Elicit: Clinical Outcomes of Guselkumab in Psoriasis
Clinical Outcomes of Guselkumab in Psoriasis
Clinical outcomes of guselkumab in plaque psoriasis and related diseases
I'll search for clinical trial data and outcomes research on guselkumab across plaque psoriasis and related conditions like psoriatic arthritis.
Plaque psoriasis — pivotal trials
The core evidence comes from VOYAGE 1 and VOYAGE 2, both large double-blind phase III RCTs with active adalimumab comparators. In VOYAGE 1 (n=837), guselkumab achieved PASI 90 in 73.3% vs 49.7% with adalimumab at week 16, and 76.3% vs 47.9% at week 48 — a consistent, substantial superiority. Blauvelt et al. 2017 VOYAGE 2 (n=992) replicated this finding and added a clinically important piece: adalimumab non-responders switched to guselkumab achieved PASI 90 in 66.1% by week 48, supporting a viable switching strategy. Reich et al. 2017 The ECLIPSE head-to-head trial showed guselkumab superior to secukinumab in PASI 90 at week 48. Puig 2019
Durability and long-term efficacy
The long-term data are unusually robust for a biologic of this generation. VOYAGE 1 extensions show response rates that were stable or improved from year 1 to year 4: PASI 90 by treatment failure rules was ~80% at week 52 and 82.2% at week 204. Griffiths et al. 2020 The two-year analysis confirmed PASI 90 in 82.1% and PASI 100 in 49% at week 100. Puig 2019 The real-world literature broadly corroborates this. A 2026 systematic review and meta-analysis of 34 real-world studies found pooled PASI 90 rising from 50.8% at weeks 12–16 to 77.1% at ≥96 weeks. Dodero-Anillo et al. 2026 A large multicenter Italian study (n=1,024; 5 years) reported drug survival of 95.9% at 12 months declining gently to 85.8% at 60 months, with mean PASI remaining around 1.0–1.3 throughout years 1–5. Mortato et al. 2025 A US claims database analysis found guselkumab persistence at 18 months was approximately double that of secukinumab and ~1.8× that of ixekizumab. Zhdanava et al. 2024 Negative predictors of response identified across real-world studies include prior biologic exposure, obesity, and prior IL-17 treatment. Mortato et al. 2025
Psoriatic arthritis — DISCOVER program
The DISCOVER-1 and DISCOVER-2 trials (n=381 and 739, respectively) established guselkumab's efficacy in PsA. The primary endpoint in both was ACR20, achieved by 60% of patients in guselkumab arms vs ~29% placebo at week 24. Coates et al. 2022 Composite disease indices from pooled DISCOVER data at week 52 showed DAPSA low disease activity in ~53% and minimal disease activity in ~33% of guselkumab-treated patients. Coates et al. 2022 Radiographic inhibition of joint damage was demonstrated in DISCOVER-2 through two years with no progression in guselkumab groups. For the relevant subset of patients with imaging-confirmed sacroiliitis (28% of the DISCOVER population), a post-hoc analysis found meaningful improvements in BASDAI and ASDAS vs placebo — BASDAI50 achieved by 38–40% vs 19% with placebo at week 24, maintained at week 52 and sustained through two years. Mease et al. 2021 The axial findings are post-hoc and the trial was not powered specifically for axial disease, so these should be treated as hypothesis-generating.
Safety
Pooled safety data from 7 phase II/III trials covering 2,891 patients and 8,662 patient-years found guselkumab's rates of serious AEs, serious infections, malignancy (0.7/100 PY), and MACE (0.3/100 PY) comparable to placebo during controlled periods and stable or declining during long-term follow-up. Lebwohl et al. 2023 Notably, no cases of inflammatory bowel disease, opportunistic infections, or active TB were attributed to guselkumab. The most common adverse events were nasopharyngitis, headache, and upper respiratory tract infections, none of which required discontinuation at meaningful rates.