Risankizumab outperforms apremilast as plaque psoriasis treatment in phase 4 study
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Key takeaways:
- At week 16, 55.9% of the risankizumab group and 5.1% of the apremilast group achieved PASI 90.
- 75.4% of risankizumab-treated patients vs. 18.4% of apremilast-treated patients achieved sPGA 0/1 by week 16.
Recently published in the British Journal of Dermatology, AbbVie’s phase 4 head-to-head study shows risankizumab demonstrates superiority over apremilast for the treatment of adults with moderate plaque psoriasis.
Risankizumab is an interleukin-23 inhibitor, whereas apremilast inhibits phosphodiesterase 4. Both are FDA-approved for the treatment of patients with plaque psoriasis; however, this study, called IMMpulse, shows that risankizumab may outperform apremilast in efficacy and treatment satisfaction.
“Achieving high levels of skin clearance is important to psoriasis patients, especially those who may not be satisfied with their current treatment,” Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health, told Healio. “IMMpulse study results highlight the efficacy and safety of risankizumab for use in systemic-eligible moderate psoriasis patients.”
The multicenter, randomized, efficacy assessor-blinded study spanned 52 weeks and included 352 patients who were candidates for systemic therapy, 118 of whom received risankizumab dosed at 150 mg at week 0 and week 4 and 234 of whom received apremilast dosed at 30 mg twice daily.
If apremilast-treated patients did not achieve a PASI 75 response at week 16, they were randomly assigned again to receive either risankizumab or apremilast.
After the first 16 weeks of the study, results showed that 55.9% (95% CI, 47%-64.9%) of patients treated with risankizumab achieved the co-primary endpoint of PASI 90 compared with 5.1% (95% CI, 2.3%-8%) of apremilast-treated patients.
The co-primary endpoint of sPGA 0/1 by week 16 was also achieved by 75.4% (95% CI, 67.7%-83.2%) of risankizumab-treated patients compared with 18.4% (95% CI, 13.4%-23.3%) of apremilast-treated patients.
After failing to reach PASI 75 during the first portion of the study, 72.3% (95% CI, 62.7%-81.9%) of patients originally assigned to apremilast and then reassigned to risankizumab achieved PASI 90 by week 52. This was in comparison with only 2.6% (95% CI, 0%-6.1%) of patients that continued on apremilast.
For those that received 52 weeks of continuous treatment, 73.7% (95% CI, 65.8%-81.7%) and 63.6% (95% CI, 54.9%-72.2%) of risankizumab-treated patients achieved PASI 90 and PASI 100, respectively, compared with 4.5% (95% CI, 0.7%-8.4%) and 2.7% (95% CI, 0%-5.8%) of apremilast-treated patients.
Risankizumab also achieved higher scores on the Treatment Satisfaction Questionnaire for Medication version 9 than apremilast. With the highest score being 100, patients treated with risankizumab reported an overall score of 80.6 for satisfaction with effectiveness, 84.9 for satisfaction with convenience and 86.2 for global satisfaction at week 16.
In comparison, patients treated with apremilast reported scores of 46.9, 69 and 47.7 for the same categories, respectively.
The safety profile for risankizumab was consistent with previously reported studies.
“Many patients with moderate psoriasis have significant disease with a major impact on their overall quality of life,” Stein Gold told Healio. “For patients that require systemic therapy, it is beneficial to offer them the most effective and safe option early to achieve rapid control of their disease.”