Adalimumab biosimilar performs well in chronic plaque psoriasis treatment
16 Sep 2022
The adalimumab biosimilar BI 695501 has demonstrated equivalent pharmacokinetics to the reference product (RP), with highly comparable efficacy, immunogenicity, and safety in patients with chronic plaque psoriasis, according to data from the phase III VOLTAIRE-X trial.
A total of 259 patients with moderate-to-severe chronic plaque psoriasis were treated with adalimumab RP during the run-in period, given at 80 mg subcutaneously on day 1, then 40 mg SC every other week (EOW) during weeks 2–12. Of these, 238 patients (mean age 44.9 years, 66 percent male) were randomized to either continue treatment with RP (n=118) or switch to BI 695501 (n=120).
Patients in the continuous arm received adalimumab RP 40 mg EOW from weeks 14 to 48. Those in the switching arm received BI 695501 40 mg at weeks 14 and 16, adalimumab RP 40 mg at weeks 18 and 20, and BI 695501 40 mg EOW Weeks 22 to 48 (switching arm). All treatments were administered subcutaneously.
The primary endpoints were pharmacokinetics parameters, area under the plasma concentration–time curve (AUCτ,30–32), and maximum observed drug plasma concentration (Cmax,30–32), measured after the third switch during the week 30–32 dosing interval.
Adjusted mean Cmax,30–32 values were 7.08 μg/mL in the switching group and 7.00 μg/mL in the continuous treatment group. The corresponding adjusted mean AUCτ,30–32 values were 2,025.8 and 1,925.9 μg h/mL.
The point estimates were 105.2 percent (90.2 percent confidence interval [CI], 96.6–114.6) for mean ratio for AUCτ,30–32 and 101.1 percent (90.2 percent CI 93.3–109.7) for Cmax,30–32. Both CIs were within the predefined bioequivalence range of 80.0–125.0 percent.
Treatment-emergent adverse events resulted in discontinuation in 0.8 percent and 1.7 percent of patients in the switching and continuous treatment groups, respectively. Likewise, Psoriasis Area and Severity Index (PASI) scores were highly similar in the two groups across the entire trial period.