Treatment with guselkumab was found to be associated with durable, complete skin clearance through 5 years in patients with moderate to severe plaque psoriasis (PsO) and improved disease activity and axial symptoms in adults with active psoriatic arthritis (PsA) through 1 year, according to a recent press release and study results presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2021, held online from April 23 to April 25, 2021.
In the VOYAGE 2 trial (ClinicalTrials.gov Identifier: NCT02207244), approximately 55.5% of patients who received guselkumab had complete skin clearance, as determined by an Investigator’s Global Assessment (IGA) score of 0, by week 252. In addition, 53% of patients had a Psoriasis Area Severity Index (PASI) 100 skin clearance response (PASI 100) by the 252-week follow-up. Up to 82% of patients achieved a PASI 90 skin clearance response, and 85% of patients had an IGA score of 0/1, indicating complete skin clearance. Efficacy rates were maintained through the 5-year treatment period.
In the DISCOVER-1 and -2 trials (ClinicalTrials.gov Identifiers: NCT03162796 and NCT03158285, respectively), patients with active psoriatic arthritis (PsA) received either placebo or 100 mg guselkumab every 4 weeks and every 8 weeks. Treatment with guselkumab improved disease activity in the joints as well as across several different domains through 52 weeks. Differences in response rates between the active treatment and placebo groups were observed at 8 weeks of treatment.
In addition, in the phase 3 VOYAGE 2 trial, the researchers showed that a significantly greater percentage of patients who received guselkumab vs placebo for 16 weeks had an IGA 0/1 response (84% vs 9%, respectively; P <.001).
Safety data from the VOYAGE 1 and 2 trials show that 78.3% of patients who received guselkumab continued treatment through week 252. Guselkumab featured a safety profile from year 1 through year 5 that was consistent with its safety profile shown in other studies. Low rates of adverse events due to treatment discontinuation were reported.
“The signs and symptom improvement seen with [guselkumab] is noteworthy for both patients who live with fear of disease recurrence and their physicians, as these data add to a growing body of evidence for this first-in-class [interleukin] (IL)-23 inhibitor treatment for moderate to severe plaque [PsO] and active [PsA],” noted the lead author of the VOYAGE 2 study.
Disclosure: The clinical trials included in this analysis were supported by Janssen Pharmaceutical Companies of Johnson & Johnson. Please see the original reference for a full list of study authors’ disclosures.
New phase 3 data showed first-in-class TREMFYA® (guselkumab) provided durable complete skin clearance through 5 years in moderate to severe plaque psoriasis (PsO) and robust joint symptom improvement through 52 weeks in active psoriatic arthritis (PsA). News release. April 23, 2021. Accessed April 26, 2021. https://www.biospace.com/article/releases/new-phase-3-data-show-first-in-class-tremfya-guselkumab-achieved-complete-skin-clearance-and-favorable-joint-efficacy-in-adult-patients-with-active-psoriatic-arthritis-psa-through-two-years/
This article originally appeared on Rheumatology Advisor