AbbVie Inc. — Rinvoq EMA EPAR public assessment report (EMEA/H/C/004760, 2019)

AbbVie Inc. · 2019 · EMA EPAR public assessment report · company profile →

Report summary

This EMA report details the assessment of AbbVie's Rinvoq (upadacitinib) for treating moderate to severe active rheumatoid arthritis in adults. The application, supported by extensive non-clinical and clinical data, outlines upadacitinib's quality, manufacturing, and pharmacology as an oral JAK inhibitor. Non-clinical studies established its pharmacokinetics, toxicology (including teratogenicity at high doses), and selective JAK1 inhibition. Clinical trials (Phase 2 and 3) demonstrated significant efficacy in achieving clinical remission, low disease activity, and reducing radiographic progression, both as monotherapy and in combination with DMARDs, compared to placebo, methotrexate, or adalimumab. The 15 mg once-daily dose was selected based on its favorable efficacy-safety balance. Safety analyses identified common adverse events and specific concerns including serious infections (herpes zoster, TB), malignancies, major adverse cardiovascular events (MACE), venous thromboembolism (VTE), and gastrointestinal perforations. Hematological changes (neutropenia, lymphopenia) and lipid elevations were also noted. Risk minimization strategies, including contraindications for pregnancy and specific patient populations, are outlined in the SmPC and RMP. The CHMP concluded that Rinvoq's benefits outweigh its risks for the approved indication.

Key findings — cited to the page

Subjects with Neutrophils Grade 4 (< 0.5)	0.5 %	Studies M13-549, M14-465, M13-542 · p.136
Subjects with Haemoglobin Grade 4 (< 70 or decreased ≥ 30)	0.8 %	Studies M13-549, M14-465, M13-542 · p.136
Subjects with Neutrophils Grade 2 (1.0 – < 1.5)	0.6 %	Studies M13-549, M14-465, M13-542 · p.136
Subjects with Neutrophils Grade 3 (0.5 – < 1.0)	0.6 %	Studies M13-549, M14-465, M13-542 · p.136
Subjects with Haemoglobin Grade 3 (70 – < 80 or decreased 21 – < 30)	2.2 %	Studies M13-549, M14-465, M13-542 · p.136
Subjects with Haemoglobin Grade 3 (70 – < 80 or decreased 21 – < 30)	2.9 %	Studies M13-549, M14-465, M13-542 · p.136
Subjects with Haemoglobin Grade 2 (Decreased 15 – < 21)	8.2 %	Studies M13-549, M14-465, M13-542 · p.136
Subjects with Haemoglobin Grade 4 (< 70 or decreased ≥ 30)	0.4 %	Studies M13-549, M14-465, M13-542 · p.136
Subjects with Neutrophils Grade 2 (1.0 – < 1.5)	4.0 %	Studies M13-549, M14-465, M13-542 · p.136
Subjects with Neutrophils Grade 3 (0.5 – < 1.0)	< 0.1 %	Studies M13-549, M14-465, M13-542 · p.136
Subjects with Haemoglobin Grade 2 (Decreased 15 – < 21)	8.5 %	Studies M13-549, M14-465, M13-542 · p.136
Subjects with Neutrophils Grade 3 (0.5 – < 1.0)	0.8 %	Any RA UPA Analysis Set · p.137

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 →