AI Article Synopsis
- BI 695501 is a biosimilar to Humira® and was tested in a Phase III trial (VOLTAIRE-PSO) for patients with moderate-to-severe chronic plaque psoriasis.
- The trial measured effectiveness based on the number of patients achieving at least a 75% reduction in psoriasis severity (PASI 75) after 16 and 24 weeks of treatment, finding similar response rates between BI 695501 and adalimumab.
- Safety results showed that both treatments had comparable rates of treatment-emergent adverse events and similar rates of anti-drug antibody positivity, indicating that BI 695501 is as safe and effective as the adalimumab reference product.
Article Abstract
: BI 695501 is an approved biosimilar to Humira® reference product (RP). : In this randomized Phase III trial (VOLTAIRE-PSO), patients with moderate-to-severe chronic plaque psoriasis received BI 695501 or adalimumab RP (24-week treatment). Primary efficacy endpoint: the proportion of patients with ≥75% reduction in Psoriasis Area and Severity Index (PASI 75) response at week 16 (±18% equivalence limits for two-sided 95% confidence interval between treatment groups). Safety, pharmacokinetics, and immunogenicity were also assessed. : Baseline characteristics were balanced between treated groups (BI 695501, = 159; adalimumab RP, = 158). PASI 75 response rates (full analysis set, = 158; = 157) were 68.2% (BI 695501) and 70.4% (adalimumab RP) at week 16 (95% CI: -14.4%, 8.7%), and 75.3% and 72.4%, at week 24, respectively. At week 24, 41.5% (BI 695501) and 44.9% (adalimumab RP) of treated patients had treatment-emergent adverse events (AEs), 3.1% and 4.4% had serious AEs, and 0.0% and 1.9% had AEs of special interest. Of treated patients, 75.3% (BI 695501) and 77.9% (adalimumab RP) were anti-drug antibody-positive. : These data demonstrate equivalent efficacy and highly similar safety and immunogenicity between BI 695501 and adalimumab RP in patients with chronic plaque psoriasis. : NCT02850965.
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| http://dx.doi.org/10.1080/14712598.2021.1851362 | DOI Listing |
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