New Findings Compare Safety of Risankizumab Versus Apremilast Among Psoriasis Patients

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In phase 4 data from the IMMpulse study, presented at AAD 2024, comparisons in efficacy were highlighted between risankizumab and apremilast for psoriasis patients eligible for systemic therapy.

Linda Stein Gold, MD

Credit: Henry Ford Health

Linda Stein Gold, MD

Credit: Henry Ford Health

In a comparison of risankizumab to apremilast among individuals with psoriasis, risankizumab shows superior efficacy with regard to quality of life, skin clearance, and treatment satisfaction among patients specifically with baseline scalp or nail psoriasis.1

These findings were presented at the 2024 American Academy of Dermatology Annual Meeting regarding the efficacy and safety profile of the interleukin (IL)-23 (IL-23)-targeted therapy risankizumab. The new data were the results of the phase 4 IMMpulse study, assessing the effectiveness and safety of risankizumab compared to that of apremilast for adult individuals with moderate plaque psoriasis who were also eligible for systemic therapy prior to their inclusion.

This new research was led by Linda Stein Gold, MD, head of the Division of Dermatology at the Henry Ford Health System and vice president of the American Academy of Dermatology. Stein Gold’s team assessed the study participants’ results following a 16-week treatment period.

Over the course of the 16-week treatment period—known as Period-A—a total of 118 study participants received 150 mg of subcutaneous risankizumab. Over the same period, 234 participants were treated with 30 mg BID of oral apremilast.

The new analysis had a particular focus on subjects’ skin clearance efficacy after 16 weeks, as determined by static Physician Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear), Psoriasis Area and Severity Index (PASI) 90, PASI75, or PASI100 scores among those with baseline nail or scalp psoriasis.

The investigators assessed subjects’ health-related quality of life through Psoriasis Symptom Scale (PSS)0/1 and Dermatology Life Quality Index (DLQI) 0/1 scores as well as their satisfaction with treatment through Treatment Satisfaction Questionnaire for Medication (TSQM-9).

The baseline characteristics of participants placed in the risankizumab and apremilast cohorts were similar, with 93 of those in the former and 195 in the latter had scalp psoriasis and 62 and 127 had nail psoriasis, respectively.

By the 16-week mark, individuals treated with risankizumab were reported by the investigators as having made substantial improvements (P < .001) from the point of baseline in their mean Nail Psoriasis Severity Index (NAPSI) and PSSI scores. Specifically, the risankizumab group had -8.5 and -14.0 changes in NAPSI and PSSI, respectively, compared to the apremilast cohort’s -5.0 and -6.8 score changes, respectively.

In a notable finding, the research team reported that there had been a higher proportion of risankizumab-treated individuals with scalp psoriasis who had achieved a sPGA0/1, PASI90, PASI75, and PASI100 (77.4%, 57.0%, 87.1%, and 32.3%, respectively) compared to apremilast (17.9%, 5.1%, 17.4%, and 1.5% respectively).

In a similar finding, the investigators expressed that a greater proportion of study participants with nail psoriasis who had been treated with risankizumab were found to have sPGA0/1, PASI90, PASI75, and PASI100 (48.4%, 69.4%, 79.0%, and 30.6%, respectively) versus those who had been given apremilast therapy (17.3%, 3.9%, 15.0%, and 1.6% respectively).

The research team added that favorable treatment outcomes had been observed in DLQI0/1, PSS0/1, and TSQM-9 in those given risankizumab compared to those given apremilast. The sum of these statistically significant findings highlight what was described as the superior efficacy of risankizumab in its ability to address life quality, skin clearance, and treatment satisfaction among individuals that had baseline scalp or nail psoriasis during initiation.

These results expand upon data from the IMMpulse study in 2023, in which risankizumab was also shown to have achieved all of its primary and secondary endpoints with no new safety signals in adults with moderate plaque psoriasis.2 Thus, the new analysis supports the drug as an effective therapy option for systemic-eligible psoriasis patients with significant area involvement.

References

  1. Stein 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, https://doi.org/10.1093/bjd/ljad252.
  2. Smith T. Risankizumab Shown to be Superior to Apremilast in Treating Adults with Moderate Psoriasis. HCPLive. July 27, 2023.https://www.hcplive.com/view/risankizumab-shown-to-be-superior-to-apremilast-in-treating-adults-with-moderate-psoriasis. Date accessed: March 8, 2024.
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