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Direct comparison of risankizumab and fumaric acid esters in systemic therapy–naïve patients with moderate-to-severe plaque psoriasis: A randomized controlled trial

British Journal of Dermatology Aug 21, 2021

Thaçi D, Eyerich K, Pinter A, et al. - According to this randomized controlled trial, risankizumab (Skyrizi) was found to be superior to fumaric acid esters (FAEs; Fumaderm) in terms of providing earlier and greater improvement in psoriasis outcomes that lasted with continued treatment, as well as more favourable safety results, which are in line with the known safety profile. There were no new safety signals for risankizumab or FAEs observed.

  • Study participants were randomly assigned (1:1) to receive subcutaneous risankizumab 150 mg (weeks 0, 4 and 16) or oral FAEs at increasing doses ranging from 30 mg daily (week 0) to 720 mg daily (weeks 8–24).

  • Key efficacy endpoints for risankizumab (n = 60) vs FAEs (n = 60) were met at week 24: a ≥ 90% improvement in Psoriasis Area and Severity Index (PASI; primary endpoint 83·3% vs 10·0%), a ≥ 100% improvement in PASI (50·0% vs 5·0%), a ≥ 75% improvement in PASI (98·3% vs 33·3%), a ≥ 50% improvement in PASI (100% vs 53·3%) and a Static Physician’s Global Assessment of clear/almost clear (93·3% vs 38·3%).

  • The FAE group had higher rates of gastrointestinal disorders, flushing, lymphopenia, and headache.

  • One risankizumab-treated patient developed a serious infection (influenza, which required hospitalization).

  • In either treatment arm, there were no malignancies, tuberculosis, or opportunistic infections.

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