P35 An experience of switching paediatric inflammatory bowel disease patients on infliximab therapy to the biosimilar ‘remsima’

2018 ◽  
Vol 103 (2) ◽  
pp. e1.39-e1
Author(s):  
Healy Mary ◽  
Crook Joanne ◽  
Chavda Charlene ◽  
Smith Elaine
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Adverse Reactions ◽  
Improve Patient Care ◽  
Biologic Treatment ◽  
Reference Molecule ◽  
Black Triangle ◽  
Complex Development ◽  
Safety Studies ◽  
Inflammatory Bowel

IntroductionThe treatment of inflammatory bowel disease (IBD) with anti-tumour necrosis factor (anti-TNF) biologic therapies such as infliximab is expensive, due to the complex development and manufacturing processes involved with the drug. The number of paediatric patients (PP) receiving infliximab at our trust is increasing, leading to NHS cost pressures. The patent for the infliximab reference molecule Remicade has expired and considerably cheaper biosimilar products are now available, such as Remsima. The license for Remsima was based on adult rheumatology patients; this data was then extrapolated across all licenses. There are currently no long term safety studies of Remsima in children.A biosimilar drug can be defined as ‘a biotherapeutic product that is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product.’1AimWe wanted to switch all PP receiving infliximab for IBD at our trust from Remicade to a new biosimilar product – Remsima.MethodThe paediatric gastroenterology MDT agreed that all new patients started on infliximab since spring 2016 would be treated with Remsima.Information was gathered regarding the safety, switchability and efficacy of Remsima before the change was made.2 For existing patients, we also contacted other trusts who had already made the switch to gain from their experience. Our current patients on Remsima were reviewed, and no problems were reported.Existing patients were identified and a letter informing their parent/guardian of why we were changing from Remicade to Remsima was posted. An agreed date after which the switch in treatment would occur allowed any concerns or questions to be addressed on previous visits to the hospital.ResultsOverall, the method used was a success: all but one of the identified patients agreed to switch to Remsima – one family refused and the child continues to receive Remicade treatment. All patients on Remsima continue to be monitored closely for adverse reactions or a decline in their disease control. Infliximab levels and antibodies are checked as per local guidelines. Any adverse reactions are reported to the MHRA via the yellow card scheme; Remsima is a black triangle medicine.3ConclusionBiosimilar medicines present a considerable cost saving to the NHS, and by switching our paediatric IBD patients receiving treatment with infliximab from the reference molecule Remicade to the biosimilar Remsima, the Trust has been able to take advantage of this.The saving is substantial and across our 60+patients is somewhere in the region of £250,000 – £2 75 000 a year. This money can be reinvested into the paediatric IBD service to improve patient care. We hope that our experience of switching can be used to support other Trusts in following suit.As further biosimilar medications become available, the NHS could continue to benefit by switching patients receiving biologic treatment.

scholarly journals S775 Seroprevalence of COVID-19 in Patients With Inflammatory Bowel Disease Under Biologic Treatment

2021 ◽  
Vol 116 (1) ◽  
pp. S359-S359
Author(s):  
Isabel Garrido ◽  
Susana Lopes ◽  
Maria João Cardoso ◽  
Angélica Ramos ◽  
João Tiago Guimarães ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Biologic Treatment ◽  
Inflammatory Bowel

scholarly journals P60 Efficacy of switching to infliximab biosimilar (Remsima®) in paediatric inflammatory bowel disease (PIBD): a 2-Year retrospective evaluation

2020 ◽  
Vol 105 (9) ◽  
pp. e37.2-e38
Author(s):  
Fatima Yaqub ◽  
Joanne Crook ◽  
John Fell
Keyword(s):  
Inflammatory Bowel Disease ◽  
Treatment Failure ◽  
Disease Activity ◽  
Patient Outcomes ◽  
Bowel Disease ◽  
Adverse Reactions ◽  
Double Blind ◽  
Time Points ◽  
Parallel Group ◽  
Inflammatory Bowel

AimTo evaluate patient outcomes 2 years post switching Infliximab therapy from Infliximab originator molecule Remicade® to biosimilar Remsima®.MethodsPatients with PIBD who experienced induction with Remicade® therapy, were <18 years old at last follow-up and were receiving active treatment with Remsima® 2 years post switching were selected to be included for evaluation. Outcome measures included monitoring disease activity and treatment failure at baseline (before switching) and at selected time points up to 2 years post-switch. Disease activity was assessed looking at a range of parameters: disease activity scores; trough infliximab levels; haematological markers (HGB, platelets, WBC); LFTs (bilirubin, ALT, ALP); inflammatory markers (ESR, CRP) and faecal calprotectin levels. Patients who failed therapy were assessed for adverse reactions and infliximab antibody formation. Data was analysed with the Cochran Q test, repeated measures ANOVA test and Friedman test; with post-hoc Bonferroni and Wilcoxon Signed-Ranks tests if appropriate.ResultsData was available for 18 patients after exclusion criteria were applied. There was a significant increase in trough infliximab levels by the end of the period from an average of 5 ug/L to 12 ug/L at 2 years. The average dose/kg increased over 2 years by 1.5 mg/kg. Disease activity markers showed no changes between time points except a decrease in ALP levels from baseline to 1 year, but values remained within normal ranges. Four patients were discontinued from Remsima® due to side effects or loss of efficacy. The average time to treatment failure on Remsima® was 38 months (~19/20 doses). Three out of four patients developed infliximab antibodies, 2 of these patients went on to suffer adverse reactions; 1 exhibited joint pain which settled weeks after each infusion and the other developed an immediate infusion reaction in the form of a rash with urticaria on the 3rd infusion of Remsima®.ConclusionInfliximab biosimilars, such as Remsima®, were approved for use in PIBD by the EMA after studies in adult populations with rheumatic diseases.1 2 Induction studies have shown efficacy in PIBD but data on switching is limited and short-term.3 4 Our data shows no significant differences in clinical patient outcomes over a 2-year period in a cohort switched from Remicade® to Remsima®. In fact, a significant increase in trough infliximab levels in patients remaining on Remsima® suggests efficacy in producing therapeutic levels in PIBD patients. Increased levels may be explained by dose intensification used by the PIBD multi-disciplinary team (MDT), reflecting careful dose optimisation strategies used at this trust throughout the time period. Patients losing response were not unexpected and are likely not due to the biosimilar switch but rather due to the length of time the patients were on treatment. The small sample size and retrospective nature of this study mean larger cohort studies are required over prolonged time periods to confirm these findings. PIBD MDTs should continue to monitor patients for adverse reactions, particularly in those who develop infliximab antibodies.ReferencesPark W, Hrycaj P, Jeka S, et al. 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. Ann Rheum Dis 2013;72:1605–1612.Yoo DH, Hrycaj P, Miranda P, et al. Extended report: a randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when co-administered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013;72:1613.Sieczkowska J, Jarzębicka D, Banaszkiewicz A, et al. Switching Between Infliximab Originator and Biosimilar in Paediatric Patients with Inflammatory Bowel Disease. Preliminary Observations. J Crohn’s Colitis 2016;10:127–132.Sieczkowska J, Jarzębicka D, Meglicka M, et al. Experience with biosimilar infliximab (CT-P13) in paediatric patients with inflammatory bowel diseases. Therap Adv Gastroenterol 2016;9:729–735.

scholarly journals Health outcomes of 1000 children born to mothers with inflammatory bowel disease in their first 5 years of life

Gut ◽  
2020 ◽  
pp. gutjnl-2019-319129
Author(s):  
Shannon Linda Kanis ◽  
Sanne Modderman ◽  
Johanna C Escher ◽  
Nicole Erler ◽  
Ruud Beukers ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Autoimmune Diseases ◽  
Health Outcomes ◽  
Bowel Disease ◽  
Adverse Reactions ◽  
Medication Use ◽  
In Utero Exposure ◽  
Tnf Α ◽  
Inflammatory Bowel

ObjectiveThe aim of this study was to describe the long-term health outcomes of children born to mothers with inflammatory bowel disease (IBD) and to assess the impact of maternal IBD medication use on these outcomes.DesignWe performed a multicentre retrospective study in The Netherlands. Women with IBD who gave birth between 1999 and 2018 were enrolled from 20 participating hospitals. Information regarding disease characteristics, medication use, lifestyle, pregnancy outcomes and long-term health outcomes of children was retrieved from mothers and medical charts. After consent of both parents, outcomes until 5 years were also collected from general practitioners. Our primary aim was to assess infection rate and our secondary aims were to assess adverse reactions to vaccinations, growth, autoimmune diseases and malignancies.ResultsWe included 1000 children born to 626 mothers (381 (61%) Crohn’s disease, 225 (36%) ulcerative colitis and 20 (3%) IBD unclassified). In total, 196 (20%) had intrauterine exposure to anti-tumour necrosis factor-α (anti-TNF-α) (60 with concomitant thiopurine) and 240 (24%) were exposed to thiopurine monotherapy. The 564 children (56%) not exposed to anti-TNF-α and/or thiopurine served as control group. There was no association between adverse long-term health outcomes and in utero exposure to IBD treatment. We did find an increased rate of intrahepatic cholestasis of pregnancy (ICP) in case thiopurine was used during the pregnancy without affecting birth outcomes and long-term health outcomes of children. All outcomes correspond with the general age-adjusted population.ConclusionIn our study, we found no association between in utero exposure to anti-TNF-α and/or thiopurine and the long-term outcomes antibiotic-treated infections, severe infections needing hospital admission, adverse reactions to vaccinations, growth failure, autoimmune diseases and malignancies.

Real-world Pattern of Biologic Use in Patients With Inflammatory Bowel Disease: Treatment Persistence, Switching, and Importance of Concurrent Immunosuppressive Therapy

2019 ◽  
Vol 25 (8) ◽  
pp. 1417-1427 ◽  
Author(s):  
Chao Chen ◽  
Abraham G Hartzema ◽  
Hong Xiao ◽  
Yu-Jung Wei ◽  
Naueen Chaudhry ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Survival Time ◽  
Median Survival ◽  
Real World ◽  
Bowel Disease ◽  
Median Survival Time ◽  
High Rate ◽  
Biologic Treatment ◽  
Treatment Persistence ◽  
Inflammatory Bowel

Abstract Background and aims Medication persistence, defined as the time from drug initiation to discontinuation of therapy, has been suggested as a proxy for real-world therapeutic benefit and safety. This study seeks to compare the persistence of biologic drugs among patients with inflammatory bowel disease (IBD). Methods Patients with newly diagnosed IBD were included in a retrospective study using Truven MarketScan database. Treatment persistence and switching was compared among biologic medications including infliximab, adalimumab, certolizumab, golimumab, and vedolizumab. Predictors for discontinuation and switching were evaluated using time-dependent proportional hazard regression. Results In total, 5612 patients with Crohn’s disease (CD) and 3533 patients with ulcerative colitis (UC) were included in this analysis. Less than half of the patients continued using their initial biologic treatment after 1 year (48.48% in CD cohort; 44.78% in UC cohort). In the first year, adalimumab had the highest persistence and lowest switching rates for both CD (median survival time: 1.04 years) and UC (median survival time: 0.84 years). In subsequent years, infliximab users were more likely to persist in the use of biologic. Combination therapy with immunomodulators significantly decreased the risk of discontinuation, especially when immunomodulator therapy was started more than 30 days before the biologic (hazard ratio [HR], 0.22; CI, 0.16, 0.32). The major predictors for noncompliance included infection and hospitalization. Conclusion Overall, the persistence profiles of biologics suggest a high rate of dissatisfaction or adverse disease outcomes resulting in discontinuation and switching to a different agent. Early initiation of immunomodulators will substantially increase the persistence of biologic treatment.

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