Risankizumab Bests Fumaric Acid Esters for Treatment-Naïve Patients With Plaque Psoriasis in Head-to-Head Trial

October 15, 2019

By Eric Ramos

MADRID, Spain -- October 13, 2019 -- A head-to-head trial comparing risankizumab (Skyrizi) with oral fumaric acid esters (FAE) for treatment-naïve patients with moderate-to-severe plaque psoriasis has demonstrated the superiority of risankizumab for all studied efficacy endpoints, researchers reported here at the 28th European Academy of Dermatology and Venereology (EADV) Congress.

“Significantly more patients randomised to risankizumab achieved clear or almost clear skin earlier than patients randomised to FAE,” said Diamant Thaci, MD, University of Lubeck, Lubeck, Germany.

At the end of the study (week 24), 83% of patients receiving risankizumab achieved the primary endpoint of Psoriasis Area and Severity Index (PASI) 90 compared with 10% of patients in the FAE arm.

The study included patients aged 18 years and older with chronic plaque psoriasis of at least 6 months duration prior to study endtry who were naïve to systemic therapy. All patients had a Psoriasis Area and Severity Index (PASI) score >10, affected body surface area of >10%, and a Dermatology Life Quality Index (DLQI) score of >10.

Patients were randomised to receive subcutaneous risankizumab 150 mg at weeks 0, 4, and 16 (n = 60) or oral FAE at increasing doses from week 0 to weeks 24 (n = 57)

PASI 77 was achieved by 98% of patients in the risankizumab arm compared with 33% of patients in FAE arm. PASI 100 was achieved by 50% and 5%, respectively.

Significantly more patients in the risankizumab arm achieved Static Physicians Global Assessment (sPGA) 0/1 starting at week 4 (PP = .048) that patients in the FAE arm. By week 24, over 90% of patients receiving risankizumab achieved sPGA 0/1 compared with less than 50% of patients in the FAE arm.

Of the patients in the risankizumab arm, 48% achieved a DLQI 0/1 score at week 16 compared with 10 patients in the FAE arm. At week 24, the rates were 67% versus 10%, respectively.

Adverse events (AEs) were similar between groups, with 82% of patients in the risankizumab arm experiencing any AE compared with 100% of patients in the FAE arm.

The most common AEs with risankizumab were nasopharyngitis, diarrhoea, and headache. The most common AEs with FAE were diarrhoea, upper abdominal pain, nasopharyngitis, and flushing.

Only 1 patient in risankizumab arm experienced a serious AE that was deemed related to the study drug.

[Presentation title: Direct Comparison of Risankizumab and Fumaric Acid Esters in Patients With Moderate-to-Severe Plaque Psoriasis Who Were Naïve to Systemic Therapy. Abstract OP02.01]