Comparison of risankizumab and apremilast for the treatment of adult patients with moderate plaque psoriasis eligible for systemic therapy: results from a randomised, open-label, assessor-blinded phase IV (IMMpulse) study
Stein Gold LF, Bagel J, Tyring SK, Hong HC, Pavlovsky L, Vender R, Pinter A, Reich A, Drogaris L, Wu T, Patel M, Soliman AM, Photowala H, Stakias V, Richter S, and Papp KA. Comparison of risankizumab and apremilast for the treatment of adult patients with moderate plaque psoriasis eligible for systemic therapy: results from a randomised, open-label, assessor-blinded phase IV (IMMpulse) study. Br J Dermatol 2023.
The British journal of dermatology
BACKGROUND: Treatment with risankizumab has demonstrated superior efficacy to other psoriasis treatments, such as adalimumab, ustekinumab, and secukinumab.
OBJECTIVES: This study compared the efficacy and safety of risankizumab and apremilast among adult patients with moderate plaque psoriasis eligible for systemic therapy. It also evaluated the efficacy and safety of switching to risankizumab versus continuing apremilast among patients who did not achieve ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75 non-responders) after 16 weeks of treatment with apremilast.
METHODS: This 52-week, phase 4, multicenter, randomised, open-label, efficacy assessor-blinded study (NCT04908475) enrolled patients (≥ 18 years) with a diagnosis of moderate chronic plaque psoriasis (≥ 6 months) and were candidates for systemic therapy. The enrolled patients (1:2) received subcutaneous risankizumab (150 mg, week 0, 4) or oral apremilast (30 mg twice daily). At week 16, all apremilast-treated patients were re-randomised (1:1) to risankizumab or apremilast, stratified by week 16 PASI 75 response. The co-primary outcomes in Period A at week 16 were the achievement of PASI 90 and static Physician's Global Assessment (sPGA) 0/1 with ≥ 2-grade improvement from baseline. At week 52, the primary endpoint in Period B was the achievement of PASI 90 in PASI 75 non-responders with apremilast at week 16. Safety was monitored throughout the study. All patients who received one dose of treatment were included in the efficacy and safety analysis.
RESULTS: At baseline, 118 and 234 patients were assigned to receive risankizumab and apremilast, respectively. At week 16, PASI 90 was achieved by 55.9% (95% CI, 47.0%, 64.9%) and 5.1% (95% CI, 2.3%, 8.0%), and sPGA 0/1 by 75.4% (95% CI, 67.7%, 83.2%) and 18.4% (95% CI, 13.4%, 23.3%), respectively. In Period B, among PASI 75 non-responders with apremilast at week 16, 83 switched to risankizumab, and 78 continued apremilast. At week 52, 72.3% (95% CI, 62.7%, 81.9%) who switched to risankizumab achieved PASI 90 versus 2.6% (95% CI, 0.0%, 6.1%) who continued apremilast. The most frequent adverse events (reported in ≥ 5%) in risankizumab-treated patients were COVID-19 and nasopharyngitis. Diarrhoea, nausea, and headache were most frequent among apremilast-treated patients.
CONCLUSIONS: For patients with moderate psoriasis, treatment with risankizumab demonstrated superior efficacy compared to apremilast, including those who did not benefit from prior treatment with apremilast. The safety profile of risankizumab was similar to prior studies, and no new safety signals were identified. These results show that risankizumab treatment can significantly improve clinical outcomes in systemic-eligible patients with moderate psoriasis compared to apremilast.
ePub ahead of print