A switch from originator-adalimumab to the biosimilar SB5 in patients with Crohn's disease: an analysis of two propensity score-matched cohorts
Language English Country England, Great Britain Media print-electronic
Document type Journal Article
- Keywords
- Crohn’s disease, adalimumab, biosimilar,
- MeSH
- Adalimumab adverse effects MeSH
- Biosimilar Pharmaceuticals * adverse effects MeSH
- Crohn Disease * chemically induced drug therapy MeSH
- Adult MeSH
- Cohort Studies MeSH
- Humans MeSH
- Adolescent MeSH
- Propensity Score MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Adolescent MeSH
- Publication type
- Journal Article MeSH
- Names of Substances
- Adalimumab MeSH
- Biosimilar Pharmaceuticals * MeSH
BACKGROUND/AIMS: Originator-adalimumab, an established treatment for patients with Crohn's disease (CD), showed no difference in efficacy or adverse events versus adalimumab biosimilar SB5 (SB5-adalimumab) over 10 weeks (W) of treatment. To understand the long-term effectiveness of SB5-adalimumab in CD, patients switched from originator-adalimumab to SB5-adalimumab were compared with patients remaining on originator-adalimumab over 104 W. METHODS: Data on patients aged ≥18 years, diagnosed with CD and treated at ISCARE, were collected prospectively from July 2018 to January 2021. Primary outcome: clinical disease activity at W52, measured by Harvey-Bradshaw index (HBI). Secondary outcomes: C-reactive protein (CRP), faecal calprotectin (FC) and adalimumab concentrations at W10, 26, 52 and 104, and treatment persistence. To ensure comparable cohorts, patients were propensity score (PS)-matched for age, gender and disease activity. RESULTS: After matching, 54 patients remained per cohort. At W52, mean (SD) HBI score was 3.2 (2.5) for originator-adalimumab and 4.0 [3.6] for SB5-adalimumab (difference [95% CI] -0.78 [-2.8, 1.3]; n = 18/cohort); no clinically meaningful differences in CRP, FC or drug concentrations were noted. Kaplan-Meier's estimates (95% CI) of remaining on treatment were originator-adalimumab: 0.870 (0.785-0.965) versus SB5-adalimumab: 0.648 (0.533-0.789) at W52 and significantly lower for SB5-adalimumab versus originator-adalimumab (p < .001) over 104 W. Local skin reaction events/pain was the main reason for treatment discontinuation in the SB5-adalimumab cohort (n = 20/54 [37%]). CONCLUSIONS: These long-term results of CD patients receiving originator-adalimumab or following nonmedical switch to SB5-adalimumab show similar therapeutic effects on clinical disease activity, biological parameters and pharmacokinetic profile in both cohorts from 52 to 104 W. A separation in persistence was observed beyond W26, mainly due to differences in local reactions at the injection site.
1st Medical Faculty Charles University Prague Czech Republic
IBD Clinical and Research Centre ISCARE a s Prague Czech Republic
Institute of Computer Science of the Czech Academy of Sciences Prague Czech Republic
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