Risankizumab Demonstrated Superior to Apremilast for Patients With Moderate Psoriasis

Risankizumab (Skyrizi; AbbVie) is more effective than apremilast (Otezla; Amgen) at reducing the severity of psoriasis symptoms in patients with moderate disease at 16 weeks, according to the authors of an abstract presenting phase 4 clinical trial data at the 2024 American Academy of Dermatology Annual Meeting from March 8 to 12 in San Diego, California.¹

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“These data build on the well-studied efficacy of risankizumab in patients with psoriasis, including patients impacted by difficult-to-treat areas such as the scalp or nail,” said Linda Stein Gold, MD, the director of Research, and head of Division of Dermatology at the Henry Ford Health System, in an interview with Pharmacy Times.

Investigators conducted the 2-period phase 4 IMMpulse study (NCT04908475) to compare the superiority of risankizumab to apremilast on safety and efficacy outcomes for moderate plaque psoriasis in adults who are systemic-eligible. Patients were randomized 1:2 to receive subcutaneous risankizumab at weeks 0 and 4 (n=118, 150 mg; at labeled dosing) or oral apremilast (n=234, 30 mg BID) for 16 weeks. Patient demographic and disease characteristics were comparable between treatment arms at baseline.²

During period A (weeks 0 to 16), the co-primary end points include 90% (+) improvement on the Psoriasis Area and Severity Index (PASI; PASI 90), and improvement of 2 grades on the static Physician’s Global Assessment (sPGA 0/1) at 16 weeks. PASI measures disease severity (PASI90 [90% improvement], PASI 75 [75% improvement], and PASI 100 [100% improvement]).²

At 16 weeks, 55.9% of patients on risankizumab achieved PASI 90 (95% confidence interval (CI) 47.0-64.9) compared with 5.1% (95% CI 2.3-8.0) of patients on apremilast. In addition, 75.4% of patients on risankizumab achieved sPGA 0/1 (95% CI 67.7-83.2) compared with18.4% (95% CI 13.4-23.3) of patients on apremilast.

Among patients treated with risankizumab for scalp psoriasis, 57.0% achieved PASI 90, 87.1%achieved PASI75, 32.3% experienced PASI 100, and 77.4% achieved sPGA0/1. Only 17.9%, 5.1%, 17.4% and 1.5% of patients achieved these scores with apremilast, respectively.¹

In addition, 69.4% of patients treated with risankizumab for nail psoriasis achieved sPGA0/1compared with 17.3% on apremilast at 16 weeks. PASI scores were also higher in the risankizumab arm, with 48.4% achieving PASI 90, 79.0% achieving PASI 75, and 30.6%achieving PASI 100 compared with 3.9%, 15.0% and 1.6% of patients in the apremilast arm achieving these PASI, respectively.

During period B, investigators evaluated risankizumab for patients who did not achieve at least75% improvement in PASI (nonresponders) with apremilast at week 16, and the primary end point was 90% response at 52 weeks. Of those who switched to risankizumab after not achieving PASI 75 with apremilast, 72.3% (95% CI 62.7-81.9) achieved PASI 90. Only 2.6% (95% CI 0.0-6.1) of patients who continued apremilast achieved PASI 90 at 52 weeks.²

Investigators also evaluated safety and quality of life— PSS0/1 and DLQI0/1 scales measured health-related quality of life, and TSQM-9 identified treatment satisfaction. More patients on risankizumab have favorable quality-of-life and satisfaction outcomes, according to Gold.¹

Risankizumab also displayed a similar safety profile compared to previous studies. The most common adverse events were COVID-19 infection and nasopharyngitis, and apremilast was linked to diarrhea, nausea, and headache.²

“These results support risankizumab as an effective treatment in systemic-eligible psoriasis patients with high-impact area involvement, [and] I believe that it’s critical for physicians and patients to discuss risankizumab as a potential option when making treatment decisions,” Gold said to Pharmacy Times.¹

REFERENCES

1. Gold L, Efficacy of Risankizumab Versus Apremilast Among Patients with Scalp or Nail Psoriasis from the Phase 4 IMMpulse Study. Abstract. Accessed on March 13, 2024. AAD Annual Meeting. San Diego, California. March 8 to 12, 2024.

2. Gold L, 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. British Journal of Dermatology, 2023;ljad252. doi:10.1093/bjd/ljad252