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Extending Dosing Interval for Guselkumab Noninferior in Psoriasis

Extending the interval to 16 weeks from eight weeks is noninferior for patients with moderate-to-severe psoriasis

By Dermsquared Editorial Team | August 07, 2024

WEDNESDAY, Aug. 7, 2024 -- For patients with moderate-to-severe psoriasis receiving guselkumab, with early skin clearance at two consecutive visits, extending the dosing interval is noninferior to maintaining the dosing interval, according to a study published online July 31 in JAMA Dermatology.

Kilian Eyerich, M.D., from the University of Freiburg in Germany, and colleagues examined early intervention with and prolonging the dosing interval for guselkumab in patients with moderate-to-severe psoriasis as part of the GUIDE phase 3b clinical trial. In GUIDE part 1, patients received guselkumab 100 mg at week (W) 0, 4, 12, and 20; those achieving a Psoriasis Area and Severity Index (PASI) of 0 at both W20 and W28 were considered super responders (SRes). SRes were randomly allocated to guselkumab 100 mg every eight or 16 weeks in part 2 (148 and 149 patients, respectively), while non-SRes continued open-label guselkumab every eight weeks (525 patients).

The researchers found that the primary end point of noninferiority of guselkumab every 16 versus every eight weeks was met in SRes, with 91.9 and 92.6 percent of SRes receiving dosing every 16 and every eight weeks, respectively, having a PASI lower than 3 at W68. The clinical effects corresponded with immunologic changes; from baseline, there was a rapid decrease seen in skin CD8-positive tissue resident memory T-cell count, which remained low in both dosing groups. Significant decreases were also seen in serum interleukin (IL)-17A, IL-17F, IL-22, and β defensin-2 levels, which remained low in both groups to W68.

"Data from the GUIDE trial add new insights into the concepts of disease modification and long-term maintenance of efficacy," the authors write.

Several authors disclosed ties to pharmaceutical companies, including Janssen, which manufactures guselkumab and funded the study.

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