Longer guselkumab maintenance dosing noninferior to shorter intervals
MILAN — Individuals with psoriasis who responded well to guselkumab maintained disease control with every 16-week dosing, possibly lengthening the dosing interval for some patients.
Data from the randomized, placebo-controlled, double-blind, parallel-group, multicenter, phase 3b GUIDE study of guselkumab (Janssen) was presented during the European Academy of Dermatology and Venereology Congress.
“The GUIDE study was designed to understand the impact of early intervention and potential dosing interval flexibility on the long-term disease course in adult patients with moderate to severe plaque psoriasis,” Kilian Eyerich, MD, PhD, professor of dermatology and venereology at the University of Freiburg, told Healio. “The week 68 data looked at how well the disease is controlled under dosing interval elongation in the super responders.”
Patients in the study’s initial part received 100 mg of guselkumab at weeks 0, 4, 12 and 20. Subjects who achieved complete skin clearance, defined as PASI 0, at weeks 20 or 28 were deemed “super responders” and were then randomly assigned to receive guselkumab every 8 weeks or every 16 weeks.
Patients who had disease duration of less than 2 years and those who were biologic naïve were more likely to be super responders.
At week 68, 92.6% of patients in the 8-week group and 91.9% of those in the 16-week group maintained a PASI score of less than 3, while a PASI score of 1 or less was maintained by 89.9% of the 8-week group and 79.2% of the 16-week group. PASI 0 was maintained in 81.1% of the 8-week cohort and 69.1% of the 16-week cohort.
Additionally, DLQI response of 0 or 1 was achieved at week 68 by 83.1% of the 8-week group and 77.9% of the 16-week group.
“These new results suggest patients who receive treatment soon after disease onset may see higher rates of psoriasis clearance,” Eyerich said. “We hope in the future that dosing interval flexibility could be a consideration that would allow this patient subpopulation to have a therapy strategy tailored to the patient’s needs and expectations.”