P61 Proactive therapeutic drug monitoring versus routine care with the novel biologics in psoriasis: a pragmatic, multicentric, randomized, controlled study: the HELIOS study

Abstract Introduction & Objectives Psoriasis is a chronic immune-mediated inflammatory skin disease for which treatment with biologics is highly effective. In general, these drugs are prescribed according to a ‘one-dose-fits-all’ principle, which might lead to under- or overdosing, causing suboptimal response and unnecessary high drug exposure, respectively. A tool that may support the rational use of biologics is therapeutic drug monitoring (TDM). TDM is the measurement of blood drug concentrations in order to individualize dosing regimens to achieve maximal clinical efficacy and minimize adverse events. The primary objective of this trial is to assess whether proactive TDM of IL-17 and/or IL-23 inhibitors is non-inferior compared with standard of care (SOC) with respect to sustained disease control in patients with moderate-to-severe psoriasis. Materials & Methods This is a pragmatic, multicentre, individually randomized, controlled non-inferiority trial. A total of 210 patients using secukinumab, ixekizumab or guselkumab for at least 6 months according to the standard dosing scheme, will be randomized (1:1) to TDM or SOC. In the TDM group, dosing intervals will be prolonged or shortened stepwisely. This will happen based on the blood drug concentrations of the biologic, measured every 3 months and in accordance with the decision tree. Disease activity and quality of life will be monitored every 3 months by PASI, IGA, BSA, DLQI-R and SF-36. The primary endpoint is sustained disease control, defined as an absolute PASI ≤2 or a delta PASI from baseline ≥50% for at least 80% of all 3-monthly study visits over a period of 18 months. Secondary outcomes include courses of PASI and DLQI, serious adverse events, health-related quality of life, cost-effectiveness and treatment satisfaction. The outcomes of TDM will be compared with those of SOC. Results Inclusion will start in August 2024. The first preliminary results will be presented at the European Academy of Dermatology and Venereology Congress 2026. Conclusion With this study, we aim to assess whether proactive TDM of IL-17 and IL-23 inhibiting biologics is feasible, safe and cost-effective. Proactive TDM in psoriasis patients may lead to more efficient and rational use of the highly effective—though expensive—biologics.