Immunogenicity of Guselkumab Is Not Clinically Relevant in Patients with Moderate-to-Severe Plaque Psoriasis

Summary In pivotal Phase-3 studies (VOYAGE-1, VOYAGE-2), patients (N=1,829) with moderate-to-severe plaque psoriasis were randomized to subcutaneous guselkumab 100mg (Weeks0, 4, then every-8-weeks), placebo with guselkumab crossover at Week16, or adalimumab with guselkumab crossover at Week28 or Week52. The design of VOYAGE-2 incorporated a randomized withdrawal and retreatment period for patients who achieved ≥90% improvement in the Psoriasis Area and Severity Index (PASI) score at Week28. To assess guselkumab immunogenicity, we evaluated sera for anti-drug antibodies (ADA), systemic exposure (serum drug concentrations), efficacy (Investigator’s Global Assessment, PASI), and safety (injection-site reactions). Through Week100, 8.5% of evaluable guselkumab-treated patients were ADA+. Neither ADA development nor guselkumab withdrawal and retreatment reduced systemic drug exposure or clinical efficacy or increased the occurrence of injection-site reactions.