Long-Term Safety Profile of Guselkumab Consistent With Short-Term Outcomes

Historically, there have been concerns about using TNF inhibitors to treat psoriasis due to increased risk for tuberculosis.

Guselkumab is associated with a robust long-term safety profile in the setting of psoriatic disease, according to study results published in British Journal of Dermatology.

Researchers pooled safety data from 7 phase 2 and phase 3 clinical trials of guselkumab for the treatment of psoriasis. The studies compared outcomes with placebo in 5 studies, and the guselkumab treatment durations lasted between 52 and 264 weeks.

Overall, 3708 participants were included in the final analysis. Stratified by study cohort, patients had a mean age of 43.5 to 48.8 years, of whom 67.5% to 75.5% were men, and 77.6% to 93.4% of the participants were White in 6 of the trials (100% of participants were Asian in the seventh trial). Mean Psoriasis Area and Severity Index (PASI) scores were 18.0 to 26.1 points, and patients had an affected body surface area (BSA) of 8.9% to 20.0%.

In the 16-week placebo-controlled period, 1220 patients received guselkumab and 544 received placebo. The exposure-adjusted incidence rates (EAIR) of adverse events were 346 (95% CI, 327-365) per 100 person-years for guselkumab and 341 (95% CI, 314-371) per 100 person-years for placebo.

Safety event rates in guselkumab-treated patients were similar to those observed with placebo and were consistent throughout long-term treatment.

Similarly, the rates of serious adverse events (EAIR, 6.34 vs 6.66 per 100 person-years), adverse events leading to discontinuation (EAIR, 5.02 vs 9.69 per 100 person-years), serious infections (EAIR, 1.06 vs 1.21 per 100 person-years), malignancies (EAIR, 0.53 vs 0 per 100 person-years), major adverse cardiovascular events (EAIR, 0.26 vs 0 per 100 person-years), inflammatory bowel disease (EAIR, 0 vs 0 per 100 person-years), and suicidal ideation or behavior (EAIR, 0 vs 0 per 100 person-years) did not differ significantly between guselkumab and placebo recipients, respectively.

In the long-term safety analysis of guselkumab with 2891 participants and an 8662 person-years follow-up, rates of adverse events were consistent with the placebo-controlled period. Specifically, the adverse event rate was 169 per 100 person-years, serious adverse event rate was 5.26 per 100 person-years, and the rate of adverse events leading to discontinuation was 1.59 per 100 person-years.

No study reported serum sickness or anaphylactic reactions.

Limitations of the study include the lack of generalizability to real-world patient populations, as all data were sourced from clinical trials with strict eligibility criteria.

Study authors conclude, “In this pooled analysis in 2891 patients with psoriasis treated for up to 5 years, guselkumab demonstrated [favorable] safety, consistent with previous reports.”

Disclosures: This research was supported by Janssen Scientific. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Lebwohl MG, Merola JF, Rowland K, et al. Safety of guselkumab treatment for up to 5 years in patients with moderate-to-severe psoriasis: pooled analyses scross seven clinical trials with greater than 8600 patient-years of exposure. Br J Dermatol. 2023;ljad115. doi:10.1093/bjd/ljad115