Selective IL-23 blocker crushes fumaric acids in all assessed efficacy endpoints

A head-to-head comparison of the selective IL-23 blocker risankizumab with oral fumaric acid esters in treatment-naïve patients with moderate-to-severe psoriasis demonstrated superiority of the biologic in all assessed efficacy endpoints at week 24 [1].

In the Netherlands, Germany, the United Kingdom, and Ireland, fumaric acid esters are frequently used for systemic therapy of moderate-to-severe psoriasis [2-4]. A new head-to-head trial included systemic treatment-naïve adult patients with chronic moderate-to-severe plaque psoriasis of at least 6 months duration. All patients qualified for systemic therapy: they had a psoriasis area and severity index score >10, an affected body surface area of >10%, and their quality of life was severely impaired (dermatology life quality index score of >10). Patients were randomised to receive subcutaneous risankizumab 150 mg at weeks 0, 4, and 16 (n=60) or oral fumaric acid esters in increasing doses from week 0 to week 24 (n=57).

At the end of the study, 83% of patients receiving risankizumab achieved the primary endpoint of PASI improvement by 90% compared with only 10% of patients in the fumaric acid ester arm (see Figure). This striking superiority was also demonstrated in the static physician’s global assessment (sPGA). Starting at week 4, significantly more patients in the risankizumab arm achieved clear or almost clear skin lesions (corresponding to sPGA 0/1) than patients treated with fumaric acid esters.

At the end of the study, over 90% of patients treated with the cytokine blocker achieved the endpoint compared with less than half of patients treated with fumaric acid esters. “Significantly more patients randomised to risankizumab achieved clear or almost clear skin earlier than patients randomised to fumaric acid esters,” said Prof. Diamant Thaçi (University of Lübeck, Germany). This superiority was mirrored in a high percentage of patients achieving a quality of life that was no longer impaired by the psoriasis: 67% of patients treated with the biologic compared with 10% of patients in the fumaric acid group reached this endpoint.

Adverse events were similar between groups, with 82% of patients in the risankizumab arm experiencing any adverse event compared with 100% of patients in the fumaric acid ester arm.

Figure: Summary of efficacy results at week 24 [1]

P<0.001 vs fumaric acid estersFAE, fumaric acid esters oral formulation; PASI, Psoriasis Area and Severity Index; RZB, risankizumab; sPGA, static Physician’s Global Assessment.

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   1. Thaçi D, et al. OP02.01, EADV 2019, 9-13 Oct, Madrid, Spain.
   2. Falkvoll S, et al. Dtsch Dermatol Ges 2019;17:906-12.
   3. Nast A, et al. J Dtsch Dermatol Ges 2018;16:645-69.
   4. Nast A, et al. J Eur Acad Dermatol Venereol 2015;29:2277-94.

Posted on 9 October 201912 March 2021