Janssen-Cilag International NV (“Janssen”) presented a new analysis from VOYAGE 1 assessing efficacy responses based on absolute Psoriasis Area and Severity Index score (PASI), as reported through two years of TREMFYA®(guselkumab) treatment in adult patients with moderate to severe psoriasis.
The data, presented at the 8th International Congress of Psoriasis from Gene to Clinic, showed that guselkumab treatment led to significantly higher rates of skin clearance vs Humira® (adalimumab) through one year, as measured by absolute PASI (p <0.001). In patients who received continuous treatment with guselkumab, high level PASI responses were also maintained through the two years.
“The chronicity and often unpredictable nature of psoriasis mean that percentage improvements in signs and symptoms don’t always translate into improvements in quality of life for patients,” said Dr Kim Papp, K Papp Clinical Research and Probity Medical Research, Waterloo, Canada and study lead investigator. “By directly analysing PASI values in this trial, we focused on a direct and objective measurement of disease severity, not just the percentage of improvement. Results from VOYAGE 1 demonstrate that treatment with guselkumab translates into clinically meaningful improvements for patients.”
The aim of this post-hoc analysis was to objectively measure the area of the body affected by the reddening, scaling and thickening associated with psoriasis plaques, rather than reporting on the relative percentage improvement in PASI score from baseline seen with treatment. Efficacy through to two years (week 100) was analysed based on absolute PASI responses of 0, ≤1 and ≤3 on a scale of 0 to 72, with higher scores indicating greater disease severity. The results showed that at week 48, 72.0% of patients treated with guselkumab had a PASI score of ≤1 vs 43.4% of patients treated with adalimumab (p <0.001). Furthermore, 47.4% of guselkumab treated patients had clear skin (PASI 0) vs 23.4% of those treated with adalimumab (p <0.001). After 2 years (week 100) high skin clearance rates continued to be seen among patients receiving guselkumab, 68.6% had a PASI score of ≤1 and nearly half (49%) had clear skin (PASI score of 0).
Janssen also presented new two-year data from VOYAGE 1 and VOYAGE 2, evaluating the safety of guselkumab in adult patients with moderate to severe plaque psoriasis. The analysis considered patients who were initially randomised to guselkumab and those randomised to placebo and crossed over to guselkumab at week 16. The results showed that safety event rates for both groups of guselkumab-treated patients were comparable between year 1 and year 2. In addition, the safety data for patients who were initially randomised to adalimumab and later crossed over to receive guselkumab were consistent with overall guselkumab safety data, with no additional safety signals identified.
Adverse events reported in at least five percent of guselkumab-treated patients during the first 16 weeks in the VOYAGE 1 and 2 trials included: nasopharyngitis, upper respiratory tract infection, injection site erythema, headache, arthralgia, pruritus and back pain. The types of adverse events reported remained generally consistent through 48 weeks of treatment, and through to week 100.