PTU-059 Early Experience with Biosimilar Infliximab at a District General Hospital for an Entire Crohns Disease Patient Cohort Switch from Remicade to Inflectra

Abstract

IntroductionSwitching from an established biologic to a biosimilar to save costs was considered likely to be ‘inappropriate and ineffective’ by ECCO.1MethodsWith Area Prescribing Committee approval, all Crohns disease (CD) patients established on Remicade were provided with written and verbal information regarding the proposed switch, and all patients infused after April 2015 received Inflectra. Baseline calprotectin and Infliximab antibody and trough levels were undertaken. Harvey Bradshaw Indices (HBI) were assessed at every 8 week infusion.Results21 CD patients were already established on Remicade treatment. 1 patient did not receive Inflectra as he was relapsing with high antibody and low trough levels. 4 other patients with high antibody levels (>10iU/L) did receive Inflectra, but increasing symptoms led to alternative immunosuppression in 3 of these patients (2 with Adalumimab, 1 with Allopurinol/Azathioprine). A decision was made just to stop infliximab in the 4’th pt as they were in full clinical remission. The results of the remaining 16 patients are illustrated below.ConclusionAlthough this is a small dataset, early results are encouraging. Patients understood the rationale behind the switch. There were no significant adverse events as a consequence of the switch. The majority of patients either remained in clinical remission or improved during the follow up period. The annual confirmed cost savings of £220,000 permitted investment in further IBD nurse monitoring (0.5 WTE) and allowed the introduction of infliximab trough and antibody testing which has certainly optimised and rationalised treatment decisions in these complex patients.Abstract PTU-059 Figure 1Changes in HBIAbstract PTU-059 Figure 2CalprotectionReference1 Danese S, et al. ECCO position statement: the use of biosimilar medicines in the treatment of IBD. J Crohns Colitis 2013;7(7): 586–9.Disclosure of InterestNone Declared

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review

“…Eight studies reported that switching generally had no noticeable effect, but did not provide a formal statistical analysis of between-group comparisons or based this conclusion on modelling [44, 45, 52, 65, 83, 88–90]. Two studies reported on switching from infliximab originator to biosimilar.…”

“…In terms of safety data after switching, eight studies reported no concerns or similar safety profiles before and after switching [43, 44, 47, 50, 62, 63, 79, 87, 89], six studies reported no general safety data [45, 51, 72, 77, 83, 90], and 12 studies reported adverse events such as injection site pain, acute hypersensitivity reactions, rash and infusion reactions after switching (although most did not provide comparative data from before switching) [46, 48, 49, 52, 54, 58, 65–68, 71, 88]. …”

“…Pain (29 mm vs 38 mm; P  = 0.028) and CRP values (1.95 vs 4.0 mg/L; P  = 0.001) significantly higher during longer follow-upNo significant difference in number of SAEs (2 vs 3), AEs (numbers NR) or infusion reactions (1 vs 1) during follow-up periods. 5 patients discontinued INXNRAla et al 2016 (abstract) [44]With IBD ( N  = 20)20INX RP, duration NRCT-P13, 6 months post-switchMost patients remained in clinical remission or improved during follow-up (actual numbers NR)No significant AEs reported post-switchNRArguelles-Arias et al 2017 [45]With IBD ( N  = 120)98Originator INX, median duration 297 weeks, or INX-naiveCT-P13, follow-up 6 monthsRemained in clinical remission, switched vs naïve, CD, 3 months: 88 vs 67%; 6 months: 84 vs 50%. UC, 3 months: 92 vs 44%; 6 months: 91 vs 67%NR separately for the 2 treatment groupsNRBennett et al 2016 (abstract) [46]With IBD ( N  = 104)104INX RP, median time 162 weeksCT-P13, follow-up 6 monthsPre-switch vs post-switch, median CRP: 2 vs 2 ( P  = 0.81); median DAS: 1 vs 1 ( P  = 0.44); remission: 85 vs 81% ( P  = 0.51)After switch: 4 patients had AEs (2 minor infusion reactions, 2 skin disease); 19 patients stopped treatment (6 electively, 9 loss of response, 4 for other reasons)Pre-switch vs post-switch: 29 vs 27 patients ( P  = 0.88)Benucci et al 2017 [47]With SpA ( N  = 41)41Originator INX, median duration 74 monthsBiosimilar INX, follow-up 6 months6 months before vs 6 months after switch, median BASDAI (2.6 vs 2.7), BASFI (2.2 vs 2.3), ASDAS-CRP (1.3 vs 1.4); DAS28-CRP (2.7 vs 2.7), MASES (0.2 vs 0.4), VAS pain (17 vs 18) (all P  > 0.05).…”

The Economic Impact of Originator-to-Biosimilar Non-medical Switching in the Real-World Setting: A Systematic Literature Review

“…The characteristics associated with treatment discontinuation following originator-to-biosimilar NMS are presented in Table S2 in the electronic supplementary material. Biosimilar discontinuation rates were variable between studies and disease areas ranging from 2.6% to 38.5% [ 32 , 35 , 36 , 39 , 42 , 44 , 45 , 50 – 70 ]. Switch-back rates (to the reference biologic) ranged from 0.5% to 16% [ 7 , 32 , 36 , 41 – 44 , 61 , 63 , 64 , 67 – 73 ], while the rate of switching to an alternative drug ranged from 0.9% to 18.2% [ 32 , 35 , 37 , 39 , 41 , 42 , 45 , 50 , 54 , 55 , 57 , 61 , 62 , 64 , 67 – 70 ].…”

“…Biosimilar discontinuation rates were variable between studies and disease areas ranging from 2.6% to 38.5% [ 32 , 35 , 36 , 39 , 42 , 44 , 45 , 50 – 70 ]. Switch-back rates (to the reference biologic) ranged from 0.5% to 16% [ 7 , 32 , 36 , 41 – 44 , 61 , 63 , 64 , 67 – 73 ], while the rate of switching to an alternative drug ranged from 0.9% to 18.2% [ 32 , 35 , 37 , 39 , 41 , 42 , 45 , 50 , 54 , 55 , 57 , 61 , 62 , 64 , 67 – 70 ]. Common reasons for discontinuation resulting in a switch included loss of response (LOR) [ 39 , 44 , 52 – 57 , 59 , 62 , 63 , 66 , 69 , 70 ], disease activity [ 41 – 43 , 45 , 50 , 51 , 65 , 67 – 69 , 72 ], and AEs [ 42 – 45 , 51 , 53 – 55 , 57 , 59 – 61 , 63 – 65 , 67 , 69 , 70 , 73 ], all of which could be directly asso...…”