusions This is the first study to show that switching from RP to its biosimilar CT-P13 is possible without negative effects on safety or efficacy in patients with AS . In the maintenance group , CT-P13 was effective and well tolerated over 2 years of treatment . Trial registration number NCT01571206 ; Results BACKGROUND & AIMS Infliximab is effective in closing fistulas in patients with Crohn 's disease . We examined the effect of infliximab maintenance treatment on hospitalizations , surgeries , and procedures in patients with fistulizing Crohn 's disease enrolled in the ACCENT II study . METHODS After 5 mg/kg infliximab at weeks 0 , 2 , and 6 , a total of 282 patients were separately r and omized at week 14 as responders ( at least a 50 % reduction from baseline in the number of draining fistulas at both weeks 10 and 14 ) or nonresponders to receive placebo or 5 mg/kg infliximab maintenance every 8 weeks . At week 22 and later , patients who lost response could be treated with a maintenance dose 5 mg/kg higher . Data on Crohn 's disease-related hospitalizations , surgeries , and procedures were compared between the treatment groups for responders and all r and omized patients . RESULTS A total of 282 patients were r and omized at week 14 , of whom 195 were r and omized as responders . Among patients r and omized as responders , those who received infliximab maintenance had significantly fewer mean hospitalization days ( 0.5 vs. 2.5 days ; P < .05 ) , mean numbers ( per 100 patients ) of hospitalizations ( 11 vs. 31 ; P < .05 ) , all surgeries and procedures ( 65 vs. 126 ; P < .05 ) , inpatient surgeries and procedures ( 7 vs. 41 ; P < .01 ) , and major surgeries ( 2 vs. 11 ; P < .05 ) , compared with those who received placebo maintenance . CONCLUSIONS In patients with fistulizing Crohn 's disease , infliximab 5 mg/kg every 8 weeks significantly reduced hospitalizations , surgeries , and procedures compared with placebo Biosimilars of infliximab were first approved by the European Medicine Agency in 2013,1 , 2 based on pre- clinical studies on biosimilarity and on clinical data coming from two r and omised controlled trials conducted in rheumatoid arthritis [ RA ] and ankylosing spondylitis [AS].3 , 4 Initially the European Crohn ’s Colitis Organisation [ ECCO ] raised some caution on the use of biosimilars.5 This cautious approach was also supported by several national inflammatory bowel disease [ IBD ] societies5–12 [ Table 1 ] . An insufficient underst and ing of the characteristics and use of biosimilars became evident in a web survey among ECCO members in the same period.13 View this table : Table 1 . Available society guidelines . Since biosimilars were introduced in the EU market in early 2015 , more data from IBD patients 14–19 have supported the biosimilarity of biosimilar infliximab CT-P13 and the reference product , with no significant differences in terms of efficacy or safety , in either naive or switched patients in cohort studies . Importantly , a study showed clear cross-reactivity between the infliximab originator and CT-P13.20 Recently , a large nationwide Norwegian r and omised controlled trial [ NOR-SWITCH ] on patients with immune-mediated diseases [ Crohn ’s disease ; ulcerative colitis ; psoriasis ; psoriatic arthritis ; RA and AS ] found no differences in terms of clinical response , maintenance of remission , or adverse events in patients receiving CT-P13 compared with those receiving originator infliximab.21 Consideration of these findings 22 together with a better underst and ing of the process of biosimilar development and regulatory approval , have contributed to a change in the perception of IBD experts , who now prescribe biosimilars with significantly more confidence.23 A task-force including Governing Board representatives and one representative from pertinent ECCO Committees performed a literature search and made relevant statements to summarise their shared position . The proposed statements were then discussed , agreed and approved in a Consensus meeting . The licensing of any biosimilar medication 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 Anti-tumor necrosis factor ( anti-TNF ) monoclonal antibodies have revolutionized the treatment of inflammatory bowel diseases ( IBD ) . However , because of their complexity , their production is expensive contributing to their high price . As the patent protection of these therapies has expired in several countries , biosimilars have been developed to reduce the healthcare costs . The aim of this article is to review the literature on the safety , efficacy and immunogenicity of biosimilars in IBD . METHODS A PubMed literature search was performed using the following terms until May 2016 :  ' biosimilars ' , ' CT-P13 ' , ' infliximab ' , ' Crohn 's disease ' , ' ulcerative colitis ' , ' inflammatory bowel diseases ' , ' efficacy ' , ' safety ' , ' immunogenicity ' . Additionally , abstract s from international meetings were also review ed . RESULTS A total of eleven studies in IBD patients provided real-world evidence on the efficacy , safety and immunogenicity profile of biosimilars in IBD patients . Based on the available evidence , CT-P13 is efficacious and well tolerated in IBD patients in a real-life setting . The vast majority of studies only included IBD patients who had never received biological therapies . Information regarding the interchangeability between CT-P13 and its originator is currently being investigated in the NOR-SWITCH trial . Otherwise , the immunogenicity profile of CT-P13 seems to be similar to the originator . CONCLUSION The infliximab biosimilar seems to be efficacious , safe and with a similar immunogenicity profile as the originator in IBD . Large prospect i ve post-marketing studies are needed to assess the long-term safety profile of CT-P13 . The use of infliximab biosimilars may lead to major healthcare cost savings 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 : The first monoclonal antibody biosimilar to be used in clinical practice is the tumour necrosis factor-alpha inhibitor Remsima ® ( CT-P13 ) . The drug is approved for all indications as the originator infliximab ( Remicade ® ) although clinical efficacy has been demonstrated only in rheumatic diseases . Since the fall of 2013 , Remsima ® has been available in Norway and from January 2014 , it has been the drug of choice when initiating biological treatment in biologics naïve patients with inflammatory bowel disease ( IBD ) . However , many gastroenterologists have been greatly concerned about the extrapolation of indication . Switching between Remsima ® and the innovator product is another issue that has been discussed . Key Messages : Good efficacy , tolerability and safety were demonstrated in a prospect i ve observational study of IBD patients with moderate to severe disease activity . After 14 weeks of treatment there was a significant reduction in the Harvey Bradshaw index in patients with Crohns disease ( CD ) and reduction in the partial Mayo score and simple clinical colitis activity index in patients with ulcerative colitis . In both patient groups , there was also a significant reduction in fecal calprotectin and C-reactive protein ( CRP ) . In another observational study , IBD patients on maintenance treatment with Remicade ®  were switched to Remsima ® . By comparing values before and after switch , no changes in activity indices , CRP or calprotectin were observed . However , a significant increase in infliximab trough levels was shown in the CD group . No unexpected adverse events occurred after switching . Conclusions : Based on our experience in Norway , Remsima ® seems to be efficacious and well tolerated in IBD . The increasing use of Remsima ® in clinical practice has also contributed to significant cost savings on the health budget . Results from the NOR-SWITCH study will be available during 2016 and will hopefully contribute to answer some of the important questions that have been raised following the introduction of biosimilars as a treatment option for IBD and other immune-mediated inflammatory diseases 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 Objectives To assess the efficacy and safety of switching from the infliximab reference product ( RP ; Remicade ) to its biosimilar CT-P13 ( Remsima , Inflectra ) or continuing CT-P13 in patients with rheumatoid arthritis ( RA ) for an additional six infusions . Methods This open-label extension study recruited patients with RA who had completed the 54-week , r and omised , parallel-group study comparing CT-P13 with RP ( PLANETRA ; NCT01217086 ) .  CT-P13 ( 3 mg/kg ) was administered intravenously every 8 weeks from weeks 62 to 102 . All patients received concomitant methotrexate . Endpoints included American College of Rheumatology 20 % ( ACR20 ) response , ACR50 , ACR70 , immunogenicity and safety . Data were analysed for patients who received CT-P13 for 102 weeks ( maintenance group ) and for those who received RP for 54 weeks and then switched to CT-P13 ( switch group ) . Results Overall , 302 of 455 patients who completed the PLANETRA study enrolled into the extension . Of these , 158 had received CT-P13 ( maintenance group ) and 144 RP ( switch group ) .  Response rates at week 102 for maintenance versus switch groups , respectively , were 71.7 % vs 71.8 % for ACR20 , 48.0 % vs 51.4 % for ACR50 and 24.3 % vs 26.1 % for ACR70 . The proportion of patients with antidrug antibodies was comparable between groups ( week 102 : 40.3 % vs 44.8 % , respectively ) . Treatment-emergent adverse events occurred in similar proportions of patients in the two groups during the extension study ( 53.5 % and 53.8 % , respectively ) . Conclusions Comparable efficacy and tolerability were observed in patients who switched from RP to its biosimilar CT-P13 for an additional year and in those who had long-term CT-P13 treatment for 2 years . Trial registration number NCT01571219 ; Results BACKGROUND Recently , two infliximab biosimilar monoclonal antibodies ( mAb ) have been approved by the European Medical Agency for all immune-mediated inflammatory diseases ( IMID ) , including inflammatory bowel disease ( IBD ) . Current knowledge regarding biosimilars among gastroenterologists and in particular among IBD specialists is unknown . Therefore we developed a web survey to evaluate the awareness of biosimilar mAb among IBD specialists and their readiness to use these therapies . METHODS A 15- question multiple choice anonymous web survey was conducted with the logistic support of ECCO , with questions covering the most relevant aspects on biosimilars . R and omly selected ECCO members were invited by e-mail to participate . A descriptive analysis of responses was performed and analyzed
AIM To review the effectiveness and safety of switching from an originator anti-TNF ( Remicade ® ) to a biosimilar ( CT-P13 ) in patients with inflammatory bowel disease ( IBD ) .