Clarifying Risks and Efficacy of Biologic Agents for Psoriasis

No Dose-Related Toxicity Detected in Five-Year Ustekinumab Data

Rates of adverse events (AEs) reported in ustekinumab (Stelara, Janssen) psoriasis trials are generally comparable to those reported for other biologics approved for the treatment of moderate-to-severe psoriasis, according to a new study. Researchers evaluated the safety of ustekinumab in patients with moderate-to-severe psoriasis treated for up to five years, pooling safety data from four studies. Rates of AEs, serious AEs (SAEs), and AEs of interest (infections, non-melanoma skin cancers [NMSC], other malignancies, and major adverse cardiovascular events [MACE]) per 100 patient-years (PY) of follow-up were analyzed by ustekinumab dose (45mg or 90mg) and by year of follow-up (year one to five) to evaluate dose-response and impact of cumulative exposure. They then compared observed rates of overall mortality and other malignancies with those expected in the general US population. Through year five, event rates (45mg, 90mg) for overall AEs (242.6, 225.3), SAEs (7.0, 7.2), serious infections (0.98, 1.19), NMSC (0.64, 0.44), other malignancies (0.59, 0.61), and MACE (0.56, 0.36) were comparable between dose groups. The researchers did observes some year-toyear variability, but no increasing trend was evident. They concluded that rates of overall mortality and other malignancies were comparable with those expected in the general US population. Thus, no dose-related or cumulative toxicity was observed with increasing duration of ustekinumab exposure for up to five years.

Biologic-Naive Patients Fare Well With Introduction of Therapy

Patients with moderate to severe psoriasis benefit from biological agents in clinical practice, and patients with the highest pretreatment PASI and DLQI scores see the most benefit, according to a new study. Researchers analyzed PASI and DLQI scores in psoriasis patients who switched from conventional systemic treatment to biological agents in clinical practice. They found that biological-naïve patients who switched to a biological agent significantly improved in all measures. Moreover, patients with DLQI ≥10 and/or PASI ≥10 had the greatest benefits from biological agents.