The FDA has approved guselkumab for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The US Food and Drug Administration (FDA) has approved guselkumab (Tremfya) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, according to a statement from Janssen Biotech, the developer of the interleukin-23 inhibitor.
The approval was based on findings from the phase 3 VOYAGE 1, VOYAGE 2, and NAVIGATE trials. In the studies, guselkumab demonstrated significant skin clearance and improvements in plague psoriasis symptoms compared with placebo in the NAVIGATE trial. In the VOYAGE 1 and 2 studies, guselkumab was superior in Psoriasis Area Severity Index (PASI) 90 scores for skin clearance when compared with adalimumab (Humira) at weeks 16, 24, and 48.
“Tremfya represents a significant milestone in the treatment of moderate to severe plaque psoriasis as evidenced by the proven skin clearance demonstrated in the majority of study patients receiving this IL-23—specific therapy at week 16 and up to week 48,” study investigator Andrew Blauvelt, MD, MBA, President of Oregon Medical Research Center, said in a statement. “We continue to make progress in understanding the science of psoriasis and the important role IL-23 plays in the pathogenesis of this disease, which is another reason why today’s approval of Tremfya is exciting, both as a researcher and a practicing dermatologist.”
In the VOYAGE 1 and 2 trials, patients were randomized to guselkumab at 100 mg on weeks 0, 4, 12, and 20 or placebo on weeks 0, 4, and 12 followed by either guselkumab on weeks 16 and 20 or adalimumab at 80 mg on week 0 then 40 mg on week 1 and every 2 weeks through week 23. The VOYAGE 1 trial included 837 patients and the VOTAGE 2 study had 992 participants.
In the guselkumab arm of the VOYAGE 1 study, 85.1% of patients achieved cleared (IGA 0) or minimal disease (IGA 1) compared with 6.9% of those in the placebo group (P <.001). Moreover, 73.3% of patients in the guselkumab group had a PASI 90 response compared with 2.9% in the placebo group (P <.001). In VOYAGE 2, 84.1% of those in the guselkumab arm achieved IGA 0 or 1 versus 8.5% in the placebo group (P <.001). PASI 90 was achieved by 70% of those in the guselkumab group versus 2.4% in the placebo arm (P <.001).
In the NAVIGATE trial, 871 patients received open-label ustekinumab on weeks 0 and 4. Those with an IGA score of ≥2 (n = 268) were randomized to guselkumab at 100 mg on week 16 and 20 followed by every 8 weeks until week 44 or continued ustekinumab every 12 weeks until week 40. Those with an IGA score of 0 or 1 at week 16 continued to receive ustekinumab every 12 weeks until week 40 (n = 585).
Those who switched to guselkumab showed greater improvements in psoriasis between weeks 28 and 40 compared with those who continued to receive ustekinumab. At week 28, 31% of those treated with guselkumab achieved IGA 0 or 1 versus 14% with ustekinumab.
“Addressing the need for additional safe and effective plaque psoriasis therapies has been a critical area of focus at Janssen for more than 15 years,” Andrew Greenspan, MD, Vice President of Medical Affairs at Janssen, said in a statement. “Considering this, we applied a priority review voucher to the application for Tremfya to bring this novel treatment to patients sooner.”