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

moderate-to-severe psoriasis

The primary endpoint is sustained disease control, defined as an absolute PASI ≤ 2 OR a delta PASI from baseline ≥ 50% during at least 80% of all 3-monthly study visits over a period of 18 months.

● Change from baseline at 18 months in PASI score. The PASI measures disease activity. The scores ranges from 0 (skin lesion free) to 72 with higher scores indicating higher disease activity., ● Change from baseline at 18 months in DLQI_R score. The DLQI_R measures QoL. The score ranges from 0 (no impact) to 30 (greatest impact) with higher scores indicating higher impact on quality of life., ● Change from baseline at 18 months in SF-36 score. The SF-36 measures QoL. The score ranges from 0 (maximum disability) to 100 (no disability). In the field of dermatology, the SF36 has been proposed as the instrument of choice for evaluating QoL in a generic way by Both et al.. Although we acknowledge that the SF36 can be perceived as more difficult to fill in by the patients, comparison of QoL measures by Fernandez-Penas et al, showed that SF‐36 was more sensitive than other instruments in d, ● New onset or flare of arthritis, ● Drug discontinuation (incl. reasons), ● Serious adverse events (SAE), ● Adverse events of special interest (AEoSI) ○ occurrence of infusion reactions ○ infections, ● Cost of treatment (medication used and cost of TDM), ● Healthcare consumption (iMCQ), ● Number of dose modifications during the 18 months (0 – 6), ● Change from baseline at 18 months in TSQM score. The TSQM measures treatment satisfaction. TSQM is a 9-point questionnaire with scores ranging from 0 to 100. Higher scores indicate higher satisfaction., ● Change from baseline at 18 months in VAS score. The VAS measures treatment satisfaction. The VAS is a horizontal line of 100mm, with scores ranging from 0 (no satisfaction) to 10 (extreme satisfaction)., ● iMCQ and EQ-5D-5L to measure cost-effectiveness. Shikiar et al. showed that the EQ-5D index score is generally more highly correlated with clinical endpoints, compared with the SF-36, but displayed about the same degree of responsiveness. The MCID for the EQ-5D score is considered 6 units.

No related papers found yet.

Belgium