Johnson & Johnson — Tremfya EMA EPAR public assessment report (EMEA/H/C/004271, 2017)
Johnson & Johnson · 2017 · EMA EPAR public assessment report · company profile →
Report summary
This EMA report assesses Tremfya (guselkumab) for moderate to severe plaque psoriasis, detailing its regulatory submission, IL-23 inhibition mechanism, and proposed dosing. It covers manufacturing quality, non-clinical safety (toxicology, pharmacokinetics), and clinical development. Phase 2 and 3 trials (PSO2001, PSO3001, PSO3002, PSO3003) demonstrated superior efficacy over placebo and adalimumab, with high PASI 90/100 and IGA 0/1 response rates maintained up to Week 48. Guselkumab also showed benefits for ustekinumab non-responders. Safety analysis revealed comparable adverse event rates to comparators, with low serious infection and malignancy rates, and specific monitoring for cardiovascular events and immunogenicity.
Key findings — cited to the page
| Chemistry CTCAE toxicity grade ≥2 (guselkumab) | 2.5 % | · p.122 |
| Proportion of subjects with IGA 0/1 and >=2-grade improvement | 14.3% % | Study PSO3003 · p.79 |
| Proportion of subjects with IGA 0/1 and >=2-grade improvement | 31.1% % | Study PSO3003 · p.79 |
| Chemistry CTCAE toxicity grade ≥2 (guselkumab) | 1.5 % | · p.122 |
| Chemistry CTCAE toxicity grade ≥2 (guselkumab) | 2.8 % | · p.122 |
| Hematology CTCAE toxicity grade 3 (guselkumab) | 0.2 % | · p.121 |
| Number of visits with IGA 0/1 and >=2-grade improvement | 1.5 | Study PSO3003 · p.78 |
| Number of visits with IGA 0/1 and >=2-grade improvement | 0.7 | Study PSO3003 · p.78 |
| Abnormal hematology laboratory values (CTCAE toxicity grade ≥2) frequency (guselkumab) | ≤1.5 % | · p.130 |
| Abnormal hematology laboratory values (CTCAE toxicity grade ≥2) frequency (guselkumab) | <2.0 % | · p.130 |
| Abnormal hematology laboratory values (CTCAE toxicity grade ≥2) frequency (guselkumab) | ≤2.6 % | · p.130 |
| Clinical chemistry abnormalities (CTCAE toxicity grade ≥2) frequency (guselkumab) | ≤1.5 % | · p.130 |
Source: Johnson & Johnson ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →