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
AbbVie Inc. submitted a Type II variation for Rinvoq (upadacitinib) to the EMA for severe alopecia areata (AA) in adults and adolescents (12+ years), based on two pivotal Phase 3 studies (M23-716 Study 1 and Study 2). Both studies met their primary endpoint, demonstrating significant efficacy of 15 mg and 30 mg once daily doses in achieving SALT score <= 20 at Week 24 compared to placebo. Population pharmacokinetic analysis confirmed dose-proportionality and exposure-response relationships. The safety profile, including integrated 52-week data, did not identify new adverse drug reactions, with safety consistent across adult and adolescent populations. While specific adverse events like serious infections, malignancy, and thrombotic events were monitored, the overall benefit-risk assessment for upadacitinib in severe AA is positive, with risk minimization activities and educational materials in place to address known JAK inhibitor class warnings.
Key findings — cited to the page
| Proportion of subjects achieving ClinRO measure for Beard Hair Loss Grade of 2 or 3 with ≥ 2-point improvement from Baseline to Week 24 | 36.8 % | M23-716 Study 2 · Global · p.79 |
| Proportion of subjects achieving ClinRO measure for Beard Hair Loss Grade of 2 or 3 with ≥ 2-point improvement from Baseline to Week 24 | 26.9 % | M23-716 Study 1 · Global · p.79 |
| Proportion of subjects achieving ClinRO measure for Beard Hair Loss Grade of 2 or 3 with ≥ 2-point improvement from Baseline to Week 24 | 2.3 % | M23-716 Study 2 · Global · p.79 |
| Proportion of subjects achieving ClinRO measure for Beard Hair Loss Grade of 2 or 3 with ≥ 2-point improvement from Baseline to Week 24 | 41.7 % | M23-716 Study 2 · Global · p.79 |
| Proportion of subjects achieving ClinRO measure for Beard Hair Loss Grade of 2 or 3 with ≥ 2-point improvement from Baseline to Week 24 | 0 % | M23-716 Study 1 · Global · p.79 |
| Proportion of subjects achieving ClinRO measure for Beard Hair Loss Grade of 2 or 3 with ≥ 2-point improvement from Baseline to Week 24 | 42.5 % | M23-716 Study 1 · Global · p.79 |
| Grade 3 and 4 CPK increases | similar | Global · p.108 |
| Grade 3 and 4 CPK increases in adolescent subgroup | reported | Global · p.108 |
| Grade 4 triglyceride increases | <0.1 % | Global · p.110 |
| Grade 3 and 4 CPK increases | reported | Global · p.108 |
| Grade 3 triglyceride increases | 0.6 % | Global · p.110 |
| Grade 3 and 4 CPK increases in adolescent subgroup | 3 subjects | Global · p.108 |
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 →