Dose reduction of the new generation biologics (IL17 and IL23 inhibitors) in psoriasis: A pragmatic, multicentre, randomized, controlled, non-inferiority study - BeNeBio study

Psoriasis is a chronic skin disease characterized by erythematous, scaly plaques and associated with important comorbidities such as cardiovascular disease and psoriatic arthritis. Psoriasis affects approximately 2-3% of the Western population (approximately 500.000 patients in NL, and 330.000 in BE). The disease burden is high, with reduced disease-related quality of life similar to that of cancer or depression patients. In the past years, effective targeted biological treatments have become available for patients with moderate-to-severe psoriasis, and frequently prescribed by dermatologists. These biologics block specific cytokines (TNFα, interleukin (IL)-12, IL23, or IL17) in the psoriasis pathogenesis pathway. In general, biologics are considered relatively safe, but their very long-term safety profile has yet to be established. The new generation biologics entered the market in recent years: IL17 inhibitors since 2016 (secukinumab, ixekizumab, brodalumab and bimekizumab) and IL23 inhibitors since 2018 (guselkumab; risankziumab and tildrakizumab will follow). Trial data are promising, and effectiveness rates were often higher than in first generation biologics like TNFα-inhibitors or ustekinumab. [1-3] The problem is that, like most biologics, the new agents are marketed in a fixed dose despite the fact that thriving for the lowest possible, effective dose of biologics should be self-evident. The main research question for the current proposal is: is it possible to taper the dose of the new biologics (IL17 and IL23 inhibitors) in clinical practice?