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 .
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 
P<0.001 vs fumaric acid esters
FAE, fumaric acid esters oral formulation; PASI, Psoriasis Area and Severity Index; RZB, risankizumab; sPGA, static Physician’s Global Assessment.
- Thaçi D, et al. OP02.01, EADV 2019, 9-13 Oct, Madrid, Spain.
- Falkvoll S, et al. Dtsch Dermatol Ges 2019;17:906-12.
- Nast A, et al. J Dtsch Dermatol Ges 2018;16:645-69.
- Nast A, et al. J Eur Acad Dermatol Venereol 2015;29:2277-94.
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Table of Contents: EADV 2019
Letter from the Editor
IL-17A blocker effective in paediatric psoriasis patients
Rituximab beats mycophenolate mofetil in pemphigus vulgaris
Novel JAK1/2 inhibitor shows remarkable efficacy in alopecia areata
Acne highly influenced by climate, pollutants, and unhealthy diet
JAK inhibition plus TCS lead to high clearance rates in AD
No cancer risk with long-term use of tacrolimus, a topical calcineurin inhibitor, in children with AD
Green light for a second JAK inhibitor in AD
Topical ruxolitinib effective in vitiligo
Small molecules: interesting novel treatment options in AD
IL-1⍺ blockade: a new treatment option in AD
IL-4/IL-13 blockade leads to rapid itch reduction in adolescents
How to manage conjunctivitis in AD patients treated with a biologic
Biologics: increasingly used in paediatric dermatology
Spotlight on Psoriasis
IL-17 blocker: effective and safe in patients with comorbidities
ESPRIT registry: sharp decline in mortality in patients treated with a TNF blocker
Relationship psoriasis and NAFLD: new data on the hepato-dermal axis
Novel selective IL-23 blocker equally effective in patients with metabolic syndrome
Selective IL-23 blocker crushes fumaric acids in all assessed efficacy endpoints
No hint of teratogenicity through ixekizumab
New Insights in Photoprotection
Systemic photoprotection: a valuable addition to topical sun protection
The underestimated effect of visible light
Comorbidities more common in chronic urticaria, psoriasis, and AD
D-Dimer as future biomarker in CSU management?
Ligelizumab for CSU: symptom control and high response rates in re-treatment
Rosacea – From New Spectrum to New Therapy
New guidance on rosacea therapy according to phenotype
Best of the Posters
Above-the-neck melanoma more prone to metastases
Reduced sleep quality in dermatoses influenced by itch and pain
Anxiety and depression are common in families of AD infants
Certolizumab pegol efficacious for head and neck psoriasis
Small molecules, apremilast, and TYK2