GUIDE demonstrates: Hit hard and early in psoriasis

Patients with moderate-to-severe psoriasis who were treated with guselkumab at an early stage of their disease had a considerably longer treatment-free interval than those with more established or long-standing disease in the phase 3b GUIDE trial. Thus, very early therapy could pave the way to disease modification.

The ongoing phase 3b, randomised, double-blind GUIDE study (NCT03818035) assesses the efficacy of the IL-23 inhibitor guselkumab in patients with moderate-to-severe psoriasis. Previous interim results demonstrated the benefit of early intervention with guselkumab for achieving super responder status, defined as patients who achieve complete healing of their psoriatic lesions (i.e. absolute Psoriasis Area Severity Index [PASI]=0) at both week 20 and week 28 with a dose of 100 mg guselkumab every 8 weeks [1]. Part 3 of the GUIDE trial (week 68–220) was a withdrawal phase in which treatment with the IL-23 inhibitor was stopped in participants with an absolute PASI <3.

Prof. Knut Schäkel (University Clinic Heidelberg, Germany) presented another interim analysis (week 68–140) of the GUIDE trial [2]. In this analysis, the participants with short disease duration (i.e. ≤2 years from symptom onset) were divided into evenly-sized subgroups of participants with ultra-short disease duration (i.e. <15 months from symptom onset) and those with intermediate-short disease duration (i.e. ≥15 to ≤24 months); these groups were then compared with participants with long disease duration (>24 months), regarding PASI outcomes and median treatment-fee duration after withdrawal.

At week 116, maintenance of disease control (PASI <3) was significantly higher in the ultra-short disease duration group (40.3%) compared with both the intermediate-short disease duration (21.1%; P=0.0356) and long disease duration (11.9%; P<0.0001) groups. Moreover, a higher proportion of participants achieved PASI ≤1 and PASI=0 at week 115. Participants with disease duration <15 months also remained treatment-free significantly longer than those with longer disease duration: 456 days versus 291 days in participants with intermediate-short duration (P<0.0001) and 259 days (P<0.0001) in participants with long disease duration.

According to the authors, these findings indicate the positive impact of very early intervention with guselkumab on disease modification.

1. 
   
   1. Schäkel K, et al J Eur Acad Dermatol Venereol 2023;37:2016–27.
   2. Schäkel K, et al. GUIDE trial results after withdrawal in part 3: Long-term remission in patients with psoriasis treated with guselkumab within 15 months from onset of symptoms. P50236, 2024 AAD Annual Meeting, 8­–12 March, San Diego, USA.

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Posted on 22 April, 202422 April, 2024