<p>Tildrakizumab: An Evidence-Based Review of Its Use in the Treatment of Moderate-to-Severe Chronic Plaque Psoriasis</p>

Abstract

Psoriasis is a common immune-mediated chronic inflammatory disease, and observations have pointed toward the IL-23/Th17 cell axis as having a key role in the pathogenesis of psoriasis. This new immunological understanding of the pathogenesis has been translated into targeted and highly effective biologic therapies. Tildrakizumab is a humanized IgG1/k monoclonal antibody targeting the p19 unit of IL-23 and has been registered for the treatment of patients with moderate-to-severe chronic plaque psoriasis in adults since 2018. This review provides an overview of the efficacy and safety of tildrakizumab, focusing on the results from clinical trials. In both Phase II and III trials, tildrakizumab 100 and 200 mg was significantly more efficacious than both placebo and etanercept at week 12. The effect of tildrakizumab continued to increase until week 28. Long-term follow-up showed high levels of efficacy for up to 3 years. Despite no difference between 100 and 200 mg in Phase III studies, subgroup analyses showed better efficacy when treated with 200 mg in patients with bodyweight ≥90 kg. The overall drug safety was good, and besides discrete higher incidence of nasopharyngitis, the conducted clinical trials show that tildrakizumab was very well tolerated without any safety concerns. Compared to other IL-23p19 inhibitors, tildrakizumab seemed to have slightly lower efficacy. However, to determine its position in the treatment algorithm of psoriasis, head-to-head trials with other IL-17, IL-12/23, and IL-23 inhibitors and long-term real-world data are required.

Retrospective Analysis in Patients With Moderate to Severe Plaque Psoriasis Treated With Tildrakizumab: Real-Life Clinical Data

“…The EMA label also accepts dosage with 200 mg in patients with high disease burden or body weight ≥90 kg; however, this dosage is not approved anywhere else in the world. 6 Previous studies demonstrated higher efficacy of tildrakizumab in plaque psoriasis clearance as measured by PASI 75 and PASI 90 compared with the tumor necrosis factor inhibitor etanercept. 7,8 Tildrakizumab has also been shown to be well tolerated, with minimal risk of serious adverse events.…”

“…The EMA label also accepts dosage with 200 mg in patients with high disease burden or body weight ≥90 kg; however, this dosage is not approved anywhere else in the world. 6…”

Tildrakizumab: A new therapeutic option for erythrodermic psoriasis?

“…Currently, as pointed out by a systematic review, positive responses have been described in cases treated by different classes of biologics, from anti‐TNF‐α to anti‐IL23. 3 , 4 Up until now, no case describing EP successfully treated by the latest anti‐IL23 approved in Europe, 5 Tildrakizumab, has been described. Here we firstly report a case of a 61‐year old man with EP successfully and safely treated by Tildrakizumab.…”

Tildrakizumab for treatment of moderate to severe psoriasis: an expert opinion of efficacy, safety, and use in special populations

“…At present, the differences between the clinical benefits of inhibition of IL-17 and IL-23 remain unclear, although inhibition of IL-23 might have a broader range of effects compared to IL-17 inhibition, such as the potential clinical impact of inhibition of the production of IL-22. Regarding sustained response over time, it is tempting to speculate that the favorable long-term results with tildrakizumab may possibly be related to its inhibition of IL-23, which acts upstream in the IL-23/Th17 pathway, and as a consequence may be less prone to the triggering of collateral pathways which could favor the loss of response over time [49]. The possibility that anti-IL-23 agents are associated with more durable responses compared to agents acting on other more downstream pathways is interesting and warrants further investigation.…”