Risankizumab Demonstrates Superior Efficacy Over Apremilast in Phase IV IMMpulse Study for Moderate Plaque Psoriasis

On July 26, AbbVie published the results of the Phase IV IMMpulse study comparing risankizumab (Skyrizi) head-to-head with apremilast (Otezla) for the treatment of moderate plaque psoriasis in the British Journal of Dermatology. The results showed that risankizumab was more effective than apremilast in treating patients with moderate plaque psoriasis.

This study is a multi-center, randomized, open-label, Phase IV clinical trial with blinded efficacy evaluators. A total of 352 adult patients with moderate plaque psoriasis who were eligible for systemic therapy were enrolled, with 118 patients assigned to the risankizumab group (150 mg, once monthly) and 234 patients assigned to the apremilast group (30 mg, twice daily). After 16 weeks of treatment (Period A), patients in the control group were re-randomized 1:1 to either the risankizumab group or the apremilast group for an additional 36 weeks of treatment.

The primary endpoints of the study were the proportion of patients achieving 90% or greater improvement in Psoriasis Area and Severity Index (PASI 90) at Week 16, the proportion of patients with static Physician Global Assessment (sPGA) scores of 0 or 1 and at least a 2-point improvement at Week 16, and the proportion of apremilast non-responders reaching PASI 90 at Week 52 (Treatment Period B).

Overall, this study met all primary and secondary endpoints, and no new safety signals were identified. The specific details are as follows:

At week 16, a significantly higher proportion of patients in the risankizumab group achieved PASI 90 (55.9% vs. 5.1%; P<0.001), and the proportion achieving sPGA 0/1 was also markedly higher than in the apremilast group (75.4% vs. 18.4%; P<0.001).

At week 52, a significantly higher proportion of patients who were re-randomized to risankizumab achieved PASI 90 compared to those who did not achieve PASI 75 after 16 weeks of apremilast treatment and continued on apremilast (72.3% vs. 2.6%; P<0.001).

At week 52, 73.7% and 63.6% of patients in the risankizumab group achieved PASI 90 and PASI 100, respectively, compared with 4.5% and 2.7% in the apremilast group.

The most common adverse events (incidence rate ≥5%) in the risankizumab group were COVID-19, nasopharyngitis, and upper respiratory tract infections. The most common adverse events in the apremilast group were diarrhea, nausea, and headache. During the 16-week treatment period and the 52-week treatment period, serious adverse events were reported in 0.8% and 2.9% of patients in the risankizumab group, respectively, compared to 1.7% and 2.1% in the apremilast group.

Moreover, at Week 16, the treatment satisfaction of patients in the risankizumab group was higher than that in the apremilast group, including efficacy satisfaction score (80.6 vs. 46.9), convenience satisfaction score (84.9 vs. 69.0), and overall satisfaction score (86.2 vs. 47.7).

Lifonzumab is an interleukin-23 (IL-23) inhibitor developed by Boehringer Ingelheim (BI). It selectively blocks IL-23-mediated signaling by binding to the IL-23 p19 subunit. IL-23 is a cytokine involved in inflammatory processes and is considered to be associated with many chronic immune-mediated diseases.

In February 2016, AbbVie reached an agreement with Boehringer Ingelheim (BI) to acquire the development and global commercialization rights for risankizumab for $595 million upfront. In March 2019, risankizumab was first launched in Japan for the treatment of adult plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis, and psoriatic arthritis in patients who have had an inadequate response to conventional therapies.

Apremilast is a phosphodiesterase 4 (PDE4) inhibitor developed by Celgene (acquired by BMS), which was first launched in the United States in March 2014. In August 2019, Amgen acquired the product from Celgene for a total deal worth $13.4 billion. Currently, Apremilast is approved for indications including psoriatic arthritis, Behçet's disease, and plaque psoriasis.

As of today, in the field of plaque psoriasis, risankizumab has outperformed ustekinumab, adalimumab, secukinumab, and apremilast, four commonly used drugs. It is foreseeable that the annual sales of risankizumab will grow strongly in the future. Last year, the sales of this product reached $5.165 billion (+76%).

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