Janssen-Cilag International’s innovator biologic drug guselkumab (Tremfya) has received approval from the European Commission (EC) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Tremfya is the first European Commission-approved biologic that selectively blocks interleukin-23 (IL-23), a cytokine that is a key driver of the immune inflammatory response in psoriasis. The drug is also the only FDA-approved selective IL-23 blocker for the treatment of plaque psoriasis.
Tremfya is a self-injectable treatment that requires 2 starter doses, 1 initially and another 4 weeks later, followed by a maintenance dose every 8 weeks thereafter. Tremfya’s good safety profile, superior head-to-head results compared with Humira (adalimumab) in the VOYAGE 1 and 2 trials, and its mode of action suggest that Tremfya could be a potential competitor to Humira.
The European Commission’s approval of Tremfya, like the earlier approval of the medication by the FDA, was based on data from 3 phase 3 clinical studies:
- The VOYAGE 1 and VOYAGE 2 trials, which compared guselkumab with placebo and Humira (adalimumab) and showed high levels of skin clearance after 16 weeks with a 90% reduction in Psoriasis Area Severity Index (PASI 90) in 73.3% and 70.0% of patients taking guselkumab, compared with 49.7% and 46.8% of patients taking Humira (P <.001).
- The NAVIGATE trial, which evaluated patients who did not achieve a response of cleared or minimal disease on the Investigator’s Global Assessment (IGA) score of 0 or 1 by week 16 when treated with Stelara (ustekinumab), who were then randomized to either switch to Tremfya or continue on Stelara. The group taking Tremfya benefited significantly from the switch, with a higher mean number of visits at which patients achieved an IGA score of 0 or 1 and at least a 2-grade improvement from week 28 through week 40, compared with the Stelara group (1.5 versus 0.7; P <.001).
There were no clear signs of an increased risk of malignancy, major cardiovascular events, or serious infections in patients taking Tremfya.
In September, Janssen announced new, long-term data from the open-label extension of the VOYAGE 1 trial, which further solidified Tremfya’s efficacy:
- 82.1% of Tremfya-treated patients achieved at least a 90% improvement in PASI 90, or near complete skin clearance, and 82.4% achieved an IGA score of 0 (clear) or 1 (minimal disease) at week 100. These patients included those initially started on Humira or placebo. In addition, 49% of patients achieved PASI 100, and an IGA of 0 was achieved by 53.8% of patients at week 100.
- Week 100 data were consistent with rates of skin clearance at week 52 with maintenance therapy administered every 8 weeks. Patients who switched from Humira to Tremfya had improved rates of skin clearance that were consistent at weeks 52 and 100. The proportion of PASI 90 scores rose from 50.5% at week 52 to 81.1% at week 100. The proportion of patients achieving IGA 0 or 1 increased from 60.4% to 84.0%, and the proportion of patients achieving PASI 100 rose from 24% to 51.6% and from 27.3% to 51.6% in the proportion of patients who had IGA 0 scores.
- Scores on the patient-reported Psoriasis Symptoms and Signs Diary (PSSD) were consistent over the 2-year period with Tremfya; patients who were switched to Tremfya from Humira showed substantial improvement in PSSD scores from Week 48 to Week 100.