P122 Switching from originator adalimumab to biosimilar SB5(Imraldi) – IBD service assessment and needs

• Published in: Gut Vol. 70; no. Suppl 1; p. A105
• Main Authors: Koumoutsos, Ioannis, Cowperthwaite, Susan, Glover, Sharon, Sheil, Chloe, Vakeeswarasarma, Vithushan, Strickland, Christopher
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group LTD 01.01.2021
• Subjects: Biochemical markers; Biological products; C-reactive protein; Cost control; Immunotherapy; Monoclonal antibodies; Patients; Pharmacists; Remission; TNF inhibitors
• ISSN: 0017-5749; 1468-3288
• DOI: 10.1136/gutjnl-2020-bsgcampus.197

IntroductionBiosimilar versions of adalimumab became available in the UK in late 2018. BSG suggests that automatic substitution to biosimilars would be inappropriate and patients should be switched to biosimilar if stable or in remission.AimTo review whether biosimilar of Adalimumab(SB5) was inferior to originator drug and assess efficiency of IBD service throughout the process.MethodsWe reviewed Adalimumab prescriptions from 1/2015 until 12/2018 when the switch to biosimilars was performed. Disease activity was assessed using laboratory parameters (C-reactive protein (CRP) and faecal calprotectin (FC) where available and patient reported outcomes.ResultsIn total 121 Adalimumab prescriptions were issued from 1/2015 until 12/2018. We identified 77 patients that were switched to SB5 Adalimumab. Despite having an automatic substitution being implemented by our pharmacists, none of the patients declined change of treatment due to associated cost savings and only one patient requested to return to the originator following clinical deterioration.Secondary loss of response 52 wks post switch of treatment occurred in 16.8% (13/77) following change to biosimilar, whereas 12.4% (15/121) patients have experienced secondary loss of response to originator drug prior to transition period (p:0.3). 23.3% of patients reported clinical deterioration of symptoms, and 13% (10/77) of pts were changed to second line biosimilar due to side effects (mainly pain at the site of injection).From patients with baseline biochemical markers available, 25.3% (18/71) of patients had raised CRP and 36% (17/45) of patients had raised calprotectin. Worsening of CRP and faecal calprotectin were noted in 33% and 43% of these respectively. Subtherapeutic Adalimumab levels (<5UG/ml) were identified in 14 patients but non-significant change of Adalimumab levels was seen in patients that had levels performed prior and after the transition period.In terms of follow up, 28.6% (22/77) of patients were not seen 6 months pre or post transition period, and 35% (27/77) of patients still have not been reviewed 1 year post transition.ConclusionBiosimilar SB5 was not inferior to originator and patient acceptance was very good due to associated cost savings. Whereas switching to a biosimilar should be performed in patients in remission, 25–36% had biochemical markers suggestive of active disease. Follow up of patients was suboptimal due to staffing issues. This indicates the importance of investment of cost savings back into IBD services to optimise their performance.