Guselkumab demonstrates long-term efficacy, safety in psoriasis

Key takeaways:

• PASI 90 and PASI 100 was achieved by 71.58% and 55.79% of patients, respectively, by week 52.
• At 2 years, 79.63% and 61.11% achieved the same.

Guselkumab can effectively and safely treat patients with psoriasis for up to 2 years, according to a study.

“Guselkumab is the first human IgG1 lambda monoclonal antibody that inhibits [interleukin]-23 selectively, and it has been evaluated in three phase 3 clinical trials, showing superior efficacy compared with placebo, adalimumab and ustekinumab,” Luigi Gargiulo, MD, of the department of biomedical sciences at Humanitas University in Italy, and colleagues wrote.

In this study, the authors determined the long-term efficacy and safety of guselkumab in a real-world setting for the treatment of moderate to severe plaque psoriasis. Of the 102 patients included in this retrospective, single-center study, 95 completed 52 weeks of treatment and 54 had at least 2 years of follow-up.

Each patient received 100 mg of guselkumab at baseline and week 4, followed by every 8 weeks. After 16 weeks of treatment, results showed that 49.02% and 32.35% of patients treated with guselkumab achieved PASI 90 and PASI 100. The proportion of patients achieving PASI 90 and PASI 100 only increased with time, with 71.58% and 55.79%, respectively, reaching the endpoints at week 52 and 79.63% and 61.11% at 2 years.

While responses were comparable among patients with different weights, 100% of those with overweight and 97.63% of those with normal weight achieved an absolute PASI of 2 or less vs. 80.95% of those with obesity (P = .005).

At week 52, responses among bio-experienced patients were lower than bio-naïve patients, with 56.52% and 43.48% of bio-experienced patients reaching PASI 90 and PASI 100, respectively, vs. 85.71% and 67.35% of bio-naïve patients. There were no significant differences in effectiveness at week 104 regarding biologics exposure. There were also no differences regarding absolute PASI of 2 or less.

There were no significant safety concerns associated with guselkumab treatment up to 2 years, at which point 91.57% of patients were still on treatment.

“Our study confirmed the effectiveness of guselkumab throughout 104 weeks, with a high percentage of patients maintaining the treatment after 24 months,” the authors concluded. “Our data demonstrate the high effectiveness of guselkumab in routine clinical practice in an extensive cohort of patients with moderate to severe plaque psoriasis, with a higher proportion of bio-experienced patients compared with clinical trials.”