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Summary: Tildrakizumab is a fairly new type of medicine called a biologic, used for the treatment of moderate‐to‐severe psoriasis. The drug prevents the action of a specific molecule in the body involved in inflammation, known as cytokine interleukin (IL)‐23p19. Previous studies have shown it to be superior to a placebo (an inactive substance, like a "sugar pill") and to an older biologic drug, the TNF inhibitor etanercept. However, trials rarely reflect real‐world experience, where patients may switch from one drug to another, change drug dosage or interrupt treatment, e.g. because of an infection. The authors, based in U.S.A., Canada and Germany, reviewed results from two studies, one comparing two different doses of tildrakizumab (100mg or 200mg per day) with placebo, and the other comparing it with etanercept, including a total of 1862 adults with moderate‐to‐severe plaque psoriasis. Treatments were re‐randomised during the course of the study. They found that the response to tildrakizumab was sustained (meaning it kept working), without the secondary failure (decreasing responsiveness to a drug after an initial satisfactory response) seen in some patients on etanercept, and the drug regained effective control of the psoriasis after treatment was interrupted. Overall the drug was well tolerated, meaning that side effects were minimal. This is a summary of the study: Efficacy and safety of tildrakizumab for plaque psoriasis with continuous dosing, treatment interruption, dose adjustments and switching from etanercept: results from phase III studies Linked Article: Kimball et al. Br J Dermatol 2020; 182:1359–1368 [ABSTRACT FROM AUTHOR]

Summary: Background: Fumaric acid esters (FAEs; Fumaderm®) are the most frequently prescribed first‐line systemic treatment for moderate‐to‐severe plaque psoriasis in Germany. Risankizumab (Skyrizi®) is a humanized IgG1 monoclonal antibody that specifically binds to the p19 subunit of interleukin 23. Objectives: To compare risankizumab treatment to FAEs in patients with psoriasis. Methods: This phase III randomized, active‐controlled, open‐label study with blinded assessment of efficacy was conducted in Germany. Patients were randomized (1 : 1) to subcutaneous risankizumab 150 mg (weeks 0, 4 and 16) or oral FAEs at increasing doses from 30 mg daily (week 0) up to 720 mg daily (weeks 8–24). Enrolled patients were adults naïve to and candidates for systemic therapy, with chronic moderate‐to‐severe plaque psoriasis. Phototherapy was not allowed within 14 days before or during the study. Results: Key efficacy endpoints were met at week 24 for risankizumab (n = 60) vs. FAEs (n = 60) (P < 0·001): achievement of a ≥ 90% improvement in Psoriasis Area and Severity Index (PASI; primary endpoint 83·3% vs. 10·0%), ≥ 100% improvement in PASI (50·0% vs. 5·0%), ≥ 75% improvement in PASI (98·3% vs. 33·3%), ≥ 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 rates of gastrointestinal disorders, flushing, lymphopenia and headache were higher in the FAE group. One patient receiving risankizumab reported a serious infection (influenza, which required hospitalization). There were no malignancies, tuberculosis or opportunistic infections in either treatment arm. Conclusions: Risankizumab was found to be superior to FAEs, providing earlier and greater improvement in psoriasis outcomes that persisted with continued treatment, and more favourable safety results, which is consistent with the known safety profile. No new safety signals for risankizumab or FAEs were observed. What is already known about this topic? Risankizumab (Skyrizi®) is approved as treatment for patients with moderate‐to‐severe plaque psoriasis who are candidates for systemic therapy.Risankizumab is a humanized IgG1 monoclonal antibody that specifically binds to the p19 subunit of interleukin 23.Fumaric acid esters (FAEs) are the most frequently prescribed first‐line systemic treatment for moderate‐to‐severe plaque psoriasis in Germany. What does this study add? In patients with psoriasis who were naïve to systemic treatment, risankizumab treatment was superior to FAEs, providing earlier and greater improvement in psoriasis outcomes that persisted to week 24.Risankizumab showed more favourable safety results than FAEs and no new safety signals.The results support risankizumab treatment for patients with moderate‐to‐severe plaque psoriasis who are naïve to systemic treatment. Linked Comment: P. Fleming. Br J Dermatol 2022; 186:4–5. Plain language summary available online [ABSTRACT FROM AUTHOR]