Tremfya Five-Year Data Show No New Safety Signals
New data published in the Journal of the American Academy of Dermatology show that Tremfya® (guselkumab) from Janssen demonstrates a favorable safety profile and is well tolerated in adult patients with moderate to severe psoriasis (PsO) for up to 5 years. This is the first report on immunogenicity for an IL-23 inhibitor through 5 years.
The reported data reflects a total of 7,166 patient-years (PY). Overall, 1,349 of 1,721 guselkumab-treated patients (78.4%) continued treatment through week 252.
Event rates at week 264 were generally similar to those at week 52 in VOYAGE 1 and at week 100 in VOYAGE 2. Rates of adverse events of interest were low. These include serious infections (0.85/100 PY), nonmelanoma skin cancer (0.34/100 PY), malignancies other than nonmelanoma skin cancer (0.45/100 PY), and major adverse cardiovascular events (0.29/100 PY). The authors note that ear-to-year variability was evident, but no increasing trend was observed.