Rationale: Biologics have significantly improved the lives of psoriasis patients. Research indicates that the dose of TNFa-blocking biologics can be reduced in a substantial number of patients, in order to improve safety and reduce costs. No evidence regarding dose tapering of interleukin (IL)17 and IL23 inhibitors exists. These new agents possess different working mechanisms and safety profiles, exploring their potential for dose tapering is therefore important.
Objectives: To investigate if dose reduction of the newest biologics is non-inferior to usual care regarding persistent disease flares. Secondary aims are to investigate: successful dose reductions, clinical effectiveness and dermatology-related quality of life (DLQI), predictors for dose reduction, safety, pharmacokinetics (PK) and cost-effectiveness of dose reduction.
Study design: A pragmatic, multicentre, randomized, controlled, non-inferiority study.
Study population: Psoriasis patients using IL23 or IL17 inhibitors with stable low disease activity. In total, 244 patients will be randomized (2:1).
Intervention: Tight controlled dose reduction
Main study parameters: Primary outcome: cumulative incidence of persistent flares. Secondary outcomes: % successful dose reductions, course of PASI and DLQI, predictors for dose tapering, adverse events, PK, and cost-effectiveness.
Expectations: With this intervention, the safety profile is expected to improve, costs are expected to decrease with 30% (6 million savings).