Boehringer Ingelheim Reports P-III (VOLTAIRE-X) Trial Results of BI 695501 (biosimilar, adalimumab) for Chronic Plaque Psoriasis
Shots:
- The P-III (VOLTAIRE-X) trial evaluates BI 695501 vs Humira in 259 patients at 49 sites across EU & North America
- PK equivalence was demonstrated with highly similar efficacy, clinical outcomes, and immunogenicity, comparable safety was observed who received adalimumab RP continuously or who switched b/w adalimumab RP and BI 695501
- At 32wk., 85% & 79% of patients in switching & continuous groups had a 75% reduction in PASI scores; 70% & 65% had a static sPGA response of 1 or lower (clear or almost clear); 90% & 95% developed anti-drug Abs; 41% & 42% neutralizing Abs; TEAEs related to study treatment (12% & 18%); treatment discontinuation due to TEAEs in 0.8% & 1.7%, PASI scores were highly similar across the entire trial period, respectively
Ref: Centerforbiosimilars | Image: Boehringer Ingelheim
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