BeNeBio (EudraCT 2019-004230-42) is a randomised controlled trial assessing the non-inferiority of IL-17 and IL-23 dose reduction in plaque psoriasis compared to usual care [1]. It included 244 adult patients with low disease activity defined by PASI ≤5 for ≥6 months, together with a DLQI ≤5. Dr Juul van den Reek (Radboud UMC, the Netherlands) reported that roughly half of the participants were on IL-17 and half on IL-23 inhibitors.
Participants were followed every 3 months up to 18 months. In the DR (N= 164), the first step to 67% of the standard dose was achieved by prolonging the dosing interval by 1.5. If disease activity remained low, dosing intervals were further prolonged to twice the initial interval. In cases of persistent flares (PASI ≥5 for ≥3months), participants returned to the last effective dose. The non-inferiority margin was set at 15%.
Baseline characteristics showed a mean age of 51 years, 67% women, and median PASI and DLQI scores of 0.0 in the DR group versus 0.1 and 0.0 in the usual care arm. Overall, 14% of participants also had a diagnosis of PsA.
Results showed an incidence of the primary outcome of persistent flares in 2.1% on DR and 1.5% on usual care, with a difference of 0.6% (95% CI -5.8 to 4.5). “You can conclude non-inferiority when the confidence interval of this difference is below the non-inferiority margin,” Prof. van den Reek explained. Secondary outcomes showed persistently low PASI and DLQI values in both groups, with no statistically significant differences: PASIs <1.5 and DLQIs <2 at all timepoints. Overall, 75%of participants were successfully tapered, with a trend toward higher success rates for IL-23 inhibitors (86%) compared to IL-17 inhibitors (61%).
“We found no serious adverse events related to dose reduction,” remarked Prof van den Reek. New-onset PsA was reported only in the DR group (N=3), whereas worsening of pre-existing PsA occurred more frequently in the usual care arm (5.8% vs 3.4%).
- Van den Reek J, et al. Dose Reduction of IL-17 and IL-23 Inhibitors in Patients with Plaque Psoriasis is Non-inferior to Usual Care: an International Pragmatic Randomised Controlled Trial – the BeNeBio study. D2T01.4E, EADV Congress 2025, 17–20 September, Paris, France.
Medical writing support was provided by Dr Susanne Kammerer and Karin Drooff
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