120 Safety of Guselkumab in Patients with Moderate to Severe Psoriasis: Pooled Analyses Across Clinical Studies

Guselkumab (GUS) studies in plaque psoriasis (PsO) have established a favorable safety profile for the drug. To evaluate the cumulative safety experience in PsO, we pooled safety for the placebo-controlled (wk 0-16 in CNTO1959PSO2001, CNTO1959PSO3001/3002, and CNTO1959PSO3006) and end-of-reporting (wk 0-40 for CNTO1959PSO3006; wk16-44 for CNTO1959PSO3003; wk0-52 for CNTO1959PSO2001 and CNTO1959PSO3004; wk0-56 for CNTO1959PSO3009; and through wk264 for CNTO1959PSO3001/3002) periods from phase2/3 studies of GUS. Pooled data were adjusted by exposure /100 patient (pts)-years of follow-up (100PY). During the placebo (PBO)-controlled period, 544 pts received PBO (165PY) and 1220 received GUS (378PY). Adverse event (AE) rates were similar for PBO (341.12/100PY) and GUS (345.63/100PY); corresponding serious AE (SAE) rates were 6.66/100PY and 6.34/100PY. Infection rates were: PBO, 83.61/100PY; GUS, 95.92/100PY. Serious infections (SIs) occurrence rates were PBO, 1.21/100PY; GUS, 1.06/100PY. The rate was 0.26/100PY for both nonmelanoma skin cancer (NMSC) and malignancies other than NMSC in the GUS group; none in PBO. Through the end-of-reporting period (n=2891 pts; 8662PY), rates remained low for GUS -treated pts: AE, 169.02/100PY; SAE, 5.26/100PY; infections, 65.92/100PY; SIs, 0.88/100PY. Other AEs of interest rates were: malignancies, 0.43/100PY; NMSC, 0.35/100PY; major adverse cardiovascular events, 0.33/100PY. In GUS-treated pts, there were no reported active tuberculosis or opportunistic infections; no serum sickness-like/anaphylactic reactions related to GUS were reported. This pooled analyses confirm the established safety profile of GUS for pts treated for up to 5 years.