Risankizumab Achieved Superiority Vs Apremilast for Co-Primary Endpoints Among Adult Patients with Moderate Plaque Psoriasis Advances

Data from the head-to-head Phase 4 IMMpulse study showed the superior efficacy and safety of risankizumab when compared to apremilast among adult patients with moderate plaque psoriasis eligible for systemic therapy.¹ 

The study consisted of 118 and 234 patients who were randomized 1:2 to receive subcutaneous risankizumab (150 mg at weeks 0 and 4) or oral apremilast (30 mg twice daily).² The enrolled patients were ages 18 years and older, had a diagnosis of moderate chronic plaque psoriasis of at least 6 months, and were candidates for systemic therapy.

At week 16, all patients treated with apremilast were re-randomized (1:1) to risankizumab or apremilast, stratified by week 16 Psoriasis Area and Severity Index (PASI) 75 response. The co-primary outcomes in period A at week 16 were the achievement of 90% or more improvement (PASI 90) and static Physician’s Global Assessment (sPGA) 0/1 with a 2-grade or better improvement from baseline. At week 52, the primary endpoint in period B was the achievement of PASI 90 in PASI 75 nonresponders with apremilast at week 16.

At week 16, a significantly higher proportion of patients who received risankizumab achieved the primary endpoints of PASI 90 and sPGA 0/1 (55.9% [66/118] of patients achieved PASI 90 and 75.4% [89/118] achieved sPGA 0/1 with risankizumab vs 5.1% [12/234] and 18.4% [43/234] with apremilast; both with P<.001).² At week 52, within patients who failed to achieve PASI 75 after 16 weeks of treatment with apremilast, a significantly higher proportion of patients re-randomized to treatment with risankizumab achieved the period B primary endpoint of PASI 90 as compared to those re-assigned to continue treatment with apremilast (72.3% [60/83] vs 2.6% [2/78]; P<.001].

Risankizumab selectively blocks IL-23, a cytokine involved in inflammatory processes that is thought to be linked to several chronic immune-mediated diseases, including psoriasis.³ Risankizumab is already approved by the US Food and Drug Administration for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

References
1. SKYRIZI (risankizumab) achieved superiority versus apremilast for co-primary endpoints among adult patients with moderate plaque psoriasis in phase 4 head-to-head study. Press release. AbbVie. Accessed August 31, 2023. https://news.abbvie.com/news/press-releases/skyrizi-risankizumab-achieved-superiority-versus-apremilast-for-co-primary-endpoints-among-adult-patients-with-moderate-plaque-psoriasis-in-phase-4-head-to-head-study.htm

2. Stein Gold LF, Bagel J, Tyring SK, et al. 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. Published online ahead of print July 25, 2023. doi:10.1093/bjd/ljad252

3. Duvallet E, Semerano L, Assier E, Falgarone G, Boissier MC. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011;43(7):503-511. doi:10.3109/07853890.2011.577093

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