TY - JOUR
T1 - Effectiveness and Safety of Adalimumab Biosimilar SB5 in IBD
T2 - Outcomes in Originator to SB5 Switch, Double Biosimilar Switch and Bio-Naieve SB5 Observational Cohorts
AU - Derikx, Lauranne A A P
AU - Dolby, Heather W
AU - Plevris, Nikolas
AU - Lucaciu, Laura
AU - Rees, Caitlin S
AU - Lyons, Mathew
AU - Siakavellas, Spyros I
AU - Constantine-Cooke, Nathan
AU - Jenkinson, Philip
AU - Su, Shanna
AU - O'Hare, Claire
AU - Kirckpatrick, Laura
AU - Merchant, Lynne M
AU - Noble, Colin
AU - Arnott, Ian D
AU - Jones, Gareth-Rhys
AU - Lees, Charlie W
N1 - © The Author(s) 2021. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.
PY - 2021/6/5
Y1 - 2021/6/5
N2 - BACKGROUND AND AIMS: Multiple adalimumab (ADA) biosimilars are now approved for use in IBD; however, effectiveness and safety data remain scarce. We aimed to investigate long-term outcomes of the adalimumab (ADA) biosimilar SB5 in IBD patients following a switch from the ADA originator (SB5-switch cohort) or after start of SB5 (SB5-start cohort).METHODS: We performed an observational cohort study in a tertiary IBD referral centre. All IBD patients treated with Humira® underwent an elective switch to SB5. We identified all these patients in a biologic prescription database that prospectively registered all ADA start and stop dates including brand names. Data on IBD phenotype, CRP, drug persistence, ADA drug and antibody levels, and faecal calprotectin were collected.RESULTS: 481 patients were treated with SB5, 256 in the SB5-switch cohort (median follow-up: 13.7 months [8.6-15.2]) and 225 in the SB5-start cohort (median follow-up: 8.3 months [4.2-12.8]). 70.8% of the SB5-switch cohort remained on SB5 beyond one year; 90/256 discontinued SB5, mainly due to adverse events (46/90) or secondary loss of response (37/90). In the SB5-start cohort, 81/225 discontinued SB5 resulting in SB5-drug persistence of 60.3% beyond one year. No differences in clinical remission (p=0.53), CRP (p=0.80), faecal calprotectin (p=0.40) and ADA trough levels (p=0.55) were found between baseline, week 26 and week 52 following switch. Injection site pain was the most frequently reported adverse event.CONCLUSION: Switching from ADA originator to SB5 appeared effective and safe in this study with over 12 months of follow-up.
AB - BACKGROUND AND AIMS: Multiple adalimumab (ADA) biosimilars are now approved for use in IBD; however, effectiveness and safety data remain scarce. We aimed to investigate long-term outcomes of the adalimumab (ADA) biosimilar SB5 in IBD patients following a switch from the ADA originator (SB5-switch cohort) or after start of SB5 (SB5-start cohort).METHODS: We performed an observational cohort study in a tertiary IBD referral centre. All IBD patients treated with Humira® underwent an elective switch to SB5. We identified all these patients in a biologic prescription database that prospectively registered all ADA start and stop dates including brand names. Data on IBD phenotype, CRP, drug persistence, ADA drug and antibody levels, and faecal calprotectin were collected.RESULTS: 481 patients were treated with SB5, 256 in the SB5-switch cohort (median follow-up: 13.7 months [8.6-15.2]) and 225 in the SB5-start cohort (median follow-up: 8.3 months [4.2-12.8]). 70.8% of the SB5-switch cohort remained on SB5 beyond one year; 90/256 discontinued SB5, mainly due to adverse events (46/90) or secondary loss of response (37/90). In the SB5-start cohort, 81/225 discontinued SB5 resulting in SB5-drug persistence of 60.3% beyond one year. No differences in clinical remission (p=0.53), CRP (p=0.80), faecal calprotectin (p=0.40) and ADA trough levels (p=0.55) were found between baseline, week 26 and week 52 following switch. Injection site pain was the most frequently reported adverse event.CONCLUSION: Switching from ADA originator to SB5 appeared effective and safe in this study with over 12 months of follow-up.
U2 - 10.1093/ecco-jcc/jjab100
DO - 10.1093/ecco-jcc/jjab100
M3 - Article
C2 - 34089587
SN - 1873-9946
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
ER -