Efficacy and Safety of Risankizumab Compared with Apremilast in Patients with Moderate Plaque Psoriasis: Mean PASI and BSA Results From the Phase 4 IMMpulse Trial

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Linda Stein Gold
Jerry Bagel
Stephen Keith Tyring
Chih-ho Hong
Lev Pavlovsky
Andreas Pinter
Adam Reich
Leonidas Drogaris
Tianshuang Wu
Huzefa Photowala
Vassilis Stakias
Sven Richter
Kim Papp


Risankizumab, Moderate Psoriasis, IMMpulse, Phase 4



The IMMpulse study (NCT04908475) demonstrated superior efficacy of risankizumab (RZB) compared to apremilast (APR) in systemic-eligible patients with moderate plaque psoriasis (PsO).

Material and Methods

This phase 4, multi-center, randomized, open-label, assessor-blinded, active comparator study compared RZB to APR in adult systemic-eligible patients with moderate plaque PsO. In period A, patients  were randomized 1:2 to receive RZB (150 mg) or APR (30 mg twice daily) for 16 weeks. In period B, all APR-treated patients were re-randomized 1:1 to RZB or APR stratified by their ≥ 75% improvement in psoriasis area and severity index (PASI75) response. All RZB patients in period A continued treatment till week 52. Pre-specified efficacy endpoints included change in PASI and body surface area (BSA) from baseline. Continuous endpoints were assessed using mixed-effect model repeat measures to handle missing data.


Baseline characteristics were similar between the treatment arms. At week 16, PASI75 was achieved by 84.7% (RZB-treated) and 18.8% (APR-treated) patients. Mean PASI improved from 14.6 at baseline to 1.7 (RZB-treated), and from 14.5 at baseline to 8.8 (APR-treated) patients. Mean BSA improved from 13.1% to 2.6% with RZB, and from 13.1% to 10.6% for APR-treated patients. APR-treated patients not achieving PASI75 at week 16 who switched to RZB achieved a mean PASI of 0.7 at week 52, compared to 3.1 at week 52 in patients who continued with APR. In these same patients, those that switched to RZB achieved a mean BSA of 1.4% at week 52 compared to 6.3% for patients who continued APR. Most frequently observed treatment emergent adverse events were COVID-19 and nasopharyngitis for RZB, and diarrhea, nausea, and headache for APR.


These results demonstrate minimal residual disease observed with continuous RZB treatment and support the opportunity to elevate treatment outcomes with RZB in systemic-eligible patients with moderate plaque PsO.


1. 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, Papp KA. Comparison of risankizumab and apremilast for the treatment of adults with moderate plaque psoriasis eligible for systemic therapy: results from a randomized, open-label, assessor-blinded phase IV study (IMMpulse). Br J Dermatol. 2023 Oct 25;189(5):540-552. doi: 10.1093/bjd/ljad252. PMID: 37488811.

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