AbbVie Inc. — Rinvoq EMA EPAR variation assessment report (EMEA/H/C/004760, 2019)
AbbVie Inc. · 2019 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of a post-marketing observational study (P19-565) in Japan for Rinvoq (upadacitinib) in rheumatoid arthritis patients, including a pediatric cohort. The three-year study evaluated Rinvoq's real-world safety and effectiveness. The CHMP concluded that no new safety concerns or changes to the benefit-risk profile were identified, and no updates to the Summary of Product Characteristics were deemed necessary.
Key findings — cited to the page
| Study size | 1000 patients | P19-565 · Japan · p.5 |
| Safety analysis set N | 2739 patients | P19-565 · Japan · p.5 |
| Effectiveness analysis set N | 1911 patients | P19-565 · Japan · p.5 |
| Adverse Events (AEs) in pediatric patients | No AEs | P19-565 · Japan · p.5 |
| DAS28-CRP remission rate in pediatric patients | All 4 patients | P19-565 · Japan · p.5 |
| Benefit-risk balance for Rinvoq | unchanged | Global · p.5 |
Source: AbbVie Inc. ↗ · 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 →